Common use of Regulatory Filings and Regulatory Approvals Clause in Contracts

Regulatory Filings and Regulatory Approvals. 5.2.1 Except as expressly provided herein, as between the Parties, TRANSCEPT (itself or through its sublicensees) shall have the sole right to and be responsible for preparing and submitting to applicable Regulatory Authorities any and all Regulatory Materials for the Product and obtaining and maintaining any and all Regulatory Approvals for the Product for the Field within the Territory. TRANSCEPT shall keep SNBL reasonably and regularly informed of the preparation and submission of all Regulatory Materials, Regulatory Authority communications and review of Regulatory Materials, and Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and expense, to make available as described in the following sentence information in SNBL’s Control or otherwise execute, acknowledge and deliver further instruments, as reasonably necessary to assist TRANSCEPT in preparing or submitting Regulatory Materials and obtaining or maintaining Regulatory Approvals for the Product for the Field within the Territory. SNBL may, at its election, either (i) provide directly to TRANSCEPT such data, results and other information generated from the development or manufacturing of the Device hereunder that are Controlled by SNBL, or (ii) submit and maintain a Device Master File and other similar confidential Regulatory Materials with the FDA and other Regulatory Authorities for the Device, in those regulatory jurisdictions where the Regulatory Authority allow such filings and provide TRANSCEPT and its sublicensees the right to reference such Device Master Files or such other Regulatory Materials; in each case (i) and (ii), to the extent reasonably necessary to support any Regulatory Approval Application for the Product for the Field within the Territory. It is understood that SNBL shall own the Device Master File and such other similar confidential Regulatory Materials and reserves the right to grant Third Parties the right to reference its Device Master Files and other similar confidential Regulatory Materials for purposes other than obtaining Regulatory Approval for the Product for the Field within the Territory. Except as expressly set forth in this Agreement or otherwise mutually agreed by the Parties in writing, SNBL shall not be obligated to undertake any development activities or otherwise generate any new information, document or materials in connection with its obligations under this Section 5.2. 5.2.2 To the extent that SNBL has not filed a Device Master File as of the Effective Date and elects to prepare, and then submit and maintain, a Device Master File and other similar confidential Regulatory Materials, SNBL shall provide TRANSCEPT an opportunity to review and provide comments; provided that, to the extent that any portion of the Device Master File or other similar confidential Regulatory Materials is confidential, SNBL shall provide to TRANSCEPT a general summary of such portion. SNBL shall consider in good faith any comments and suggestions provided by TRANSCEPT and, if such comments and suggestions are reasonably necessary for obtaining Regulatory Approval for the Product, incorporate such comments and suggestions into the Device Master File or other similar confidential Regulatory Materials. In the event that the Parties disagree with respect to any comment or suggestion provided by TRANSCEPT, the Parties agree to submit such disagreement to a Third Party that is mutually acceptable to each of SNBL and TRANSCEPT to consider whether such comment or suggestion should be adopted under this Section 5.2.2.

Regulatory Filings and Regulatory Approvals. 5.2.1 Except At Infinity’s request, AbbVie shall, promptly following the effectiveness of such termination, assign and transfer to Infinity, all Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations for Products that are held or controlled by or under authority of AbbVie or its Affiliates or Sublicensees as expressly provided hereinof the effective date of termination, with respect to the terminated country or the Territory, as between the Partiescase may be, TRANSCEPT and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations to Infinity. If this Agreement is terminated in its entirety, AbbVie shall also promptly transfer control of and responsibility for maintaining the global safety database for Products to Infinity (itself if previously held by AbbVie or through its sublicensees) Affiliates), and Infinity shall accept such transfer and responsibility. If applicable Law prevents or delays the transfer of ownership of any such Regulatory Filing, filing for Pricing and Reimbursement Approval or Marketing Authorizations to Infinity, AbbVie shall grant, and does hereby grant, to Infinity an exclusive and irrevocable right of access and Right of Reference to such Regulatory Filing, filing for Pricing and Reimbursement Approval and Marketing Authorizations for the Products in the Territory or the terminated country, as the case may be, and shall reasonably cooperate to make the benefits of such Regulatory Filings, filings for Pricing and Reimbursement Approval and Marketing Authorizations available to Infinity or its designee(s). Infinity shall have the sole right to and be responsible for preparing and submitting to applicable Regulatory Authorities any and all Regulatory Materials for the Product and obtaining and maintaining any and all Regulatory Approvals for the Product for the Field within the Territory. TRANSCEPT shall keep SNBL reasonably and regularly informed of the preparation and submission of all Regulatory Materials, Regulatory Authority communications and review of Regulatory Materials, and Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and expense, to make available as described in the following sentence information in SNBL’s Control or otherwise execute, acknowledge and deliver further instruments, as reasonably necessary to assist TRANSCEPT in preparing or submitting Regulatory Materials and obtaining or maintaining Regulatory Approvals for the Product for the Field within the Territory. SNBL may, at its election, either (i) provide directly to TRANSCEPT such data, results and other information generated from the development or manufacturing of the Device hereunder that are Controlled by SNBL, or (ii) submit and maintain a Device Master File and other similar confidential Regulatory Materials with the FDA and other Regulatory Authorities for the Device, in those regulatory jurisdictions where the Regulatory Authority allow such filings and provide TRANSCEPT and its sublicensees the right to reference such Device Master Files or such other Regulatory Materials; in each case (i) and (ii), to the extent reasonably necessary to support any Regulatory Approval Application for the Product for the Field within the Territory. It is understood that SNBL shall own the Device Master File and such other similar confidential Regulatory Materials and reserves the right to grant Third Parties licenses or sublicenses (as applicable) under the right rights granted to reference its Device Master Files and other similar confidential Regulatory Materials for purposes other than obtaining Regulatory Approval for the Product for the Field within the Territory. Except as expressly set forth in this Agreement or otherwise mutually agreed by the Parties in writing, SNBL shall not be obligated to undertake any development activities or otherwise generate any new information, document or materials in connection with its obligations it under this Section 5.2. 5.2.2 To the extent that SNBL has not filed a Device Master File as of the Effective Date 12.3.6 to its Affiliates and elects to prepareThird Parties, and then submit and maintain, a Device Master File and other similar confidential Regulatory Materials, SNBL shall provide TRANSCEPT an opportunity to review and provide comments; provided that, to the extent that any portion of the Device Master File or other similar confidential Regulatory Materials is confidential, SNBL shall provide to TRANSCEPT a general summary of such portionthrough multiple tiers. SNBL shall consider in good faith any comments and suggestions provided by TRANSCEPT and, if such comments and suggestions are reasonably necessary for obtaining Regulatory Approval for the Product, incorporate such comments and suggestions into the Device Master File or other similar confidential Regulatory Materials. In the event that the Parties disagree with respect to any comment or suggestion provided by TRANSCEPTFor clarity, the Parties agree to submit such disagreement to a Third Party that is mutually acceptable to each of SNBL rights and TRANSCEPT to consider whether such comment or suggestion should be adopted under obligations in this Section 5.2.212.3.6 shall not apply to Regulatory Filings and Regulatory Approvals relating to or involving AbbVie Combination Compounds.

Regulatory Filings and Regulatory Approvals. 5.2.1 Except as expressly provided herein5.1.1 Immatics Pre-Clinical Studies, as between the PartiesImmatics CMC Activities, TRANSCEPT and Immatics GDP Trial. (itself or through its sublicenseesa) shall have the sole right to and Immatics will be responsible for preparing the preparation of all Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided that such Regulatory Materials shall be subject to the prior review and submitting approval of BMS, such approval not to be unreasonably withheld or delayed. BMS will provide such approval, or a written explanation for why such approval is being withheld or delayed, within [**] (or such shorter time period as required by a Regulatory Authority) after receiving Immatics’ request therefor. Once approved by BMS, Immatics shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. All Regulatory Materials for any Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial will be held and owned by Immatics (or its Affiliate) in its name, until such time as such Regulatory Materials, if any, are transferred and assigned to BMS (or its designee) pursuant to Section 5.1.1(c). After such transfer of Regulatory Materials, BMS (or its designee) shall be responsible for any submissions to Regulatory Authorities related to the Immatics Generated Data. (b) Immatics shall interact with Regulatory Authorities in connection with respect to matters related to the Immatics Pre-Clinical Studies, Immatics CMC Activities or the Immatics GDP Trial; provided, that, in connection with any such activities by Immatics, Immatics shall consult and coordinate with BMS with respect thereto (including allowing BMS to attend or participate in any meetings or other interactions with Regulatory Authorities) and Immatics shall accommodate and comply with any requests made by BMS in connection therewith (including that Immatics shall submit to BMS a copy of (i) any proposed filings and correspondence with any Regulatory Authority for BMS’ review and approval prior to submission thereof, and (ii) any correspondence received from any Regulatory Authority). (c) At BMS’ written request following the completion of the Immatics GDP Trial, Immatics shall assign and transfer, or cause to be assigned and transferred to the extent not owned by Immatics, to BMS (or its designee), promptly ([**]) any and all Regulatory Materials for the Product Licensed Product, including providing true, accurate and obtaining complete hard and maintaining any and all Regulatory Approvals for the Product for the Field within the Territory. TRANSCEPT shall keep SNBL reasonably and regularly informed electronic copies thereof to BMS, provided Immatics may retain copies of the preparation and submission of all Regulatory Materials, Regulatory Authority communications and review of Regulatory Materials, and Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and expense, to make available as described in the following sentence information in SNBL’s Control or otherwise execute, acknowledge and deliver further instruments, as reasonably necessary to assist TRANSCEPT in preparing or submitting Regulatory Materials and obtaining or maintaining Regulatory Approvals for the Product for the Field within the Territory. SNBL may, at its election, either (i) provide directly to TRANSCEPT such data, results and other information generated from the development or manufacturing of the Device hereunder that are Controlled by SNBL, or (ii) submit and maintain a Device Master File and other similar confidential Regulatory Materials with the FDA and other Regulatory Authorities for the Device, in those regulatory jurisdictions where the Regulatory Authority allow such filings and provide TRANSCEPT and its sublicensees the right to reference such Device Master Files or such other Regulatory Materials; in each case (i) and (ii), to the extent reasonably necessary to support any Regulatory Approval Application for the Product for the Field within the Territory. It is understood that SNBL shall own the Device Master File and such other similar confidential Regulatory Materials and reserves the right to grant Third Parties the right to reference its Device Master Files and other similar confidential Regulatory Materials for purposes other than obtaining Regulatory Approval for the Product for the Field within the Territory. Except as expressly set forth in this Agreement or otherwise mutually agreed by the Parties in writing, SNBL shall not be obligated to undertake any development activities or otherwise generate any new information, document or materials in connection sole purpose of compliance with its obligations under this Section 5.2Applicable Law. 5.2.2 To the extent that SNBL has not filed a Device Master File as of the Effective Date and elects to prepare, and then submit and maintain, a Device Master File and other similar confidential Regulatory Materials, SNBL shall provide TRANSCEPT an opportunity to review and provide comments; provided that, to the extent that any portion of the Device Master File or other similar confidential Regulatory Materials is confidential, SNBL shall provide to TRANSCEPT a general summary of such portion. SNBL shall consider in good faith any comments and suggestions provided by TRANSCEPT and, if such comments and suggestions are reasonably necessary for obtaining Regulatory Approval for the Product, incorporate such comments and suggestions into the Device Master File or other similar confidential Regulatory Materials. In the event that the Parties disagree with respect to any comment or suggestion provided by TRANSCEPT, the Parties agree to submit such disagreement to a Third Party that is mutually acceptable to each of SNBL and TRANSCEPT to consider whether such comment or suggestion should be adopted under this Section 5.2.2.

Regulatory Filings and Regulatory Approvals. 5.2.1 Except as expressly (a) Unless the Parties agree otherwise, Bayer will use Commercially Reasonable Efforts to: (i) obtain Scientific Advice from the EMEA; or (ii) file for Regulatory Approval in one or more countries in Europe based on the data provided hereinby ZGEN in the initial eCTD for the Initial Licensed Product described in paragraph 1(a) of Exhibit G regarding one or more of the Initial Licensed Products within [ * ] after the Effective Date; provided, however, that Bayer shall not be in breach of this Agreement, and ZGEN shall have no right to terminate this Agreement if, despite Bayer’s Commercially Reasonable Efforts, Bayer fails to accomplish the task in subparagraph (i) or (ii) above within such [ * ] time period. For the sake of clarity, Bayer may choose between the two options set forth above but it must pursue one unless the Parties mutually agree otherwise. Bayer shall provide a summary of the results of Scientific Advice to ZGEN within [ * ] of receipt. Notwithstanding the foregoing, if Bayer fails to accomplish the task in subparagraph (i) or (ii) above within such [ * ] period, then Bayer will provide to ZGEN, as between soon as practicable after ZGEN’s request, a written report setting forth in reasonable detail the Partiesactivities undertaken, TRANSCEPT results achieved and problems experienced by Bayer and such other matters that demonstrate the Commercially Reasonable Efforts applied by Bayer in connection with its efforts to accomplish one or the other of such tasks. Bayer shall make qualified personnel available to answer questions relating to the report and will provide such additional supporting documentation as ZGEN may reasonably request. (itself or through b) Bayer will prepare and file (at its sublicenseessole cost and expense) and shall have the sole right to own all right, title and be responsible for preparing and submitting to applicable Regulatory Authorities any and interest in all Regulatory Materials for Filings designed to obtain or support Regulatory Approval in the Product and obtaining and maintaining any Bayer Territory and all Regulatory Approvals for in the Product for the Field within the Bayer Territory. TRANSCEPT All such Regulatory Filings and Regulatory Approvals will be maintained in accordance with Section 15.3.2. (c) ZGEN will prepare and file (at its sole cost and expense) and shall keep SNBL reasonably own all right, title and regularly informed of interest in all Regulatory Filings designed to obtain or support Regulatory Approval in the preparation ZGEN Territory and submission all Regulatory Approvals in the ZGEN Territory. All such Regulatory Filings and Regulatory Approvals will be maintained in accordance with Section 15.3.2. (d) Each Party will provide the other Party with copies of all Regulatory MaterialsFilings, Regulatory Authority communications Approvals and review of all material official correspondence submitted to or received from Regulatory MaterialsAuthorities relating to Licensed Products (and Bulk Drug Substance incorporated therein) in, and Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and expense, to make available as described in the following sentence information case of ZGEN, the United States and, in SNBL’s Control the case of Bayer, any Major Country, without undue delay after submission or otherwise execute, acknowledge and deliver further instruments, as reasonably necessary to assist TRANSCEPT in preparing or submitting Regulatory Materials and obtaining or maintaining Regulatory Approvals for the Product for the Field within the Territory. SNBL may, at its election, either (i) provide directly to TRANSCEPT such data, results and other information generated from the development or manufacturing receipt of the Device hereunder that are Controlled by SNBL, same. Prior to a Party submitting such Regulatory Filings or (ii) submit and maintain a Device Master File and other similar confidential Regulatory Materials material correspondence with the FDA and other Regulatory Authorities in the United States or any Major Country, including proposals for the Devicechanges to labeling (which, in those regulatory jurisdictions where the Regulatory Authority allow such filings and provide TRANSCEPT and its sublicensees the right with respect to reference such Device Master Files or such other Regulatory Materials; in each case (i) and (iiCollaboration Products, shall also be subject to Section 7.3), such Party will use reasonable efforts to afford the extent reasonably necessary to support any Regulatory Approval Application for other Party the Product for the Field within the Territory. It is understood that SNBL shall own the Device Master File and such other similar confidential Regulatory Materials and reserves the right to grant Third Parties the right to reference its Device Master Files and other similar confidential Regulatory Materials for purposes other than obtaining Regulatory Approval for the Product for the Field within the Territory. Except as expressly set forth in this Agreement or otherwise mutually agreed by the Parties in writing, SNBL shall not be obligated to undertake any development activities or otherwise generate any new information, document or materials in connection with its obligations under this Section 5.2. 5.2.2 To the extent that SNBL has not filed a Device Master File as of the Effective Date and elects to prepare, and then submit and maintain, a Device Master File and other similar confidential Regulatory Materials, SNBL shall provide TRANSCEPT an opportunity to review and comment on such Regulatory Filings or material correspondence. Each Party will notify the other Party and, at the request and expense of the other Party, provide comments; provided that, copies to the extent other Party, of any Regulatory Filings, Regulatory Approvals or official correspondence submitted to or received from Regulatory Authorities that any are material to the Development or Commercialization of Licensed Product in every other country in the notifying Party’s portion of the Device Master File Territory. Notwithstanding the foregoing, each Party will provide the other Party with notice of any safety-related correspondence, reports or other similar confidential complaints received from any Regulatory Materials is confidential, SNBL shall provide to TRANSCEPT a general summary Authority within [ * ] of such portion. SNBL shall consider in good faith any comments and suggestions provided by TRANSCEPT and, if such comments and suggestions are reasonably necessary for obtaining Regulatory Approval for receipt of the Product, incorporate such comments and suggestions into the Device Master File or other similar confidential Regulatory Materials. In the event that the Parties disagree with respect to any comment or suggestion provided by TRANSCEPT, the Parties agree to submit such disagreement to a Third Party that is mutually acceptable to each of SNBL and TRANSCEPT to consider whether such comment or suggestion should be adopted under this Section 5.2.2same.

Regulatory Filings and Regulatory Approvals. 5.2.1 Except as expressly provided herein, as between the Parties, TRANSCEPT (itself or through its sublicenseesa) Licensee shall have the sole right to and be responsible for preparing and submitting to applicable Regulatory Authorities any filing Drug Approval Applications and all Regulatory Materials for the Product and obtaining seeking and maintaining any and all Regulatory Approvals for the Product for the Field within the Territory. TRANSCEPT shall keep SNBL reasonably and regularly informed of the preparation and submission of all Regulatory Materials, Regulatory Authority communications and review of Regulatory Materials, and Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and expense, to make available as described in the following sentence information in SNBL’s Control or otherwise execute, acknowledge and deliver further instruments, as reasonably necessary to assist TRANSCEPT in preparing or submitting Regulatory Materials and obtaining or maintaining Regulatory Approvals for the Product for the Field within the Territory. SNBL may, at its election, either (i) provide directly to TRANSCEPT such data, results and other information generated from the development or manufacturing of the Device hereunder that are Controlled by SNBL, or (ii) submit and maintain a Device Master File and other similar confidential Regulatory Materials with the FDA and other Regulatory Authorities for the Device, in those regulatory jurisdictions where the Regulatory Authority allow such filings and provide TRANSCEPT and its sublicensees the right to reference such Device Master Files or such other Regulatory Materials; in each case (i) and (ii), to the extent reasonably necessary to support any Regulatory Approval Application for the Product for the Field within the Territory. It is understood that SNBL shall own the Device Master File and such other similar confidential Regulatory Materials and reserves the right to grant Third Parties the right to reference its Device Master Files and other similar confidential Regulatory Materials for purposes other than obtaining Regulatory Approval for the Product for in the Field within in each jurisdiction in the Licensee Territory, including preparing all documentation and reports necessary in connection therewith, as well as securing data and market exclusivity where applicable in compliance with Applicable Laws in the Licensee Territory. All such Drug Approval Applications and Regulatory Approvals shall be owned by Licensee and Licensee shall promptly provide to OPKO a comprehensive summary in English and a copy in its original language of each such Drug Approval Application, Regulatory Approval and material submission to and communication with a Regulatory Authority regarding the same. Except as expressly set forth in this Agreement or otherwise mutually agreed Agreement, all costs and expenses incurred by the Parties in writing, SNBL shall not be obligated to undertake any development activities or otherwise generate any new information, document or materials Licensee in connection with its obligations under this Section 5.2the preparation, filing and maintenance of Drug Approval Applications and Regulatory Approvals for the Product in the Field in the Licensee Territory shall be borne solely by Licensee. Notwithstanding the foregoing to the contrary, any costs and expenses related to the translation to English of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in the Licensee Territory to be provided to OPKO by Licensee shall be borne by OPKO, while any costs and expenses related to the translation to Chinese of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in OPKO Territory to be provided to Licensee shall be borne by Licensee. 5.2.2 To (b) OPKO shall (i) make available to Licensee all information and data Controlled by OPKO, its Affiliates and Third Party contract manufacturers and suppliers that Licensee reasonably indicates to OPKO is required to file Drug Approval Applications or obtain Regulatory Approval for the extent Product in the Field in the Licensee Territory, (ii) make its personnel with relevant subject matter expertise available on a reasonable basis to consult with Licensee with respect thereto, and (iii) cooperate, and use Commercially Reasonable Efforts to cause its Affiliates and Third Party contract manufacturers and suppliers to cooperate, with Licensee to make changes, at Licensee’s reasonable cost, to the manufacturing of the Compound and/or Product that SNBL are required in order to ensure that the Compound and/or Product supplied to Licensee is compliant with requirements by Regulatory Authority and Applicable Laws in the Licensee Territory. (c) If OPKO has in its possession information of the nature described in Section 6.1(b)(i) above from an Other Licensee, but does not filed a Device Master File have the right to provide this information to Licensee for its use in the Field and the Licensee Territory, then OPKO shall use Commercially Reasonable Efforts to obtain those rights from such Other Licensee, [***] to Licensee. (d) OPKO represents that as of the Effective Date Date, Schedule 6.1(d) lists OPKO’s Other Licensees and elects to prepare, direct contract manufacturers and then submit and maintain, a Device Master File and other similar confidential Regulatory Materials, SNBL shall provide TRANSCEPT an opportunity to review and provide comments; provided thatsuppliers for the Product and, to the extent that any portion best of the Device Master File or other similar confidential Regulatory Materials is confidentialOPKO’s knowledge, SNBL shall provide to TRANSCEPT a general summary of such portion. SNBL shall consider in good faith any comments all contract manufacturers and suggestions provided by TRANSCEPT and, if such comments and suggestions are reasonably necessary for obtaining Regulatory Approval suppliers for the ProductProduct that are engaged by its direct contract manufacturers and suppliers, all of whom are subject to Sections 6.1(b) and 6.1(c), as applicable. To the extent there is any change to the Other Licensees or contract manufacturers or suppliers for the Product at any time during the Term, OPKO shall promptly inform Licensee by writing, upon which notice Schedule 6.1(d) shall be considered automatically amended to incorporate such comments and suggestions into the Device Master File or other similar confidential Regulatory Materials. In the event that the Parties disagree with respect to any comment or suggestion provided by TRANSCEPT, the Parties agree to submit such disagreement to a Third Party that is mutually acceptable to each of SNBL and TRANSCEPT to consider whether such comment or suggestion should be adopted under this Section 5.2.2change.

Regulatory Filings and Regulatory Approvals. 5.2.1 Except as expressly provided herein, as between the Parties, TRANSCEPT (itself or through its sublicenseesa) Licensee shall have the sole right to and be responsible for preparing and submitting to applicable Regulatory Authorities any filing Drug Approval Applications and all Regulatory Materials for the Product and obtaining seeking and maintaining any and all Regulatory Approvals for the Product for the Field within the Territory. TRANSCEPT shall keep SNBL reasonably and regularly informed of the preparation and submission of all Regulatory Materials, Regulatory Authority communications and review of Regulatory Materials, and Regulatory Approvals for the Product for the Field within Territory. SNBL agrees, at TRANSCEPT’s request and expense, to make available as described in the following sentence information in SNBL’s Control or otherwise execute, acknowledge and deliver further instruments, as reasonably necessary to assist TRANSCEPT in preparing or submitting Regulatory Materials and obtaining or maintaining Regulatory Approvals for the Product for the Field within the Territory. SNBL may, at its election, either (i) provide directly to TRANSCEPT such data, results and other information generated from the development or manufacturing of the Device hereunder that are Controlled by SNBL, or (ii) submit and maintain a Device Master File and other similar confidential Regulatory Materials with the FDA and other Regulatory Authorities for the Device, in those regulatory jurisdictions where the Regulatory Authority allow such filings and provide TRANSCEPT and its sublicensees the right to reference such Device Master Files or such other Regulatory Materials; in each case (i) and (ii), to the extent reasonably necessary to support any Regulatory Approval Application for the Product for the Field within the Territory. It is understood that SNBL shall own the Device Master File and such other similar confidential Regulatory Materials and reserves the right to grant Third Parties the right to reference its Device Master Files and other similar confidential Regulatory Materials for purposes other than obtaining Regulatory Approval for the Product for in the Field within in the License Territory, including preparing all documentation and reports necessary in connection therewith, as well as securing data and market exclusivity where applicable in compliance with the Act on Drugs and Medical Devices and other Applicable Laws in the License Territory. All such Drug Approval Applications and Regulatory Approvals shall be owned by Licensee and Licensee shall promptly provide to OPKO a copy of each such Drug Approval Application, Regulatory Approval and material submission to and communication with a Regulatory Authority regarding the same. Upon OPKO’s request, Licensee shall, [***], provide an English translation thereof. Except as expressly set forth in this Agreement or otherwise mutually agreed Agreement, [***] incurred by the Parties in writing, SNBL shall not be obligated to undertake any development activities or otherwise generate any new information, document or materials Licensee in connection with its obligations under this Section 5.2the preparation, filing and maintenance of Drug Approval Applications and Regulatory Approvals for the Product in the Field in the License Territory shall be borne solely by [***]. Notwithstanding the foregoing to the contrary, any costs and expenses related to the translation to English of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in the License Territory to be provided to OPKO by Licensee shall be borne by [***], while any costs and expenses related to the translation to Japanese of the Drug Approval Applications, Regulatory Approvals or material communications with a Regulatory Authority in OPKO Territory to be provided to Licensee shall be borne by [***]. 5.2.2 To the extent that SNBL has not filed a Device Master File as of the Effective Date and elects (b) OPKO shall (i) make available to prepareLicensee all information, data, and then submit and maintain, a Device Master File and other similar confidential Regulatory Materials, SNBL shall provide TRANSCEPT an opportunity reports Controlled by OPKO or its Affiliates that Licensee reasonably indicates to review and provide comments; provided that, OPKO is required to the extent that any portion of the Device Master File file Drug Approval Applications or other similar confidential Regulatory Materials is confidential, SNBL shall provide to TRANSCEPT a general summary of such portion. SNBL shall consider in good faith any comments and suggestions provided by TRANSCEPT and, if such comments and suggestions are reasonably necessary for obtaining obtain Regulatory Approval for the ProductProduct in the Field in the License Territory, incorporate such comments and suggestions into the Device Master File or other similar confidential Regulatory Materials. In the event that the Parties disagree (ii) make its personnel with relevant subject matter expertise available on a \BA - 046396/000002 - 691149 v24 reasonable basis to consult with Licensee with respect thereto. Licensee shall reimburse the out-of-pocket expenses incurred by OPKO. (c) If OPKO, its Affiliates or its contract manuracturers desire to any comment protect their respective trade secrets, OPKO shall, or suggestion provided by TRANSCEPTshall use reasonable efforts to cause its contract manufacturers to, submit and maintain an appropriate drug master files application(s) in accordance with the Parties agree Applicable Law in the License Territory at the cost of OPKO or the contract manufacturers. (d) If OPKO does not have the rights to submit such disagreement provide the information of the nature described in Section 7.1(b)(i) to a Third Party that is mutually acceptable Licensee for its use in the Field and the License Territory, then OPKO shall use [***] to each of SNBL and TRANSCEPT to consider whether such comment or suggestion should be adopted under this Section 5.2.2[***].