Common use of Regulatory Matters Clause in Contracts

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete Following the transfer of an IND to AstraZeneca pursuant to Section 2.13, AstraZeneca shall be solely responsible for all regulatory filings and accurate list communications with each Regulatory Health Authority with respect to that IND, and AstraZeneca shall be solely responsible for any and all subsequent filings and communications with the Regulatory Health Authority including, without limitation, for the preparation and filing of all material additional INDs (except in relation to such IND(s) as are retained by Ardelyx pursuant to Section 2.13) and for providing, in the format required by Regulatory Authorizations relating Health Authorities, the data and information required to be submitted to such Regulatory Health Authorities for Regulatory Approval of Licensed Products, including without limitation data from all Clinical Trials and all Manufacturing and controls information required for Regulatory Approval of such Licensed Product by the Regulatory Health Authorities. AstraZeneca shall, subject to the Credit Parties conditions and their Subsidiarieswithin the limitations set forth in Section 4.4(a), the conduct of their business, and the use Commercially Reasonable Efforts to obtain Regulatory Approval for Licensed Products (on a per Product basis). All such material Regulatory Authorizations are in (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted LiensMajor Markets, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect countries where AstraZeneca determines at its sole discretion that it is commercially viable to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesdo so. (b) (i) All regulatory filings required During the Term, whether through the DCC while such committee is in effect, or by any Regulatory Authority providing Information and Materials directly to Ardelyx after the DCC has been disbanded, AstraZeneca shall report to Ardelyx regarding the status of each pending or in respect of any Regulatory Authorization with respect to any proposed IND application or Drug Approval Application covering a Licensed Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityTerritory. (c) The Credit PartiesIf Ardelyx has exercised the Co-Promote Option (as described in Section 7.1 below) the following shall apply: AstraZeneca shall keep Ardelyx informed on an ongoing basis regarding the schedule and process for the preparation of the Drug Approval Application in respect of the relevant Co-Promote Product in the U.S. Territory, their Subsidiaries provide final (or close to final) drafts of those sections of the Drug Approval Application requested by Ardelyx, and the agents thereof are permit Ardelyx to review and comment on sections of such drafts in parallel with AstraZeneca’s review process and in compliance with the timelines AstraZeneca has stipulated for its internal purposes, and AstraZeneca shall use reasonable efforts to incorporate Ardelyx’s comments therein. Notwithstanding the aforesaid, if the Parties are unable to achieve a consensus regarding any comments made or changes proposed by Ardelyx, AstraZeneca shall make the final determination as to whether and when to file the Drug Approval Application as well as the form and content thereof. The purpose of such foregoing interactions shall be to identify and resolve any potential reasonable concerns of Ardelyx in advance of the proposed filing of such Drug Approval Applications (and in particular the initial Drug Approval Application) in the U.S. Territory. Following the filing of the initial Drug Approval Application in the U.S. Territory, AstraZeneca shall continue to work with Ardelyx in the manner outlined above in this Section 4.6(c) in connection with any subsequent Drug Approval Applications in the U.S. Territory for the Co-Promote Product in respect of which Ardelyx has exercised the Co-Promote Option, and AstraZeneca shall provide Ardelyx with a copy in electronic form of all filings to Regulatory Health Authorities in the U.S. Territory that it makes hereunder in connection with such foregoing Drug Approval Applications. AstraZeneca shall further promptly furnish Ardelyx with copies of all material respects correspondence or minutes from any material meetings with all applicable statutesany Regulatory Health Authority, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect in each case relating to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth any such Drug Approval Application in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoU.S. Territory. (d) Except as set forth on Schedule 6.19(d)During the period when the DCC is in effect, no Credit Party nor AstraZeneca shall notify Ardelyx of any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings request for [***] and AstraZeneca shall allow [***]. The foregoing shall apply with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more [***]. AstraZeneca shall as soon as reasonably practicable furnish Ardelyx with copies of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from all substantive correspondence AstraZeneca has had with any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d)Health Authority, there have been no recalls, market withdrawals, field notifications and contact reports concerning substantive conversations or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by substantive meetings with any Regulatory Health Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of relating to any such IND or Drug Approval Application. As from the foregoingdate when the DCC is disbanded, which representedArdelyx’s rights hereunder shall cease, provided, however, that if Ardelyx has exercised the Co-Promote Option, then during the period when the SCC is in effect, Ardelyx shall have the aggregate, 15% or more of Net Sales rights set out in this subsection (d) but such rights shall (i) be limited to the U.S. Territory and the Co-Promote Product and (ii) further be limited such that Ardelyx may participate as an observer in any applicable year within meeting or conference call as set forth above only to the last five (5) yearsextent invited to do so by AstraZeneca. (e) No Credit Party, nor Ardelyx shall notify AstraZeneca of any request for a meeting or substantive telephone conference call with any Regulatory Health Authority relating to any IND or IND equivalent for which Ardelyx is the sponsor and Ardelyx shall allow one (1) representative of its Subsidiaries, nor AstraZeneca to participate as an observer in any officer, employee such meeting or agent thereof, conference call. The foregoing shall apply with respect to meetings or conferences initiated by Ardelyx or by a Regulatory Health Authority. [***] Certain information in this document has made an untrue statement of a material fact or fraudulent statements been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyomitted portions. (f) Except as set forth on Schedule 6.19(f)If Ardelyx has exercised the Co-Promote Option, no Credit Party nor and any of its Subsidiaries has received any written notice that the FDA Regulatory Health Authority threatens or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, initiates any action to withdraw any Regulatory Authorization, requested the recall remove a Licensed Product (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participatedthe Co-Promote Option has been exercised) from the market in the U.S. Territory, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsAstraZeneca shall notify Ardelyx of such communication within [***] of receipt by AstraZeneca. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set Except as expressly set forth on Schedule 6.19(a) is a complete in Section 8.10 or the Transition Services Agreement, from and accurate list of all material Regulatory Authorizations relating to after the Credit Parties Closing, Purchaser, at its cost, shall be solely responsible and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are liable for (i) legally taking all actions, paying all fees and beneficially owned exclusively conducting all communication with the appropriate Governmental Authority required by Applicable Law in respect of the Credit Parties Regulatory Approvals, including preparing and their Subsidiariesfiling all reports (including adverse drug experience reports) with the appropriate Governmental or Regulatory Authority (whether the Product is sold before or after transfer of such Regulatory Approval), as applicable(ii) taking all actions and conducting all communication with third parties in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), free and clear of including responding to all Liens other than Permitted Lienscomplaints in respect thereof, including complaints related to tampering or contamination, and (iiiii) as applicable, validly registered investigating all complaints and on file with adverse drug experiences in respect of the applicable Governmental Authority, in compliance with all filing and maintenance requirements Product sold pursuant to such Regulatory Approval (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications whether sold before or notifications, reports (including field alerts, medical device reports (MDRs) and other reports after transfer of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiessuch Regulatory Approval). (b) From and after the Closing, and subject to Section 8.10 hereof and the Transition Services Agreement, Seller promptly (i) All regulatory filings and in any event within the time periods required by any Regulatory Authority Applicable Law) shall notify Purchaser within three (3) Business Days if Seller receives a complaint or a report of an adverse drug experience in respect of any Regulatory Authorization the Product. In addition, Seller shall cooperate with respect Purchaser’s reasonable requests and use commercially reasonable efforts to assist Purchaser in connection with the investigation of and response to any Product complaint or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed adverse drug experience related to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityProduct sold by Seller. (c) The Credit PartiesFrom and after the Closing, their Subsidiaries Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the agents thereof are Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), including recalls required by any Governmental Authority and recalls of units of the Product sold by Seller deemed necessary by Seller in compliance in all material respects with all applicable statutesits reasonable discretion; provided, rules however, that Seller shall reimburse Purchaser for the reasonable expenses and regulations (including all Healthcare Laws and Regulatory Authorizations) costs of all applicable Governmental Authoritiesconducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the FDA costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Inventory, and all other Regulatory Authorities, reasonable credits extended to customers in connection with respect to each Product and all Product Development and Commercialization Activities related theretothe recall. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Seller shall notify Purchaser promptly in the FD&C Act or equivalent regulation event that a recall of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretosold by Seller is necessary. (d) Except as set forth on Schedule 6.19(d)Seller shall, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which representedwithin fifteen (15) days after the Closing, in notify the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any transfer of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements Regulatory Approvals to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted Purchaser in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsApplicable Laws. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete Sanofi shall be solely responsible for all regulatory filings and accurate list communications with each Regulatory Health Authority including, without limitation, for the preparation and filing of all material INDs and applications for pricing and reimbursement approval and for providing, in the format required by Regulatory Authorizations Health Authorities, the data and information required to be submitted to such Regulatory Health Authorities as part of a Drug Approval Application for a Program Product, including data from all Clinical Trials and all Manufacturing and controls information required for Regulatory Approval of such Program Product by the Regulatory Health Authorities. Sanofi shall own all right, title and interest in and to any Regulatory Filings and all Regulatory Approvals relating to the Credit Parties Program Compounds or Program Products and their Subsidiariesthey shall be held in the name of Sanofi or its designated Affiliate, Sanofi Licensee, Sublicensee or other designee. Ardelyx shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall, at Sanofi’s cost and expense, do and cause to be done such acts and things, including the conduct filing of their businesssuch assignments, agreements, documents and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariesinstruments, as applicable, free may be necessary under or as Sanofi may reasonably request in connection with or to carry out more effectively the purpose of or to better assure and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesconfirm unto Sanofi its rights under this Section 4.5(a). (b) (i) All regulatory filings required by any Regulatory Authority During the Term, through the DAC, or in respect otherwise, if the DAC has been terminated pursuant to Section 3.2, Sanofi shall report to Ardelyx regarding the status of any Regulatory Authorization with respect to any each pending or proposed IND application or Drug Approval Application covering a Program Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityTerritory. (c) The Credit Parties, their Subsidiaries If Ardelyx has exercised the Co-Promote Option (as described in Section 5.1 below) the following provisions of this Section 4.5(c) shall apply during the term of the [***] Certain information in this document has been omitted and filed separately with the agents thereof are in compliance in all material respects with all applicable statutes, rules Securities and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretoExchange Commission. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities Confidential treatment has been requested with respect to the Products omitted portions. Co-Promote Agreement: Sanofi shall keep Ardelyx informed on an ongoing basis regarding the schedule and process for the preparation of the Drug Approval Application in respect of the relevant Co-Promote Product in the U.S. Territory, provide final (or close to final) drafts of those sections of the Drug Approval Application requested by Ardelyx, and permit Ardelyx to review and comment on sections of such drafts in parallel with Sanofi’s review process and in compliance with the timelines Sanofi has stipulated for its internal purposes, and Sanofi shall use reasonable efforts to incorporate Ardelyx’s comments therein. Notwithstanding the aforesaid, if the Parties are unable to achieve a consensus regarding any comments made or changes proposed by Ardelyx, Sanofi shall make the final determination as to whether and when to file the Drug Approval Application as well as the form and content thereof. The purpose of such foregoing interactions shall be to identify and resolve any potential reasonable concerns of Ardelyx in advance of the proposed filing of such Drug Approval Applications (and in particular the initial Drug Approval Application) in the U.S. Territory. Following the filing of the initial Drug Approval Application in the U.S. Territory, Sanofi shall continue to work with Ardelyx in the manner outlined above in this Section 4.5(c) in connection with any subsequent Drug Approval Applications in the U.S. Territory for the Co-Promote Product in respect of which Ardelyx has exercised the Co-Promote Option, and Sanofi shall provide Ardelyx with a copy in electronic form of all Product Development and Commercialization Activities related theretofilings to Regulatory Health Authorities in the U.S. Territory that it makes hereunder in connection with such foregoing Drug Approval Applications. Sanofi shall further promptly furnish Ardelyx with copies of all material correspondence or minutes from any material meetings with any Regulatory Health Authority, in each case relating to any such Drug Approval Application in the U.S. Territory. (d) Except as set forth on Schedule 6.19(d)If Ardelyx has exercised the Co-Promote Option, no Credit Party nor the following provisions of this Section 4.5(d) shall apply during the term of the Co-Promote Agreement: Sanofi shall notify Ardelyx of any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings request for [***] and Sanofi shall allow [***]. The foregoing shall apply with respect to any Product [***]. Sanofi shall as soon as reasonably practicable furnish Ardelyx with copies of all substantive correspondence Sanofi has had with the FDA, and contact reports concerning substantive conversations or any Product Development and Commercialization Activities related thereto which represented, in substantive meetings with the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C ActFDA, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in relating to any applicable year within the last five (5) yearssuch Drug Approval Application for a Co-Promote Product. (e) No Credit PartyIf Ardelyx has exercised the Co-Promote Option, nor and any of its Subsidiaries, nor any officer, employee Regulatory Health Authority threatens or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, initiates any action to withdraw any Regulatory Authorizationremove a Co-Promote Product from the market in the U.S. Territory, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities Sanofi shall notify Ardelyx of such Credit Party or such Subsidiarycommunication as promptly as reasonably practical under the circumstances, in each case, which represented, in the aggregate, 15% or more of Net Sales but in any applicable year,event within [***] of receipt of such communication from the Regulatory Health Authority. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: In the event that Celgene determines that any regulatory filings for any Licensed Antibodies and/or Licensed Products are required for any activities hereunder, including INDs, ▇▇▇▇ and other Regulatory Approvals (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable), free and clear of all Liens other than Permitted Liens, and then Celgene (iior its designee) as applicable, validly registered and on file with shall have the applicable Governmental Authoritysole right, in compliance with all filing its discretion, to seek to obtain and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all maintain such regulatory filings (in its or its designee’s name). In addition, Celgene (or its designee) shall have the sole right to communicate and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects otherwise interact with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d)Licensed Antibodies and/or Licensed Products, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings including with respect to any Product Regulatory Materials in connection therewith. Prothena (and its Affiliates) shall have no right to, and shall not, make any regulatory filings related to any Licensed Antibodies and/or Licensed Products or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from otherwise interact with any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements Authorities with respect to the FDA or any other Regulatory AuthorityLicensed Antibodies and/or Licensed Products; provided that, failed to disclose a material fact required to be disclosed as and to the FDA or any other extent reasonably requested by Celgene in writing, Prothena shall interact with Regulatory Authority, or committed an act, made a statement, or failed Authorities in connection with Licensed Antibodies and/or Licensed Products with respect to make a statement that, at matters related to the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests Licensed Program activities conducted by or on behalf of Prothena under the Master Collaboration Agreement or sponsored by with respect to any Prothena Ongoing Program Activities. Notwithstanding the Credit Parties foregoing, until such time as a given Existing Regulatory Material is assigned and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted transferred to Celgene in accordance with Section 2.2.1 or 2.2.2 (as applicable), Prothena shall be responsible for all applicable communications and interactions with Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions Authorities with respect to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usesuch Existing Regulatory Material; provided that, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with any such activities by Prothena, Prothena shall, to the transactions contemplated herebyextent reasonably requested by Celgene, consult and coordinate with Celgene with respect thereto (including allowing Celgene to attend or participate in any meetings or other interactions with Regulatory Authorities to the Liens granted extent such attendance is not prohibited or limited by such Regulatory Authority) and Prothena shall accommodate and comply with any reasonable requests made by Celgene in connection herewith therewith (including that Prothena shall submit to Celgene a copy of any proposed filings and correspondence with any Regulatory Authority for Celgene’s review and approval prior to submission thereof). At the exercise request of rights Celgene, Prothena shall reasonably assist Celgene in communications and remedies filings with Regulatory Authorities with respect theretoto the Licensed Antibodies and/or Licensed Products.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete Each of CZFS, CZFSAC and accurate list of FCCB has timely filed all material Regulatory Authorizations relating reports, registrations and statements, together with any amendments required to the Credit Parties and their Subsidiariesbe made with respect thereto, the conduct of their businessthat it was required to file since January 1, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file 2020 with the applicable any Governmental Authority, and has paid all fees and assessments due and payable in compliance with all filing connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and maintenance requirements (including any fee requirements) thereofregulations, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications FCCB has a Community Reinvestment Act rating of “satisfactory” or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesbetter. (b) (i) All regulatory filings Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development the Securities Act and Commercialization Activities which representedthe Exchange Act and such documents, in as the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years same may have been madeamended, and all such filings above such threshold are complete and correct and have complied complied, at the time filed with the SEC, in all material respects with all applicable laws the Securities Act and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityExchange Act. (c) The Credit PartiesNeither CZFS, FCCB nor any of their Subsidiaries respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory AuthorizationsFRB) of all applicable Governmental Authorities, including or the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act supervision or equivalent regulation of each other it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority having jurisdiction over that such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of all issuing or requesting) any Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoOrder. (d) Except Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as set forth on Schedule 6.19(damended, and its implementing regulations (31 C.F.R. Chapter X), no Credit Party nor the USA PATRIOT Act, and the regulations promulgated thereunder, any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings order issued with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in anti-money laundering by the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 U.S. Department of the FD&C ActTreasury’s Office of Foreign Assets Control, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d)applicable anti-money laundering statute, there have been no recalls, market withdrawals, field notifications rule or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, regulation; or (for example c) to be deemed not to be in material compliance with the case of a recall) initiated by Credit Party applicable requirements contained in any federal and state privacy or any of its Subsidiariesdata security laws and regulations, relating to any Products which representedincluding, without limitation, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any Title V of the Products is misbranded or adulterated ▇▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Act of 1999 and regulations promulgated thereunder, as defined in well as the FD&C Act, in each case provisions of the foregoinginformation security program adopted by CZFS pursuant to 12 C.F.R. Part ▇▇▇, which represented▇▇▇▇▇▇▇ ▇, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g)▇▇▇▇▇▇▇▇ D. Furthermore, the clinical, preclinical, safety CZFS Board has adopted and other studies CZFS has implemented an anti-money laundering program that contains adequate and tests conducted appropriate customer identification verification procedures that has not been deemed ineffective by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with and that meets the transactions contemplated hereby, including requirements of Sections 352 and 326 and all other applicable provisions of the Liens granted in connection herewith USA PATRIOT Act and the exercise of rights and remedies with respect theretoregulations thereunder.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete Each of NBT and accurate list of NBT Bank has timely filed all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required noticesreports, registrations and listingsstatements, supplemental applications together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2022 with any Governmental Authority and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of NBT and/or NBT Bank, no Governmental Authority has initiated any proceeding, or notificationsto the Knowledge of NBT, reports (including field alertsinvestigation into the business or operations of NBT and/or NBT Bank, medical device reports (MDRs) and other reports of adverse experiences since January 1, 2022. There is no unresolved violation or product malfunctions, and reports of corrections or removal) and other required filings matter requiring attention by any Governmental Authority with respect to the Products for the last five (5) years have been timely filed with the FDA any report or statement relating to any examinations of NBT Bank. Each of NBT and all other NBT Bank is “well-capitalized” as defined in applicable Governmental Authoritieslaws and regulations, and NBT Bank has a Community Reinvestment Act rating of “satisfactory” or better. (b) (i) All regulatory filings Since January 1, 2022, NBT has timely filed with the SEC and NASDAQ all documents required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development the Securities Act and Commercialization Activities which representedthe Exchange Act and such documents, in as the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years same may have been madeamended, and all such filings above such threshold are complete and correct and have complied complied, at the time filed with the SEC, in all material respects with all applicable laws the Securities Act and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityExchange Act. (c) The Credit PartiesNeither NBT, NBT Bank nor any of their Subsidiaries respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or institutions engaged in the insurance of deposits (including, without limitation, the OCC and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory AuthorizationsFRB) of all applicable Governmental Authorities, including or the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act supervision or equivalent regulation of each other it. Neither NBT nor NBT Bank has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority having jurisdiction over that such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of all issuing or requesting) any Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoOrder. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any Without limiting the generality of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g8.10(b), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating parties acknowledge that this Section 4.11 is subject to the Products in any material manner, and no consent or other authorization limitations of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 8.10(b) hereof.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a(i) The Company and each of its Subsidiaries are, and since January 1, 2016, has been in material compliance with all applicable Health Care Laws, which affect the business, Product Candidates, properties, assets and activities of the Company or any of its Subsidiaries, (ii) there is a complete no pending or, to the Company’s Knowledge, threatened in writing Action against the Company or any of its Subsidiaries alleging any violation by the Company of any such Health Care Law, (iii) each Product Candidate has been developed, manufactured, labeled, stored, tested and accurate list otherwise produced in material compliance with applicable Health Care Laws, (iv) each of the Company and its Subsidiaries holds, and is operating and has operated in material compliance with, all material Regulatory Authorizations required by applicable Health Care Laws relating to the Credit Parties and their Subsidiaries, the conduct of their business, Product Candidates, properties, assets and activities of the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally Company and beneficially owned exclusively by the Credit Parties and their its Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (iiv) as applicable, validly registered each of the Company and on file with the applicable Governmental Authority, in compliance with its Subsidiaries has fulfilled and performed all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings its material obligations with respect to such Regulatory Authorizations and, to the Products for Knowledge of the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesCompany, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. (b) With respect to each Product Candidate, the Company has made available to Parent complete and accurate copies of all material applications (iincluding each IND), registrations, licenses, waivers, accreditations, authorizations, approvals, and clinical and preclinical data in the possession or control of the Company and its Subsidiaries and all material written correspondence between the Company or its Subsidiaries and the applicable Regulatory Authorities (including minutes and official contact reports of communications with any applicable Regulatory Authorities) and all material supporting documents, in each case as requested by Parent. (c) All regulatory filings required preclinical and clinical trials conducted by the Company or any of its Subsidiaries, or by any Person acting on behalf of the Company or any of Subsidiaries, are being, or have been, conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Clinical Practices and Good Laboratory Practices, informed consent and the requirements and conditions imposed by the relevant “Institutional Review Board,” as such term is defined by the FDA, and all applicable Health Care Laws of the relevant Regulatory Authorities outside the United States. No clinical trial conducted by the Company or any of its Subsidiaries or by any Person acting on behalf of the Company or any of its Subsidiaries has been terminated or suspended by the FDA or any other applicable Regulatory Authority or Institutional Review Board, and neither the FDA nor any other applicable Regulatory Authority has commenced or threatened in respect writing to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by the Company or any of its Subsidiaries or by any Regulatory Authorization Person acting on behalf of the Company or any of its Subsidiaries. (d) All manufacturing operations conducted by the Company and its Subsidiaries, or, to the Knowledge of the Company, by any Person acting on behalf of, or for the benefit of, the Company or its Subsidiaries, with respect to any Product or any Product Development and Commercialization Activities which represented, Candidate being used in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all human clinical and pre-clinical trials, if any, of investigational Products trials have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects in accordance with all the applicable statutesrequirements of Good Manufacturing Practices. None of the Company, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authoritiesits Subsidiaries, including the FDA and all other Regulatory Authoritiesor, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth Knowledge of the Company, any Person acting on Schedule 6.19(d), no Credit Party nor behalf of the Company or any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings has, with respect to any Product Candidate, (i) been subject to a Regulatory Authority (including FDA) shutdown or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% import or more of Net Sales in any applicable year, including export prohibition or (ii) received any FDA Form 483 483, or other Regulatory Authority notice of inspectional observations, notices of violations, Warning Letters, “warning letters,” “untitled letters, criminal proceeding notices under Section 305 ” or written requests or requirements to make any change to any Product Candidate or any of the FD&C ActCompany’s or its Subsidiaries’ processes or procedures, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications correspondence or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved notice from the FDA or any other Regulatory Authority indicating any breach in respect of the Company or violation of its Subsidiaries or their respective business operations alleging or asserting noncompliance with any applicable Health Care Law, permit or such requests or requirements of a Regulatory AuthorizationAuthority and, including that any to the Knowledge of the Products Company, neither the FDA nor any other Regulatory Authority is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsconsidering such action. (e) No Credit PartyAll applications, nor any of its Subsidiariesnotifications, nor any officersubmissions, employee information, claims, reports, statistics and other data required to be filed, maintained or agent thereof, has made an untrue statement of a material fact or fraudulent statements furnished to the FDA or any other Regulatory AuthorityAuthority by the Company or its Subsidiaries for any Product Candidate have been so filed, failed to disclose a material fact required to be disclosed to maintained or furnished. All applications, notifications, submissions, information, claims, reports, statistics and other data submitted in connection with any and all Regulatory Authorizations from the FDA or any other Regulatory Authority relating to the Company and its Subsidiaries, their business operations, Product Candidates, when submitted to the FDA or such other Regulatory Authority were complete and accurate in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or such other Regulatory Authority. None of the Company, its Subsidiaries, or any of their respective officers, employees, agents or, to the Knowledge of the Company, any clinical investigator acting for the Company or any of its Subsidiaries, has committed an any act, made a statement, any statement or failed to make a any statement that, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of the Company, its Subsidiaries, or any of its officers, employees, agents or, to the Knowledge of the Company, any clinical investigator acting for the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar policyLaw, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (f) Except as set forth No Product Candidate that is or has been manufactured, tested, distributed, or marketed by or on Schedule 6.19(f), no Credit Party nor behalf of the Company or any of its Subsidiaries has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such Product Candidate or pre-market approvals or marketing authorizations are pending or, to the Knowledge of the Company, threatened in writing against the Company or any of its Subsidiaries or any of its Affiliates, nor have any such proceedings been pending since January 1, 2016. The Company and its Subsidiaries have made available to Parent all information about adverse drug experiences obtained or otherwise received by the Company from any written notice source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature and unpublished scientific papers relating to any Product Candidate that is or has been manufactured, tested, distributed, or marketed by or on behalf of the Company or any of its licensors or licensees in the possession of the Company (or to which it has access). In addition, the Company and its Subsidiaries have timely filed all annual and periodic reports, amendments and safety reports required for any of its Product Candidates required to be made to the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Authority. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety The Company and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or its Subsidiaries have complied in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance all material respects with all applicable Regulatory Authorizations security and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights privacy standards regarding protected health information under (or i) the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, Health Insurance Portability and no consent or other authorization Accountability Act of any Governmental Authority is required in connection with the transactions contemplated hereby1996 (18 U.S.C. Section 3801 et. seq.), including the Liens granted regulations promulgated thereunder and (ii) any applicable state or foreign privacy Laws applicable in connection herewith and any other jurisdiction in which the exercise of rights and remedies with respect theretoCompany or its Subsidiaries operate.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d)7.1(kk) and (i) each Loan Party has obtained and holds in its name all Material Licenses required by the FDA, no Credit Health Canada or any other Governmental Authority, for the conduct of their Business as currently conducted, to permit any manufacturing, distribution, sales, testing, marketing or research and development activities of such Loan Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings to date (the “Activities to Date”) with respect to any Product each Product; (B) all such Material Licenses are in full force and effect and no event has occurred which allows, or any Product Development and Commercialization Activities related thereto which representedafter notice or lapse of time would allow, in the aggregate, 15% revocation or more of Net Sales termination thereof or results in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 other material impairment of the FD&C Actrights of the holder of any Material License; (C) each Loan Party in compliance in all respects with all terms and conditions of each Material License, and with all Applicable Laws and requirements pertaining to the Activities to Date with respect to each Product; (D) each Loan Party is in compliance with all Applicable Laws regarding registration or notification for the site at which the Products are manufactured, processed, packed, held for distribution or from which and into which they are distributed; (ii) all manufacturing operations performed by or on behalf of each Loan Party are in compliance with current good manufacturing practice requirements and Applicable Laws and Material Licenses; and (iii) each Loan Party is in compliance with all reporting requirements for all Material Licenses, including, without limitation plant registrations. (ii) All applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Material License from the FDA, Health Canada, or other Governmental Authority relating to the Loan Parties or the Business or Products, when submitted to the FDA, Health Canada, United States Department of Agriculture or other Governmental Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification have been submitted to the FDA, Health Canada, or other similar communication from any Regulatory Authority within Governmental Authority. The claims for the last five Products are valid and supported by proper research, design, testing, analysis and disclosure. (5iii) years. Except as set forth on out in Schedule 6.19(d7.1(kk), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened each Product that is subject to the Applicable Laws promulgated by any a Regulatory Authority, is manufactured, packaged, labelled, imported, exported, stored, distributed, sold (whether or not for consideration), advertised and marketed in compliance with all such Applicable Laws, (except for example in the case of a recallimmaterial non-compliance) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales as well as all material terms and conditions imposed in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any Licenses and permits issued in respect of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsProducts. (eiv) No Credit PartyNone of the Loan Parties nor, nor any to the knowledge of its Subsidiariesthe Borrower, nor any officer, employee employee, contractor or agent thereof, of the Loan Parties has ever made an untrue statement of a material fact or fraudulent statements statement to the FDA a Regulatory Authority or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other a Regulatory Authority, or committed an any act, made a any statement, or failed to make a statement thatany statement, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or Health Canada or other Governmental Authority to invoke any similar policypolicy or law. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally The Company and beneficially owned exclusively its Subsidiaries are in compliance, in all material respects, with all applicable laws administered or issued by the Credit Parties United States Food and their SubsidiariesDrug Administration (the “FDA”) or the similar governmental entity in any applicable jurisdiction (together with the FDA, the “Regulating Authority”). (ii) The Company and its Subsidiaries have obtained all necessary and applicable exemptions, approvals, clearances, authorizations, licenses and registrations required by Regulating Authorities to permit the development, manufacture, pre-clinical and clinical testing of its products, if any, as applicable, free presently conducted in jurisdictions where the Company and clear of its Subsidiaries currently conduct such activities. The Company and its Subsidiaries have properly registered any human clinical trials to the extent required by applicable law. (iii) All preclinical and clinical studies conducted by or (to the Company’s Knowledge) for the Company and its Subsidiaries (i) have been conducted in accordance with recognized good clinical and good laboratory practices in all Liens other than Permitted Liensmaterial respects, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, are in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted administered or promulgated by the Credit Parties Regulating Authority regarding preclinical and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (hiv) The transactions contemplated There have been no recalls ordered or adverse regulatory actions taken (or, to the Company’s Knowledge, threatened) by the Loan Documents (FDA or contemplated any other Regulating Authority with respect to any of the products of the Company and its Subsidiaries, if any, including any facilities where any such products are manufactured, processed, packaged or stored by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of Company and its Subsidiaries’ ownership of . (v) No false information or rights under (significant omission has been made in any products application or the license or the right to use, as the case may be) any Regulatory Authorizations relating products-related submission to the Products in any material mannerRegulating Authority by or, to the Company’s Knowledge, on behalf of the Company and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoits Subsidiaries.

Regulatory Matters. With respect to each Product: (a) Set All existing Registrations held by Reliant as of the date of this Agreement are set forth on in Schedule 6.19(a) 1.1.102. Reliant is a complete the sole and accurate list exclusive owner of all material Regulatory Authorizations relating the Registrations. Reliant has delivered to the Credit Parties Purchaser true and their Subsidiariescorrect copies of the Registrations and has made available to the Purchaser copies of material written communications between Reliant, on the conduct of their businessone hand, and the Products FDA or any other applicable Medical Product Regulatory Authority, on the other hand, since October 11, 2000 (on a per the “Reliant Acquisition Date”), and any existing written summaries of material discussions between Reliant and the FDA or any other applicable Medical Product basis). All such material Regulatory Authorizations are Authority since the Reliant Acquisition Date, including, without limitation, copies of (i) legally all warning letters, FD-483s, notices of adverse findings and beneficially owned exclusively similar correspondence received by Reliant from the Credit Parties and their SubsidiariesFDA since the Reliant Acquisition Date, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file all audit reports relating to audits for compliance with the applicable Governmental Authority, in compliance with all filing Act performed since the Reliant Acquisition Date and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect submitted to the Products for the last five FDA; (5iii) years have been timely filed with any document concerning any significant oral or written communication received from the FDA by Reliant (whether directly or via any third party) since the Reliant Acquisition Date; and all (iv) any written notification from the FDA or any other applicable Governmental AuthoritiesMedical Product Regulatory Authority indicating that the Product is misbranded or adulterated as defined in the Act. Reliant has delivered any of the foregoing materials sent to or received by the third party manufacturer of the Product that are currently in Reliant’s possession. (b) (i) All regulatory filings required by any Regulatory Authority or in respect The promotion, distribution, marketing and sale and, to Reliant’s Knowledge, manufacture of any Regulatory Authorization with respect to any the Product or any Product Development and Commercialization Activities which represented, in the aggregateTerritory has been conducted in compliance with the Registrations and all applicable Laws, 15% or more including the Act and the PDM Act. The Registrations required for the manufacturing, promotion, marketing, sale and distribution of Net Sales in any applicable year, the Product in the last five (5) years have been made, Territory are in full force and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityeffect. (c) The Credit PartiesThere are no proceedings pending against Reliant or, their Subsidiaries and to Reliant’s Knowledge, threatened which could result in the agents thereof are revocation, cancellation or suspension of any Registrations listed in Schedule 1.1.102. (d) Reliant is in compliance in all material respects with all Laws applicable statutesto the ownership, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) operation, storage, distribution, marketing, pricing, sale, promotion, warehousing, packaging, labeling, handling and/or testing of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect Acquired Assets and, to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d)Knowledge of Reliant, no Credit Party nor has not received any notice that any non-compliance of its Subsidiaries has received from any Regulatory Authority the foregoing or any notice of alleged manufacturing non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Actbeing alleged, in each case of except to the foregoing, which represented, in extent that such non-compliance has been remedied or to the aggregate, 15% or more of Net Sales in any applicable year within extent the last five (5) yearsfailure to comply therewith has not had a Material Adverse Effect. (e) No Credit PartyReliant has not received any written or, nor to Reliant’s Knowledge, other notice of proceedings from a Governmental Authority alleging that the Product or any of its Subsidiariesthe Acquired Assets or the ownership, nor manufacturing, operation, storage, distribution, marketing, pricing, sale, promotion, warehousing, packaging, labeling, handling and/or testing thereof is in violation of any officerapplicable Law and such violation has not been remedied, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time except for such disclosure was made (or was violations that would not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of have Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyAdverse Effect. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries Reliant has received any written notice that completed and timely filed all annual or other reports required by the FDA or any other applicable Medical Product Regulatory Authority has commenced or initiated, or threatened in order to commence or initiate, any action to withdraw any Regulatory Authorization, requested maintain the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Registrations. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is Except as would not reasonably be expected to have a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesMaterial Adverse Effect, the conduct of their businesseach Acquired Corporation is, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariessince January 1, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority2022 has been, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all healthcare-related Legal Requirements, in each case as applicable laws to the operation of its business, including (i) the FDCA and regulations, the regulations promulgated thereunder; (ii) all clinical the Public Health Service Act (42 U.S.C. § 262) and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, promulgated thereunder; and (iii) the Credit Parties federal Medicare and their Subsidiaries Medicaid statutes. No Acquired Corporation is subject to any ongoing enforcement, regulatory or administrative proceedings against such Acquired Corporation alleging non-compliance with the FDCA or similar Legal Requirements, and no such enforcement, regulatory or administrative proceeding has been threatened in writing, and there are no circumstances of such noncompliance that occurred or existed on or prior to January 1, 2022 that remain active or for which the Company could have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityongoing liability. (cb) The Credit PartiesAcquired Corporations hold all Regulatory Permits required for their business as currently conducted, their Subsidiaries and the agents thereof each such Regulatory Permit is valid and in full force and effect. The Acquired Corporations are in compliance in all material respects with all applicable statutesthe terms and requirements of such Regulatory Permits. Since January 1, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all 2022, no material deficiencies have been asserted in writing by any applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings Body with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 Regulatory Permits of the FD&C ActAcquired Corporations, and there are no such deficiencies that occurred or existed on or prior to January 1, 2022 that remain active or for which the Company could have any other similar communication from any Regulatory Authority within ongoing liability. (c) To the last five (5) years. Except as set forth on Schedule 6.19(d)knowledge of the Company, there all preclinical and clinical investigations sponsored by the Acquired Corporations have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example and are being conducted in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any material compliance with applicable year within the last five (5) yearshealthcare-related Legal Requirements. No Credit Party nor any of its Subsidiaries Acquired Corporation has received any written notification that remains unresolved notice from the FDA or any other Regulatory Authority indicating Governmental Body performing functions similar to those performed by the FDA with respect to any breach ongoing clinical or violation preclinical studies or tests requiring or recommending the termination, suspension or material modification of such studies or tests. (d) The Acquired Corporations have filed with the FDA or any other Governmental Body performing functions similar to those performed by the FDA all required material filings, declarations, listings, registrations, reports or submissions. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed or have been supplemented in a subsequent filing, and no material deficiencies have been asserted in writing by any applicable Regulatory AuthorizationGovernmental Body with respect to any such filings, including that any of the Products is misbranded declarations, listings, registrations, reports or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearssubmissions. (e) No Credit PartyTo the knowledge of the Company, nor any of its Subsidiaries, nor any officer, employee or agent thereof, no Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal GratuitiesGratuities Final Policy. As of the date of this Agreement, set forth no Acquired Corporation is the subject of any pending or, to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. No Acquired Corporation nor, to the knowledge of the Company, any officers, employees, or agents of the Company has been debarred, excluded from participation in 56 Fed. Reg. 46191 federal healthcare programs or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (September 10, 1991A) debarment under 21 U.S.C. § 335a or any similar policyLegal Requirement or (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries No Acquired Corporation has received any written notice that the FDA either voluntarily or any other applicable Regulatory Authority has commenced or involuntarily initiated, conducted or threatened issued, or caused to commence be initiated, conducted or initiateissued, any action to withdraw any Regulatory Authorizationrecall, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiatefield notifications, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiaryfield corrections, in each casewarning, which represented“dear doctor” letter, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinicalinvestigator notice, safety and alert or other studies and tests conducted by notice or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations action relating to an alleged lack of safety, efficacy or regulatory compliance of the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoCompany Product.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aThe Acquired Corporations have filed with the applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA) is a complete all required material filings, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports and accurate list of all material Regulatory Authorizations relating aggregate safety reports that are required to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis)be filed. All such filings, declarations, listings, registrations, reports or submissions were in material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Lienscompliance with applicable Legal Requirements when filed, and (ii) as applicable, validly registered and on file with the no deficiencies have been asserted by any applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Body with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesany such filings, declarations, listing, registrations, reports or submissions. (b) Except as would not reasonably be expected to have a Material Adverse Effect, (i) All regulatory filings required all preclinical and clinical investigations sponsored by any Regulatory Authority or in respect the Acquired Corporations, and, to the Knowledge of any Regulatory Authorization the Company, all activities with respect to any Product the Acquired Corporations conducted by contract manufacturing organizations, contract research organizations or any Product Development and Commercialization Activities which representedother suppliers of the Acquired Corporations, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties in material compliance with applicable Legal Requirements, rules, regulations and their Subsidiaries in accordance with all applicable laws guidances, including Good Clinical Practices and current Good Manufacturing Practices requirements, Environmental Laws, other laws, rules and regulations along with appropriate monitoring relating to occupational safety and health, and federal and state laws, rules, regulations and guidances restricting the use and disclosure of clinical investigator trial sites for their complianceindividually identifiable health information, and (iiiii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives Knowledge of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit PartiesCompany, their Subsidiaries and all collaborators of the agents thereof Acquired Corporations are in compliance with applicable safety data reporting obligations and have provided the Acquired Corporations with material safety data and serious adverse events from collaborator studies. To the Knowledge of the Company, all safety data from collaborator studies is consistent in all material respects with all applicable statutes, rules the safety data made available to Parent and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretoPurchaser. The Credit Parties and their Subsidiaries Acquired Corporations have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has not received any written notification that remains unresolved notices or other correspondence from the FDA or any other Regulatory Authority indicating any breach foreign, federal, state or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded local governmental or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.regulatory authority performing functions

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is Except as has not had, individually or in the aggregate, a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesMaterial Adverse Effect, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally each of the Acquired Corporations holds all Governmental Authorizations under the FDCA (including Section 510(k) thereof) and beneficially owned exclusively the European Medical Device Directive (“MDD”), and all Governmental Authorizations of any applicable Governmental Body that has regulatory authority over the quality, identity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of the products currently sold by the Credit Parties and their SubsidiariesAcquired Corporations (“Company Product”) (any such Governmental Body, as applicable, free and clear a “Company Regulatory Agency”) necessary for the lawful operation of all Liens other than Permitted Liens, and the businesses of the Acquired Corporations in each jurisdiction in which such Acquired Corporation operates (the “Company Regulatory Permits”); (ii) as applicable, validly registered all such Company Regulatory Permits are valid and on file with in full force and effect; and (iii) the applicable Governmental Authority, Company is in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports terms of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesCompany Regulatory Permits. (b) (i) All regulatory filings required by any Regulatory Authority Except as has not had, individually or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more a Material Adverse Effect, the businesses of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and each Acquired Corporation are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancecompliance with, and have appropriate internal controls that are reasonably designed to ensure compliance with, as applicable, (iiii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations FDCA (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in Section 510 of the FD&C FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 807); (ii) any applicable comparable foreign Legal Requirements for any Company Products (including the MDD); (iii) Legal Requirements set forth in title XVIII or XIX of the Social Security Act including, without limitation, the mandatory reporting and return of overpayments (42 U.S.C. § 1320a-7k(d)) requirements, (iv) state and provincial anti-kickback, anti-solicitation, patient brokering, patient capping, or equivalent regulation fee-splitting laws; (v) if, and to the extent applicable, federal, state or provincial licensing, disclosure and reporting requirements for Company Products; (vi) if, and to the extent applicable, the Health Insurance Portability and Accountability Act of each 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any federal, state, or local privacy, security, data breach reporting or other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities Legal Requirements with respect to the Products collection, protection, security, confidentiality, use, transfer, and disclosure of all Product Development personally identifiable information collected or maintained by or on behalf of each Acquired Corporation (“Personal Data”); (vii) reporting and Commercialization Activities related theretoother requirements relating to financial relationships between health care providers and pharmaceutical manufacturers, including the federal Physician Payments Sunshine Act (42 U.S.C. §1320a-7h), state “sunshine acts” and gift ban or reporting statutes, and the Code on Interactions with health Care Professionals as promulgated by the Pharmaceutical Research and Manufacturers of America; (viii) any Legal Requirement regulating ordering, prescribing, storing or distributing controlled substances or radioactive materials; (ix) any applicable Legal Requirement regulating the handling and disposal of bio-hazards, pharmaceutical or medical waste and (x) the applicable rules and regulations promulgated pursuant to all such applicable Legal Requirements, each as amended from time to time (collectively, “Company Healthcare Laws”). Since January 1, 2015, no Acquired Corporation has received any written notification from any Company Regulatory Agency, including without limitation the FDA and the Department of Health and Human Services or any other “notified body” or “competent authority” or corresponding Company Regulatory Agency in any jurisdiction, of noncompliance by, or liability of the Acquired Corporation under, any Company Healthcare Laws, except where such noncompliance or liability has not had, individually or in the aggregate, a Material Adverse Effect on the Acquired Corporations. (c) No Acquired Corporation nor to the knowledge of the Company any stockholder, director, officer, employee, agent or contractor of an Acquired Corporation (i) has been assessed a civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder; (ii) has been debarred, excluded, or suspended from participating in any federal or state health care program (as such terms are defined by the Social Security Act) or other third party payment program, or from receiving a contract or subcontract paid in whole or in part by federal or state funds; (iii) is or has been a party to any corporate integrity agreement, corporate compliance agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or similar agreements with or imposed by any Company Regulatory Agency and, to the Company’s knowledge, no such action is currently proposed or pending a corporate integrity agreement, as a result of an alleged violation of any Company Healthcare Law; (iv) has been convicted of any criminal offense under any Company Healthcare Law; (v) is or has been a party to or subject to any criminal, civil or administrative action or proceeding, or to the knowledge of the Company, any threatened action or proceeding, concerning any of the matters described in clauses (i) through (iv) above. (d) Except as set forth on Schedule 6.19(d)As of the date hereof, no Credit Party nor Acquired Corporation (i) is subject to any pending or, to its knowledge, threatened investigation by a Company Regulatory Agency or any unsealed qui tam action, (ii) has received or been served with any search warrant, subpoena or civil investigative demand from any Company Regulatory Agency; (iii) is subject to any statement of deficiencies for which there is not an approved plan of correction, the conditions of which have been or are being fully met; and (iv) is subject to any pending or, to its knowledge, threatened notice or action to suspend, revoke, or modify any Governmental Authorization, and no Acquired Corporation has reason to believe that any such action is likely to occur. (e) All pre-clinical and clinical investigations conducted or sponsored by each Acquired Corporation are being conducted in compliance with all applicable Legal Requirements administered or issued by the applicable Company Regulatory Agencies, including, without limitation, (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 Part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 Parts 50, 54, 56 and 812 of the Code of Federal Regulations, (iii) any comparable foreign Legal Requirements for any of its Subsidiaries the foregoing or other Legal Requirements regulating the conduct of pre-clinical and clinical investigations and (iv) federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had a Material Adverse Effect on the Acquired Corporations. (f) Since January 1, 2015, no Acquired Corporation has received any written notice from the FDA (including any Regulatory Authority inspection reports on Form 483) or any notice foreign agency with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of alleged non-compliance medical devices which would reasonably be expected to lead to the denial, suspension or adverse findings revocation of any application or grant for marketing approval with respect to any material Company Product currently pending before or any Product Development and Commercialization Activities related thereto which representedpreviously cleared by the FDA or such other Company Regulatory Agency. (g) Since January 1, in the aggregate2015, 15% or more of Net Sales in any applicable yearall reports, including any FDA Form 483 inspectional observationsdocuments, claims, permits, notices and Medical Device Reports of violationsadverse events (“MDRs”) required to be filed, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, maintained or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating furnished to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Company Regulatory Authority indicating any breach Agency by the Acquired Corporations have been so filed, maintained or violation of any applicable Regulatory Authorizationfurnished in a timely manner, including that any of the Products is misbranded except where failure to file, maintain or adulterated as defined in the FD&C Actfurnish such reports, in each case of the foregoingdocuments, which representedclaims, permits, notices or MDRs has not had, individually or in the aggregate, 15% a Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or more were corrected in or supplemented by a subsequent filing if subject to such a Legal Requirement). None of Net Sales in any applicable year within the last five (5) years. (e) No Credit PartyAcquired Corporations, nor any nor, to the knowledge of its Subsidiariesthe Company, nor any officer, employee employee, agent or agent thereofdistributor of the Acquired Corporations, has made an untrue statement of a material fact or a fraudulent statements statement to the FDA or any other Company Regulatory AuthorityAgency, failed to disclose a material fact required to be disclosed to the FDA or any other Company Regulatory AuthorityAgency, or committed an act, made a statement, or failed to make a statement statement, in each such case, related to the business of the Acquired Corporations, that, at the time such disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that for the FDA or any other applicable Company Regulatory Authority has commenced or initiatedAgency to invoke any similar policy. None of the Acquired Corporations, or threatened nor, to commence or initiatethe knowledge of the Company, any action to withdraw any Regulatory Authorizationofficer, requested employee, agent or distributor of the recall (whether by correction Acquired Corporations, has been debarred or removal) convicted of any Products crime or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales engaged in any applicable year,conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Legal Requirement or authorized by 21 U.S.C. § 335a(b) or any similar Legal Requirement. (gh) Except as set forth on Schedule 6.19(g)As to each Company Product or Company Product candidate subject to the FDCA, the clinicalregulations of the FDA promulgated thereunder or similar Legal Requirement in any foreign jurisdiction (including the MDD) that is or has been developed, preclinicalmanufactured, safety and other studies and tests conducted tested, distributed or marketed by or on behalf of or sponsored by the Credit Parties and their SubsidiariesAcquired Corporations, except, as has not had, individually or in respect of which any Products the aggregate, a Material Adverse Effect, each such Company Product or Company Product candidates under development have participatedcandidate is being or has been developed, were (manufactured, stored, distributed and if still pending, are) being conducted marketed in accordance compliance with all applicable Regulatory Authorizations Legal Requirements, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and Healthcare Laws security. There is no action or proceeding pending or, to the knowledge of the Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in all material respectseach case alleging any violation applicable to any Company Product or Company Product candidate by the Acquired Corporations of any Legal Requirement, except, as has not had, individually or in the aggregate, a Material Adverse Effect. (hi) The transactions contemplated Since January 1, 2015, each of the Acquired Corporations have neither voluntarily nor involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued any “Class I” or “Class II” recall or material field corrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged material lack of safety, efficacy or regulatory compliance of any Company Product or is currently considering initiating, conducting or issuing any “Class I” or “Class II” recall of any Company Product. Since January 1, 2015, the Acquired Corporations have not received any written notice from the FDA or any other Company Regulatory Agency regarding, (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by the Loan Documents Acquired Corporations, (ii) a change in the marketing classification or contemplated by a material change in the conditions to effectiveness labeling of any Loan Documentsuch Company Products, or (iii) will not impair any Credit Party’s a termination, enjoinment or any suspension of its Subsidiaries’ ownership the manufacturing, marketing, or distribution of such Company Products that in each case, has had or rights under (or would reasonably be expected to have a material impact on the license or business of the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoAcquired Corporations.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally Each of the Company and beneficially owned exclusively by its Subsidiaries has all Licenses necessary to conduct its business as presently conducted, including all such Licenses of the Credit Parties United States Food and their Subsidiaries, as applicable, free and clear of all Liens Drug Administration (the “FDA”) or any other than Permitted Liens, and applicable U.S. or foreign drug regulatory authority (ii) as applicable, validly registered and on file collectively with the applicable Governmental AuthorityFDA, in compliance with all filing and maintenance requirements the “Regulatory Authorities”) necessary to conduct its business as presently conducted (including any fee requirements) thereofcollectively, and are in good standingthe “Regulatory Licenses”), valid and enforceable with except those Licenses the applicable Governmental Authority. All required noticesabsence of which, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority individually or in respect the aggregate with other such absences, would not reasonably be expected to have a Company Material Adverse Effect and would not reasonably be expected to prevent, materially delay or materially impair the consummation of the transactions contemplated hereby. There has not occurred any revocation or termination of any Regulatory Authorization with respect to any Product License, or any Product Development and Commercialization Activities which representedmaterial impairment of the rights of the Company or its Subsidiaries under any Regulatory License, except for any such revocation, termination or impairment that, individually or in the aggregateaggregate with other such revocations, 15% or more of Net Sales in any applicable yearterminations and impairments, in the last five (5) years would not reasonably be expected to have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives a Company Material Adverse Effect. Each of the Credit Parties (Company and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their its Subsidiaries and the agents thereof are has operated in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act administered or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened enforced by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed except where the failure so to disclose a material fact required to be disclosed to comply, individually or in the FDA or any aggregate with other Regulatory Authoritysuch failures, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was would not made), could reasonably be expected to provide have a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Company Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyAdverse Effect. (fii) Except as set forth on Schedule 6.19(f)Since January 1, no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated2009, or threatened to commence or initiateall preclinical studies and clinical trials, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or or, to the Knowledge of the Company, on behalf of the Company or sponsored by the Credit Parties and their Subsidiariesits Subsidiaries have been and, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) are being conducted in accordance compliance with all applicable Laws (including those pertaining to Good Laboratory Practice and Good Clinical Practice contained in 21 C.F.R. Part 58 and Part 312 and all applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54 and 56), except for noncompliances that, individually or in the aggregate with other such noncompliances, would not reasonably be expected to have a Company Material Adverse Effect. Since January 1, 2009, except for such exceptions that, individually or in the aggregate with other such exceptions, would not reasonably be expected to have a Company Material Adverse Effect, no clinical trial conducted by or, to the knowledge of the executive officers of the Company, on behalf of the Company or its Subsidiaries has been terminated or suspended prior to completion for safety or other non-business reasons, and neither the FDA nor any other applicable Regulatory Authorizations and Healthcare Laws in all material respectsAuthority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries has commenced, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any ongoing clinical investigation conducted by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries. (hiii) The transactions contemplated by Since January 1, 2009, (A) neither the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any of their officers, directors, employees or agents has been convicted of any crime or engaged in any conduct that in any such case has resulted, or is reasonably likely to result, in debarment under 21 U.S.C. Section 335a and (B) neither the Company nor any of its Subsidiaries has hired any employee under debarment or used a vendor that, to the Knowledge of the Company, employed any person under debarment. (iv) The Company has made available to Parent complete and correct copies of each Investigational New Drug Application, each similar state or foreign regulatory filing made on behalf of the Company or its Subsidiaries’ ownership , including all related supplements, amendments and annual reports, and all correspondence between the Company and any of or rights under (or the license or the right to use, as the case may be) its Affiliates on one hand and any Regulatory Authorizations relating Authority on the other hand. (v) Since January 1, 2009 to the Products in any material mannerdate of this Agreement, and no consent each medicinal or other authorization of any Governmental Authority pharmaceutical product that is required in connection with the transactions contemplated herebyor has been researched, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.developed, manufactured, labeled, supplied, promoted, co-promoted, co-developed, co-marketed,

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) Each of the Company’s Subsidiaries that engages in the sale of electricity at wholesale is regulated as a complete “public utility” under the FPA and accurate list of all material Regulatory Authorizations relating has been authorized by the FERC, pursuant to the Credit Parties FPA, to make such sales at market-based rates. Each of the Company’s Subsidiaries that directly owns generating facilities has obtained an order from the FERC finding it to be, or has self-certified itself to the FERC as, an Exempt Wholesale Generator under the Public Utility Holding Company Act of 2005 (“PUHCA”) and their Subsidiaries, pursuant to Part 366 of the conduct of their business, FERC’s Rules and the Products Regulations (on a per Product basis18 C.F.R. Part 366 (2009)). All such material Regulatory Authorizations There are (i) legally and beneficially owned exclusively by no pending, or to the Credit Parties and their Subsidiariesknowledge of the Company, threatened, judicial or administrative proceedings to revoke a Subsidiary’s market-based rate authorization or Exempt Wholesale Generator status, as applicable. To the knowledge of the Company, free and clear there are no facts that are reasonably likely to cause any of all Liens other than Permitted Liensthe Company’s Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization or any of the Company’s Subsidiaries that directly owns generating facilities to lose its status as an Exempt Wholesale Generator under PUHCA. Neither the Company nor any of its Subsidiaries owns, and (ii) as applicabledirectly or indirectly, validly registered and on file with the applicable Governmental Authority, any interest in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications nuclear generation station or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences manages or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesoperates any nuclear generation station. (b) All filings (iother than immaterial filings) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted be made by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act Company or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice during the three years preceding the date hereof, with the FERC under the FPA, the Public Utility Holding Company Act of alleged non-compliance 1935 or adverse findings with respect to any Product PUHCA, the Department of Energy or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usestate public utility commissions, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and no consent or other authorization all such filings complied, as of any Governmental Authority is required in connection their respective dates, with the transactions contemplated hereby, including the Liens granted in connection herewith all applicable requirements of applicable statutes and the exercise rules and regulations promulgated thereunder, except for filings the failure of rights which to make or the failure of which to make in compliance with all applicable requirements of applicable statutes and remedies with respect theretothe rules and regulations promulgated thereunder, would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.

Regulatory Matters. With respect the exception of the drug master file (or equivalent) for Licensed Vaccines and Licensed Products ("CureVac DMF") and all Manufacturing permits and authorizations necessary for the Manufacture of the Licensed Vaccines, BI shall be solely responsible for all regulatory matters including the filing for approvals to each Product: (a) Set forth the Licensed Vaccines and Licensed Products in the Field. BI shall own, directly or through an Affiliate, all Regulatory Approvals. With the exception only of matters which require prompt attendance, CureVac shall have the right and the obligation to review and comment on Schedule 6.19(a) is a complete all regulatory filings inasmuch as they relate to the Licensed Vaccines and accurate list Licensed Products, and BI will take such comments into reasonable consideration. Furthermore, BI will provide copies of all regulatory approvals and material correspondence with Regulatory Authorizations Authorities in the Major Market Countries relating to the Credit Parties Clinical Trials with respect to Licensed Vaccines and their SubsidiariesLicensed Products to CureVac, and will reasonably consider a request by CureVac to participate in a meeting with Regulatory Authorities. Notwithstanding the conduct foregoing, CureVac shall have the right and the obligation to participate in a meeting with Regulatory Authorities if and to the extent such meeting relates to the CMC Development. For the avoidance of their businessdoubt, BI will have final say on all regulatory matters of the Licensed Vaccines, and the dispute resolution process laid down in Sections 8.5 and 8.6 of this Agreement does not apply. CureVac shall use Commercially Reasonable Efforts to support BI on all regulatory matters with respect to the Non-clinical and Clinical Development and Commercialization of the Licensed Vaccines and Licensed Products (on a per Product basis)and shall maintain all permits and authorizations necessary for the Manufacture of the Licensed Vaccines, including the CureVac DMF. All such material Regulatory Authorizations are CureVac shall use Commercially Reasonable Efforts to generate and provide to BI (i) legally CMC Development-related and beneficially owned exclusively by the Credit Parties Manufacturing-related documentation, data and their Subsidiariesreports, as applicable, free and clear of all Liens other than Permitted Liensincluding those listed in Exhibit 4.3, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) CMC Development-related technical and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Actassistance, in each case (i) and (ii) as reasonably required for obtaining Regulatory Approvals and for required interactions with Regulatory Authorities regarding the Licensed Vaccines, including scientific advices. In addition to the obligations under Section 10 below, BI shall ensure that such CMC Development- and/or Manufacturing-related documentation, data and reports are not circulated within Bl’s and Bl’s Affiliates’ organizations except as required for the purposes mentioned in the foregoing sentence. Each Party shall designate one or more individual(s) to facilitate the provision of the foregoingdocumentation, which representedmaterials, data and reports as described in this Section 4.3. To the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit extent required by a Party, nor a BI Affiliate or a CureVac Affiliate to achieve or maintain regulatory clinical trial and/or marketing application approvals or to comply with any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements related requests from regulatory authorities related to the FDA Licensed Vaccines, or, if so required by CureVac or by a CureVac Affiliate, to any RNA based product owned or in-licensed by CureVac or its Affiliate, the Parties shall authorize and hereby authorize each other or their respective Affiliate (but not licensees of the other Party) to cross reference to the sections of the IND/regulatory dossiers of the clinical trials related to vaccines or RNA based products Controlled by the other Party or its Affiliate and to any other Regulatory Authority, failed relevant regulatory filings and any other relevant documentation Controlled by the other Party or its Affiliate. The Parties shall inform each other in writing prior to disclose any such cross-referencing. BI shall consider in good faith any request by CureVac to authorize a material fact required future licensee of CureVac to be disclosed cross-reference to the FDA sections of the IND/regulatory dossiers of the Clinical Trials related to Licensed Vaccine or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 FedLicensed Product. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT CONFIDENTIAL

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aThe Company’s lixivaptan product candidate (“Lixivaptan”) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their businessbeing, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally at all times since January 1, 2007 has been, developed, tested, manufactured and beneficially owned exclusively by the Credit Parties and their Subsidiariesstored, as applicable, free in compliance in all material respects with the Federal Food, Drug and clear of all Liens other than Permitted LiensCosmetic Act (the “FDA Act”) and applicable regulations issued thereunder by the United States Food and Drug Administration (“FDA”), and (ii) including, as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance those requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect relating to the Products for the last five (5) years have been timely filed with the FDA FDA’s current good manufacturing practices, good laboratory practices and all other applicable Governmental Authoritiesgood clinical practices. (b) The Company has made available to the Buyer as of the date of this Agreement a complete and correct copy of each New Drug Application (“NDA”) and each Investigational New Drug application (“IND”) submitted to the FDA with respect to Lixivaptan, including all supplements and amendments thereto. The Company has completed and analyzed all clinical investigations, preclinical investigations, and any other studies, analyses, or other work necessary to compile and submit the Lixivaptan NDA for substantive review by FDA. The Lixivaptan NDA is complete, accurate, and in compliance, in each case in all material respects, with all relevant provisions of the FDC Act and FDA regulations and guidances, including but not limited to the content and format requirements set forth at 21 C.F.R. sec. 314.50. (c) The clinical trials conducted by the Company or any of its Subsidiaries with respect to Lixivaptan were conducted in all material respects in accordance with all applicable clinical trial protocols and applicable requirements of the FDA and any Institutional Review Board (“IRB”), including, as applicable, the FDA’s good clinical practices and good laboratory practices regulations. (d) None of the Company nor any of its Subsidiaries is subject to any investigation that is pending and of which the Company or such Subsidiary has been notified in writing or, to the Company’s Knowledge, which has been threatened, in each case by (i) All regulatory filings required by the FDA or (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b) (known as the “Anti-Kickback Statute”) or the Federal False Claims Act (31 U.S.C. §3729). (e) To the Company’s Knowledge, none of the Company nor any Regulatory Authority of its Subsidiaries has submitted any claim for payment to any government healthcare program in connection with any referrals related to Lixivaptan that violated in any material respect any applicable self-referral Law, including the Federal Ethics in Patient Referrals Act, 42 U.S.C. §1395nn (known as the “▇▇▇▇▇ Law”), or any applicable state self-referral law. (f) To the Company’s Knowledge, none of the Company nor any of its Subsidiaries has submitted any claim for payment to any government healthcare program related to Lixivaptan in respect material violation of any Regulatory Authorization with respect laws relating to any Product false claim or fraud, including the Federal False Claim Act, 31 U.S.C. § 3729, or any Product Development applicable state false claim or fraud law. (g) The Company and Commercialization Activities which represented, in the aggregate, 15% or more each of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have its Subsidiaries has complied in all material respects with all applicable laws security and regulationsprivacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, including the regulations promulgated thereunder (collectively “HIPAA”) and (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,state privacy laws. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a6.18(a) is a complete and accurate list as of the Closing Date of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesLoan Parties, the conduct of their business, business and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicableLoan Parties, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in material compliance with all registration, filing and maintenance requirements (including any fee requirements) thereof, and are (iii) in good standing, valid and enforceable with the applicable Governmental AuthorityAuthority in all material respects. All required and material notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and or other reports of adverse experiences or product malfunctions, and reports of corrections or removalexperiences) and other required and material filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All material regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization or Product Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct in all material respects and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with each Loan Party according to all applicable laws and regulations in all material respects along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have each Loan Party has disclosed to the Agent Lender all such material regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) each Loan Party and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries Borrower and each other Loan Party and the Borrower’s agents and the agents thereof of each other Loan Party are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws Regulatory Authorizations and Regulatory Product Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties Borrower and their Subsidiaries have each other Loan Party has and maintain maintains in full force and effect all the necessary and requisite Regulatory Authorizations and Product Authorizations. The Credit Parties Borrower and their Subsidiaries are each other Loan Party is in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere Each Loan Party adheres in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party Neither the Borrower nor any of its Subsidiaries other Loan Party has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearthereto, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) yearsAuthority. Except as set forth on Schedule 6.19(d), there There have been no seizures conducted or, to the Borrower’s knowledge, threatened by any Regulatory Authority with respect to any Product, and no recalls, market withdrawals, field notifications or corrections, detentions, seizuresnotifications, notifications or allegations of misbranding or adulteration or safety alerts conducted, requestedrequested or, or to the Borrower’s knowledge, threatened by any Regulatory AuthorityAuthority with respect to any Product, and no recalls, market withdrawals, field notifications, notifications of misbranding or (for example in adulteration or safety alerts have been conducted, requested or, to the case of a recall) initiated Borrower’s knowledge, threatened by Credit Party or any of its Subsidiaries, Regulatory Authority relating to any Products which represented, in Products. Neither the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party Borrower nor any of its Subsidiaries other Loan Party has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Product Authorization or Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of Act or the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsrules and regulations promulgated thereunder. (e) No Credit Party, Neither the Borrower nor any of its Subsidiaries, other Loan Party nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party Neither the Borrower nor any of its Subsidiaries other Loan Party has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or, to the knowledge of the Borrower or any such Loan Party, threatened to commence or initiate, any action to withdraw any Regulatory Authorization, Authorization or Product Authorization or requested the recall (whether by correction or removal) of any Products or commenced or initiated or, to the knowledge of the Borrower or any such Loan Party, threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of the Borrower or any such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Loan Party. (g) Except as set forth on Schedule 6.19(g), the The clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties Borrower and their Subsidiarieseach other Loan Party, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted materially in accordance with standard medical and scientific research procedures and all applicable Regulatory Authorizations Product Authorizations. The Borrower and Healthcare Laws each other Loan Party has operated within, and currently is in compliance in all material respects. (h) The transactions contemplated by respects with, all applicable laws, Product Authorizations and Regulatory Authorizations, as well as the rules and regulations of the FDA and each other Regulatory Authority. Neither the Borrower nor any other Loan Documents (Party has received any notices or contemplated by other correspondence from the conditions to effectiveness FDA or any other Regulatory Authority requiring the termination or suspension of any Loan Document) will not impair any Credit Party’s clinical, preclinical, safety or other studies or tests used to support regulatory clearance of, or any of its Subsidiaries’ ownership of Product Authorization or rights under (or the license or the right to useRegulatory Authorization for, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoProduct.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aExcept as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, each of the Company and its Subsidiaries holds or is in the process of acquiring (A) is a complete all authorizations under the U.S. Food, Drug, and accurate list Cosmetic Act of all material Regulatory Authorizations relating to 1938 (the Credit Parties and their Subsidiaries, the conduct of their business“FDCA”), and the applicable regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, (B) all authorizations under the U.S. Federal Insecticide, Fungicide and Rodenticide Act of 1910 (the “FIFRA”), the U.S. Food Quality Protection Act of 1996 (the “FQPA”) and the applicable regulations of the U.S. Environmental Protection Agency (the “EPA”) promulgated thereunder and (C) authorizations of the FDA, U.S. Department of Agriculture (“USDA”) and any other applicable Governmental Entity that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Company Products (on any such Governmental Entity, a per Product basis“Company Regulatory Agency”), in each case, that is necessary for the lawful operation of the businesses of the Company or any of its Subsidiaries as currently conducted (the “Company Regulatory Permits”). All Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such material Company Regulatory Authorizations Permits are (i) legally valid and beneficially owned exclusively by in full force and effect and the Credit Parties Company and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, its Subsidiaries are in compliance with the terms of all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesCompany Regulatory Permits. (b) (i) All regulatory filings required by any Regulatory Authority Except as would not reasonably be expected to have, individually or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more a Company Material Adverse Effect, each of Net Sales the Company and its Subsidiaries is in compliance with all regulations and requirements of the FDA, USDA, EPA and other Company Regulatory Agencies, including any applicable yearGood Manufacturing Practices, Hazard Analysis Critical Control Point (HACCP) requirements, labeling requirements, testing requirements and protocols, shipping requirements, record keeping and reporting requirements, monitoring requirements, packaging or repackaging requirements, laboratory controls, storage and warehousing procedures and marketing restrictions. Except as would not reasonably be expected to have, individually or in the last five (5) years aggregate, a Company Material Adverse Effect, since January 1, 2019, all Company Products have been madeproduced, distributed, labeled, marketed and sold, and all raw materials and ingredients in such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their complianceprocured, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutesApplicable Laws governing the procurement, rules production, distribution, labeling and regulations (including all Healthcare Laws and Regulatory Authorizations) sale of all applicable Governmental Authoritiessuch products, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretoraw materials or ingredients. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d)would not reasonably be expected to have, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance individually or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yeara Company Material Adverse Effect, including any FDA Form 483 inspectional observationssince January 1, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d)2019, there have been no recalls, market withdrawalswithdrawals or suspensions with respect to any Company Products produced, field notifications distributed, labeled, marketed or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened sold by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party Company or any of its Subsidiaries. Except as would not reasonably be expected to have, relating to any Products which represented, individually or in the aggregate, 15% or more of Net Sales in any applicable year within a Company Material Adverse Effect, since January 1, 2019, neither the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party Company nor any of its Subsidiaries has received any written notice that the FDA of or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiateotherwise is aware of, any action Company Regulatory Agency untitled letters, warning letters, notices of warning or withholding, suspension or withdrawal of inspection, seizure, criminal referral or other similar federal, state or private enforcement actions with respect to withdraw any Regulatory Authorizationsuch Company Products. Except as would not reasonably be expected to have, requested the recall (whether by correction individually or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% a Company Material Adverse Effect, since January 1, 2019, neither the Company nor any of its Subsidiaries is subject (or more of Net Sales in has been subject) to any applicable year,adverse inspection finding, recall, investigation, penalty assessment, audit or other compliance or enforcement action by the FDA, USDA, EPA and other Company Regulatory Agencies. (gc) Except as set forth on Schedule 6.19(g), Neither the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or Company nor any of its Subsidiaries’ ownership of Subsidiaries is party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or rights under (similar agreements with or imposed by any Company Regulatory Agency, except as would not reasonably be expected to have, individually or in the license or the right to useaggregate, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoa Company Material Adverse Effect.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aEach of Parent’s Subsidiaries that engages in the sale of electricity at wholesale (other than any such Subsidiaries that own one or more facilities that constitute a “qualifying facility” as such term is defined under PURPA and the rules and regulations of FERC that are entitled to exemption from regulation under Section 205 of the FPA) is regulated as a complete “public utility” under the FPA and accurate list has market-based rate authorization to make such sales at market-based rates. Each of all material Regulatory Authorizations relating to the Credit Parties Parent’s Subsidiaries that directly owns generating facilities and operates their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, power generation facilities in compliance with all filing and maintenance requirements (including any fee requirements) thereofapplicable standards of NERC, and other than non-compliance that would not reasonably be expected to have, individually or in the aggregate, a material impact on Parent. There are in good standingno pending, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for Knowledge of Parent, threatened, judicial or administrative proceedings to revoke a Parent’s Subsidiary’s market-based rate authorization. To the last five (5) years have been timely filed with Knowledge of Parent, there are no facts that are reasonably likely to cause any of Parent’s Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization, if applicable, other than where such loss would not reasonably be expected to have, individually or in the FDA and all other applicable Governmental Authoritiesaggregate, a material impact on Parent. (b) All filings (iother than immaterial filings) All regulatory filings required to be made by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product Parent or any Product Development of its Subsidiaries since January 1, 2009, with the FERC under the FPA, the NRC under the Atomic Energy Act, the Department of Energy and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable yearstate public utility commissions, in as the last five (5) years case may be, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and all such filings above such threshold are complete and correct and have complied in all material respects complied, as of their respective dates, with all applicable laws requirements of applicable statutes and regulationsthe rules and regulations promulgated thereunder, (ii) all clinical and pre-clinical trials, if any, except for filings the failure of investigational Products have been and are being conducted by which to make or the Credit Parties and their Subsidiaries failure of which to make in accordance compliance with all applicable laws requirements of applicable statutes and the rules and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancepromulgated thereunder, and (iii) would not reasonably be expected to have, individually or in the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all aggregate, a material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityimpact on Parent. (c) The Credit PartiesSince January 1, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes2008, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party neither Parent nor any of its Subsidiaries has received any written notice that or, to Parent’s Knowledge, other communication from the FDA NERC regarding any actual or any other applicable Regulatory Authority has commenced or initiatedpossible material violation of, or threatened material failure to commence or initiatecomply with, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Law. (gd) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted This Section 5.13 excludes any representation or warranty by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s Parent or any of its Subsidiaries’ ownership Subsidiaries or any Joint Venture of or rights under (or the license or the right Parent with respect to use, as the case may be) any Regulatory Authorizations matters relating to the Products or arising under Environmental Laws or Hazardous Materials which are addressed in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 5.8.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to Until the Credit Parties and their SubsidiariesFirst Closing Date, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are Seller shall be solely responsible for (i) legally taking all actions, paying all fees and beneficially owned exclusively conducting all communication with the appropriate Regulatory Authority required by Law in respect of Regulatory Approvals, including preparing and filing all reports (including adverse drug experience reports, product deviation reports, annual reports, with the Credit Parties appropriate Regulatory Authority), (ii) submitting all applications for marketing authorizations of new drugs, where such authorizations have not yet been granted, and their Subsidiaries, as applicable, free and clear variation of all Liens other than Permitted Liensexisting authorizations, and (iiiii) as applicable, validly registered investigating all complaints and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse drug experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiessold pursuant to such Regulatory Approvals. (b) Until the Second Closing Date, Seller shall be solely responsible for (i) All regulatory filings taking all actions, paying all fees and conducting all communication with the appropriate Regulatory Authority required by Law in respect of Regulatory Approvals solely for the PTB Indication, including preparing and filing all reports (including adverse drug experience reports, product deviation reports, annual reports, with the appropriate Regulatory Authority), (ii) submitting all applications for marketing authorizations of new drugs solely for the PTB Indication, where such authorizations have not yet been granted, and variation of existing authorizations, and (iii) investigating all complaints and adverse drug experiences with respect to Products sold pursuant to such Regulatory Approvals. The costs incurred by Seller for activities pursuant to this Section 8.5(b) shall constitute Development Costs of Seller subject to the Seller Development Costs Cap. (c) From and after the First Closing, Buyer, at its cost shall be solely responsible for taking all actions and conducting all communication with third parties with respect to Products sold pursuant to such Regulatory Approvals (whether sold before or after transfer of such Regulatory Approval), including responding to all complaints in respect thereof, including complaints related to tampering, contamination, or counterfeiting. (d) Seller shall provide Buyer with such data as is reasonably necessary to comply with Buyer’s reporting obligations for Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)), Average Manufacturers Price (as defined at 42 U.S.C. § 1396r-8(k)(1)) and Average Sales Price (as defined at 42 U.S.C. § 1395w-3(a)(c)) for such period as is reasonably necessary, not to exceed one (1) year after the First Closing Date. (e) From and after the First Closing Date, Buyer promptly (and in any event within the time periods required by Law) shall notify Seller within three (3) Business Days if Buyer receives a complaint or a report of an adverse drug experience with respect to Products. In addition, Buyer shall cooperate with Seller’s reasonable requests and use Commercially Reasonable Efforts to assist Seller in connection with the investigation of and response to any complaint or adverse drug experience related to Products sold by Buyer. (f) From and after the First Closing Date, Buyer shall be responsible for (i) conducting all voluntary and mandatory recalls of units of Products sold pursuant to such Regulatory Approvals (whether sold before or after transfer of such Regulatory Approval), including recalls required by any Regulatory Authority or and recalls of units of Products sold by Seller deemed necessary by Seller in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulationsits reasonable discretion, (ii) conducting all clinical communications and pre-clinical trials, if any, of investigational Products have been and are being conducted by submitting all required reports to any Regulatory Authority concerning the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, recalls and (iii) notifying customers and consumers about the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretorecalls. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Seller promptly shall notify Buyer in the FD&C Act or equivalent regulation event that a recall of each other Governmental Authority having jurisdiction over such PersonProducts sold by Seller is necessary. The Credit Parties Seller shall be responsible for all costs associated with recalls of Products sold prior to First Closing Date; provided, however, if Buyer and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Seller sell Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorizationsame lot, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to then Buyer and Seller shall be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis responsible for the FDA or any other Regulatory Authority cost of recalls of Products sold from such lot in proportion to invoke its policy respecting Fraud, Untrue Statements their pro-rata sales of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of from such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,lot. (g) Except as set forth on Schedule 6.19(g)Seller and Buyer each agree to promptly prepare and file whatever filings, the clinical, preclinical, safety and other studies and tests conducted by requests or on behalf of applications are required or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance deemed advisable to be filed with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including Transactions and transfer and assumption of the Liens granted in connection herewith Regulatory Approvals and to cooperate with one another as reasonably necessary to accomplish the exercise of rights and remedies with respect theretoforegoing.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aAll Products which have been developed by Geron as of the date hereof (the “Geron Products”) is a complete and accurate list of all material Regulatory Authorizations relating that are subject to the Credit Parties and their Subsidiaries, jurisdiction of the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years FDA have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are developed in compliance in all material respects with all applicable statutesrequirements, rules if any, under the Food and regulations Drug and Cosmetic Act (including “FDCA”), the Public Health Service Act and their applicable implementing regulations. (b) To the Knowledge of Geron, all Healthcare Laws preclinical studies and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA clinical trials and all other Regulatory Authoritiespreclinical research, clinical development and manufacturing activities conducted by or on behalf of Geron with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries the Technology have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance been conducted in all material respects with all applicable registration and listing requirements set forth Legal Requirements, including those relating to protection of human subjects. (c) All manufacturing operations conducted by Geron with respect to Geron Products being used in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere human clinical trials have been conducted in accordance, in all material respects to respects, with the FDA’s cGMP regulations. To the Knowledge of Geron, all applicable regulations manufacturing operations conducted for the benefit of all Regulatory Authorities Geron with respect to the Geron Products and being used in human clinical trials have been conducted in accordance, in all Product Development and Commercialization Activities related theretomaterial respects, with the FDA’s cGMP regulations. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 As of the FD&C Actdate of this Agreement, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries Geron has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened in writing to commence or initiate, any action to withdraw suspend any Regulatory Authorizationclinical trial relating to the Technology. (e) Neither Geron nor, requested to the recall (whether by correction or removal) Knowledge of any Products or commenced or initiated or threatened to commence or initiateGeron, any action Representatives acting for Geron, has committed any act, made any statement in writing or failed to enjoin make any Product Development statement in writing that would reasonably be expected to provide a valid basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Commercialization Activities Illegal Gratuities” set forth in 56 Fed. Reg 46191 (September 10, 1991) and any amendments thereto. (f) As of such Credit Party the date hereof, there are no Proceedings pending with respect to a violation by Geron of the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or such Subsidiary, in each case, which represented, in any other Legal Requirement promulgated by a Governmental Body with respect to the aggregate, 15% or more of Net Sales in any applicable year,Geron Products. (g) Except as set forth on Schedule 6.19(g)To the Knowledge of Geron, there have been no reports of any serious adverse events affecting any patients participating in the clinicalGRNOPC1 clinical trials for spinal cord injury that, preclinicalprior to the Closing, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsbeen determined to be product-related. (h) The transactions Regulatory Filings identified in Schedule 1.1(h) include all material documents filed with the FDA by or on behalf of Geron relating to the Technology of the type contemplated by the Loan Documents (or contemplated by the conditions to effectiveness definition of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoFilings.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) Each of Parent’s Subsidiaries that engages in the sale of electricity at wholesale is regulated as a complete “public utility” under the FPA and accurate list of all material Regulatory Authorizations relating has been authorized by the FERC, pursuant to the Credit Parties and their SubsidiariesFPA, to make such sales at market-based rates. Each of Parent’s Subsidiaries that directly owns generating facilities has obtained an order from the conduct FERC finding it to be, or has self-certified itself to the FERC as, an Exempt Wholesale Generator under PUHCA or the Public Utility Holding Act of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries1935, as applicable, free and clear pursuant to Part 366 of all Liens other than Permitted Liensthe FERC’s Rules and Regulations (18 C.F.R. Part 366 (2009)), and (ii) if applicable. There are no pending, or to the knowledge of Parent, threatened, judicial or administrative proceedings to revoke a Subsidiary’s market-based rate authorization or Exempt Wholesale Generator status, as applicable. To the knowledge of Parent, validly registered and on file with the applicable Governmental Authoritythere are no facts that are reasonably likely to cause any of Parent’s Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization or any of Parents Subsidiaries that directly own generating facilities to lose its status as an Exempt Wholesale Generator under PUHCA. Neither Parent nor any of its Subsidiaries owns, directly or indirectly, any interest in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications nuclear generation station or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences manages or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesoperates any nuclear generation station. (b) All filings (iother than immaterial filings) All regulatory filings required to be made by any Regulatory Authority Parent or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice during the three years preceding the date hereof, with the FERC under the FPA, the Public Utility Holding Company Act of alleged non-compliance 1935 or adverse findings with respect to any Product PUHCA, the Department of Energy or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usestate public utility commissions, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and no consent or other authorization all such filings complied, as of any Governmental Authority is required in connection their respective dates, with the transactions contemplated hereby, including the Liens granted in connection herewith all applicable requirements of applicable statutes and the exercise rules and regulations promulgated thereunder, except for filings the failure of rights which to make or the failure of which to make in compliance with all applicable requirements of applicable statutes and remedies with respect theretothe rules and regulations promulgated thereunder, would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.

Regulatory Matters. With respect to each Product: (a) Set Subject to Pernix’s performance of the Services and its responsibility for the operations of the Company as set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiariesherein, the conduct Company under the oversight and supervision of their businessPernix (through the Company Officers) shall have responsibility and decision making-authority for its regulatory activities, including communications and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariesfilings with any Governmental Authorities, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products Product in and out of the Territory. As such pertains to the Corporate Services provided by Pernix, the Company shall promptly share with Pernix any written correspondence and/or communications of any kind that it receives from a Governmental Authority, including but not limited to copies of any and all Regulatory Materials and Regulatory Approvals (including all correspondence with Governmental Authorities) and keep Pernix promptly informed of the submission to Governmental Authorities of any significant Regulatory Materials, meetings with Governmental Authorities, and its receipt of, or any material changes to existing, Regulatory Approvals, in the case of this clause (ii), for the last five (5) years have been timely filed Product, whether in or outside the Territory. In connection with obtaining and maintaining the Regulatory Approvals in the Territory in connection with the FDA Distribution Service, Pernix shall have the right to reference during the Term any and all of the data submitted in support of the Regulatory Materials and Regulatory Approvals, including any Company Intellectual Property. The Company shall be the legal owner of the Regulatory Approvals associated with the Product in the Territory. At times and upon agreement by the Parties, as part of the Corporate Services, the Company may appoint Pernix as its agent with respect to such Regulatory Materials and Regulatory Approvals, including the right to file Regulatory Materials or take any other applicable Governmental Authoritiesactions required by (or advisable under) Applicable Law or this Agreement in respect of the Product in the Territory on behalf of the Company. (b) (i) All Pernix and its Affiliates shall have the responsibility in the Territory for complying with all Applicable Laws, regulatory filings and reporting requirements required to be undertaken by any Regulatory Authority or Pernix acting as a distributor of the Product in respect the Territory. Pernix shall promptly notify the appropriate, designated persons within the Company of any Regulatory Authorization report of an adverse drug reaction/experience concerning the Product to the extent known by Pernix. Pernix shall cooperate with respect the Company as necessary to report such adverse drug reaction/experience when so required as a distributor of the Product under Applicable Laws. Pernix shall also promptly notify the appropriate, designated persons within the Company of any material complaints related to the Product or any of which the applicable personnel of Pernix becomes aware regarding problems with the Product Development other than those associated with adverse drug reactions/experiences. Subject to the foregoing, the Company shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Commercialization Activities which representedsafety data relating to the #90879273v29 Product to the appropriate Governmental Authorities in and outside of the Territory, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with Applicable Law and requirements of Governmental Authorities in the Territory or the applicable jurisdiction outside of the Territory, as the case may be. As such pertains to the Corporate Services provided by Pernix, the Company shall promptly share all applicable laws and regulations along such reports with appropriate monitoring of clinical investigator trial sites for their compliancePernix, and (iii) the Credit Parties and their Subsidiaries have disclosed in all cases shall use its commercially reasonably efforts to provide such reports to Pernix before or simultaneous to the Agent all issuance of such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityreports to Governmental Authorities. (c) The Credit Parties, their Subsidiaries Company shall use its commercially reasonable efforts to obtain and maintain all Regulatory Approvals in the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretoTerritory. The Credit Parties and their Subsidiaries have and maintain in full force and effect Company shall be responsible for all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects Product-related communications with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other any Governmental Authority having jurisdiction over such Person. The Credit Parties in or outside of the Territory regarding the Product, unless previously agreed between the Company and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoPernix. (d) Except as set forth on Schedule 6.19(d), no Credit Each Party nor shall keep the other Party reasonably informed in writing in a timely manner of any of its Subsidiaries has received from information that such Party receives that (i) raises any Regulatory Authority any notice of alleged non-compliance material concerns regarding the safety or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 efficacy of the FD&C Act, Product; (ii) indicates or any other similar communication from any Regulatory Authority within suggests a potential material liability of either Party to third parties (including Governmental Authorities) in connection with the last five Product; (5iii) years. Except as set forth on Schedule 6.19(d), there have been no recalls, is reasonably likely to lead to a recall or market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations withdrawal of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, the Product; or (for example in iv) relates to the case of Product and is reasonably likely to have a recall) initiated by Credit Party material impact on a Regulatory Approval or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any commercialization of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsProduct. (e) No Credit PartyAt the request of designated persons within the Company, nor any of its SubsidiariesPernix will supply distribution information and other information reasonably requested by the Company, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority purposes of inclusion into the Company’s Annual Report to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyFDA. (f) Except as set forth on Schedule 6.19(fPernix shall ensure that the Distribution Service activities of Pernix, its Affiliates, Pernix Parties and sublicensees related to the Product shall be compliant with Applicable Laws. Pernix shall ensure that Pernix, its Affiliates, Pernix Parties and sublicensees shall not use any Promotional Materials not expressly approved for Pernix’s use by the Company Board (or its delegee). “Promotional Materials” means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, but not limited to, journal advertisements, sales aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, Internet postings, broadcast advertisements and sales reminder aids (for example, scratch pads, pens and other such items), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA used or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether intended for use by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with any promotion, distribution, marketing, advertising, importation, use, offer for sale, or sale of the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoProduct.

Regulatory Matters. With respect to each Product: (a) Set forth Neither AstraZeneca, any of its Affiliates nor, to AstraZeneca’s Knowledge, any Merck Party, or any Person on Schedule 6.19(a) behalf of any of the foregoing, is a complete and accurate list of all material Regulatory Authorizations relating to Exploiting any Other Products in the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesHorizon Territory. (b) (i) All regulatory filings required by any AstraZeneca, or an Affiliate of AstraZeneca, owns all Regulatory Authority or in respect of any Approvals and Regulatory Authorization with respect Documentation necessary to any conduct the Product or any Product Development and Commercialization Activities which represented, Business in the aggregate, 15% or more Horizon Territory as currently conducted and such Regulatory Approvals are in full force and effect. AstraZeneca has the right to grant the right of Net Sales in any applicable year, in reference and use under the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries Licensed Regulatory Documentation to Horizon in accordance with all the License Agreement. Neither AstraZeneca nor its Affiliates has received any written communication from any Governmental Authority threatening to withdraw or suspend any such Regulatory Approvals. No proceeding is pending or, to AstraZeneca’s Knowledge, threatened regarding the revocation of any such Regulatory Approval. AstraZeneca and its Affiliates have not voluntarily or involuntarily surrendered, terminated or permitted to lapse or expire any Regulatory Approval used or maintained by them in the conduct of the Product Business, except where any such Regulatory Approval has been not renewed in the ordinary course of business. AstraZeneca or its Affiliates have filed with the applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and Governmental Authority all material communications between representatives filings, declarations, listings, registrations, reports or submissions, including adverse event reports required in connection with the conduct of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit PartiesProduct Business. All such filings, their Subsidiaries and the agents thereof are declarations, listings, registrations, reports or submissions were in compliance in all material respects with all applicable statutesLaws when filed, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all no deficiencies have been asserted by any applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, Authority with respect to each Product and all Product Development and Commercialization Activities related theretoany such filings, declarations, listings, registrations, reports or submissions. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party Neither AstraZeneca nor any of its Subsidiaries has received from Affiliates is in violation of the terms of any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in Approval for the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsHorizon Territory. (ec) No Credit Party, nor There has not been any of its Subsidiaries, nor any officer, employee product recall or agent thereof, has made an untrue statement of a material fact market withdrawal or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests replacement conducted by or on behalf of AstraZeneca concerning the Product in the Horizon Territory or sponsored any product recall, market withdrawal or replacement conducted by or on behalf of any Third Party as a result of any alleged defect in the Credit Parties Product in the Horizon Territory. AstraZeneca has made available to Horizon copies of material field alerts, dear doctor letters, complaints and their Subsidiaries, notices of alleged defect or adverse reaction with respect to the Product in respect of which any Products or Product candidates under development the Horizon Territory that have participated, were (been received in writing by AstraZeneca and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsits Affiliates. (hd) The transactions contemplated Product has been Manufactured in compliance with applicable Law, including cGMP, and applicable Regulatory Approvals. Neither AstraZeneca nor any Affiliate or Third Party engaged by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useit, as the case may be) any Regulatory Authorizations relating to the Products in any material mannercapacity, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated herebyManufacture of the Product has received in the past [...***...] years or is currently subject to a Warning Letter (as defined in the Act) with respect to any facility manufacturing Product for Exploitation in the Horizon Territory. Subject to backorders or delays in the ordinary course, including AstraZeneca or its Affiliate has fulfilled all purchase orders submitted for the Liens granted Product in the Horizon Territory. (e) All studies, tests and preclinical and clinical trials conducted by or on behalf of AstraZeneca or its Affiliates relating to the Product were conducted, and all studies, tests and trials currently being conducted by or on behalf of AstraZeneca or its Affiliates in connection herewith with the clinical trials listed in Section 3.1.9(e) of the Disclosure Schedules are being conducted, in either case in all material respects in accordance with cGCP and other applicable Laws. AstraZeneca has completed all pediatric assessments or postmarketing commitments required by the exercise of rights and remedies FDA with respect theretoto the Product in the Horizon Territory. Neither AstraZeneca nor any Affiliate of AstraZeneca has received any written notices or correspondence from any applicable Governmental Authority requiring the termination, suspension, material modification or clinical hold of any clinical trials listed in Section 3.1.9(e) of the Disclosure Schedules.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aExcept as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) is a complete each of Parent and accurate list of its Subsidiaries holds (A) all material Regulatory Authorizations relating to authorizations under the Credit Parties and their SubsidiariesFDCA, the conduct of their businessPHSA, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by regulations of the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted LiensFDA promulgated thereunder, and (iiB) as applicable, validly registered and on file authorizations of any applicable Governmental Authority that are concerned with the applicable quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Parent Products (any such Governmental Authority, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of its Subsidiaries as currently conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent and its Subsidiaries are in compliance with the terms of all filing and maintenance requirements (including any fee requirements) thereof, and Parent Regulatory Permits. All Parent Regulatory Permits are in good standingfull force and effect, valid except where the failure to be in full force and enforceable with effect has not had and would not reasonably be expected to have, individually or in the applicable Governmental Authority. All required noticesaggregate, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesa Parent Material Adverse Effect. (b) (i) All regulatory filings required Neither Parent nor any of its Subsidiaries are party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityAgency. (c) The Credit PartiesAll pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by Parent or any of its Subsidiaries are being and, their Subsidiaries and the agents thereof are since January 1, 2017 have been, conducted in compliance in all material respects with all Applicable Laws administered or issued by the applicable statutes, rules and regulations (including all Healthcare Laws and Parent Regulatory Authorizations) of all applicable Governmental AuthoritiesAgencies, including (i) FDA standards for the FDA design, conduct, performance, monitoring, auditing, recording, analysis and all other Regulatory Authoritiesreporting of clinical trials contained in Title 21 parts 50, with respect 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that has not had and would not reasonably be expected to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth have, individually or in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoaggregate, a Parent Material Adverse Effect. (d) Except as set forth on Schedule 6.19(d)has not had and would not reasonably be expected to have, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance individually or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yeara Parent Material Adverse Effect, including any FDA Form 483 inspectional observationsduring the period beginning on January 1, notices of violations2017 and ending on the date hereof, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party neither Parent nor any of its Subsidiaries has received any written notification that remains unresolved notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of the Parent Products which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Parent Regulatory Permits or of any application for marketing approval currently pending before the FDA or such other Parent Regulatory Agency. (e) During the period beginning on January 1, 2017 and ending on the date hereof, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Authority indicating any breach Agency by Parent and its Subsidiaries have been so filed, maintained or violation of any applicable Regulatory Authorizationfurnished, including that any of the Products is misbranded except where failure to file, maintain or adulterated as defined in the FD&C Actfurnish such reports, in each case of the foregoingdocuments, which representedclaims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, 15% a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete in all material respects on the date filed (or more of Net Sales were corrected in any applicable year within the last five (5) years. (e) No Credit Partyor supplemented by a subsequent filing). Since January 1, 2017, neither Parent nor any of its Subsidiaries, nor nor, to the knowledge of Parent, any officer, employee employee, agent or agent thereofdistributor of Parent or any of its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statements statement to the FDA or any other Parent Regulatory AuthorityAgency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AuthorityAgency, or committed an act, made a statement, or failed to make a statement statement, in each such case, related to the business of Parent or any of its Subsidiaries, that, at the time such disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, since January 1, 2017, (i) neither Parent nor any of its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by Parent to be sold; and (ii) neither Parent nor any of its Subsidiaries, nor, to the knowledge of the Parent, any officer, employee, agent or distributor of Parent or any of its Subsidiaries, has been excluded from participation in any federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law or program. (f) Except as set forth has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, as to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by Parent or any of its Subsidiaries to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on Schedule 6.19(f)behalf of Parent or any of its Subsidiaries, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no Credit Party action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of its Subsidiaries of any Applicable Law, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. (g) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, during the period beginning on January 1, 2017 and ending on the date hereof, neither Parent nor any of its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts as of the date hereof which are reasonably likely to cause, and neither Parent nor any of its Subsidiaries has received any written notice that from the FDA or any other applicable Parent Regulatory Authority has commenced Agency during the period beginning on January 1, 2017 and ending on the date hereof regarding (i) the recall, market withdrawal or initiatedreplacement of any Parent Product sold or intended to be sold by Parent or its Subsidiaries (other than recalls, withdrawals or replacements that are not material to Parent and its Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities distribution of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their SubsidiariesParent Products, or (iv) a material negative change in respect reimbursement status of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsa Parent Product. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aEach of Rockets’ Subsidiaries that engages in the sale of electricity at wholesale (other than any such Subsidiaries that exclusively own solely one or more facilities that constitute a “qualifying facility” as such term is defined under the Public Utility Regulatory Policies Act (“PURPA”) and that qualify for exemption from regulation under Section 205 of the FPA pursuant to the rules and regulations of FERC) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally regulated as a “public utility” under the FPA and beneficially owned exclusively has been authorized by the Credit Parties FERC, pursuant to the FPA, to make sales at market-based rates or (ii) located within the Electric Reliability Council of Texas (“ERCOT”) and their Subsidiariesregistered as a “Power Generation Company” with the PUCT. Each of Rockets’ Subsidiaries that directly owns generating facilities has obtained an order from the FERC finding it to be, or has self-certified itself to the FERC as, an “Exempt Wholesale Generator” under either the Public Utility Holding Company Act of 1935 (“PUHCA 1935”) or the Public Utility Holding Company Act of 2005 (“PUHCA 2005”) or has obtained an order from the FERC finding it to be, or has self-certified itself to the FERC as, or is entitled to exemption from regulation as, a qualifying facility under PURPA. Neither Rockets nor any of its Subsidiaries are subject to the books and records requirements of FERC under Part 366 of the FERC’s Rules and Regulations (18 C.F.R. Part 366 (2009)). There are no pending or, to the Knowledge of Rockets, threatened judicial or administrative proceedings to revoke a Subsidiary’s market-based rate authorization, “Exempt Wholesale Generator” status or qualifying facility status, as applicable. To the Knowledge of Rockets, free and clear there are no events, facts or conditions that are reasonably likely to cause: (i) any of all Liens other than Permitted Liens, and Rockets’ Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization; or (ii) any of Rockets’ Subsidiaries that directly owns generating facilities to lose its status as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesan “Exempt Wholesale Generator” under PUHCA 2005. (b) (i) All regulatory filings required to be made by any Regulatory Authority Rockets or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice during the three (3) years preceding the date hereof with the FERC under the FPA or PUHCA 2005, the Department of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which representedEnergy, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA PUCT or any other applicable Regulatory Authority has commenced or initiatedstate public utility commissions, or threatened to commence with any governing ISO or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useregional reliability entity, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and no consent all such filings complied, as of their respective dates, with all applicable requirements of applicable Law, except for filings the failure of which to make or other authorization the failure of any Governmental Authority is required which to make in connection compliance with all applicable Law, would not reasonably be expected to have, individually or in the transactions contemplated herebyaggregate, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoa Rockets Material Adverse Effect.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis)Products. All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in material compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All material required notices, registrations and listings, applications, supplemental applications or notifications, reports (including recalls, field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removalexperiences) and other required material filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All material regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are materially complete and correct and have complied in all material respects with all applicable laws and regulationsHealthcare Laws, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in material accordance with all applicable laws and regulations Healthcare Laws along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such material regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are and for the past three (3) years have been in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any material written notice of alleged non-compliance, potential non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearthereto, including any FDA Form 483 inspectional observations483, notices of violations or potential violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five three (53) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any material breach or violation of any applicable Regulatory Authorization, including that any of the Products is are misbranded or adulterated as defined in the FD&C Act, in each case of or the foregoingrules and regulations promulgated thereunder, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the a recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in material accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsLaws. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their businessEach Acquired Corporation is, and since the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental AuthorityApplicable Date has been, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all Health Care Laws, in each case as applicable laws and regulationsto the operation of its business. Since the Applicable Date, no Acquired Corporation, nor, to the knowledge of the Company, any third parties that have performed or are performing any development, collaboration, manufacturing, testing, quality control, batch release, distribution or shipment activities on behalf of an Acquired Corporation or with respect to a Product Candidate, including any CMO, CRO, Clinical Trial site or investigator, while acting in such capacity (each, a “Collaboration Partner”) (i) has been subject to any enforcement, regulatory or administrative proceedings alleging non-compliance with any Health Care Laws; (ii) all clinical and pre-clinical trialshas received written notice threatening any such enforcement, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and regulatory or administrative proceeding; or (iii) has been issued a FDA Form 483, warning letter, notice of violation of Health Care Laws, or similar correspondence from any Governmental Body, except where any such issuance or violation would not be reasonably expected, individually or in the Credit Parties and their Subsidiaries have disclosed aggregate, to be material to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityAcquired Corporations taken as a whole. (cb) Since the Applicable Date, the Acquired Corporations have held all Regulatory Permits required for their business as then-conducted, and each Regulatory Permit required for their business as currently conducted is valid and in in full force and effect. The Credit Parties, their Subsidiaries and the agents thereof Acquired Corporations are in compliance in all material respects with all applicable statutesthe terms and requirements of such Regulatory Permits. Since the Applicable Date, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all no deficiencies have been asserted in writing by any applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings Body with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 Regulatory Permits of the FD&C ActAcquired Corporations. None of the Acquired Corporations has received written notice that any material Regulatory Permit will not or is likely not to be issued. (c) To the knowledge of the Company, all preclinical and clinical investigations, studies, or any other similar communication from any Regulatory Authority within trials (“Clinical Trials”) sponsored or conducted by or on behalf of the last five (5) years. Except as set forth on Schedule 6.19(d), there Acquired Corporations have been no recallsand are being conducted in material compliance with applicable Health Care Laws and Data Privacy Laws. No Acquired Corporation, market withdrawalsnor, field notifications or correctionsto the knowledge of the Company, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiariestheir Collaboration Partners or other Persons acting directly on their behalf, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved notice or other correspondence from the FDA or any other Regulatory Authority indicating Governmental Body performing functions similar to those performed by the FDA with respect to any breach ongoing Clinical Trial requiring or violation recommending a clinical hold, or the termination, suspension or material modification of any applicable Regulatory Authorizationsuch Clinical Trials. (d) The Acquired Corporations have filed with the FDA or any other Governmental Body performing functions similar to those performed by the FDA all required material filings, declarations, listings, registrations, reports or submissions, including that but not limited to adverse event reports, and any of the Products is misbranded required updates, corrections or adulterated as defined in the FD&C Act, in modifications to each case of the foregoing. All such filings, which representeddeclarations, listings, registrations, reports or submissions were in the aggregatematerial compliance with applicable Health Care Laws when filed, 15% or more of Net Sales and no deficiencies have been asserted in writing by any applicable year within the last five (5) yearsGovernmental Body with respect thereto. (e) No Credit PartyTo the knowledge of the Company, nor no Acquired Corporation, nor, to the knowledge of the Company, any of Collaboration Partner or other Person acting directly on its Subsidiaries, nor any officer, employee or agent thereof, behalf has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal GratuitiesGratuities Final Policy or for any Governmental Body to invoke a similar policy that may be applicable in another jurisdiction to an Acquired Corporation. No Acquired Corporation is the subject of any pending or, set forth to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. No Acquired Corporation nor, to the knowledge of the Company, any Collaboration Partner, officer, employee, agent or other Person acting on behalf of any Acquired Corporation has been debarred or disqualified, excluded from participation in 56 Fed. Reg. 46191 federal healthcare programs or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (September 10, 1991A) debarment under 21 U.S.C. § 335a or any similar policyLegal Requirement, (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement, or (C) disqualification pursuant to 21 CFR Part 312.70 or any similar Legal Requirement. (f) Except as set forth on Schedule 6.19(f)Since the Applicable Date, no Credit Party nor any of its Subsidiaries has the Acquired Corporations have not received any written notice from a Governmental Body that any of their products are misbranded as defined in 21 U.S.C. § 352 or adulterated as defined in 21 U.S.C. § 351, as amended, and the FDA or any other applicable Regulatory Authority has commenced or initiatedrules and regulations promulgated thereunder, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, as defined in each case, which represented, in the aggregate, 15% or more of Net Sales comparable Legal Requirements in any applicable year,jurisdiction. (g) Except as set forth on Schedule 6.19(g)has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the clinicalAcquired Corporations and, preclinicalto the knowledge of the Company, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their SubsidiariesCollaboration Partners, or other Persons acting directly on their behalf have prepared, submitted and implemented timely responses and, as applicable, any corrective action plans required to be prepared and submitted in respect response to all internal or third-party audits, inspections, investigations or examinations of which any Products or the Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (Candidates or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoAcquired Corporation’s business.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete Parent and accurate list of the Parent Subsidiaries hold all material Regulatory Authorizations relating to licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all authorizations under the Credit Parties and their SubsidiariesFDCA, the conduct PHSA and the regulations of their businessthe FDA promulgated thereunder, and any other Government Authority that regulates the Products quality, identity, strength, purity, safety, efficacy or manufacturing of Parent’s current or under-development products (on any such Government Authority, a per Product basis“Parent Regulatory Agency”) required for the lawful operation of the businesses of Parent and the Parent Subsidiaries (the “Parent Permits”). All such material Regulatory Authorizations Parent Permits are (i) legally valid and beneficially owned exclusively by the Credit Parties in full force and their Subsidiarieseffect. None of such Parent Permits will be terminated or impaired or become terminable, in whole or in part, as applicablea result of the transactions contemplated by this Agreement. Parent and the Parent Subsidiaries are the sole and exclusive owner of the Parent Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to Parent and the Parent Subsidiaries (collectively, the “Parent Regulatory Filings”) and hold all right, title and interest in and to all Parent Regulatory Filings free and clear of all Liens other than Permitted Liensany encumbrance. Parent and the Parent Subsidiaries have not granted any third party any right or license to use, and (ii) as applicableaccess or reference any of the Parent Regulatory Filings, validly registered and on file with including, without limitation, any of the applicable Governmental Authority, know-how contained in compliance with all filing and maintenance requirements any of the Parent Regulatory Filings or rights (including any fee requirementsregulatory exclusivities) thereof, and are in good standing, valid and enforceable associated with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritieseach such Parent Regulatory Filing. (b) Since January 1, 2008, there has not occurred any breach or violation of, default (iwith or without notice or lapse of time or both) All regulatory filings required by any Regulatory Authority under or in respect of any Regulatory Authorization with respect event giving rise to any Product right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries Parent Permit. Parent and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Parent Subsidiaries are in compliance in all material respects with the terms of all applicable registration Parent Permits, and listing requirements set forth no event has occurred and no facts or circumstances exist that, to the knowledge of Parent, would reasonably be expected to result in the FD&C Act revocation, cancellation, non-renewal or equivalent regulation adverse modification of each any Parent Permit. (c) Since January 1, 2008, all material applications, submissions, information and data utilized by Parent or the Parent Subsidiaries as the basis for, or submitted by or, to the knowledge of Parent, on behalf of Parent or the Parent Subsidiaries in connection with, any and all requests for Parent Permits when submitted to the FDA or other Governmental Authority having jurisdiction over such Person. The Credit Parties Parent Regulatory Agency, were accurate and their Subsidiaries adhere complete in all material respects as of the date of submission, and any updates, changes, corrections or modifications to all applicable regulations of all Regulatory Authorities with respect such applications, submissions, information and data required under Applicable Law have been submitted to the Products and all Product Development and Commercialization Activities related theretoFDA or other Parent Regulatory Agency. (d) Except as set forth on Schedule 6.19(d)Since January 1, no Credit Party 2008, neither Parent nor any of its the Parent Subsidiaries has received from committed any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make a any statement that, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Parent Regulatory Authority Agency to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities” or similar policies under Applicable Law. Neither Parent’s nor any of the Parent Subsidiaries’ agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Government Authority, set forth and there are no proceedings pending or threatened that reasonably might be expected to result in 56 Fed. Reg. 46191 criminal or civil liability or debarment or disqualification by the FDA or any other Government Authority. (September 10e) Neither Parent nor any of the Parent Subsidiaries nor, 1991to the knowledge of Parent, any director, officer, agent, employee or other Person associated with or acting on behalf of Parent or any of the Parent Subsidiaries has: (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the FCPA or any similar policyApplicable Law; or (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment. (f) Except as set forth on Schedule 6.19(f)Since January 1, no Credit Party nor 2008, there has not been any of its Subsidiaries has received any written notice that the FDA voluntarily or any other applicable Regulatory Authority has commenced or involuntarily initiated, conducted, or threatened issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to commence an alleged material lack of safety or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) efficacy of any Products product of Parent or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities product candidate of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Parent. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety Parent and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or its Subsidiaries are in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws compliance in all material respectsrespects with all Applicable Laws and any other letters, notices or guidance issued by the FDA or any Government Authority which regulate the sale of pharmaceutical products or biological, or device products in any jurisdiction. There are no pending or, to the knowledge of Parent, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against Parent or its Subsidiaries. Since January 1, 2008 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any Applicable Law relating to Parent or any Parent Subsidiary or the products or product candidates of Parent or any Parent Subsidiary or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Government Authority with regard to any product or any product candidate of Parent or any Parent Subsidiary. (h) The transactions contemplated manufacture of the products of Parent or any Parent Subsidiary is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the Loan Documents FDA. (i) Parent and its Subsidiaries are and have been in compliance in all material respects with all Applicable Laws requiring the maintenance or contemplated submission of reports or records under requirements administered by the conditions FDA or any other Government Authority, including Adverse Experiences, Serious Adverse Events, and Serious Injuries. There have been no Serious Adverse Events or Serious Injuries associated with the use (including in clinical trials) of the products or product candidates of Parent or any Parent Subsidiary that have not been reported to effectiveness the FDA in accordance with Applicable Law. (j) To the knowledge of Parent, all studies, tests, and preclinical and clinical research being conducted by Parent and Parent Subsidiaries, and to the knowledge of Parent, on behalf of Parent and Parent Subsidiaries, are being, and at all times have been, conducted incompliance in all material respects with all Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable laws of any Loan Document) will not impair any Credit Party’s other Government Authority. No clinical trial conducted by Parent or any Parent Subsidiary or, to the knowledge of its Subsidiaries’ ownership Parent, on behalf of Parent or rights any Parent Subsidiary has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other Person or entity involved in any such clinical trial. (k) Neither Parent nor any Parent Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of Parent or any Parent Subsidiary, nor, to the knowledge of Parent, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of Parent or any Parent Subsidiary is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Government Authority concerning compliance with the laws governing Federal Health Care Programs. (l) Neither Parent nor any Parent Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of Parent or any Parent Subsidiary, nor, to the knowledge of the Parent, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of Parent or any Parent Subsidiary: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act; (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the knowledge of Parent, is the target or the license subject of any current investigation by a Government Authority relating to any Federal Health Care Program related offense; or the right to use, as the case may be(v) is currently charged with or convicted of any Regulatory Authorizations criminal offense relating to the Products in delivery of an item or service under any material mannerFederal Health Care Program. (m) To the knowledge of Parent, and there are no consent pending or other authorization threatened filings against Parent or any Parent Subsidiary of an action relating to Parent or any Governmental Authority is required in connection with the transactions contemplated herebyParent Subsidiary under any federal or state whistleblower statute, including under the Liens granted False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (n) To the knowledge of Parent, neither Parent nor any Parent Subsidiary is under investigation by any Government Authority for a violation of HIPAA or the regulations contained in connection herewith 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local laws. Neither Parent nor any Parent Subsidiaries are “covered entities” as that term is defined in HIPAA. Parent and the exercise of rights Parent Subsidiaries have been in compliance in all material respects with federal and remedies with respect theretostate data breach laws.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aEach of Mavericks’ Subsidiaries that engages in the sale of electricity at wholesale (other than any such Subsidiaries that exclusively own solely one or more facilities that constitute a “qualifying facility” as such term is defined under PURPA and that qualify for exemption from regulation under Section 205 of the FPA pursuant to the rules and regulations of FERC) is located within ERCOT and registered as a complete and accurate list “Power Generation Company” with the PUCT. Each of all material Regulatory Authorizations relating Mavericks’ Subsidiaries that directly owns generating facilities has obtained an order from the FERC finding it to be, or has self-certified itself to the Credit Parties FERC as, an “Exempt Wholesale Generator” under either PUHCA 1935 or PUHCA 2005 or has obtained an order from the FERC finding it to be, or has self-certified itself to the FERC as, or is entitled to exemption from regulation as, a qualifying facility under PURPA. Neither Mavericks nor any of its Subsidiaries are subject to the books and their Subsidiaries, records requirements of FERC under Part 366 of the conduct of their business, FERC’s Rules and the Products Regulations (on a per Product basis18 C.F.R. Part 366 (2009)). All such material Regulatory Authorizations There are (i) legally and beneficially owned exclusively by no pending or, to the Credit Parties and their SubsidiariesKnowledge of Mavericks, threatened judicial or administrative proceedings to revoke a Subsidiary’s “Exempt Wholesale Generator” status or qualifying facility status, as applicable. To the Knowledge of Mavericks, free and clear there are no events, facts or conditions that are reasonably likely to cause any of all Liens other than Permitted Liens, and (ii) Mavericks’ Subsidiaries that directly owns generating facilities to lose its status as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesan “Exempt Wholesale Generator” under PUHCA 2005. (b) (i) All regulatory filings required to be made by any Regulatory Authority Mavericks or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any during the three (3) years preceding the date hereof with the FERC under the FPA or PUHCA 2005, the Department of Energy, the Nuclear Regulatory Authority any notice Commission (“NRC”) under the Atomic Energy Act of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five 1954 (5) years. Except as set forth on Schedule 6.19(d“AEA”), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA PUCT or any other applicable Regulatory Authority has commenced or initiatedstate public utility commissions, or threatened to commence with any governing ISO or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useregional reliability entity, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and no consent all such filings complied, as of their respective dates, with all applicable requirements of applicable Law, except for filings the failure of which to make or other authorization the failure of which to make in compliance with all applicable Law, would not reasonably be expected to have, individually or in the aggregate, a Mavericks Material Adverse Effect. (c) Except as would not reasonably be expected to have, individually or in the aggregate, a Mavericks Material Adverse Effect, (i) the operations of Comanche Peak by Mavericks and its Subsidiaries are, and since January 1, 2016, have been conducted, in compliance with all Mavericks Permits, including those Mavericks Permits providing for (A) the development and maintenance of emergency plans designed to respond to any unplanned releases of radioactive materials from Comanche Peak, (B) the handling and storage of spent nuclear fuel at Comanche Peak, (C) decommissioning planning for Comanche Peak, and (D) the maintenance of insurance against a nuclear incident, and (ii) (A) the operations of Comanche Peak are not the subject of any Governmental Authority outstanding notices of violation, any ongoing proceeding, heightened or additional inspections above the NRC baseline inspection program or requests for information from the NRC or any other agency with jurisdiction over such facility and (B) Comanche Peak is required not listed by the NRC in connection with the transactions contemplated hereby, including “unacceptable performance” column of the Liens granted in connection herewith and NRC Action Matrix as a part of the exercise NRC’s Assessment of rights and remedies with respect theretoLicensee Performance.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and Neither GLB nor any of its Subsidiaries nor any of their Subsidiariesrespective properties is a party to or is subject to any order, as applicabledecree, free and clear agreement, memorandum of all Liens other than Permitted Liensunderstanding or similar arrangement with, and (ii) as applicableor a commitment letter or similar submission to, validly registered and on file with the applicable Governmental Authorityor extraordinary supervisory letter from, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Bank Regulatory Authority or in respect any federal or state governmental agency or authority charged with the supervision or regulation of any Regulatory Authorization with respect to any Product issuers of securities or the supervision or regulation of GLB or any Product Development of its Subsidiaries (individually, a "GLB Regulatory Authority" and, collectively, the "GLB Regulatory Authorities"). GLB and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their its Subsidiaries have disclosed to the Agent paid all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and assessments made or imposed by any GLB Regulatory Authority. (cii) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party Neither GLB nor any of its Subsidiaries has received from been advised by, nor does it have any knowledge of facts that could give rise to a written advisory notice by, any GLB Regulatory Authority that such GLB Regulatory Authority is contemplating issuing or requesting, or is considering the appropriateness of issuing or requesting, any notice such order, decree, agreement, memorandum of alleged non-compliance understanding, commitment letter, supervisory letter or adverse findings similar submission. (iii) GLB and each of its Subsidiaries have timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that they were required to any Product file since January 1, 2002 with (A) the Federal Reserve Board, (B) the FDIC, (C) the Department or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or (D) any other similar communication from any Regulatory Authority within state regulatory authority and (E) the last five (5) yearsSEC, and all other reports and statements required to be filed by them since January 1, 2001, and have paid all fees and assessments due and payable in connection therewith. Except as set forth on in Schedule 6.19(d)5.2(i) of the GLB Disclosure Schedule and except for normal examinations conducted by Bank Regulatory Authorities, there have been (A) no recallsBank Regulatory Authority has initiated or has pending any proceeding or, market withdrawalsto the knowledge of GLB, field notifications investigation into the business or correctionsoperations of GLB, detentionsexcept where such proceedings or investigation are not reasonably likely to have, seizures, notifications either individually or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% a Material Adverse Effect, and (B) there is no unresolved violation, criticism or more of Net Sales in exception by any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Bank Regulatory Authority indicating any breach with respect to the business, operations, policies or violation procedures of any applicable Regulatory AuthorizationGLB that are reasonably likely to have, including that any of the Products is misbranded either individually or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsa Material Adverse Effect. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect The businesses of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years Borrowers have been made, and all such filings above such threshold are complete and correct and have complied being conducted in compliance in all material respects with all applicable laws Law, including the Healthcare Laws, and regulationsall Permits, (ii) each Product (whether manufactured by Accuray or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to Accuray or any of its Subsidiaries) has been, and currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed in compliance with all clinical applicable Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and pre-clinical trialsDocument Controls under 21 CFR 820.40 and all Product specifications as established in company documentation, if any, of investigational Products have been and are being conducted by except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Credit Parties (other than immaterial consequences), (iii) each contract between Accuray and their any of its Subsidiaries on the one hand, and any third party manufacturer on the other hand contain (and Accuray and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements, (iv) Accuray and its Subsidiaries are in compliance in all material respects with applicable Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (v) neither Accuray nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that Accuray, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Law or any Permit. (b) Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to Accuray or any of its Subsidiary is pending or, to the knowledge of the Credit Parties, threatened. None of Accuray or any of its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products. (c) Accuray and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, and (ii) to carry on the business of Accuray and each of its Subsidiaries. All such Permits are valid and in full force and effect and Accuray and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of Accuray or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease or that such Product should be withdrawn from the marketplace. (d) There have been no adverse clinical test results which have or could reasonably be expected to have a materially adverse impact on Accuray or any of its Subsidiaries, and there have been no Product recalls or voluntary Product withdrawals from any market (other than specific and discrete batches or lots not made in conjunction with a larger recall). (e) Neither Accuray nor any of its Subsidiaries have experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Accuray or any of its Subsidiaries in accordance with all applicable laws specifications thereof and regulations along the required payments related thereto in any twelve (12) month period have decreased by more than twenty percent (20%) with appropriate monitoring respect to the quantities of clinical investigator trial sites for such Product produced in the prior twelve (12) month period. (f) There has been no material untrue statement of fact and no fraudulent statement made by Accuray or any of its Subsidiaries or any of their compliancerespective agents or representatives to the FDA, NRC, or any other Governmental Authority, and (iii) the Credit Parties and their Subsidiaries have there has been no failure to disclose any material fact required to be disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and FDA, NRC or any Regulatory other Governmental Authority. (cg) The To the best knowledge of the Credit Parties, their no insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and treatments performed using the CyberKnife and TomoTherapy Products, or (ii) reduced the scope of coverage or the rate of reimbursement it provides for procedures and treatments performed using the CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to have a materially adverse impact on the revenues of Accuray and its Subsidiaries. None of Accuray or any of its Subsidiaries has been the subject of any “for cause” inspection, investigation or audit by any Governmental Authority in connection with any alleged improper activity. (h) There is no arrangement relating to Accuray or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by Accuray and the agents thereof each of its Subsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental AuthoritiesLaw, including the FDA Healthcare Laws. (i) None of Accuray or any of its Subsidiaries, or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for any federal or state health program-related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Credit Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of Accuray or any of its Subsidiaries or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of any crime or engaged in any conduct including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Law. No debarment proceedings or investigations in respect of the business of Accuray or any of its Subsidiaries are pending or, to the knowledge of the Credit Parties, threatened against Accuray or any of its Subsidiaries or any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries. (j) All studies, tests and all other Regulatory Authoritiespreclinical and clinical trials conducted relating to the Products, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their sponsored by Accuray or any of its Subsidiaries have been conducted, and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance currently being conducted, in all material respects in accordance with all applicable registration Law and listing requirements set forth in IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the FD&C Act extent required by applicable Law, Accuray and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or equivalent regulation on behalf of each other Governmental Authority having jurisdiction over Accuray or such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoSubsidiary, as applicable. (dk) Except as set forth on Schedule 6.19(d)To the knowledge of the Credit Parties, none of the clinical investigators in any clinical trial sponsored by Accuray or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Credit Parties, no Credit Party nor such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of Accuray or any of its Subsidiaries has received from any Regulatory the FDA or other applicable Governmental Authority any notice notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of alleged non-compliance any studies, tests or adverse findings clinical trials with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoProducts.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete At all times during the Term, LL shall maintain the production facility, equipment and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiariesprocesses (including, without limitation, the conduct of their business, process used in producing the Product and the Products (on a per Product basis). All such material Regulatory Authorizations are (iin performing LL’s other obligations under this Agreement) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with this Agreement, the Quality Agreement and all filing and maintenance requirements Applicable Laws (including any fee requirements) thereofincluding, and are in good standingwithout limitation, valid and enforceable with cGMP, the applicable Governmental Authority. All required noticesFDA and, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products extent applicable, the EMA guidelines, employment and labor law requirements, electrical, fire and safety at work codes and regulations and guidelines issued by any applicable Drug Regulatory Authorities in the Territory). LL shall make available for inspection, upon the last five (5) years have been timely filed with the FDA and request of Cadence, all other applicable Governmental Authoritiesdocumentation relating to such compliance. (b) (i) All regulatory filings required LL shall permit representatives of Cadence to conduct inspections from time to time at all Facilities utilized by any Regulatory Authority or in respect of any Regulatory Authorization with respect LL and its Affiliates hereunder to any Product or any Product Development and Commercialization Activities which representedmanufacture the Product, as agreed between the Parties in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityQuality Agreement. (c) The Credit PartiesIf either Party is notified that the Product manufactured at the Facility or the Facility will be subject to an inspection by FDA or any other Drug Regulatory Authority, their Subsidiaries such Party shall as soon as possible notify the other Party by telephone and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) e-mail of its receipt of such notification. LL shall provide Cadence copies of all applicable Governmental AuthoritiesDrug Regulatory Authority-issued inspection observation reports (including, including the FDA without limitation, Form 483s and all equivalent forms from other Drug Regulatory Authorities) and correspondence, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation purged only of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect confidential information that is unrelated to the Products Product. LL shall permit Cadence’s quality assurance representative to be present at the Facility during any such inspection by FDA or any other Drug Regulatory Authority that relates to the Product or LL’s performance under this Agreement, provided, however, that Cadence shall only have access to or communicate with the inspectors during the facility inspection as permitted under the Quality Agreement. LL will also notify Cadence as soon as possible of LL’s receipt of any other Form 483’s or warning letters or any other significant regulatory action which LL’s quality assurance group determines could impact the regulatory status of the Product. LL and all Cadence will cooperate in resolving any concerns with any Drug Regulatory Authority, and Cadence may review LL’s responses to any such reports and communications. LL will in its reasonable discretion incorporate into such responses any comments received from Cadence. LL will also inform Cadence of any action taken by any Drug Regulatory Authority against LL or any of its officers or employees which may be reasonably expected to adversely affect the Product Development and Commercialization Activities related theretoor LL’s ability to supply the Product hereunder within [***]. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor LL hereby grants Cadence the right to reference any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any drug master file regarding the Product or similar regulatory filing in the Territory that may now exist, or that may exist at any Product Development and Commercialization Activities related thereto which representedtime during the Supply Term or any extension thereof, in the aggregate, 15% any and all regulatory or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has filings made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of Cadence, its Affiliates or sponsored by sublicensees. Upon the Credit Parties and their Subsidiariesrequest of Cadence, or in respect LL shall provide Cadence with a letter evidencing such right of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsreference. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance 4.1 Company shall comply with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed in relation to the Agent all such regulatory filings manufacturing and all material communications between representatives handling of the Credit Parties (Product in the Territory and their Subsidiaries) and in any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and country outside the agents thereof are in compliance in all material respects Territory where Company manufactures Product or has Product manufactured on its behalf. Distributor shall comply with all applicable statutes, rules regulations and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain laws in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect relation to the Products handling, storage, distribution and all sale of the Product Development in those areas of the Territory where the Product is distributed and Commercialization Activities related theretosold by Distributor. 4.2 Each Party will report to the other all adverse events (d) Except as set forth on Schedule 6.19(dhereinafter called "AE"), no Credit Party nor any of customer complaints, technical or quality-related incidents and/or issues, which come to its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect attention relating to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearProduct, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, that come to a Party's attention through publications in journals or other media. Each party shall report any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, serious adverse events relating to any Products which representedProduct, in within 48 hours of receipt, to the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsother. 4.3 Distributor shall be responsible for preparing and submitting medical device reports (e"MDRs") No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required responsible national governmental authorities in the Territory. Company shall review and evaluate all Product complaints forwarded by Distributor. If Distributor believes that an MDR report needs to be disclosed filed, Company shall fully investigate the complaint and shall provide all information necessary to Distributor for Distributor to file the MDR report. With respect to adverse events and the like occurring with the Product outside the [*]CONFIDENTIAL TREATMENT REQUESTED 7 CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION CONFIDENTIAL DOCUMENT Territory, Company shall provide to Distributor all information relating to such complaints that may be or are subject to the FDA's reporting MDR requirements. Distributor shall evaluate this information and shall determine whether an MDR should be submitted. Company shall evaluate such events in relation to the standard operating procedures of Distributor's that will be adopted by Distributor and agreed upon by the parties. Company shall designate Distributor as agent to the FDA for these reporting purposes. 4.4 Within 15 days of the Effective Date of this Agreement, Company shall provide Distributor with copies of all documents relating to or constituting Company's 510(k) filing with the FDA. 4.5 Company agrees that it will not modify the Present Product or any other Regulatory AuthorityProduct whose specifications have been agreed upon by the Parties without prior notification to and approval by Distributor (which approval shall not be unreasonably withheld) so that Distributor can ascertain whether Distributor will need to file any additional Rule 510(k) filings. 4.6 Company will register as the Product manufacturer with the FDA. Distributor will list Product with FDA as approved for marketing. 4.7 Each Party will maintain such records and procedures to ensure that any batch of Products can be effectively and completely recalled from the market in the event that such action is required. 4.8 If, for any reason, it shall become necessary to trace back or recall any particular lot of the Product, or committed to identify the customer or customers to whom units from such lot will have been delivered, each party shall co-operate fully with the other in doing so. In the event that either Party has reason to believe that one or more lots of the Product should be recalled or withdrawn from distribution in the Territory, such Party shall immediately notify the other Party in writing. To the extent permitted by the circumstances, the Parties will confer before initiating any recall, but the decision as to whether or not to initiate a recall of the Product and to notify regulatory authorities in the Territory shall be Distributor's alone. If the recall is required because of a modification or withdrawal of an actapproval from a competent regulatory authority or a failure of the Product to conform to its Specifications, made a statementCompany shall promptly reimburse Distributor for the reasonable costs and expenses of such recall, and, at Distributor's option, Company shall replace the recalled Product free of additional charge, or failed credit or refund the Purchase Price of the recalled Product. If the recall is required because of a negligent act or omission of Distributor in handling, storage or distribution of the Product, then such recall shall be conducted by Distributor at its sole cost and expense and Distributor shall not be entitled to any such credits, replacements or refunds from Company. If such recall is required because of a joint act or omission of the Parties, Distributor shall conduct the recall, the Parties shall divide the cost of such a recall, and any replacement Product required by Distributor shall be provided by the Company to the Distributor at cost. 4.9 Each Party shall furthermore notify the other immediately of any information that it receives regarding any threatened or pending action by any Regulatory Authority which may affect the safety or efficacy claims of the Product within the Territory or the continued marketing of same. Upon receipt of any such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall be construed as restricting either Party's right to [*]CONFIDENTIAL TREATMENT REQUESTED 8 CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION make a statement that, at timely report of such matter to any Regulatory Authority in the time such disclosure was made (Territory or was not made), could reasonably be expected to take any further action that either Party deems appropriate or is required by applicable law or regulation. 4.10 Distributor will provide a basis for medical information service concerning the FDA or any other Regulatory Authority Products to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery the health professionals and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, patients in the aggregate, 15% or more of Net Sales in any applicable year,Territory. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set Each of the products currently marketed by ANI or any of its Subsidiaries and each of the products under development by ANI or any of its Subsidiaries is identified in Section 3.16(a) of the ANI Disclosure Schedule (the “ANI Products”). Except as set forth on Schedule 6.19(ain Section 3.16(a) is a complete of the ANI Disclosure Schedule, ANI and accurate list of the ANI Subsidiaries hold all material Regulatory Authorizations relating to licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all required authorizations under the Credit Parties Federal Food, Drug and their SubsidiariesCosmetic Act of 1938, as amended (the “FDCA”), the conduct Public Health Service Act of their business1944, as amended (the “PHSA”) and the regulations of the FDA promulgated thereunder, and any other Government Authority that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the ANI Products (on a per Product basisany such Government Authority, an “ANI Regulatory Agency”) required for the lawful operation of the businesses of ANI and the ANI Subsidiaries (the “ANI Permits”). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, except, in each case, as applicablewould not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on ANI. Except as set forth in Section 3.16(a) of the ANI Disclosure Schedule all such ANI Permits are valid and in full force and effect. Except as set forth in Section 3.16(a) of the ANI Disclosure Schedule, none of such ANI Permits will be terminated or impaired or become terminable, in whole or in part, as a result of the transactions contemplated by this Agreement. ANI and the ANI Subsidiaries are the sole and exclusive owner of the ANI Permits and the associated filings and applications with the FDA, including any biologics license application, new drug application, abbreviated new drug application, drug master files, biologics master files, master files for devices, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to ANI and the ANI Subsidiaries (collectively, the “ANI Regulatory Filings”) and hold all right, title and interest in and to all ANI Regulatory Filings free and clear of all Liens other than Permitted Liensany Lien. ANI and the ANI Subsidiaries have not granted any third party any right or license to use, and (ii) as applicableaccess or reference any of the ANI Regulatory Filings, validly registered and on file with including any of the applicable Governmental Authority, know-how contained in compliance with all filing and maintenance requirements any of the ANI Regulatory Filings or rights (including any fee requirementsregulatory exclusivities) thereof, and are in good standing, valid and enforceable associated with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritieseach such ANI Regulatory Filing. (b) Except as set forth in Section 3.16(b) of the ANI Disclosure Schedule, since January 1, 2010, there has not occurred any breach or violation of, default (iwith or without notice or lapse of time or both) All regulatory filings required by any Regulatory Authority under or in respect of any Regulatory Authorization with respect event giving rise to any Product right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any Product Development and Commercialization Activities which represented, ANI Permit. Except as set forth in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5Section 3.16(b) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit PartiesANI Disclosure Schedule, their Subsidiaries ANI and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their ANI Subsidiaries are in compliance in all material respects with the terms of all applicable registration ANI Permits, and listing requirements no event has occurred and no facts or circumstances exist that, to the knowledge of ANI, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any material ANI Permit. (c) Except as set forth in Section 3.16(c) of the FD&C Act ANI Disclosure Schedule, since January 1, 2010, all material applications, submissions, information and data used by ANI or equivalent regulation the ANI Subsidiaries as the basis for, or submitted by or, to the knowledge of each ANI, on behalf of ANI or the ANI Subsidiaries in connection with, any and all requests for ANI Permits when submitted to the FDA or other Governmental Authority having jurisdiction over such Person. The Credit Parties ANI Regulatory Agency, were, to ANI’s knowledge, accurate and their Subsidiaries adhere complete in all material respects as of the date of submission, and any updates, changes, corrections or modifications to all applicable regulations of all Regulatory Authorities with respect such applications, submissions, information and data required under Applicable Law have been submitted to the Products and all Product Development and Commercialization Activities related theretoFDA or other ANI Regulatory Agency. (d) Except as set forth on Schedule 6.19(d)Since January 1, no Credit Party 2010, neither ANI nor any of its the ANI Subsidiaries has received from committed any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make a any statement that, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other ANI Regulatory Authority Agency to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” or similar policies under Applicable Law. Except as set forth in 56 Fed. Reg. 46191 Section 3.16(d) of the ANI Disclosure Schedule, neither ANI nor any of its ANI Subsidiaries nor, to the knowledge of ANI, any agent, subcontractor, director, officer, employee or other Person associated with or acting on behalf of ANI has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Government Authority, and there are no proceedings pending or threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Government Authority. (September 10e) Neither ANI nor any of the ANI Subsidiaries nor, 1991to the knowledge of ANI, any director, officer, agent, employee or other Person associated with or acting on behalf of ANI or any of the ANI Subsidiaries has: (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), or any similar policyApplicable Law; or (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment. There are no pending or, to the knowledge of ANI, threatened filings against ANI or any ANI Subsidiary of an action relating to the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)). (f) Except as set forth on Schedule 6.19(f)Since January 1, no Credit Party nor 2010, there has not been any of its Subsidiaries has received any written notice that the FDA voluntarily or any other applicable Regulatory Authority has commenced or involuntarily initiated, conducted, or threatened issued recall, field notification, field correction, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to commence an alleged material lack of safety or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) efficacy of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,ANI Product. (g) Except as set forth on Schedule 6.19(g)in Section 3.16(g) of the ANI Disclosure Schedule, the clinicalANI and its Subsidiaries are in compliance in all material respects with all Applicable Laws and any other letters, preclinical, safety and other studies and tests conducted by notices or on behalf of or sponsored guidance issued by the Credit Parties FDA or any Government Authority which regulate the clinical investigation, manufacture, sale, promotion, sampling and their Subsidiariesdistribution of pharmaceutical products or biological, or device products in respect of which any Products or Product candidates under development have participatedjurisdiction. ANI has at all times and is currently distributing, were (marketing, promoting, labeling and if still pending, are) being conducted selling its products in accordance with all applicable Regulatory Authorizations the FDCA and Healthcare Laws Prescription Drug Marketing Act of 1987. There are no pending or, to the knowledge of ANI, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against ANI or its Subsidiaries. Since January 1, 2010 there have been no written notices, reports, FDA Form 483 observations that have not been disclosed by ANI, warning letters, or untitled letters alleging or asserting noncompliance in all any material respectsrespect with any Applicable Law relating to ANI or any ANI Subsidiary or any ANI Product or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Government Authority with regard to any ANI Product. (h) The transactions contemplated manufacture of the ANI Products is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the Loan Documents FDA. ANI has been in material compliance with FDA’s registration and listing requirements to the extent required by FDA. (i) ANI and its Subsidiaries are and have been in compliance in all material respects with all Applicable Laws requiring the maintenance or contemplated submission of reports or records under requirements administered by the conditions to effectiveness FDA or any other Government Authority, including Adverse Experiences, Serious Adverse Events, and Serious Injuries. Except as set forth in Section 3.16(i) of the ANI Disclosure Schedule, there have been no Serious Adverse Events or Serious Injuries associated with the use (including in clinical trials) of any Loan DocumentANI Products that have not been reported to the FDA in accordance with Applicable Law. (j) will not impair any Credit Party’s or any To the knowledge of its ANI, all studies, tests, and preclinical and clinical research being conducted by ANI and ANI Subsidiaries’ ownership , and to the knowledge of or rights under (or the license or the right to useANI, on behalf of ANI and ANI Subsidiaries, are being, and at all times have been, conducted in compliance in all material respects with all Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated herebyFDA, including the Liens granted ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable laws of any other Government Authority. No clinical trial conducted by ANI or any ANI Subsidiary or, to the knowledge of ANI, on behalf of ANI or any ANI Subsidiary has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in connection herewith any such clinical trial has initiated, or, to the knowledge of ANI, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other Person or entity involved in any such clinical trial. (k) Neither ANI nor any ANI Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of ANI or any ANI Subsidiary, nor, to the knowledge of ANI, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of ANI or any ANI Subsidiary is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, monitoring agreement, consent decree, settlement order, deferred prosecution agreement or other formal or informal agreement with any Government Authority concerning compliance with the laws governing any “Federal Health Care Program” (which means Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act) and any other state or federal health care program). ANI meets all the exercise requirements of rights participation and remedies with respect theretopayment of Medicare, Medicaid, and any other governmental health care programs and third party payment programs to the extent in which it participates (collectively, “Programs”). There is no action pending, received or, to ANI’s knowledge, threatened against ANI which relates in any way to a violation of any health care laws or which could result in the imposition penalties against or the exclusion of ANI from participation in any Programs. Neither ANI nor any ANI Subsidiary nor officer, director, managing employee have engaged in any activities which are cause for civil penalties or mandatory or permissive exclusion from any Program. To ANI’s knowledge, there is no pending, proposed or final Medicare national or local coverage determination that, if finalized, would restrict coverage for ANI’s Products. ANI has not established any reimbursement support program, such that payment for ANI product is contingent upon a purchaser’s receipt of payment from a third party payer. ANI does not furnish any coverage, coding or billing advice to any health care professionals regarding off-label indications of ANI products.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete Subject to any obligations of Seller under the Transition Services Agreement, from and accurate list of all material Regulatory Authorizations relating to after the Credit Parties Closing Date, Purchaser, at its cost, shall be solely responsible and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are liable for (i) legally taking all actions, paying all fees and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of conducting all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file communication with the applicable Governmental AuthorityAuthority required by Law in respect of the Applicable Permits, in compliance with including preparing and filing all filing and maintenance requirements reports (including any fee requirementsadverse drug experience reports) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required noticesAuthority (whether the Product is sold before or after transfer of the Registrations), registrations (ii) taking all actions and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings conducting all communication with Third Parties with respect to Product sold pursuant to the Products for Registrations (whether sold before or after transfer of the last five Registrations), including responding to all complaints in respect thereof, including complaints related to tampering or contamination, (5iii) years have been timely filed investigating all complaints and adverse drug experiences with respect to Product sold pursuant to the Registrations (whether sold before or after transfer of the Registrations), and (iv) carrying out any Phase IV post approval commitment (such as patient surveys) consistent with those described on Schedule 4.10(g) of the Seller Disclosure Schedule. At Purchaser's reasonable request, Seller shall cooperate, at its own expense, in connection with the FDA and all other applicable Governmental Authoritiesactivities of Purchaser contemplated by this Section 8.6(a). (b) From and after the Closing Date, Seller shall promptly notify the Purchaser of complaints or reports received of an adverse drug experience with respect to the Product. (ic) All regulatory filings Subject to the terms in the Supply Agreement with respect to Product Manufactured by Seller, from and after the Closing Date, Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the Product sold pursuant to such Registrations (whether sold before or after transfer of such Registrations), including recalls required by any Regulatory applicable Governmental Authority and recalls of units of the Product sold by Seller deemed necessary by Seller in its reasonable discretion; provided, however, that Seller shall reimburse Purchaser for the reasonable expenses and costs of conducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Product, and reasonable credits extended to customers in respect connection with the recall, provided that such recall is not attributable to the negligence or willful misconduct of Purchaser in conducting the Business. Seller promptly shall notify Purchaser in the event that a recall of the Product sold by Seller is necessary, and at Purchaser's reasonable request, Seller shall cooperate, at its own expense, in connection with any Regulatory Authorization such recall. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to any Product the omitted portions. (d) To the extent not otherwise previously completed pursuant to Sections 3.2(a)(ii) or any Product Development and Commercialization Activities which represented3.2(a)(iii), in Seller shall, within fifteen (15) days of the aggregateClosing Date, 15% or more notify the FDA of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, transfer of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries Registrations to Purchaser in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsLaws. (e) No Credit PartyTo the extent not otherwise previously completed pursuant to Section 3.2(b)(iv), nor any Purchaser shall, within fifteen (15) days of the Closing Date, notify the FDA of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement assumption of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted Registrations from Seller in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsLaws. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to All Permits held by the Credit Parties and their Subsidiaries, the conduct of their business, Borrower and the Products (on a per Product basis). All such material Regulatory Authorizations Subsidiaries are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicableBorrower or such Subsidiary, free and clear of all Liens other than Permitted LiensLiens permitted pursuant to Section 8.3, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority, it being understood and agreed that, as of the Closing Date, the Borrower and its Subsidiaries do not have medical device clearances or approvals from the FDA for its LDTs. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities, except where the failure to file the same would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. (b) Except in each case as would not reasonably be expected to have a Material Adverse Effect, since January 1, 2019, (i) All regulatory filings required by the Products, as well as the business of the Borrower and the Subsidiaries, comply with (A) all applicable Laws, including, without limitation, applicable requirements of CLIA and the FD&C Act (it being understood and agreed that, as of the Closing Date, the Borrower and its Subsidiaries do not have medical device clearances or approvals from the FDA for its LDTs), and (B) the terms of all Product Authorizations and other Permits; (ii) all laboratory testing services have been conducted in compliance with CLIA and all federal and state laws regarding laboratory testing services; (iii) all LDTs have been designed, developed, validated, and performed in compliance with CLIA, the FD&C Act, and all federal and state laws regarding laboratory testing services; (iv) none of the Borrower and the Subsidiaries, or, to the knowledge of the Borrower, their respective suppliers, have received any Regulatory Authority inspection reports, warning letters, untitled letters or in respect of any Regulatory Authorization similar documents with respect to any Product and/or with respect to the business of the Borrower and/or the Subsidiaries, from any Governmental Authority that assert lack of compliance with any applicable Laws (other than inspection reports that do not contain material findings or that have been remedied); (v) none of the Borrower or any of the Subsidiaries has received any written notice of, or otherwise have knowledge of, any pending regulatory enforcement action, investigation, or inquiry against the Borrower or any of the Subsidiaries or, to the knowledge of the Borrower, any of their respective suppliers, with respect to the Products; (vi) to the knowledge of the Borrower, there have been no Product Development recalls, safety alerts, withdrawals, clinical holds, marketing suspensions, removals, seizures, injunctions or the like conducted, undertaken or issued by any Person, whether or not at the request, demand or order of any Governmental Authority or otherwise, with respect to any Product nor, to the knowledge of the Borrower, has any such action been requested, demanded, or ordered by any Governmental Authority; (vii) to the knowledge of the Borrower, none of the Borrower or any of the Subsidiaries has received any written notice of (A) any criminal, injunctive, seizure, detention or civil penalty actions that have at any time been commenced or threatened in writing by any Governmental Authority with respect to or in connection with any Products, or (B) any consent decrees (including plea agreements) which relate to any Products; and Commercialization Activities which represented(viii) to the knowledge of the Borrower, in there is no basis for commencement of any criminal, injunctive, seizure, detention, or civil penalty actions by any Governmental Authority relating to the aggregateProducts or for issuance of any consent decrees. To the knowledge of the Borrower, 15% none of the Borrower or more any of Net Sales in the Subsidiaries is employing or utilizing the services of any individual who has been debarred or suspended under any applicable yearLaw since January 1, in the last five (5) years have 2019, other than, with respect to a Delayed Draw Closing Date, any employee or service provider that has been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted terminated by the Credit Parties and their Borrower reasonably promptly following the Borrower or its Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring becoming aware of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authoritysuspension or debarment. (c) The Credit PartiesAs of the Closing Date (and, their except as would not reasonably be expected to result in a Material Adverse Effect, as of each Delayed Draw Closing Date), none of the Borrower or the Subsidiaries has received any written notice from, any Governmental Authority or an institutional review board or ethics committee alleging any material non-compliance with applicable laws or GCPs or otherwise requiring the termination or suspension any clinical trial (in-whole or in-part) conducted, or being conducted, by or on behalf of the Borrower and the agents thereof are Subsidiaries with respect to any Product. Except as would not reasonably be expected to have a Material Adverse Effect, no clinical trial conducted, or being conducted, by or on behalf of the Borrower, and/or the Subsidiaries with respect to any Product has used, or is using, any clinical investigator who has been disqualified from conducting clinical investigations by FDA or other Governmental Authority. (d) Except in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authoritieseach case as would not reasonably be expected to have a Material Adverse Effect, with respect to the Products, since January 1, 2019: (i) all activities (including, without limitation, testing, validating, performing, marketing, sale, recordkeeping) by the Borrower or any of the Subsidiaries and, to the knowledge of the Borrower, their respective suppliers relating to the Products have been conducted, and are currently being conducted, in compliance with the applicable requirements of CLIA, the FD&C Act, other applicable requirements of Governmental Authorities, and (ii) none of the Borrower or any of the Subsidiaries, or, to the knowledge of the Borrower, any of their respective suppliers, has received written notice or threat of commencement of action by any Governmental Authority to withdraw its approval of any Product, to enjoin or prevent the performance of any LDT or otherwise prevent Borrower or any of its Subsidiaries from performing laboratory services, or to otherwise disrupt the business of the Borrower and the Subsidiaries, in each Product case, it being understood and agreed that, as of the Closing Date, the Borrower and its Subsidiaries do not have medical device clearances or approvals from the FDA for its LDTs. (e) [Reserved]. (f) [Reserved]. (g) Except as would not have a Material Adverse Effect, all Product Development studies, tests and Commercialization Activities related thereto. The Credit Parties preclinical and their clinical trials relating to the Products conducted by or on behalf of the Borrower or any of the Subsidiaries have been conducted, and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are currently being conducted, in compliance in all material respects with all applicable registration Laws, including, but not limited to, applicable provisions of the CLIA and listing requirements set forth in the FD&C Act Act, including applicable GCPs and applicable GLPs, it being understood and agreed that, as of the Closing Date, the Borrower and its Subsidiaries do not have medical device clearances or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to approvals from the Products and all Product Development and Commercialization Activities related theretoFDA for its LDTs. (dh) To the Borrower’s knowledge, there has been no untrue statement of fact and no fraudulent statement made by the Borrower or any of the Subsidiaries at the time such statements were made, or to the knowledge of the Borrower, any of their respective agents or representatives (when acting in such capacity) in any filing with the CMS, the FDA or any other Governmental Authority, and there has been no failure to disclose any fact required to be disclosed to any Regulatory Agency, in each case, except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect. (i) Except as set forth on Schedule 6.19(d6.18(i), no Credit Party nor any as of its the Closing Date (and, except as would not reasonably be expected to result in a Material Adverse Effect, as of each Delayed Draw Closing Date), the Borrower and the Subsidiaries has received from any Regulatory Authority any notice of alleged non-are in material compliance or adverse findings with respect to any Product or any Product Development federal and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearstate fraud and abuse laws, including any FDA Form 483 inspectional observationsthe federal Anti-Kickback Statute, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C False Claims Act, the Foreign Corrupt Practices Act, and similar applicable state, federal or any other similar communication from any Regulatory Authority within the last five (5) yearsforeign laws. Except as set forth on Schedule 6.19(d6.18(i), there have been no recallsfrom January 1, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements 2019 to the FDA or any other Regulatory AuthorityClosing Date (and, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was except as would not made), could reasonably be expected to provide result in a basis for Material Adverse Effect, from January 1, 2019 to each Delayed Draw Closing Date), none of the FDA Borrower or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its the Subsidiaries has received any written notice that from the FDA United States Department of Justice, any U.S. Attorney, any State Attorney General, or any other applicable Regulatory similar Governmental Authority has commenced or initiated, or threatened to commence or initiate, alleging any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) violation of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales laws in any material respect. The Borrower and its Subsidiaries have established and implemented a compliance program designed to ensure material compliance with federal and state fraud and abuse laws, including the federal Anti-Kickback Statute, the False Claims Act, the Foreign Corrupt Practices Act, and similar applicable year,state, federal or foreign laws. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (hj) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not materially impair any Credit Partythe Borrower’s or any of its the Subsidiaries’ ownership of or rights under (or the license or the other right to use, as the case may be) any Regulatory Authorizations Key Permits relating to the Products Products. (k) [Reserved]. (l) Except as set forth on Schedule 6.18(l), since January 1, 2019, none of the Borrower or any of the Subsidiaries, nor, to the Borrower’s knowledge, any individual who is an officer, director, manager or employee of the Borrower or any of the Subsidiaries has been convicted of or, to the Borrower’s knowledge, charged with or investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in any material mannersuch program, and no consent or other authorization except, as of any Governmental Authority Delayed Draw Closing Date, for any such individuals who have been promptly terminated by the Borrower or its Subsidiaries following such conviction or charge or as would not reasonably be expected to result in a Material Adverse Effect. Except as set forth on Schedule 6.18(l), since January 1, 2019, none of the Borrower or any of the Subsidiaries, nor, to the Borrower’s knowledge, any individual who is required an officer or director of the Borrower or any of the Subsidiaries has been convicted of any crime that has resulted or would reasonably be expected to result in connection with a debarment or exclusion under (i) 21 U.S.C. Section 335a or (ii) any similar applicable Law, except, as of any Delayed Draw Closing Date, for any such individuals who have been promptly terminated by the transactions contemplated herebyBorrower or its Subsidiaries following such conviction or charge or as would not reasonably be expected to result in a Material Adverse Effect. Except as set forth on Schedule 6.18(l), including from January 1, 2019 through the Liens granted Closing Date (and, except as would not reasonably be expected to result in connection herewith and a Material Adverse Effect, from January 1, 2019 through each Delayed Draw Closing Date), no debarment proceedings or investigations in respect of the exercise business of rights and remedies with respect theretothe Borrower or any of the Subsidiaries are pending or, to the Borrower’s knowledge, threatened against the Borrower, any of the Subsidiaries or any individual who is an officer, director, manager or employee of the Borrower or any of the Subsidiaries.

Regulatory Matters. With respect The nonclinical studies and clinical trials conducted by or to each Product: the Company’s Knowledge on behalf of the Company that are described in the General Disclosure Package and the Prospectus (athe “Company Studies and Trials”) Set forth on Schedule 6.19(a) is a complete and accurate list of were and, if still pending, are being, conducted in all material Regulatory Authorizations relating respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the General Disclosure Package; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or other correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials except where such termination, suspension or material modification would not reasonably be expected to have a Material Adverse Effect, and to the Credit Parties Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and their SubsidiariesTrials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have Company has complied in all material respects with all applicable laws and regulationsregulatory rules or requirements, (ii) all including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical and pre-clinical trials, if any, of investigational Products have investigator or has been and are being conducted found by the Credit Parties FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring operations of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof its suppliers are operated in compliance in all material respects with all applicable statutes, rules rules, and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 comparable regulatory agencies outside of the FD&C Act, or any other similar communication from any Regulatory Authority within United States to which the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products Company is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearssubject. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aEach of the Company’s Subsidiaries that engages in the sale of electricity at wholesale (other than any such Subsidiaries that own one or more facilities that constitute a “qualifying facility” as such term is defined under PURPA and the rules and regulations of FERC that are entitled to exemption from regulation under Section 205 of the FPA) is regulated as a complete “public utility” under the FPA and accurate list has market-based rate authorization to make such sales at market-based rates. Each of all material Regulatory Authorizations relating to the Credit Parties Company’s Subsidiaries that directly owns generating facilities and operates their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, power generation facilities in compliance with all filing and maintenance requirements (including any fee requirements) thereofapplicable standards of NERC, and other than non-compliance that would not reasonably be expected to have, individually or in the aggregate, a material impact on the Company. There are in good standingno pending, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for Knowledge of the last five (5) years have been timely filed with Company, threatened, judicial or administrative proceedings to revoke a Company’s Subsidiary’s market-based rate authorization. To the FDA and all Knowledge of the Company, there are no facts that are reasonably likely to cause any of the Company’s Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization, if applicable, other applicable Governmental Authoritiesthan where such loss would not reasonably be expected to have, individually or in the aggregate, a material impact on the Company. (b) All filings (iother than immaterial filings) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted be made by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their complianceCompany, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development Company Joint Venture since January 1, 2009, with the FERC under the FPA, the NRC under the Atomic Energy Act, the Department of Energy and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usestate public utility commissions, as the case may be, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and all such filings complied, as of their respective dates, with all applicable requirements of applicable statutes and the rules and regulations promulgated thereunder, except for filings the failure of which to make or the failure of which to make in compliance with all applicable requirements of applicable statutes and the rules and regulations promulgated thereunder, would not reasonably be expected to have, individually or in the aggregate, a material impact on the Company. (c) Since January 1, 2008, neither the Company, any Regulatory Authorizations of its Subsidiaries nor CENG has received any written notice or, to the Company’s Knowledge, other communication from the NERC regarding any actual or possible material violation of, or material failure to comply with, any Law. (d) This Section 4.13 excludes any representation or warranty by the Company or any of its Subsidiaries or any Company Joint Venture with respect to matters relating to the Products or arising under Environmental Laws or Hazardous Materials which are addressed in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 4.8.

Regulatory Matters. With Following the transfer of the Regulatory Documentation, including INDs to MedImmune pursuant to Section 3.9, subject to the terms set forth below, MedImmune shall be solely responsible for all regulatory filings and communications with each Regulatory Health Authority with respect to each that Regulatory Documentation including any INDs relating to the Licensed Product: , and MedImmune shall be solely responsible for any and all subsequent filings and communications with the Regulatory Health Authority including, without limitation, for the preparation and filing of all additional INDs relating to the Licensed Product and for providing, in the format required by Regulatory Health Authorities, the data and information required to be submitted to such Regulatory Health Authorities for Regulatory Approval of Licensed Products, including without limitation data from all Clinical Trials and all Manufacturing and controls information required for Regulatory Approval of such Licensed Product by the Regulatory Health Authorities. Notwithstanding the foregoing, MedImmune shall (ai) Set forth on Schedule 6.19(a) is a complete and accurate list provide Innate with copies of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Documentation received from Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Health Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) provide Innate with advance copies of all clinical material Regulatory Documentation for submission to Regulatory Health Authorities in the Major Markets, with sufficient time for Innate to review and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their complianceprovide comment, and give reasonable, good faith consideration to Innate’s suggestions therefor, (iii) permit at least one Innate representative to be present at all discussions and meetings with the Credit Parties EMA and their Subsidiaries have disclosed the FDA relating to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) Licensed Products subject to Applicable Law and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened restrictions imposed by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other EMA and (iv) generate true and accurate minutes of all discussions and meetings with Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Health Authorities relating to Licensed Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to Major Markets and provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities copies of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in minutes to Innate as promptly as possible following any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.such

Regulatory Matters. With respect The nonclinical studies and clinical trials conducted by or to each Product: the Company’s Knowledge on behalf of the Company that are described in the Registration Statement and the Prospectus (athe “Company Studies and Trials”) Set forth on Schedule 6.19(a) is a complete and accurate list of were and, if still pending, are being, conducted in all material Regulatory Authorizations relating respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Registration Statement or the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any written notices or other correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials except where such termination, suspension or material modification would not reasonably be expected to have a Material Adverse Effect, and to the Credit Parties Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and their SubsidiariesTrials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have Company has complied in all material respects with all applicable laws and regulationsregulatory rules or requirements, (ii) all including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical and pre-clinical trials, if any, of investigational Products have investigator or has been and are being conducted found by the Credit Parties FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring operations of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof its suppliers are operated in compliance in all material respects with all applicable statutes, rules rules, and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 comparable regulatory agencies outside of the FD&C Act, or any other similar communication from any Regulatory Authority within United States to which the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products Company is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearssubject. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete From and accurate list after the transfer by Seller to Buyer of all material each Regulatory Authorizations relating Approval pursuant to the Credit Parties terms hereof, but consistent with Sections 8.01, 8.09 and their Subsidiaries10.14 hereof, the conduct of their businessBuyer, at its cost, shall be solely responsible and the Products (on a per Product basis). All such material Regulatory Authorizations are liable for (i) legally taking all actions, paying all fees and beneficially owned exclusively conducting all communication with the appropriate Governmental or Regulatory Authority required by Law in respect of such Regulatory Approval and its related Products, including preparing and filing all reports (including adverse drug experience reports) with the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and appropriate Governmental or Regulatory Authority; (ii) as applicabletaking all actions and conducting all communication with third parties in respect of Products sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), validly registered including responding to all complaints and on file with the applicable Governmental Authority, medical inquiries in compliance with all filing and maintenance requirements (including any fee requirements) respect thereof, including complaints related to tampering or contamination; and are (iii) investigating all complaints and adverse drug experiences in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications respect of Products sold pursuant to such Regulatory Approval (whether sold before or notifications, reports (including field alerts, medical device reports (MDRs) and other reports after transfer of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiessuch Regulatory Approval). (b) (i) All regulatory filings required From and after the transfer by any Seller to Buyer of each Regulatory Authority Approval pursuant to the terms hereof and subject to the terms of the Interim Supply Agreement, Seller promptly shall notify Buyer if Seller receives a complaint or a report of an adverse drug experience in respect of any a Product sold pursuant to such Regulatory Authorization Approval. In addition, with respect to each Party's activities relating to the Products following the Closing, each Party shall cooperate with the other Party's reasonable requests and use commercially reasonable efforts to assist the requesting Party in connection with the investigation of and response to any Product complaint or adverse drug experience related to the Products. Any notification given by Seller within seventy-two (72) hours of receipt of such complaint or report shall constitute "prompt" notification for purposes of this Section 8.07(b). In addition, Seller shall notify Buyer of any adverse drug experience or reaction reports or any Product Development and Commercialization Activities which represented, in other reports or information indicating that any of the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and any toxicity, sensitivity reactions or are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring otherwise alleged to cause illness or injury of clinical investigator trial sites for their compliance, and any kind within seventy-two (iii72) the Credit Parties and their Subsidiaries have disclosed to the Agent all hours of Seller's receipt of any such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityreports. (c) The Credit PartiesFrom and after the transfer by Seller to Buyer of each Regulatory Approval pursuant to the terms hereof, their Subsidiaries Buyer, at its cost, shall be solely responsible and the agents thereof are in compliance in liable for conducting all material respects with all applicable statutes, rules voluntary and regulations involuntary recalls of units of Products sold pursuant to such Regulatory Approval (including all Healthcare Laws and whether sold before or after transfer of such Regulatory Authorizations) of all applicable Governmental AuthoritiesApproval), including recalls required by any Governmental or Regulatory Authority and recalls of units of Products sold by Seller deemed necessary by Seller in its reasonable discretion. Seller promptly shall notify Buyer in the FDA event that a recall of product sold by Seller is necessary. All costs and all other Regulatory Authorities, Damages of such recalls with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect Products sold prior to the Products and all Product Development and Commercialization Activities related theretoClosing shall be Retained Liabilities. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set Except as set forth on Schedule 6.19(ain Section 3.16(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesCompany Disclosure Letter, the conduct of their business, Company and the Products (on a per Product basis). All such material Regulatory Authorizations are its Subsidiaries (i) legally have filed with all applicable Regulatory Authorities all required applications, filings, declarations, listings, registrations, reports or submissions, (ii) the Company and beneficially owned exclusively by its Subsidiaries own, hold, possess or validly have all Product Registrations required to exploit, commercialize, sell and market the Credit Parties Product in and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liensfor the Territories, and (iiiii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws Legal Requirements related to such Product Registrations. To the Knowledge of the Company, all such applications, filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products no material deficiencies have been and are being conducted asserted in writing to the Company or its Subsidiaries by any applicable Regulatory Authority or Governmental Authority with respect to any such applications, filings, declarations, listings, registrations, reports or submissions, except for those deficiencies that have been addressed in full by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityCompany. (cb) The Credit Parties, their Company and its Subsidiaries and the agents thereof are in compliance in hold all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory AuthorizationsPermits as set forth in Section 3.16(b) of the Company Disclosure Letter issued by all relevant Regulatory Authorities required under applicable Governmental AuthoritiesLegal Requirements in each jurisdiction for their businesses as currently conducted, including and, to the FDA Knowledge of the Company and all other its Subsidiaries, each such Regulatory Authorities, with respect to each Product Permit is valid and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizationseffect. The Credit Parties Company and their its Subsidiaries are in compliance in all material respects with all the terms and requirements of such Regulatory Permits. No material deficiencies have been asserted in writing to the Company and its Subsidiaries by any applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Regulatory Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to any material Regulatory Permits of the Products Company and its Subsidiaries. (c) Except as would not be material to the businesses of the Company and its Subsidiaries, all Product Development preclinical and Commercialization Activities related theretoclinical investigations sponsored by the Company or its Subsidiaries since January 1, 2022, have been and are being conducted in compliance with all applicable Legal Requirements, including Good Clinical Practices requirements for each relevant jurisdiction, and Legal Requirements restricting the use and disclosure of individually identifiable health information. Neither the Company nor its Subsidiaries have received any written notice from a Regulatory Authority with respect to any ongoing clinical or preclinical investigations requiring the termination, suspension or material modification of such studies or tests. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect would not be material to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 businesses of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of Company and its Subsidiaries, relating to any Products which represented, in neither the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party Company nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five have (5i) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other a Regulatory Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other a Regulatory Authority, or (iii) to the Knowledge of the Company, committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke any policy related to fraud or untrue statements. Neither the Company nor its policy respecting FraudSubsidiaries are the subject of any pending, Untrue Statements or, to the Knowledge of Material Factsthe Company, Bribery threatened investigation by a Regulatory Authority with respect to (i) – (iii). As of the date of this Agreement, to the Knowledge of the Company, no officer, employee, agent or clinical investigator engaged by the Company or its Subsidiaries has been suspended, disqualified, debarred or convicted of any crime by a Regulatory Authority or, to the Knowledge of the Company or its Subsidiaries, engaged in any conduct that could result in debarment, exclusion or the assessment of a civil monetary penalty. (e) Except as would not be material to the businesses of the Company and Illegal Gratuitiesits Subsidiaries, set forth the Products manufactured or marketed by or on behalf of the Company and its Subsidiaries have, since January 1, 2022, been in 56 Fedcompliance with all Legal Requirements issued by a Regulatory Authority applicable to the Product, pharmaceutical products and to the operation of the Company’s or its Subsidiaries’ business. Reg. 46191 To the Knowledge of the Company, no third party that manufactures or commercializes finished product on behalf of the Company or its Subsidiaries (September 10but only in their capacity as such) has been subject to any enforcement, 1991) regulatory or any similar policyadministrative proceedings initiated by a Regulatory Authority and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened. (f) Except as set forth on Schedule 6.19(f)would not be material to the businesses of the Company and its Subsidiaries, no Credit Party since January 1, 2022, neither the Company nor any of its Subsidiaries has have received any written notice from a Regulatory Authority alleging or asserting (i) any violation applicable to the Product and/or (ii) that the FDA Product is improperly labeled or any other adulterated, pursuant to applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales Legal Requirements in any jurisdiction. The Product has complied in all material respects with all applicable year,Legal Requirements, including without limitation GMP, GDP, and applicable specifications and standards. Since January 1, 2022, neither the Company nor its Subsidiaries have received any written notice of observational inspections or other written warning after inspection of a manufacturing facility, and the observations that have been received have been addressed to the satisfaction of the issuing authorities. (g) Except as set forth on Schedule 6.19(g)All dossiers for each Product are fully up-to-date, in eCTD format and with all required variations and renewals being filed by the applicable due date. (h) Since January 1, 2022, the clinicalProduct has not been recalled, preclinicalwithdrawn, safety suspended, seized or discontinued by the Company or its Subsidiaries (whether voluntarily or otherwise) and there have been no written requests from any Governmental Authority or Regulatory Authority requiring the Company or its Subsidiaries to cease manufacturing, marketing, distributing or selling the Products. There are no facts, circumstances or conditions relating to the Products that would reasonably be expected to give rise to any recall, withdrawal, seizure or discontinuation (other studies than for commercial or other business reasons) by the Company or by any of its Subsidiaries of the Products. Up to the date hereof, the Company or any of its Subsidiaries have not received any material written complaints, warnings or notifications of any kind related to nonconformity of the Product, poor product safety, or damages caused by defective Product. Since January 1, 2022, the promotional materials and tests claims made by the Company or its Subsidiaries for the products manufactured or marketed by or on behalf of the Company or its Subsidiaries have complied in all material respects with all applicable Legal Requirements in all jurisdictions. (i) There are no outstanding, pending, or, to the Knowledge of the Company, threatened claims, disputes, or proceedings, and there are no facts or circumstances that would reasonably be expected to give rise to any such claims, disputes or proceedings, by any third party (including, for the avoidance of doubt, any clinical site, investigator, contract research organization, or patient) seeking payment, compensation, indemnification, reimbursement or any other form of monetary or non-monetary compensation in connection with any preclinical or clinical investigation, study or trial sponsored or conducted by or on behalf of the Company or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. (a) All of Credit Parties’ and their Subsidiaries’ material Products and material Regulatory Required Permits (limited to those Regulatory Required Permits the loss of which would reasonably be expected to have a Material Adverse Effect) are listed on Schedule 4.17 on the Closing Date. With respect to each material Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of the Credit Parties, and have provided Agent with all notices and other information required by Section 4.1, and (ii) such Product is being tested, manufactured, marketed or sold, as the case may be, by Credit Parties (or to the Agent Credit Parties’ knowledge, by any applicable third parties) in material compliance with all such regulatory filings applicable Laws and all material communications between representatives Regulatory Required Permits. (b) None of the Credit Parties (and their Subsidiaries) and or any Regulatory AuthoritySubsidiary thereof are in violation of any Healthcare Law in any material respect. (c) The No Credit Parties, their Subsidiaries and the agents Party or any Subsidiary thereof are in compliance in all material respects with all applicable statutes, rules and regulations receives any payments directly (including all Healthcare Laws and Regulatory Authorizationsthrough any third party payment processor) of all applicable Governmental Authoritiesfrom Medicare, including the FDA and all other Regulatory AuthoritiesMedicaid, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoTRICARE. (d) Except as set forth on Schedule 6.19(dTo the Credit Parties’ knowledge (after reasonable inquiry), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 none of the FD&C ActCredit Parties or their Subsidiaries’ officers, directors, employees, shareholders, their agents or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, affiliates has made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory AuthorityFDA, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), that could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ,” set forth in 56 Fed. Reg. Regulation 46191 (September 10, 1991) or any similar policy.). MidCap / Xtant / A&R Credit, Security and Guaranty Agreement (Term Loan) (fe) Except as set forth on Schedule 6.19(f)would not reasonably be expected to result in a Material Adverse Effect, no Credit Party nor any of its Subsidiaries each Product (i) has received any written notice that the FDA or any other applicable Regulatory Authority been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being been conducted in accordance with all applicable Regulatory Authorizations Permits and Healthcare Laws Laws; and (ii) to the extent applicable, has been and/or shall be manufactured in all material respectsaccordance with Good Manufacturing Practices. (hf) The transactions contemplated by the Loan Documents (or contemplated by the conditions No Credit Party, nor any Subsidiary thereof, is subject to effectiveness of any Loan Document) will not impair proceeding, suit or, to any Credit Party’s knowledge, investigation by any federal, state or local government or quasi-governmental body, agency, board or authority or any other administrative or investigative body (including the Office of its Subsidiaries’ ownership the Inspector General of or rights under (or the license or United States Department of Health and Human Services),which could reasonably be expected to result in the right to userevocation, as the case may be) any Regulatory Authorizations relating to the Products in transfer, surrender, suspension of any material mannerPermits of Borrower or any Subsidiary thereof or otherwise be expected to result in a Material Adverse Effect. (g) As of the Closing Date, and there have been no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoRegulatory Reporting Events.

Regulatory Matters. With respect (a) Prior to each Productthe NDA Transfer Date. The Parties acknowledge that Indevus has obtained FDA Approval for Trospium Twice-Daily and Trospium Once-Daily and is Confidential treatment has been requested for portions of this document. This copy of the document filed as an Exhibit omits the confidential information subject to the confidentiality request. Omissions are designated by the symbol [...***...]. A complete version of this document has been provided separately to the Securities and Exchange Commission. the owner of the Product NDAs as of the Execution Date and is expected to be the owner of the Product NDAs as of the Effective Date. Prior to the NDA Transfer Date: (ai) Set forth on Schedule 6.19(a) is a complete Indevus shall own and accurate list of control all material Regulatory Authorizations Documents relating to a Product in the Credit Parties and their Subsidiaries, Field in the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and Territory. (ii) as applicableIndevus shall have sole authority and responsibility for the timely preparation, validly registered filing, prosecution, and on file maintenance of all Regulatory Documents relating to a Product in the Field in the Territory, including Product NDAs and any reports or amendments necessary to maintain FDA Approvals, and for seeking any revisions of the conditions of each FDA Approval. (iii) Indevus shall have sole authority and responsibility to seek and/or obtain any necessary FDA approvals of any Product Label(ing), packaging, advertising or other promotional or informational materials used in connection with Product and Promotional Materials and for determining whether the same requires FDA approval, and Indevus shall submit Promotional Materials to the FDA after approval of both Parties, in accordance with the applicable Governmental Authorityprocedures set forth in Section 5.6. (iv) Indevus shall remain the primary contact with the FDA and shall be solely responsible for all communications with the FDA that relate to any IND or NDA relating to a Product in the Field in the Territory prior to and after any FDA Approval. (v) Esprit shall have the right, but not the obligation, to assist and consult with Indevus with respect to all regulatory submissions, including applications for FDA Approvals, prior to making any such submissions. At least thirty (30) days prior to the filing of any documents with the FDA relating to Products in compliance the Field, Indevus shall provide Esprit with copies of all filing such filings, submissions, authorizations and maintenance requirements (FDA Approvals, including any fee requirementscorrespondence related to manufacturing of Products in the Field; provided that, if Indevus believes it is required by Law to make such submission sooner, Indevus shall provide Esprit with final copies of such submissions for Esprit’s review at least two (2) thereof, and are Business Days prior to filing them with the FDA. Indevus shall consider in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports faith any comments of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Esprit with respect to the foregoing. (vi) Indevus shall provide Esprit with a copy of all safety data received by Indevus regarding Products for in the last five Field worldwide. (5vii) years have been timely filed Indevus shall provide advance notice to Esprit of any planned meetings, discussions, or other communications with the FDA relating to Products in the Field. Esprit shall have the right, but not the obligation, to participate with respect to such meetings, discussions, or other communications; provided that, in providing any such assistance, Esprit shall not contact the FDA without the prior approval of Indevus and, if contacted by the FDA with respect to Product, shall refer such contact to Indevus. Confidential treatment has been requested for portions of this document. This copy of the document filed as an Exhibit omits the confidential information subject to the confidentiality request. Omissions are designated by the symbol [...***...]. A complete version of this document has been provided separately to the Securities and all Exchange Commission. (viii) If contacted by the FDA with respect to a Product in the Field, Indevus shall notify Esprit within two (2) Business Days of such contact, and provide Esprit with any related official correspondence received from the FDA, including as applicable minutes of any meetings or telephone conferences and/or discussions between Indevus and the FDA. Esprit shall have a right to participate in and provide comments with respect to any subsequent meetings, discussions, or other applicable Governmental Authoritiescommunications with respect to such contact. (ix) To the extent Esprit reasonably believes that a filing or submission relating to Products in the Territory is required by Law, Esprit shall notify Indevus. If Indevus decides not to prepare such filing or submission, Indevus shall promptly notify Esprit, but in no event later than thirty (30) days, unless notified by Esprit that a shorter period of review is mandated by FDA or Law, after such notice by Esprit of such decision, and Esprit shall be entitled to prepare such filing or submission, to be filed or submitted by Indevus; provided that Esprit shall use good faith efforts to include any comments of Indevus in such filing or submission. (x) Prior to the Processing Assumption Date, changes to the Specifications shall be made only by mutual prior agreement of the Parties, except as required by Law. The Parties shall determine whether any such changes require any supplements to a Product NDA, and each Party shall provide the other Party with notice of any such changes as soon as practicable. After the Processing Assumption Date, but prior to the NDA Transfer Date, changes to the Specifications shall be made only after prior notification to Indevus of any such changes as soon as practicable, and the Parties shall determine whether any such changes require any supplements to a Product NDA, except as required by Law. (xi) Notwithstanding anything herein to the contrary, Indevus shall not file with the FDA any regulatory submissions that are intended to change or modify the Product label or FDA-approved prescribing information for, or the indications of, Trospium Twice-Daily or Trospium Once-Daily in the Territory without providing to Esprit a draft of such submission at least ten (10) days prior to planned submission to the FDA and giving prompt and reasonable consideration to any comments Esprit may have; provided that, if and to the extent required by Law Indevus is required to file any such submission in less than ten (10) days after notice from the FDA, Indevus will notify Esprit of any such requirement promptly and in no event later than two (2) Business Days after such notice. (xii) Notwithstanding Section 14.13(f), during the period beginning on the Processing Assumption Date and ending on the NDA Transfer Date, in connection with Indevus’ responsibilities as holder of the Product NDAs, Indevus and Esprit shall cooperate in good faith, in coordination with the Supply Committee, for Indevus to subcontract or assign the performance and management of quality assurance responsibilities to Esprit, while retaining the authority for Indevus to monitor Esprit’s performance, as subcontractor to Indevus with respect to such activities, consistent with Indevus’ quality obligations under the Product NDA for Trospium Once-Daily. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in After the aggregate, 15% or more of Net Sales in any applicable year, in NDA Transfer Date. After the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.NDA Transfer Date:

Regulatory Matters. With respect to each Product:5.1 Regulatory Responsibilities in the Licensed Territory. (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to Allos will lead regulatory activities in the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings EEA with respect to the Products Product in the Field and use Reasonably Diligent Efforts in respect of the Product in the Lead Indication in the EEA until the date that is the earliest of (i) [*]; (ii) [*]; or (iii) [*] (such date, the "Transfer Date"). Prior to the Transfer Date, Mundipharma will provide non-financial support to Allos with respect to such regulatory activities, up to two (2) representatives (depending upon space constraints) of Mundipharma will be invited to observe all meetings and interactions with Regulatory Authorities in the EEA with respect to the Product in the Field, and Mundipharma will have the right to review draft responses to Regulatory Authority questions with respect to the Product in the Field. Allos will, at its sole expense, transfer to Mundipharma on or around the Transfer Date, ownership of and responsibility for: (1) the DAA filed by Allos and validated by the EMA on December 15, 2010, (2) any and all Regulatory Approvals arising therefrom, (3) all orphan drug authorizations for the last five Product in the Field in the EEA, and (54) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesEU Pediatric Investigation Plan approved by the EMA. (b) (i) All regulatory filings required by any Regulatory Authority or Commencing on the Effective Date with respect to all countries of the Licensed Territory outside the EEA, and commencing on the Transfer Date with respect to countries in the EEA, Mundipharma shall use Reasonably Diligent Efforts in respect of any the Product as the primary interface with and shall otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorization with respect Authorities concerning regulatory activities related to any the Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, Field in the last five (5) years have been madeLicensed Territory, and Mundipharma shall be responsible for preparing and filing any and all Regulatory Materials for the Product in the Field in the Licensed Territory at its sole expense in accordance with the Development Plan. Allos shall assist and cooperate at its own expense with Mundipharma in connection with the preparation and filing of such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulationsRegulatory Materials, (ii) all clinical and pre-as reasonably requested by Mundipharma, including preparation of ongoing clinical trials, if anystudy reports and Periodic Safety Update Reports ("PSURs"). Such cooperation will include promptly responding within procedural timelines set by Regulatory Authorities to any reasonable request from Mundipharma for Allos Know-How needed for the Regulatory Materials. For clarity, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance Allos shall not be obligated to provide Mundipharma with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityInformation that is not Allos Know-How. (c) The Credit PartiesSubject to Section 5.1(a), Mundipharma shall keep Allos informed at JDC meetings of regulatory developments relating to the Product in the Field in the Licensed Territory and shall promptly notify Allos in writing of any action or decision by any Regulatory Authority in the Licensed Territory regarding the Product in the Field. Mundipharma shall provide Allos for review and comment all draft Regulatory Materials (other than routine correspondence such as IND and MAA annual reports, MAA reapproval, during the investigational phase minor protocol amendments, IND amendments for new investigators or new clinical preclinical studies) at least [*] (or in the event of a shorter filing deadline, as soon as practicable) in advance of their Subsidiaries intended date of submission to a Regulatory Authority in the Licensed Territory and shall consider in good faith any comments thereto provided by Allos. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the agents thereof are Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Mundipharma shall promptly notify Allos of any Regulatory Materials (other than routine correspondence such as IND and MAA annual reports, MAA reapproval, during the investigational phase minor protocol amendments, IND amendments for new investigators or new clinical preclinical studies) submitted to or received from any Regulatory Authority in compliance the Licensed Territory and shall provide Allos with copies thereof, in all material respects electronic Common Technical Document ("eCTD") format, where applicable, within [*] after submission or receipt. Mundipharma shall provide Allos with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) reasonable advance notice of all applicable Governmental Authoritiesmeetings, including the FDA conferences and all other discussions scheduled with any Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Authority in the FD&C Act Licensed Territory concerning the Product, and shall consider in good faith any input from Allos in preparing for such meetings, conferences or equivalent regulation discussions. To the extent permitted by applicable Laws, Allos shall have the right to participate in any such meetings, conferences or discussions and Mundipharma shall facilitate such participation. If Allos elects not to participate in such meetings, conferences or discussions, Mundipharma shall provide Allos with written summaries of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere meetings, conferences or discussions in all material respects to all applicable regulations of all Regulatory Authorities with respect to English as soon as practicable after the Products and all Product Development and Commercialization Activities related theretoconclusion thereof. (d) Except as set forth on Schedule 6.19(d)Within [*] of the Effective Date, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which representedAllos shall provide Mundipharma, in the aggregateeCTD format, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 with a full copy of the FD&C ActDAA filed by Allos and validated by the EMA on December 15, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years2010. (e) No Credit Party, nor any Allos shall be responsible for compiling and providing to Mundipharma the CMC Information that is required for Mundipharma to obtain and maintain Regulatory Approval of the Product in the Licensed Territory. Mundipharma shall use the CMC Information provided to it by Allos for the purpose of obtaining and maintaining Regulatory Approval of the Product in the Licensed Territory and in connection with the exercise of its Subsidiarieslicense under section 2.1(c). At Mundipharma's request, nor any officer, employee Allos shall provide reasonable assistance to Mundipharma with respect to communications with Regulatory Authorities in the Licensed Territory regarding the manufacture of the Product or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyCMC Information. (f) Except Unless the Parties otherwise agree in writing: (i) except as set forth on Schedule 6.19(fexpressly contemplated by Section 5.1(a), no Credit Party nor 5.1(b) or 5.1(e), Allos shall not communicate with respect to the Product in the Field with any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiatedhaving jurisdiction in the Licensed Territory, or threatened unless so ordered by such Regulatory Authority, in which case Allos shall provide immediate notice to commence or initiateMundipharma of such order; and (ii) except as expressly contemplated by Section 5.1(a), any action to withdraw Allos shall not submit any Regulatory Authorization, requested Materials or seek Regulatory Approvals for the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales Field in any applicable year,the Licensed Territory. 5.2 Regulatory Responsibilities in the Allos Territory. (ga) Except as set forth on Schedule 6.19(g), Allos shall own all Regulatory Materials (including Regulatory Approvals) for the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by Product in the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material mannerAllos Territory, and no consent or other authorization of shall be responsible for preparing and filing any Governmental Authority is required and all Regulatory Materials for the Product in the Allos Territory at its sole expense. Mundipharma shall assist and cooperate with Allos in connection with the transactions preparation and filing of such Regulatory Materials, as reasonably requested by Allos and at Allos' sole expense. (b) Allos shall keep Mundipharma informed of regulatory developments relating to the Product in the Field in the Allos Territory through regular reports at the JDC [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. meetings and shall promptly notify Mundipharma in writing of any action or decision by any Regulatory Authority in the Allos Territory relating to the Product. Allos shall provide Mundipharma for review and comment all draft Regulatory Materials (other than routine correspondence such as IND and NDA annual reports, during the investigational phase minor protocol amendments, IND amendments for new investigators or new clinical preclinical studies), at least [*] (or in the event of a shorter filing deadline, as soon as practicable) in advance of the intended date of submission to a Regulatory Authority in the Allos Territory and shall consider in good faith any comments thereto provided by Mundipharma. Allos shall promptly notify Mundipharma of any Regulatory Materials (other than routine correspondence such as IND and NDA annual reports, during the investigational phase minor protocol amendments, IND amendments for new investigators or new clinical preclinical studies) submitted to or received from any Regulatory Authorities in the Allos Territory and shall provide Mundipharma with copies thereof, in eCTD format, within [*] after submission or receipt. (c) Unless the Parties otherwise agree in writing: (i) except as expressly contemplated herebyby Section 5.2(a), including the Liens granted in connection herewith and the exercise of rights and remedies Mundipharma shall not communicate with respect theretoto the Product with any Regulatory Authority having jurisdiction in the Allos Territory, unless so ordered by such Regulatory Authority, in which case Mundipharma shall provide immediate notice to Allos of such order; and (ii) Mundipharma shall not submit any Regulatory Materials or seek Regulatory Approvals for the Product in the Allos Territory.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list The Borrower, each of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their its Subsidiaries and the Borrower’s agents thereof and the agents of each of the Borrower’s Subsidiaries are in compliance in all material respects with all applicable statutes, rules laws and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties Borrower and their each of its Subsidiaries have and maintain maintains in full force and effect all the necessary and requisite material Regulatory Authorizations. The Credit Parties Borrower and their each of its Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act FDCA or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties Borrower and their each of its Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities Activities, labeling, advertising, promotion, Product descriptions and claims for the Products related thereto. (db) All notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical reports or other reports of adverse experiences) and other filings required by any Regulatory Authority with respect to the Products have been filed with the FDA and any other applicable Governmental Authority. (c) Neither the Borrower nor any of its Subsidiaries has introduced into commercial distribution any Products manufactured by or on behalf of the Borrower or its Subsidiaries that were upon their shipment by the Borrower or any of its Subsidiaries adulterated or misbranded and all Products are and have been labeled, promoted, and advertised in accordance with their Registrations and approved labeling or within the scope of an exemption from obtaining such Registration. (i) The Borrower and its Subsidiaries and, to their knowledge, their respective suppliers are, and have been in material compliance with, and each Product in current commercial distribution is designed, manufactured, prepared, assembled, packaged, labeled, stored, installed, serviced, and processed in material compliance with, the applicable Regulatory Authority manufacturing requirements; and (ii) the Borrower and its Subsidiaries are in material compliance with the written procedures, record-keeping and reporting requirements required by the FDA or any other applicable Governmental Authority pertaining to the reporting of adverse events involving the Products, including, as the case may be, the FDA’s Safety Reporting Portal, the FDA’s MedWatch, or the FDA’s Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS). (e) Except as set forth on provided in Schedule 6.19(d3.30(e), no Credit Party neither the Borrower nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearthereto, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled warning letters, criminal proceeding notices under Section 305 of the FD&C ActFDCA, or any other similar communication from any Regulatory Authority within the last five (5) yearsAuthority. Except as set forth on Schedule 6.19(d), there There have been no seizures conducted or threatened by any Regulatory Authority with respect to any Product, and no recalls, market withdrawals, field notifications or corrections, detentions, seizuresnotifications, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, requested or threatened by any Regulatory AuthorityAuthority with respect to any Product, and no recalls, market withdrawals, field notifications, notifications of misbranding or (for example in the case of a recall) initiated adulteration or safety alerts have been conducted requested or threatened by Credit Party or any of its Subsidiaries, Regulatory Authority relating to any Products which represented, in Products. Neither the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party Borrower nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of FDCA or the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsrules and regulations promulgated thereunder. (ef) No Credit Party, Neither the Borrower nor any of its Subsidiaries, Subsidiaries nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Partythe Borrower’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set Schedule 4.26(a) sets forth on Schedule 6.19(a) is a true and complete and accurate list of all Regulatory Authorizations from the FDA and all other Regulatory Authorities (including ANDAs, NDAs and marketing authorizations) and the equivalent foreign registrations and approvals, held by the Company or any of its Subsidiaries, relating to the Business Products and used in the conduct of the Company’s business (collectively, the “Company Regulatory Authorizations”), and there are no other material Regulatory Authorizations relating to required for the Credit Parties and their Subsidiaries, Company or any of its Subsidiaries or the Business Products in connection with the conduct of their business, and the Products (on a per Product basis)Company’s business as currently conducted. All such material Company Regulatory Authorizations are in all material respects, (i) legally in full force and beneficially owned exclusively by the Credit Parties and their Subsidiarieseffect, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental AuthorityRegulatory Authorities, and (iii) in compliance with all formal filing and maintenance requirements (including any fee requirements) thereof. The Company has made available to Buyer complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and data, and are in good standingall other material Regulatory Authority communications, valid documents and enforceable with other information submitted by the Company or any of its Subsidiaries to or received by the Company or any of its Subsidiaries from the FDA or any equivalent Regulatory Authority, including inspection reports, warning letters, Form 483s and similar documents, relating to the Company, any of its Subsidiaries, the conduct of the Company’s business, or the Business Products. The Company or its applicable Governmental Authority. All Subsidiary has timely filed all required notices and responses to notices, registrations and listings, supplemental applications or notificationsapplications, reports (including field alertsadverse experience reports), medical device reports (MDRs) documents, claims, permits and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed information with the FDA and all other applicable Governmental Regulatory Authorities. To the Knowledge of the Company, all such notices and responses to notices, supplemental applications, reports (including adverse experience reports), documents, claims, permits and other information were complete and accurate in all material respects on the date filed (or were correct in or supplemented by a subsequent filing). (b) Except as set forth in Schedule 4.26(b), without limiting the generality of any other representations and warranties under this Agreement, since January 1, 2011, (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development the Company and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years its Subsidiaries have been made, and all such filings above such threshold are complete and correct and have complied in compliance in all material respects with the U.S. Food, Drug, and Cosmetic Act, as amended (21 U.S.C. §§ 301, et seq.) and all other applicable laws statutes, rules and regulationsregulations of the FDA or other similar federal, state or local governmental authorities or similar foreign government authorities including with respect to the manufacture, collection, sale, labeling, storing, testing, distribution, marketing, record keeping, training and adverse event reporting; (ii) all clinical the Company and pre-clinical trials, if any, of investigational Products its Subsidiaries have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules written requirements from the FDA and regulations (including all Healthcare Laws and other Regulatory Authorizations) of all applicable Governmental Authorities, including all requirements of the FDA and all other Regulatory AuthoritiesAuthorities in warning letters, notices of adverse findings, Form 483s, Section 305 notices and similar letters or notices, and in connection with respect all product recalls, notifications and safety alerts, and any request from the FDA or any Regulatory Authority requesting the Company or any Subsidiary of the Company to each Product cease to investigate, test or market any product, and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities consent decrees (including plea agreements) issued with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party Company or any of its Subsidiaries; (iii) there have been no inspection reports, relating to any Products which representedwarning letters, in notices of adverse findings, Form 483s, Section 305 notices or similar written documents received by the aggregate, 15% Company or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries Subsidiaries; (iv) to the Knowledge of the Company, there are no (nor has received the Company been notified by a third party of any) pending regulatory actions, field alerts, investigations or inquiries of any written notification that remains unresolved from sort by the FDA or any other Regulatory Authority indicating any breach (other than non-material routine or violation of any applicable Regulatory Authorization, including that periodic inspections or reviews) against the Company or any of its Subsidiaries or with respect to any Business Products ; (v) there have been no product recalls, warnings, notifications or safety alerts, whether voluntary or involuntary, conducted or issued by the Company or any of its Subsidiaries, the FDA or any other Regulatory Authorities with respect to the Business Products is misbranded or adulterated as defined in the FD&C Act, in each case and none of the foregoing, which represented, in foregoing has been requested or demanded by the aggregate, 15% FDA or more of Net Sales in any applicable year within other Regulatory Authorities; (vi) neither the last five (5) years. (e) No Credit Party, Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any of its employees, agents or subcontractors, has been convicted of any crime or engaged in any conduct which has or would reasonably be expected to result in suspension, debarment or exclusion from participation in Federal health care programs or in Federal procurement or nonprocurement programs by the FDA or any other Regulatory Authority. No criminal, injunctive, seizure or civil penalty actions has, at any time, been commenced or threatened by any Regulatory Authority or other Governmental Entity against the Company or any of its Subsidiaries or, to the Knowledge of the Company, any of its agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any of its Subsidiaries is bound or which relate to the Business Products. Neither the Company nor any officer, employee or agent thereof, of its Subsidiaries has made an any untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Authority, Authority or Government Entity related to the Business Products nor have they failed to disclose a material any fact required to be disclosed to the FDA or any other Regulatory AuthorityAuthority related to the Business Products, or committed an act, made a statement, or failed to make a statement that, at the time such the disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) ” or for the FDA or other Regulatory Authority to invoke any similar policy. (fc) Except as set forth on Schedule 6.19(f)The Company has made available to Buyer complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, no Credit Party nor all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company or any of its Subsidiaries has to or received by the Company or any written notice that of its Subsidiaries from the FDA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to the Company, any of its Subsidiaries, the conduct of the Company’s business, or the Business Products. (d) The manufacture of Business Products by the Company and each of its Subsidiaries is, or, in the case of any Business Products manufactured by any Business Partner, to the Knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Good Manufacturing Practices. In addition, each of the Company and each of its Subsidiaries and, to the Knowledge of the Company, each of its respective Business Partners, is in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and all similar applicable Laws. No Business Product sold by the Company or any Subsidiary of the Company or held in inventory by the Company or any Subsidiary of the Company has been adulterated or misbranded. All labeling is in material compliance with the FDCA, related regulations and other Regulatory Authority requirements, and all advertising and promotional materials of the Company or any of its Subsidiaries are in material compliance with the FDCA, related regulations and other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,requirements. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete From and accurate list after the transfer by Seller to Buyer of all material each Regulatory Authorizations relating Approval pursuant to the Credit Parties terms hereof, but consistent with Sections 8.18 and their Subsidiaries8.19 hereof, the conduct of their businessBuyer, at its cost, shall be solely responsible and the Products (on a per Product basis). All such material Regulatory Authorizations are liable for (i) legally taking all actions, paying all fees and beneficially owned exclusively conducting all communication with the appropriate Governmental or Regulatory Authority required by Law in respect of such Regulatory Approval, including preparing and filing all reports (including adverse drug experience reports) with the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and appropriate Governmental or Regulatory Authority; (ii) as applicabletaking all actions and conducting all communication with third parties in respect of Products sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), validly registered and on file with the applicable Governmental Authority, including responding to all complaints in compliance with all filing and maintenance requirements (including any fee requirements) respect thereof, including complaints related to tampering or contamination; and are (iii) investigating all complaints and adverse drug experiences in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications respect of Products sold pursuant to such Regulatory Approval (whether sold before or notifications, reports (including field alerts, medical device reports (MDRs) and other reports after transfer of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiessuch Regulatory Approval). (b) (i) All regulatory filings required From and after the transfer by any Seller to Buyer of each Regulatory Authority Approval pursuant to the terms hereof, Seller promptly shall notify Buyer if Seller receives a complaint or a report of an adverse drug experience in respect of any a Product sold pursuant to such Regulatory Authorization Approval. In addition, Seller shall cooperate with respect Buyer's reasonable requests and use commercially reasonable efforts to assist Buyer in connection with the investigation of and response to any complaint or adverse drug experience related to a Product sold by Seller or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityits Affiliates. (c) The Credit PartiesFrom and after the transfer by Seller to Buyer of each Regulatory Approval pursuant to the terms hereof, their Subsidiaries Buyer, at its cost, shall be solely responsible and the agents thereof are in compliance in liable for conducting all material respects with all applicable statutes, rules voluntary and regulations involuntary recalls of units of Products sold pursuant to such Regulatory Approval (including all Healthcare Laws and whether sold before or after transfer of such Regulatory Authorizations) of all applicable Governmental AuthoritiesApproval), including recalls required by any Governmental or Regulatory Authority and recalls of units of Products sold by Seller or its Affiliates deemed necessary by Seller in its reasonable discretion. Seller promptly shall notify Buyer in the FDA event that a recall of product sold by Seller or its Affiliates is necessary. Seller shall indemnify and reimburse Buyer for all other Regulatory Authorities, costs and Damages of such recalls with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect Products sold prior to the Products and all Product Development and Commercialization Activities related theretoClosing. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth Except as would not have a material impact on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesBusiness, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted LiensAcquired Companies are, and (ii) as applicablesince December 31, validly registered and on file with the applicable Governmental Authority2016 have been, in compliance with all filing Healthcare Laws applicable to the Acquired Companies and maintenance requirements the Business, (including any fee requirementsii) thereofthe research, development, design, manufacture and testing of the Acquired Companies Products by or on behalf of the Acquired Companies is being, and are since December 31, 2016 have been, conducted in good standing, valid compliance with all applicable Healthcare Laws and enforceable with (iii) the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctionsAcquired Companies are, and reports of corrections or removal) since December 31, 2016 have been, in compliance with all registration and other required filings with respect listing requirements to the Products for the last five (5) years have been timely filed with the FDA and all other extent required by applicable Governmental AuthoritiesHealthcare Laws. (b) Except as would not have a material impact on the Business, each of the Acquired Companies (i) All regulatory filings required by holds, and since December 31, 2016 have held, such Permits necessary or advisable for the design, development, pre-clinical and clinical testing of the Acquired Companies Products in any Regulatory Authority or in respect of any Regulatory Authorization jurisdictions where it currently conducts such activities with respect to any each Acquired Company Product or any Product Development (collectively, the “Acquired Companies Licenses”) and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical is, and pre-clinical trialssince December 31, if any2016 has been, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance compliance with all applicable laws terms and regulations along with appropriate monitoring conditions of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityAcquired Company License. (c) The Credit PartiesSince December 31, their Subsidiaries and 2016, there have been no adverse regulatory Actions taken (or, to the agents thereof are in compliance in all material respects with all applicable statutesKnowledge of Seller, rules and regulations (including all Healthcare Laws and Regulatory Authorizationsthreatened) of all applicable by any Governmental Authorities, including the FDA and all other Regulatory Authorities, Authority with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all any of the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries Acquired Companies Products or any facilities where such Acquired Companies Products are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretotested. (d) Except as The Acquired Companies are not, and since December 31, 2016 have not been, the subject of any pending or, to the Knowledge of Seller, threatened investigation regarding the Acquired Companies or the Acquired Companies Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth on Schedule 6.19(din 56 Fed. Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”), no Credit Party nor or otherwise. Neither the Acquired Companies, nor, to the Knowledge of Seller, any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance officer or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 employee of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, Acquired Companies has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Governmental Authority, or failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Governmental Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) the FDA Fraud Policy or any similar policy. (f) Except policy in any country. Neither the Acquired Companies nor, to the Knowledge of Seller, any officer or employee of the Acquired Companies, has been convicted of any crime for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as set forth on Schedule 6.19(f)amended, no Credit Party nor or any of its Subsidiaries has similar Law. The Acquired Companies have not received any written notice that any of their employees is included on the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) List of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored Excluded Individuals/Entities maintained by the Credit Parties Office of Inspector General of the United States Department of Health and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsHuman Services. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the All Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutesinvestigational device exemption, rules premarket notification and/or premarket approval requirements and regulations other requirements of the Food and Drug Administration (including all Healthcare Laws and Regulatory Authorizations“FDA”) of all applicable Governmental Authorities, including the FDA or any other relevant regulatory authority and all other Regulatory AuthoritiesLicenses, with respect permissions, authorizations, notified body certificates of compliance or consents required for placing the products on the market in the European Union or elsewhere. Any modifications by the Company or any of its Subsidiaries to each any Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their marketed by the Company or any of its Subsidiaries have and maintain been made in full force and effect all the necessary and requisite Regulatory Authorizationsaccordance with applicable Law. The Credit Parties and their Subsidiaries All manufacturing facilities are operated in compliance in all material respects with the FDA’s Quality System Regulation requirements at 21 C.F.R. Part 820, as applicable, and all applicable registration manufacturing environments for sterile products are specified, controlled and listing requirements monitored in compliance with the European Council Directive 93/42/EEC concerning medical devices and relevant standards published by the International Standards Organization. (b) The Company is in material compliance with the terms of the 1995 consent decree between FDA and IPI (the “Consent Decree”). Copies of all documentation and written correspondence between the Company, IPI and/or FDA relating to this Consent Decree in the Company’s possession, have been made available or will be made available by Closing. The Company has made available or will make available at Closing copies of all reports of all expert inspections of the Company’s Chicago facility to determine conformance with relevant Law, as set forth in the FD&C Act Consent Decree. At the time of Closing, the Company will have made all notifications required by applicable Law, written or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects otherwise, to all applicable regulations necessary FDA officials and/or offices, notifying the FDA of all Regulatory Authorities a change in ownership, in accordance with respect the provisions of Section 17 of the Consent Decree. (c) For those Products marketed in the U.S. by the Company and each of its Subsidiaries based on their status as medical devices marketed prior to May 28, 1976 (“Preamendment Devices”), which Products are listed in Section 4.24(c) to the Disclosure Schedule, the Company and each of its Subsidiaries possess, or will possess at Closing, documentation that meets all of the criteria set forth for affidavits in FDA’s guidance, “Preamendment Status”, to (1) verify that these Products were marketed prior to May 28, 1976, and all Product Development and Commercialization Activities related thereto(2) have not changed significantly since that time such that they would require filing of a 510(k) premarket notification or premarket approval application with the FDA. (d) Except as set forth on Schedule 6.19(d)All preclinical and clinical trials conducted or supervised by the Company or any of its Subsidiaries have been conducted in material compliance with all applicable Laws, including, but not limited to, FDA good clinical practice and good laboratory practice requirements and European competent authority notification requirements. The Company and each of its Subsidiaries have consistently obtained and maintained any necessary Institutional Review Board (“IRB”) approvals of clinical trials or modifications thereto, conducted or supervised by the Company or any of its Subsidiaries. In no Credit Party nor clinical trial sponsored, conducted or supervised by the Company or any of its Subsidiaries has received from any Regulatory Authority any notice IRB, ethics committee or European competent authority approval ever been suspended, terminated, put on clinical hold or voluntarily withdrawn because of alleged non-compliance or adverse findings with respect deficiencies attributed to any Product the Company or any Product Development and Commercialization Activities related thereto which representedof its Subsidiaries. (e) In the last three years, in the aggregate, 15% or more of Net Sales in no Governmental Body has served any applicable year, including any FDA Form 483 inspectional observations, notices of violationsnotice, Warning LettersLetter, untitled lettersregulatory letter, criminal proceeding notices under Application Integrity Policy (“AIP”) communication, Section 305 of the FD&C Act, notice or any other similar communication from any Regulatory Authority within on the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party Company or any of its SubsidiariesSubsidiaries or, relating to the Knowledge of the Company, any of their officers, directors or employees stating that the business was or is in violation of any Law or Court Order (including, without limitation, those of the European Union) or were or are the subject of any pending, threatened or anticipated Governmental Body investigation, proceeding, review or inquiry, which might reasonably be expected to lead to any Products which representedsanction, in exclusion or loss of or refusal to renew any of the aggregate, 15% Licenses held by the Company or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received or refusal to review any written notification that remains unresolved from pending or future Product License submissions filed with any Governmental Body, and, to the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any Knowledge of the Products is misbranded Company, no facts or adulterated as defined in the FD&C Actcircumstances have occurred that are reasonably likely to give rise to any such investigation, in each case of the foregoingproceeding, which represented, in the aggregate, 15% review or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyinquiry. (f) Except as set forth on Schedule 6.19(f)disclosed in Section 4.24(f) to the Disclosure Schedule, no Credit Party in the last three years, none of the Products have been recalled or subject to FDA correction or removal requirements, and the Company and each of its Subsidiaries have not received notice, either completed or pending, of any proceeding seeking a corrective action, recall, suspension or seizure of any Products. Neither the Company nor any of its Subsidiaries has have received any written notice that order, demand or other formal proceedings from any competent authority or notified body for medical devices to undertake any form of withdrawal from the FDA market of any of the Products or any other applicable Regulatory Authority has commenced Product recall and have notified any competent authority or initiatednotified body of the intent to conduct a market withdrawal, Product recall or threatened field correction, and, to commence the Knowledge of the Company, no facts or initiatecircumstances have occurred that are reasonably likely to give rise to any such corrective action, any action to withdraw any Regulatory Authorizationrecall, requested the recall (whether by correction suspension or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,seizure. (g) Except as set forth Neither the Company nor any of its Subsidiaries are included on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsFDA’s AIP list. (h) The transactions contemplated by As of the Loan Documents (or contemplated by date hereof, neither the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or Company nor any of its Subsidiaries’ ownership , nor, to the Company’s Knowledge, any of its employees, agents or rights consultants retained to assist with Product License submissions, have been disqualified or debarred by the FDA, pursuant to 21 U.S.C. §§ 335(a) or (b), or for any purpose, been charged with or convicted under (or the license or the right to use, as the case may be) any Regulatory Authorizations United States law for conduct relating to the Products in development, approval, marketing or sale of drugs or devices or otherwise relating to the regulation of any material mannerdrug product under the Generic Drug Enforcement Act of 1992 or any other relevant law or been disbarred, disqualified or convicted under or for any equivalent or similar applicable foreign laws, including, without limitation, those of the European Union and each of its member states. (i) Neither the Company nor any of its Subsidiaries, or, to the Company’s Knowledge, any of their agents, officers, directors or employees, have violated or caused a violation of any federal or state health care fraud and abuse or false claims statute or regulation, including, but not limited to, the Medicare/Medicaid Anti-kickback provisions of the Social Security Act, 42 U.S.C. § 1320a-7b(b), and no consent the relevant regulations in 42 C.F.R. Part 1001 or other authorization have violated or caused a violation of any Governmental Authority is required in connection with equivalent or similar applicable foreign laws, including, without limitation, those of the transactions contemplated hereby, including the Liens granted in connection herewith European Union and the exercise each of rights and remedies with respect theretoits member states.

Regulatory Matters. With respect All Product, other than Prototypes, supplied to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall be produced under cGMP and in accordance with the Specifications. CIMA shall furnish [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with a Certificate of Analysis with a cGMP statement to demonstrate that each Product: (a) Set forth on Schedule 6.19(a) is a complete shipment of Product has been manufactured under cGMP and accurate list other FDA guidelines and in accordance with the Specifications. In addition, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] reserves the right, at its own expense, to audit the facility of CIMA, including its processes, records and other facets of the operation as may be necessary to assure that all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their businessapplicable regulations have been complied with, and the Products (on Specifications have been met. CIMA shall permit duly authorized representatives of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to audit all manufacturing and processing operations at reasonable times with a per Product basis)prior appointment. All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file The right to audit shall commence with the applicable Governmental Authority, in effective date of this Agreement. These audits will be conducted to assure compliance with all filing and maintenance requirements (including any fee requirements) thereofpertinent acts, regulations, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with guidelines promulgated by the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or authorities, as well as standards then in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, effect in the aggregate, 15% or more regulatory environment. Such audits will be permitted during normal business hours and will be performed with a minimum of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authoritydisruption. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product:5.1 Regulatory Responsibilities in the Licensed Territory. (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to Allos will lead regulatory activities in the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings EEA with respect to the Products Product in the Field and use Reasonably Diligent Efforts in respect of the Product in the Lead Indication in the EEA until the date that is the earliest of (i) [ * ]; (ii) [ * ]; or (iii) [ * ] (such date, the “Transfer Date”). Prior to the Transfer Date, Mundipharma will provide non-financial support to Allos with respect to such regulatory activities, up to two (2) representatives (depending upon space constraints) of Mundipharma will be invited to observe all meetings and interactions with Regulatory Authorities in the EEA with respect to the Product in the Field, and Mundipharma will have the right to review draft responses to Regulatory Authority questions with respect to the Product in the Field. Allos will, at its sole expense, transfer to Mundipharma on or around the Transfer Date, ownership of and responsibility for: (1) the DAA filed by Allos and validated by the EMA on December 15, 2010, (2) any and all Regulatory Approvals arising therefrom, (3) all orphan drug authorizations for the last five Product in the Field in the EEA, and (54) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesEU Pediatric Investigation Plan approved by the EMA. (b) (i) All regulatory filings required by any Regulatory Authority or Commencing on the Effective Date with respect to all countries of the Licensed Territory outside the EEA, and commencing on the Transfer Date with respect to countries in the EEA, Mundipharma shall use Reasonably Diligent Efforts in respect of any the Product as the primary interface with and shall otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorization with respect Authorities concerning regulatory activities related to any the Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, Field in the last five (5) years have been madeLicensed Territory, and Mundipharma shall be responsible for preparing and filing any and all Regulatory Materials for the Product in the Field in the Licensed Territory at its sole expense in accordance with the Development Plan. Allos shall assist and cooperate at its own expense with Mundipharma in connection with the preparation and filing of such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulationsRegulatory Materials, (ii) all clinical and pre-as reasonably requested by Mundipharma, including preparation of ongoing clinical trials, if anystudy reports and Periodic Safety Update Reports (“PSURs”). Such cooperation will include promptly responding within procedural timelines set by Regulatory Authorities to any reasonable request from Mundipharma for Allos Know-How needed for the Regulatory Materials. For clarity, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance Allos shall not be obligated to provide Mundipharma with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityInformation that is not Allos Know-How. (c) The Credit PartiesSubject to Section 5.1(a), Mundipharma shall keep Allos informed at JDC meetings of regulatory developments relating to the Product in the Field in the Licensed Territory and shall promptly notify Allos in writing of any action or decision by any Regulatory Authority in the Licensed Territory regarding the Product in the Field. Mundipharma shall provide Allos for review and comment all draft Regulatory Materials (other than routine correspondence such as IND and MAA annual reports, MAA reapproval, during the investigational phase minor protocol amendments, IND amendments for new investigators or new clinical preclinical studies) at least [ * ] (or in the event of a shorter filing deadline, as soon as practicable) in advance of their Subsidiaries intended date of submission to a Regulatory Authority in the Licensed Territory and shall consider in good faith any comments thereto provided by Allos. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the agents thereof are Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Mundipharma shall promptly notify Allos of any Regulatory Materials (other than routine correspondence such as IND and MAA annual reports, MAA reapproval, during the investigational phase minor protocol amendments, IND amendments for new investigators or new clinical preclinical studies) submitted to or received from any Regulatory Authority in compliance the Licensed Territory and shall provide Allos with copies thereof, in all material respects electronic Common Technical Document (“eCTD”) format, where applicable, within [ * ] after submission or receipt. Mundipharma shall provide Allos with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) reasonable advance notice of all applicable Governmental Authoritiesmeetings, including the FDA conferences and all other discussions scheduled with any Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Authority in the FD&C Act Licensed Territory concerning the Product, and shall consider in good faith any input from Allos in preparing for such meetings, conferences or equivalent regulation discussions. To the extent permitted by applicable Laws, Allos shall have the right to participate in any such meetings, conferences or discussions and Mundipharma shall facilitate such participation. If Allos elects not to participate in such meetings, conferences or discussions, Mundipharma shall provide Allos with written summaries of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere meetings, conferences or discussions in all material respects to all applicable regulations of all Regulatory Authorities with respect to English as soon as practicable after the Products and all Product Development and Commercialization Activities related theretoconclusion thereof. (d) Except as set forth on Schedule 6.19(d)Within [ * ] of the Effective Date, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which representedAllos shall provide Mundipharma, in the aggregateeCTD format, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 with a full copy of the FD&C ActDAA filed by Allos and validated by the EMA on December 15, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years2010. (e) No Credit Party, nor any Allos shall be responsible for compiling and providing to Mundipharma the CMC Information that is required for Mundipharma to obtain and maintain Regulatory Approval of the Product in the Licensed Territory. Mundipharma shall use the CMC Information provided to it by Allos for the purpose of obtaining and maintaining Regulatory Approval of the Product in the Licensed Territory and in connection with the exercise of its Subsidiarieslicense under section 2.1(c). At Mundipharma’s request, nor any officer, employee Allos shall provide reasonable assistance to Mundipharma with respect to communications with Regulatory Authorities in the Licensed Territory regarding the manufacture of the Product or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyCMC Information. (f) Except Unless the Parties otherwise agree in writing: (i) except as set forth on Schedule 6.19(fexpressly contemplated by Section 5.1(a), no Credit Party nor 5.1(b) or 5.1(e), Allos shall not communicate with respect to the Product in the Field with any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiatedhaving jurisdiction in the Licensed Territory, or threatened unless so ordered by such Regulatory Authority, in which case Allos shall provide immediate notice to commence or initiateMundipharma of such order; and (ii) except as expressly contemplated by Section 5.1(a), any action to withdraw Allos shall not submit any Regulatory Authorization, requested Materials or seek Regulatory Approvals for the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales Field in any applicable year,the Licensed Territory. 5.2 Regulatory Responsibilities in the Allos Territory. (ga) Except as set forth on Schedule 6.19(g), Allos shall own all Regulatory Materials (including Regulatory Approvals) for the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by Product in the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material mannerAllos Territory, and no consent or other authorization of shall be responsible for preparing and filing any Governmental Authority is required and all Regulatory Materials for the Product in the Allos Territory at its sole expense. Mundipharma shall assist and cooperate with Allos in connection with the transactions preparation and filing of such Regulatory Materials, as reasonably requested by Allos and at Allos’ sole expense. (b) Allos shall keep Mundipharma informed of regulatory developments relating to the Product in the Field in the Allos Territory through regular reports at the JDC [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. meetings and shall promptly notify Mundipharma in writing of any action or decision by any Regulatory Authority in the Allos Territory relating to the Product. Allos shall provide Mundipharma for review and comment all draft Regulatory Materials (other than routine correspondence such as IND and NDA annual reports, during the investigational phase minor protocol amendments, IND amendments for new investigators or new clinical preclinical studies), at least [ * ] (or in the event of a shorter filing deadline, as soon as practicable) in advance of the intended date of submission to a Regulatory Authority in the Allos Territory and shall consider in good faith any comments thereto provided by Mundipharma. Allos shall promptly notify Mundipharma of any Regulatory Materials (other than routine correspondence such as IND and NDA annual reports, during the investigational phase minor protocol amendments, IND amendments for new investigators or new clinical preclinical studies) submitted to or received from any Regulatory Authorities in the Allos Territory and shall provide Mundipharma with copies thereof, in eCTD format, within [ * ] after submission or receipt. (c) Unless the Parties otherwise agree in writing: (i) except as expressly contemplated herebyby Section 5.2(a), including the Liens granted in connection herewith and the exercise of rights and remedies Mundipharma shall not communicate with respect theretoto the Product with any Regulatory Authority having jurisdiction in the Allos Territory, unless so ordered by such Regulatory Authority, in which case Mundipharma shall provide immediate notice to Allos of such order; and (ii) Mundipharma shall not submit any Regulatory Materials or seek Regulatory Approvals for the Product in the Allos Territory.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aEach of the FCA Regulated Entities has obtained all licenses required and all such licenses are valid and subsisting, none of the FCA Regulated Entities is in breach of any licenses and, to the knowledge of the CorpAcq Parties, no circumstances exist which may result in any such license being suspended, cancelled revoked, modified or not renewed, in whole or in part. (b) is Since the later of January 1, 2021 or the date upon which such FCA Regulated Entity became a complete and accurate list member of the CorpAcq Group, each of the FCA Regulated Entities (i) has conducted its business in all material Regulatory Authorizations relating to respects in accordance with, and has complied in all material respects with, all Laws, rules and regulations of the Credit Parties and their Subsidiaries, relevant jurisdictions having authority over the conduct of their its business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, has not received written notice that it is in compliance with all filing and maintenance requirements (including default under any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authoritylicense. (c) The Credit PartiesEach of the FCA Regulated Entities has at all times since January 1, their Subsidiaries 2021 complied with its material regulatory reporting and filing obligations in accordance with the agents thereof are in compliance in all material respects with all requirements of any applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoregulator. (d) Except as set forth on Schedule 6.19(dEach of the FCA Regulated Entities has in place policies and procedures, and where required has taken appropriate technical and organizational measures (including the provision of adequate training of relevant employees), no Credit Party nor any of designed to ensure its Subsidiaries has received from any Regulatory Authority any notice of alleged noncompliance with applicable anti-compliance or adverse findings with respect to any Product or any Product Development money laundering and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsterrorist financing Laws and Anti-Corruption Laws. (e) No Credit PartyThere are not pending, nor or in existence, any investigations or enquiries by, or on behalf of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA FCA or any other Regulatory Authoritycourt, failed to disclose a material fact required to be disclosed regulatory body or governmental body in respect of the affairs of any of the FCA Regulated Entities or the CorpAcq Group’s business and all necessary notifications to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was foregoing regulatory bodies have been made (or was not madeto the extent required), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except So far as set forth on Schedule 6.19(f)required by applicable Law, no Credit Party nor any each of its Subsidiaries the FCA Regulated Entities has, and has received any written notice that had for the FDA three years prior to the date of this Agreement, sufficient regulatory capital to satisfy the regulatory requirements of the FCA or any other regulatory body or government body applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action it from time to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,time. (g) Except as set forth on Schedule 6.19(g)Each person who, the clinical, preclinical, safety and other studies and tests conducted by virtue of their carrying out a particular function or having a particular role for or on behalf of or sponsored any the FCA Regulated Entities, is required to be approved for such purpose by the Credit Parties and their SubsidiariesFCA or any regulatory body or governmental body, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsis so approved. (h) The transactions contemplated by During the Loan Documents (past twelve months, none of the FCA Regulated Entities has received material customer complaints in writing concerning their products or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoservices.

Regulatory Matters. (a) With respect to each the Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are : (i) legally (A) the Vendor, its Affiliates and beneficially owned exclusively Subco have obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental AuthorityAuthorities, including, without limitation, the CE M▇▇▇, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Product in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings jurisdictions where it currently conducts such activities with respect to the Products for Product (collectively, the last five “Regulatory Approvals”), (5B) years have been timely filed with the FDA Vendor, its Affiliates and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or Subco are in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied compliance in all material respects with all applicable laws terms and regulationsconditions of each Regulatory Approval, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iiiC) the Credit Parties Vendor, its Affiliates and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof Subco are in compliance in all material respects with all applicable statutesLaws regarding registration, rules license and regulations certification for each jurisdiction at which the Product is labeled, sold, or distributed, and (including D) to the extent that the Product has been exported, it has only been exported in compliance in all Healthcare material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Vendor, its Affiliates and Subco have been and are being conducted in all material respects in compliance with applicable Laws relating to quality systems in each country where compliance is required; (iii) all non-clinical laboratory studies of the Product sponsored by the Vendor, its Affiliates and/or Subco used or intended to be used to support regulatory clearance or approval, have been and Regulatory Authorizations) of all are being conducted in compliance with the applicable Governmental AuthoritiesLaws, including Health Care Laws; and (iv) the FDA Vendor, its Affiliates and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries Subco are in compliance in all material respects with all applicable registration reporting requirements for all Regulatory Approvals or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in each country where compliance is required. (b) The Vendor, its Affiliates and listing requirements set forth Subco are in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere compliance in all material respects to with all applicable regulations Governmental Authority (in each country where compliance is required) and similar provincial, state and local Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Product. Section 3.29(b) of the Disclosure Schedule sets forth a list of all Regulatory Authorities applicable adverse event reports related to the Product. Set forth on Section 3.29(b) of the Disclosure Schedule are complaint review and analysis reports of the Vendor, its Affiliates and Subco with respect to the Products Business through the date hereof, including information regarding complaints, categorized by root cause analysis of closed complaints, which reports are correct in all material respects. (c) Except as set forth in Section 3.29(c) of the Disclosure Schedule, none of the Vendor, its Affiliates or Subco have received any written notice or other written communication from any Governmental Authority: (i) contesting the approval of, the uses of or the labeling and all Product Development and Commercialization Activities related theretopromotion of the Product; or (ii) otherwise alleging any violation of any Laws by the Vendor, its Affiliates or Subco with respect to the use, sale or manufacture of the Product. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, disclosed in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 3.29(d) of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d)Disclosure Schedule, there have been no recalls, market withdrawals, field notifications or correctionsseizures ordered or adverse regulatory actions taken (or, detentionsto the Knowledge of the Vendor, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened threatened) by any Regulatory AuthorityGovernmental Authority with respect to the Product, including any facilities where the Product is produced, processed, packaged or (for example in stored and none of the case of a recall) initiated by Credit Party Vendor, its Affiliates or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year Subco have within the last five three (53) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from , either voluntarily or at the FDA or any other Regulatory Authority indicating any breach or violation request of any applicable Regulatory AuthorizationGovernmental Authority, including that any initiated or participated in a recall of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsProduct. (e) No Credit PartyAll filings with and submissions to any Governmental Authority made by the Vendor, its Affiliates and/or Subco with regard to the Product, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update, and such filings, submissions and updates comply with all regulations of such Governmental Authorities in all material respects. (f) None of the Vendor, its Affiliates nor Subco is the subject, officially or otherwise, of any pending or, to the Knowledge of the Vendor, threatened investigation by any Governmental Authority pursuant to any anti-bribery Law related to the Business, the Purchased Assets, or the Product. None of the Vendor, its SubsidiariesAffiliates nor, nor to the Knowledge of the Vendor, any officer, employee or agent thereofof the Vendor or its Affilites, has (A) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Governmental Authority, (B) failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, or (C) committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Regulatory Governmental Authority to invoke its policy respecting Fraudrelated to such Laws, Untrue Statements of Material Factsin each case, Bribery and Illegal Gratuitiesrelated to the Business, set forth in 56 Fed. Reg. 46191 (September 10the Purchased Assets, 1991) or any similar policythe Product. (fg) Except as set forth on Schedule 6.19(f)None of the Vendor, no Credit Party nor its Affiliates or Subco, or, to the Knowledge of the Vendor, any officer, employee or agent of the Vendor, its Subsidiaries Affiliates or Subco, has been convicted of any crime or engaged in any conduct for which debarment is mandated by applicable Law or authorized by applicable Law with respect to the Business. None of the Vendor, its Affiliates or Subco, or, to the Knowledge of the Vendor, any officer, employee or agent of the Vendor, its Affiliates or Subco, has been convicted of any crime or engaged in any conduct for which such person or entity could be excluded from participating in any aspect of the Business under applicable Law. (h) None of the Vendor, its Affiliates or Subco has received any written notice that the FDA or any other applicable Regulatory Governmental Authority has commenced or initiated(a) commenced, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested its approval or request the recall of the Product, or (whether by correction or removalb) of any Products or commenced or initiated commenced, or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities production of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Product. (gi) Except as The Vendor and its Affiliates with respect to the Business are and at all times have been in material compliance with: (i) the provisions of applicable Laws relating to investigational use, premarket clearance or marketing approval (or exemptions thereto) to market a product, good manufacturing practices, labeling, advertising, record keeping, filing of reports and security; (ii) the applicable provisions relating to the privacy and security of individually identifiable health information, and all regulations thereunder; (iii) any applicable antikickback Laws; and (iv) health care fraud Laws. Since January 1, 2011, none of the Vendor or its Affiliates has received any written notice or other communication from any Governmental Authority regarding any actual or possible violation of, or failure to comply with, any legal requirement set forth on Schedule 6.19(g), in this Section 3.29(i) with respect to the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsBusiness. (hj) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of No Employee has been excluded from participation in any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usehealth care program or, as the case may be) any Regulatory Authorizations relating to the Products Knowledge of the Vendor, committed any offense that would be the basis for such exclusion in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoa health care program.

Regulatory Matters. With respect to each Product: (a) Set The Company and the Company Subsidiaries hold all Permits issued by the FCC or the state public service or public utility commissions or other similar state regulatory bodies (“State PSCs”), and all other material regulatory Permits, including franchises, ordinances and other agreements granting access to public rights of way, issued or granted to the Company or any Company Subsidiary by a Governmental Entity (the “Company Licenses”) that are required for the Company and each Company Subsidiary to conduct its business, as presently conducted. Section 3.16(a) of the Company Disclosure Letter sets forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesCompany Licenses, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file together with the applicable Governmental Authority, in compliance with all filing name of the entity holding such Company License. True correct and maintenance requirements complete copies of each Company License (including any fee requirementsall modifications and amendments thereto and waivers thereunder) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesmade available to Parent. (b) Each Company License is valid and in full force and effect and has not been suspended, revoked, cancelled or adversely modified. No Company License is subject to (i) All regulatory filings required by any Regulatory Authority conditions or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, requirements that have not been imposed generally upon licenses in the aggregatesame jurisdictions, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trialsany pending proceeding by or before the FCC or State PSCs to suspend, if anyrevoke or cancel such Company License, or any judicial review of investigational Products have been and are being conducted a decision by the Credit Parties and their Subsidiaries FCC or State PSCs with respect thereto. To the knowledge of the Company, there has not been any event, condition or circumstance that would preclude any Company License from being renewed in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and the ordinary course (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all extent that such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityCompany License is renewable by its terms). (c) The Credit Parties, their Subsidiaries and the agents thereof are Company License is in compliance in all material respects with such Company License and has fulfilled and performed all applicable statutesof its obligations with respect thereto, rules and regulations (including all Healthcare Laws reports, notifications and Regulatory Authorizationsapplications required by the Communications Act of 1934, as amended (the “Communications Act”), or the rules, regulations, written policies and orders of the FCC (together with the Communications Act, the “FCC Rules”) or similar state telecommunications laws (the “State Telecommunications Laws”) and the rules, regulations, written policies and Orders of State PSCs (collectively with the State Telecommunications Laws, the, “PSC Rules”), and the payment of all regulatory fees and contributions, except for exemptions, waivers or similar concessions or allowances. Without limiting the foregoing, the licensee of each Company License is in material compliance with the applicable Governmental Authoritiesrequirements of the Federal and state Universal Service Fund programs, the Federal Telecommunications Relay Service programs, the Federal North American Numbering Plan Administration program, the Federal Local Number Portability Administration program (collectively, the “USF Programs”), the Communications Assistance to Law Enforcement Act (“CALEA”), and the FCC’s regulations concerning treatment and protection of Customer Proprietary Network Information (“CPNI”). All reports and other submissions required in connection with the USF Programs, CALEA, CPNI regulations, including contribution remittances, have been timely filed in materially true, correct and complete form. To the FDA knowledge of the Company and all the Company Subsidiaries, there are no pending or threatened investigations, inquiries, audits, examinations or other Regulatory Authoritiesproceedings in connection with the performance of the Company and the Company Subsidiaries of their USF Programs, with respect to each Product CALEA and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoCPNI obligations. (d) Except as set forth on Schedule 6.19(d)in Section 3.16(d) of the Company Disclosure Letter, no Credit Party neither the Company nor any of its Subsidiaries Company Subsidiary has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act(i) implemented, or any other similar communication from any Regulatory Authority within the last five been alleged or found to have implemented, an unauthorized change of an end user’s carrier (5“Slamming”) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recallii) initiated by Credit Party placed or any of its Subsidiaries, relating been alleged or found to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five have placed an unauthorized charge on customer billing (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years“Cramming”). (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, Except as set forth in 56 Fed. Reg. 46191 (September 10Section 3.16(e) of the Company Disclosure Letter, 1991) the Company and all Company Subsidiaries have timely complied with any compensation, restoration, reimbursement, reporting, or any similar policyother obligations arising in connection with public and private right-of-way access and pole attachment agreements. (f) Except as set forth on Schedule 6.19(f)in Section 3.16(f) of the Company Disclosure Letter, the Company and all Company Subsidiaries have timely submitted all required international traffic and circuit status reports in materially true, correct and complete form. Except as set forth in Section 3.16(f) of the Company Disclosure Letter, the licensee of each Company License is in material compliance with the applicable requirements of federal and state network outage reporting (“NOR”) requirements. All reports and other submissions required in connection with federal and state NOR requirements have been timely filed in materially true, correct and complete form. To the knowledge of the Company and the Company Subsidiaries, there are no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, pending or threatened to commence investigations, inquiries, audits, examinations or initiate, any action to withdraw any Regulatory Authorization, requested other proceedings in connection with the recall (whether by correction or removal) performance of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development the Company and Commercialization Activities the Company Subsidiaries of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,their NOR requirements. (g) Except as set forth The Company or a wholly-owned Subsidiary of the Company directly or indirectly owns 100% of the Equity Interests and controls 100% of the voting power and decision-making authority of each holder of the Company Licenses. No Company License, Order or other agreement, obtained from, issued by or concluded with any State PSC would impose restrictions on Schedule 6.19(g)the ability of any Company Subsidiary to make payments, dividends or other distributions to the Company or any Company Subsidiary that limits, or would reasonably be expected to limit, the clinical, preclinical, safety cash funding and management alternatives of the Company on a consolidated basis in a manner disproportionate to restrictions applied by other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsState PSCs. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aPart 3.18(a) is of the Disclosure Letter contains a complete and accurate list of all material Regulatory Authorizations relating each Governmental Authorization that is held by any Acquired Company or that otherwise relates to the Credit Parties business of, or to any of the assets owned or used by, any Acquired Company, including but not limited to product approvals and their Subsidiariesclearances issued by the FDA and similar foreign Governmental Bodies and product submissions to the FDA and similar foreign Governmental Bodies which are currently in process (the "SUBMISSIONS"). Except for the Submissions, each Governmental Authorization issued by a United States Governmental Body, and, to the Knowledge of the Company, each Governmental Authorization issued by a foreign Governmental Body, listed or required to be listed in Part 3.11(b) of the Disclosure Letter is valid and in full force and effect. (b) Except as set forth in Part 3.11(b) of the Disclosure Letter, to the Knowledge of the Company, the Governmental Authorizations listed in Part 3.18(a) of the Disclosure Letter collectively constitute all of the Governmental Authorizations necessary to permit the Acquired Companies to lawfully conduct of and operate their businessbusinesses in the manner they currently conduct and operate such businesses and to permit the Acquired Companies to own and use their assets in the manner in which they currently own and use such assets. (c) In calendar year 1999, the Company recorded no "complaints" (as such term is defined in 21 C.F.R. Section 820.198) and the Products reported no Medical Device Reports (on a per Product basis"MDRS"). All such material Regulatory Authorizations are (iFrom January 1, 2000 through the date of this Agreement, the Company recorded no "complaints" and reported no MDRs. Except as set forth in Part 3.18(c) legally of the Disclosure Letter, to the Knowledge of the Company, these "complaints" and beneficially owned exclusively by MDRs would not reasonably lead to the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications conclusion that there is a trend or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings failure mode with respect to the Products a particular product. (d) The Acquired Companies manufacture and for the last five (5) past three years have manufactured their products in all material respects in accordance with all applicable FDA rules and regulations (including the Good Manufacturing Practices and the Quality System regulations promulgated by the FDA) and the European Medical Device Directive (93142/ECC) and quality control procedures of the Acquired Companies in effect at the time of manufacture. To the extent required, all of the products currently sold by the Acquired Companies have been timely filed with approved for sale by the FDA and all other applicable Governmental Authorities. (b) (i) All federal, state, local and foreign regulatory filings required agencies. The Acquired Companies are authorized by any Regulatory Authority or in respect of any Regulatory Authorization with respect their "notified body" to any Product or any Product Development and Commercialization Activities which represented, in apply the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed "CE" ▇▇▇▇ to the Agent all such regulatory filings and all material communications between representatives products listed in Part 3.18(d) of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsDisclosure Letter. No Credit Party nor any of its Subsidiaries Acquired Company has received any written notification that remains unresolved notice from the FDA or any other Regulatory Authority indicating federal, state, local or foreign regulatory agency questioning its manufacturing practices or threatening to revoke or curtail any breach or violation product approval, and no Acquired Company is aware of any applicable Regulatory Authorizationintent to deliver any such notice. Part 3.18(d) of the Disclosure Letter contains a complete list of all products manufactured or marketed by the Acquired Companies, including those that any require the approval of the Products is misbranded or adulterated as defined in the FD&C Actnotice to, in each case of the foregoingor registration with, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory AuthorityUnited States federal or state or foreign governmental agency or bureau under any existing law, failed to disclose a material fact regulation or policy, specifying the type of approval or notice of registration required to be disclosed to and the reference number or identification of each currently effective approval or notice and registration. Since January 1, 1995, none of the Acquired Companies has received any FDA "warning letter." None of the products identified in Part 3.18(d) of the Disclosure Letter has been the subject of any voluntary or involuntary recall or any governmental investigation other Regulatory Authoritythan routine inspections of the Acquired Companies' facilities and all United States and, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, except as set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removalPart 3.18(d) of any Products or commenced or initiated or threatened to commence or initiatethe Disclosure Letter, any action to enjoin any Product Development international regulatory approvals therefor are owned by and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, registered in the aggregate, 15% or more name of Net Sales an Acquired Company and are in any applicable year,full force and effect. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aThe Company and Company Subsidiaries have filed with the applicable regulatory authorities (including the FDA or any other Governmental Authority performing functions similar to those performed by the FDA) is a complete and accurate list of all required material Regulatory Authorizations relating to the Credit Parties and their Subsidiariesfilings, the conduct of their businessdeclarations, and the Products (on a per Product basis)listings, registrations, reports or submissions. All such filings, declarations, listings, registrations, reports or submissions were in material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Lienscompliance with applicable Law when filed, and (ii) as applicable, validly registered no material deficiencies have been asserted in writing to any of the Company and on file with the Company Subsidiaries by any applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Authority with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesany such filings, declarations, listings, registrations, reports or submissions. (b) Except as would not reasonably be expected to have a Company Material Adverse Effect, since January 1, 2020, (i) All regulatory filings the Company and the Company Subsidiaries have and have had in effect all necessary and applicable Regulatory Permits required by any Regulatory Health Authority or in respect to permit the conduct of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulationstheir respective businesses as currently conducted, (ii) all clinical of such Regulatory Permits are in full force and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, effect and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives each of the Credit Parties (Company and their Subsidiaries) applicable Company Subsidiary is in compliance with, and any is not in default under, each such Regulatory AuthorityPermit. (c) The Credit PartiesExcept as would not reasonably be expected to have a Company Material Adverse Effect, their Subsidiaries since January 1, 2020, the Company, the Company Products, and the agents thereof facilities in which the Company Products are developed, tested, made, processed, labeled, packaged, handled or stored are in compliance in all material respects with all applicable statutesrequirements under applicable Health Laws, rules any comparable applicable foreign Laws, and regulations (including all Healthcare Laws terms and Regulatory Authorizations) conditions of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoPermits. (d) Except Set forth on Section 4.13(c) of the Company Disclosure Letter is a list and description of all Regulatory Permits. Other than the Regulatory Permits in Section 4.13(c) of the Company Disclosure Letter and except as set forth on Schedule 6.19(d)in Section 4.13(c) of the Company Disclosure Letter, there are no Credit Party nor additional Regulatory Permits required by any Health Authority to permit the conduct of its Subsidiaries has received from any their respective businesses as currently conducted, except where the failure to have such Regulatory Authority any notice of alleged non-compliance Permits would not reasonably be expected to have a Company Material Adverse Effect, individually or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit PartyExcept as would not reasonably be expected to have a Company Material Adverse Effect, nor since January 1, 2020, none of the Company, any of its Subsidiariesthe Company Subsidiaries or, nor to the Knowledge of the Company, any officerof their respective directors, employee officers, employees or agent thereof, agents has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Authority, Health Authority or (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Health Authority. None of the Company, any of the Company Subsidiaries or any of their respective directors, officers, employees or agents is the subject of any pending or, to the Knowledge of the Company, threatened investigation by the FDA, or the subject of any investigation by any other Health Authority or Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time assuming such disclosure was made (investigations were determined or was not made)resolved adversely, could would be reasonably be expected to provide have a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Company Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyAdverse Effect. (f) Except as set forth on Schedule 6.19(f)would not reasonably be expected to have a Company Material Adverse Effect, no Credit Party neither the Company nor any of its the Company Subsidiaries (i) has received any material written notice that from any Health Authority or Governmental Authority (including a warning, untitled, or notice of violation letter or Form FDA 483) alleging any violation of, or non-compliance with, any Health Law, (ii) is subject to any material enforcement, regulatory or administrative proceedings against or affecting the FDA Company or any other applicable Regulatory Authority Company Subsidiary relating to or arising under any Health Law and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has commenced or initiatedbeen threatened, or threatened (iii) is a party to commence any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiaryother similar agreement, in each case, which representedentered into with or imposed by any Governmental Authority, in and no such action is pending as of the aggregate, 15% or more of Net Sales in any applicable year,date hereof. (g) Since January 1, 2020, except as would not reasonably be expected to have a Company Material Adverse Effect, neither any the Company, Company Subsidiaries, nor any of their officers, directors, managers, employees, or agents are or have been: (i) excluded, suspended or debarred from participation, or are otherwise determined to be or identified as ineligible to participate, in any Governmental Health Program, (ii) subject to a civil monetary penalty assessed under Section 1128A of the Social Security Act, sanctioned, indicted or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any Governmental Health Program requirement or Law, (iii) to the Knowledge of the Company, the target or subject of any investigation relating to any offense of any Governmental Health Program, (iv) party to any individual integrity agreement, corporate integrity agreement or other formal or informal agreement (e.g., deferred prosecution agreement) with any Governmental Authority concerning any Health Law, (v) listed on the Office of Inspector General’s List of Excluded Individuals and Entities, (vi) listed on the General Services Administration’s published list of parties excluded from federal procurement programs and non-procurement programs, or (vii) subjected to any other debarment, exclusion or sanction list or database. (h) Except as set forth on Schedule 6.19(g)Section 4.13(h) of the Company Disclosure Letter, the clinical, preclinical, safety and other studies and tests all manufacturing operations conducted by or on behalf for the benefit of or sponsored by the Credit Parties Company and their Subsidiaries, or in respect of which any Products or Product candidates under development the Company Subsidiaries have participated, were (and if still pending, are) being been conducted in accordance compliance in all material respects with all applicable Regulatory Authorizations Health Laws, including good manufacturing practices regulations, and Healthcare Laws no Company Product has been recalled, withdrawn or suspended (whether voluntarily or otherwise) or has been adulterated or misbranded by the Company or a Company Subsidiary in all material respectsa manner that would reasonably be expected to result in action by a Governmental Authority. No proceedings seeking the recall, withdrawal, suspension or seizure of any such Company Product or pre-market approvals or marketing authorizations are pending or, to the Knowledge of the Company, threatened against the Company, nor have any such proceedings been pending at any time. (hi) The transactions contemplated by Neither the Loan Documents Company nor the Company Subsidiaries are considered to be Covered Entities or a Business Associate pursuant to HIPAA. (or contemplated by the conditions j) This Section 4.13 does not apply to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useCompany Plans, as the case may be) any Regulatory Authorizations relating to the Products which are covered in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 4.9.

Regulatory Matters. With respect to each Product: (a) Set forth on Other than as disclosed in Section 3.8 of the Disclosure Schedule, the Group Companies have obtained necessary Approvals with respect to their respective operations and the Principal Business and all such Approvals are in full force and effect. The absence, or failure of renewal or maintaining, of such Approvals as disclosed in Section 3.8 of the Disclosure Schedule 6.19(a) is a complete and accurate list has not resulted in, would not be expected to result in, any Material Adverse Effect. None of all the Group Companies has engaged in any insurance or banking business or any financial services, telecommunication, utilities or other regulated business outside the scope of business as currently conducted by such Group Company. No Warrantor has reason to believe that any material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, Approval required for the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively Principal Business or any part thereof which is subject to periodic renewal will not be granted or renewed by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable relevant Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority Each registered holder or in respect beneficial owner of any Regulatory Authorization Equity Securities in the Company other than the Investors (each, a “Company Security Holder”) who is a Domestic Resident and subject to any of the registration or reporting requirements of Circular 37 or any other applicable SAFE rules and regulations (collectively, the “SAFE Rules and Regulations”) has complied with such registration and/or reporting requirements under the SAFE Rules and Regulations with respect to its investment in the Group Companies. None of the Warrantors, nor, to the Knowledge of the Warrantors, the other Company Security Holders has received any oral or written inquiries, notifications, orders or any other forms of official correspondence from SAFE or any of its local branches with respect to any Product actual or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development the SAFE Rules and Commercialization Activities related thereto which representedRegulations and the Company and the Company Security Holders have made all oral and written filings, in the aggregateregistrations, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or reporting and any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened communications required by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party SAFE or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any local branches applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory AuthorityGroup Companies. The WFOE and each Domestic Company has obtained all Approvals necessary under PRC Laws to conduct foreign exchange transactions as now being conducted by it, failed and has no reason to disclose a material fact required believe that it cannot obtain all Approvals for the conduct of foreign exchange transactions as now being conducted and planned to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyconducted. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.

Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(aWithin thirty (30) is a days after the Closing Date, Seller shall provide Buyer with complete and accurate list copies of all material Sellers Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and Approvals for the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA Territory and all correspondence or other applicable Governmental Authoritiesdocuments reasonably related to such Regulatory Approvals. (b) (i) All regulatory filings required by Buyer irrevocably grants to Seller and its Affiliates the right to reference and quote the Regulatory Approvals and all portions thereof to support Seller's Product related activities outside of the Territory and to support any Regulatory Authority veterinary pharmaceutical products, which Seller currently markets or in respect of any Regulatory Authorization with respect to any Product sells or any Product Development and Commercialization Activities which representedmay, in the aggregatefuture, 15% market or more sell. Buyer shall not amend the Regulatory Approvals for the Bicillin(R) and Wycillin(R) Products during the respective term of Net Sales in any applicable yearthe Supply Agreement for each such Product without the prior written consent of Seller, in the last five (5) years have been madesuch consent not to be unreasonably withheld, and all Seller shall respond to Buyer's request for consent within thirty (30) days from such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityrequest. (c) The Credit PartiesUpon transfer and assignment of each of the Regulatory Approvals to Buyer, their Subsidiaries as provided in Section 2.5 and Section 6.8(d), and thereafter Buyer shall be solely responsible for conducting all activities in connection with such Regulatory Approvals for the agents thereof are Bicillin(R), Wycillin(R), and Nordette(R) Products, as applicable, including, without limitation, communicating, and preparing and filing all reports (including, without limitation, adverse drug experience reports) with the appropriate Governmental Authorities in compliance in all material respects the Territory and interacting with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, any third parties with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Products sold or distributed in the FD&C Act or equivalent regulation Territory; provided, however, that for up to sixty (60) days after such transfer, Seller shall assist and cooperate in the transition of each other Governmental Authority having jurisdiction over such Personactivities to Buyer. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect Additionally, to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d)extent that Buyer is obligated, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect under Applicable Laws, to any Product or any Product Development and Commercialization Activities related thereto which represented, report to Governmental Authorities in the aggregateTerritory, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any adverse drug experiences associated with Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted sold by or on behalf of or sponsored by Seller outside of the Credit Parties and their SubsidiariesTerritory, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted Seller shall provide Buyer with information about such adverse drug experiences in accordance with all applicable Regulatory Authorizations the provisions of this Section, and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the extent that Seller is obligated under Applicable Laws to report adverse drug experiences associated with Products in any material mannersold by or on behalf of Buyer inside the Territory, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.Buyer shall

Regulatory Matters. With respect to each Product: In the event that Celgene determines that any regulatory filings for any Licensed Antibodies and/or Licensed Products are required for any activities hereunder, including INDs, ▇▇▇▇ and other Regulatory Approvals (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable), free and clear of all Liens other than Permitted Liens, and then Celgene (iior its designee) as applicable, validly registered and on file with shall have the applicable Governmental Authoritysole right, in compliance with all filing its discretion, to seek to obtain and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all maintain such regulatory filings (in its or its designee’s name). In addition, Celgene (or its designee) shall have the sole right to communicate and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects otherwise interact with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d)Licensed Antibodies and/or Licensed Products, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings including with respect to any Product Regulatory Materials in connection therewith. Prothena (and its Affiliates) shall have no right to, and shall not, make any regulatory filings related to any Licensed Antibodies and/or Licensed Products or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from otherwise interact with any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements Authorities with respect to the FDA or any other Regulatory AuthorityLicensed Antibodies and/or Licensed Products; provided that, failed to disclose a material fact required to be disclosed as and to the FDA or any other extent reasonably requested by Celgene in writing, Prothena shall interact with Regulatory Authority, or committed an act, made a statement, or failed Authorities in connection with Licensed Antibodies and/or Licensed Products with respect to make a statement that, at matters related to the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests Licensed Program activities conducted by or on behalf of Prothena under the Master Collaboration Agreement or sponsored by with respect to any Prothena Ongoing Program Activities. Notwithstanding the Credit Parties foregoing, until such time as a given Existing Regulatory Material is assigned and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted transferred to Celgene in accordance with Section 2.2.1 or 2.2.2 (as applicable), Prothena shall be responsible for all applicable communications and interactions with Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions Authorities with respect to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usesuch Existing Regulatory Material; provided that, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with any such activities by Prothena, Prothena shall, to the transactions contemplated herebyextent reasonably requested by Celgene, consult and coordinate with Celgene with respect thereto (including allowing Celgene to attend or participate in any meetings or other interactions with Regulatory Authorities to the Liens granted extent such attendance is not prohibited or limited by such Regulatory Authority) and Prothena shall accommodate and comply with any reasonable requests made by Celgene in connection herewith therewith (including that Prothena shall submit to Celgene a copy of any proposed filings and [***] Certain information in this document has been omitted and filed separately with the exercise of rights Securities and remedies Exchange Commission. Confidential treatment has been requested with respect theretoto the omitted portions. correspondence with any Regulatory Authority for Celgene’s review and approval prior to submission thereof). At the request of Celgene, Prothena shall reasonably assist Celgene in communications and filings with Regulatory Authorities with respect to the Licensed Antibodies and/or Licensed Products.