Common use of Compliance; Permits; Restrictions Clause in Contracts

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries is, and since January 1, 2010 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of Tigris, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris Subsidiary, any acquisition of material property by Tigris or a Tigris Subsidiary or the conduct of business by Tigris and any Subsidiary as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris and its Subsidiaries holds all Governmental Authorizations which are material to the operation of their businesses (collectively, the “Tigris Permits”) as currently conducted. Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is in material compliance with the terms of the Tigris Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Parent is, and since January 1February 26, 2010 2014, each of Parent and its Subsidiaries has complied in all material respects with, is not been in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisParent, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameParent. There is no agreementContract, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary Parent which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryParent, any acquisition of material property by Tigris or a Tigris Subsidiary Parent or the conduct of business by Tigris and any Subsidiary Parent as currently conducted, (ii) may would reasonably be expected to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the applicable Contemplated Transactions. (b) Each of Tigris and its Subsidiaries Parent holds all Governmental Authorizations which that are material to the operation of their businesses its business (collectively, the “Tigris Parent Permits”) as currently conducted. Part 3.9(bSection 3.12(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each As of Tigris and its Subsidiaries the date of this Agreement, Parent is in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisParent, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Parent Permit will be available to the Surviving Corporation Parent immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries Parent as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries Parent holds all required Governmental Authorizations issuable by any Drug Regulatory Agency Governmental Body necessary for the conduct of the its business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates conducted (the “Tigris Product Candidates”) (the “Tigris Parent Regulatory Permits”) and no such Tigris Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries Parent has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Tigris Parent Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (ed) All clinicalTo the Knowledge of Parent, pre-clinical and other studies and tests conducted by no material debarment or on behalf ofexclusionary claims, actions, proceedings or sponsored byinvestigations in respect of their business or products are pending or threatened against Parent or its officers, Tigris employees or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor any of its Subsidiaries agents. Parent is not the subject of any pending, or to the Knowledge of TigrisParent, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisParent, neither Tigris nor any of its Subsidiaries Parent has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Parent Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Parent, nor to the Knowledge of TigrisParent, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To . (e) There are no proceedings pending or, to the Knowledge of TigrisParent, no material debarment or exclusionary claims, actions, proceedings or investigations in threatened with respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary to an alleged violation by Parent or any of their respective officersits Subsidiaries of the FDCA, employees FDA regulations adopted thereunder, the Controlled Substances Act or agentsany other similar Legal Requirements promulgated by the FDA or other Drug Regulatory Agency. (f) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Parent or in which Parent or its products or services have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2013, Parent has not received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Parent threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or in which Parent Product Candidates, have participated.

Compliance; Permits; Restrictions. (a) Each Neither Acquirer nor any of Tigris and its Subsidiaries is, and since January 1, 2010 has complied is in all material respects conflict with, is not or in material default or in violation ofof any law, and has not received any written notices of alleged or actual material violation with respect torule, any foreign, federal, state or local statute, law or regulation, includingorder, but judgment or decree applicable to Acquirer or any of its Subsidiaries or by which Acquirer or any of its Subsidiaries or any of their respective properties is bound or affected, except for conflicts and violations that (individually or in the aggregate) would not limited be reasonably likely to all applicable Legal Requirementshave an Acquirer Material Adverse Effect. No investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body or authority Entity is pending or, to Acquirer's knowledge, has been threatened in a writing delivered to Acquirer against Acquirer or any of the Knowledge of TigrisMaterial Acquirer Subsidiaries (except for threats delivered prior to January 1, threatened against Tigris 1995 regarding matters which were subsequently resolved or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameare no longer pending). There is no material agreement, judgment, injunction, order or decree binding upon Tigris Acquirer or a Tigris Subsidiary any of the Material Acquirer Subsidiaries which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Acquirer or a Tigris Subsidiaryany the Material Acquirer Subsidiaries, any acquisition of material property by Tigris Acquirer or a Tigris Subsidiary any of the Material Acquirer Subsidiaries or the conduct of business by Tigris and any Subsidiary as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger Acquirer or any of the Contemplated TransactionsMaterial Acquirer Subsidiaries as currently conducted. (b) Each of Tigris Acquirer and its the Material Acquirer Subsidiaries holds hold, to the extent legally required, all Governmental Authorizations which permits, licenses, variances, exemptions, orders and approvals from governmental authorities that are material to and required for the operation of their businesses as currently conducted, except where the failure to hold any such Acquirer Permit would be reasonably likely to have an Acquirer Target Adverse Effect (collectively, the “Tigris "Acquirer Permits”) as currently conducted"). Part 3.9(b) Acquirer and the Material Acquirer Subsidiaries are in compliance in all material respects with the terms of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is Acquirer Permits, except where the failure to be in material compliance with the terms of the Tigris Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, Acquirer Permits would not be reasonably likely to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Timehave a Acquirer Material Adverse Effect. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Parent and each of Tigris and its Subsidiaries isare, and since January 1, 2010 has complied 2020 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened against Tigris Parent or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Tigris Parent or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Parent or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Parent and its Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Parent and its Subsidiaries as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each of Tigris Parent and its Subsidiaries is hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Parent Permit will be available to the Surviving Corporation Parent and its Subsidiaries immediately after the Effective Time on terms substantially identical similar to those enjoyed by Tigris Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisParent’s Knowledge, threatened with respect to an alleged material violation by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Legal Requirements Law administered or promulgated by a any Drug Regulatory Agency. (d) Each of Tigris Parent is not currently conducting or addressing, and its Subsidiaries holds all to Parent’s Knowledge there is no basis to expect that it will be required Governmental Authorizations issuable by to conduct or address, any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conductedcorrective actions, andincluding, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; product recalls or clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authorityholds. (e) All clinical, pre-clinical and other studies and tests conducted by or or, to Parent’s Knowledge, on behalf of, or sponsored by, Tigris Parent or a Tigris Subsidiary any of its Subsidiaries, or in which Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or their respective current products or product candidatescandidates have participated, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) of the Parent Disclosure Schedule, since January 1, 2020, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated. Parent has made available to the Company true and complete copies of all material notices, correspondence or other communications received by Parent from any Drug Regulatory Agency, if any. (f) Neither Tigris Parent nor any of its Subsidiaries is the subject of any pendingpending or, or to the Knowledge of TigrisParent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisParent’s Knowledge, neither Tigris Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisParent, any of its Subsidiaries, or Subsidiaries nor any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of Tigris, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or or, to Parent’s Knowledge, threatened against TigrisParent, any Tigris Subsidiary of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Parent and each of Tigris and its Subsidiaries isSubsidiaries, and since January 1, 2010 has complied 2019 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws, including the FDCA, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. No As of the date of this Agreement, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened against Tigris Parent or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Tigris Parent or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Parent or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Parent and its Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Parent and its Subsidiaries as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each of Tigris Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries is holding Parent Permits are in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as . (c) As of the date of this Agreement and immediately prior to the Effective Time. (c) There Agreement, there are no proceedings pending or, to the Knowledge of TigrisParent’s Knowledge, threatened with respect to an alleged material violation by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the PHSA or any other similar Legal Requirements Law administered or promulgated by a any Drug Regulatory Agency. Parent is not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Parent or a Tigris Subsidiary its Subsidiaries, or in which Tigris Parent or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidatescandidates have participated, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated. (e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against Parent or any of its Subsidiaries or any of their respective officers and employees, and Parent has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To Parent’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws. (f) Neither Tigris Parent nor any of its Subsidiaries is the subject of any pendingpending or, or to the Knowledge of TigrisParent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisParent’s Knowledge, neither Tigris Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. . (g) None of TigrisParent, any of its Subsidiaries, Subsidiaries or any of their respective officers, employees or agents to Parent’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in a material (i) debarment or exclusion (i) under 21 U.S.C. Section 335a or 335a, as amended; (ii) any similar applicable Legal Requirementdisqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. To the Knowledge of Tigris, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or or, to the Parent’s Knowledge, threatened against TigrisParent, any Tigris Subsidiary of its Subsidiaries or any of their respective officers, employees or agents. (h) Parent and its Subsidiaries have materially complied with all applicable Laws relating to patient, medical or individual health information, including HIPAA. Parent and its Subsidiaries have entered into, where required, and is in compliance in all material respects with the terms of all Business Associate Agreements to which Parent or any Subsidiary is a party or otherwise bound. Parent and its Subsidiaries, where required, have created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, neither Parent nor any of its Subsidiaries have received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to Parent, its Subsidiaries or an agent or third party subject to a Business Associate Agreement with Parent or its Subsidiaries. Parent and its Subsidiaries are not currently submitting, receiving and handling transactions governed by the Standard Transaction Rule. All capitalized terms in this Section 3.14(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.

Compliance; Permits; Restrictions. (a) Each of Tigris Buyer and its Subsidiaries iseach Buyer Subsidiary are, and since January 1, 2010 has complied 2014 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisBuyer, threatened in writing against Tigris Buyer or a Tigris any Buyer Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris Buyer or a Tigris any Buyer Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Buyer or a Tigris any Buyer Subsidiary, any acquisition of material property by Tigris Buyer or a Tigris any Buyer Subsidiary or the conduct of business by Tigris and Buyer or any Buyer Subsidiary as currently conducted, (ii) may have an adverse effect on Tigris’ Buyer’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Except for matters regarding the FDA and its except as would not reasonably be expected to have a Buyer Material Adverse Effect, Buyer and the Buyer Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Buyer (collectively, the “Tigris Buyer Permits”) as currently conducted. Part 3.9(b2.11(b) of the Tigris Buyer Disclosure Schedule identifies each Tigris Buyer Permit. Each of Tigris Buyer and its Subsidiaries each Buyer Subsidiary is in material compliance with the terms of the Tigris Buyer Permits, except as would not reasonably be expected to have a Buyer Material Adverse Effect. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisBuyer, threatenedthreatened in writing, which seeks to revoke, limit, suspend, or materially modify any Tigris Buyer Permit. The rights and benefits of each material Tigris Buyer Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Buyer and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisBuyer, threatened in writing with respect to an alleged material violation by Tigris Buyer or a Tigris Subsidiary any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by a Drug the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug or medical device products (“Drug/Device Regulatory Agency”). (d) Each Buyer and each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Buyer or such Subsidiary as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product CandidatesBuyer Products”) (collectively, the “Tigris Buyer Regulatory Permits”) ), except as would not reasonably be expected to have a Buyer Material Adverse Effect, and no such Tigris Buyer Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries Buyer and each Buyer Subsidiary is in compliance in all material respects with the Buyer Regulatory Permits and has not received any written notice or other written communication from any Drug Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Buyer Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Buyer Regulatory Permit. Except for the information and files identified in Part 3.9(d2.11(d) of the Tigris Buyer Disclosure Schedule, Tigris Buyer has made available to Potomac Lpath all information requested by Lpath in its Buyer’s or its Subsidiaries’ possession or control relating to the Tigris Buyer Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Buyer Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Drug/Device Regulatory Agency; and meeting minutes with any Drug Drug/Device Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Buyer or a Tigris Subsidiary its Subsidiaries or in which Tigris Buyer or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidates, including the Buyer Product Candidates, have participated were were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Drug/Device Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris Buyer nor any of its the Buyer Subsidiaries is the subject of any pending, or to the Knowledge of TigrisBuyer or the Buyer Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisBuyer or any of the Buyer Subsidiaries, neither Tigris Buyer nor any of its the Buyer Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisBuyer, any of its Subsidiaries, Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of TigrisBuyer, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisBuyer, any Tigris Buyer Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Except as set forth on Section 3.11(d) of Tigris the Corautus Disclosure Schedule, Corautus and its Subsidiaries iseach Corautus Subsidiary are, and since January 1have been, 2010 has complied in compliance in all material respects with, is not in material violation of, with all applicable Legal Requirements and has not received any written notices notice of violation or alleged or actual material violation with respect to, of any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisCorautus, threatened against Tigris Corautus or a Tigris any Corautus Subsidiary, nor has any Governmental Body or authority indicated to Potomac Corautus an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris Corautus or a Tigris any Corautus Subsidiary which (i) has had or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris Subsidiary, any acquisition of material property by Tigris or a Tigris Subsidiary or the conduct of business by Tigris and any Subsidiary as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated TransactionsCorautus Material Adverse Effect. (b) Each Except as set forth on Section 3.11(d) of Tigris the Corautus Disclosure Schedule: (i) Corautus and its the Corautus Subsidiaries holds hold all Governmental Authorizations which are material to the operation of their businesses the business of Corautus (collectively, the “Tigris Corautus Permits”) as currently conducted). Part 3.9(bSection 3.11(b) of the Tigris Corautus Disclosure Schedule identifies each Tigris Corautus Permit, each of which is in full force and effect. Each of Tigris Corautus and its Subsidiaries each Corautus Subsidiary is in material compliance with the terms of the Tigris Corautus Permits. No Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule: (i) no action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisCorautus, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Corautus Permit. The ; and (ii) the rights and benefits of each material Tigris Corautus Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Corautus and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule, there are no proceedings pending or, to the Knowledge of Tigris, or threatened with respect to an alleged material violation by Tigris Corautus or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act, the Public Health Service Act or any other similar Legal Requirements promulgated by a the FDA or other Drug Regulatory Agency. (d) Each Except for such Governmental Authorizations listed in Section 3.11(d) of Tigris the Corautus Disclosure Schedule, Corautus and its Subsidiaries holds (or at the relevant time, held) all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, conducted and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its existing products or product candidates (the “Tigris Product CandidatesCorautus Products”) (the “Tigris Corautus Regulatory Permits”) and and, except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule, no such Tigris Corautus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Neither Tigris nor Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule, Corautus and each of its Subsidiaries has complied in all material respects with the Corautus Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any actual or possible violation of or failure to comply with any term or requirement of any Corautus Regulatory Permit or (B) any actual or possible revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Corautus Regulatory Permit. Except for the information and files identified in Part 3.9(dSection 3.11(d) of the Tigris Corautus Disclosure Schedule, Tigris Corautus has made available to Potomac VIA all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates Corautus Products and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product CandidatesCorautus Products, including without limitation, complete and correct copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Corautus or a Tigris any Corautus Subsidiary or in which Tigris Corautus or a Tigris any Corautus Subsidiary or their respective its current products or product candidates, including the Corautus Products, have participated (the “Corautus Studies”) were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f. Except for such notices listed in Section 3.11(e) Neither Tigris of the Corautus Disclosure Schedule, neither Corautus nor any Corautus Subsidiary has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring the termination, suspension or material modification of any clinical studies conducted by or on behalf of, or sponsored by, Corautus or its Subsidiaries is or in which its current products or product candidates, including the subject Corautus Products, have participated. Except for such material obligations listed in Section 3.11(e) of any pendingthe Corautus Disclosure Schedule, Corautus and its Subsidiaries have fulfilled and performed all of their material obligations with respect to the Corautus Studies, and no event has occurred which causes, or after notice or lapse of time would reasonably be expected to the Knowledge of Tigriscause, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of a Corautus Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agentsAdverse Effect.

Compliance; Permits; Restrictions. (a) Each of Tigris TorreyPines and its Subsidiaries iseach TorreyPines Subsidiary are, and since January 1, 2010 has complied 2003 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisTorreyPines, threatened against Tigris TorreyPines or a Tigris any TorreyPines Subsidiary, nor has any Governmental Body or authority indicated to Potomac TorreyPines an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris TorreyPines or a Tigris any TorreyPines Subsidiary which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris TorreyPines or a Tigris any TorreyPines Subsidiary, any acquisition of material property by Tigris TorreyPines or a Tigris any TorreyPines Subsidiary or the conduct of business by Tigris and TorreyPines or any TorreyPines Subsidiary as currently conducted, (ii) may have an adverse effect on TigrisTorreyPines’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris TorreyPines and its the TorreyPines Subsidiaries holds hold all Governmental Authorizations which are material to the operation of their businesses the business of TorreyPines (collectively, the “Tigris TorreyPines Permits”) as currently conducted). Part 3.9(b2.11(b) of the Tigris TorreyPines Disclosure Schedule identifies each Tigris TorreyPines Permit. Each of Tigris TorreyPines and its Subsidiaries each TorreyPines Subsidiary is in material compliance with the terms of the Tigris TorreyPines Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisTorreyPines, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris TorreyPines Permit. The rights and benefits of each material Tigris TorreyPines Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris TorreyPines and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, or threatened with respect to an alleged material violation by Tigris TorreyPines or a Tigris Subsidiary any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by a the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”). (d) Each of Tigris and its Subsidiaries TorreyPines holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries TorreyPines as currently conducted, and, as applicable, conducted and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates candidates, including N▇▇-▇▇▇, ▇▇▇-▇▇▇, ▇▇▇-▇▇▇ and NGX-292 (the “Tigris TorreyPines Product Candidates”) (the “Tigris TorreyPines Regulatory Permits”) and no such Tigris TorreyPines Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Neither Tigris nor its Subsidiaries TorreyPines is in compliance in all material respects with the TorreyPines Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any actual or possible violation of or failure to comply with any term or requirement of any TorreyPines Regulatory Permit or (B) any actual or possible revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris TorreyPines Regulatory Permit. Except for the information and files identified in Part 3.9(d2.11(d) of the Tigris TorreyPines Disclosure Schedule, Tigris TorreyPines has made available to Potomac Axonyx all information in its or its Subsidiaries’ possession or control relating to the Tigris TorreyPines Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris TorreyPines Product Candidates, including without limitation, complete and correct copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary TorreyPines or in which Tigris TorreyPines or a Tigris Subsidiary or their respective its current products or product candidates, including the TorreyPines Product Candidates, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor . TorreyPines has not received any of its Subsidiaries is notices, correspondence, or other communications from any Drug Regulatory Agency requiring the subject termination, suspension or material modification of any pendingclinical studies conducted by or on behalf of, or to sponsored by, TorreyPines or in which TorreyPines or its current products or product candidates, including the Knowledge of TigrisTorreyPines Product Candidates, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agentshave participated.

Compliance; Permits; Restrictions. (a) Each of Tigris Buyer and its Subsidiaries isare, and since January 1, 2010 has complied 2019 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws. No Except as set forth on Section 3.15(a) of the Buyer Disclosure Schedule, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending oris, to the Knowledge of TigrisBuyer, pending or threatened against Tigris Buyer or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameits Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Tigris Buyer or a Tigris Subsidiary its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Buyer or a Tigris Subsidiaryits Subsidiaries, any acquisition of material property by Tigris Buyer or a Tigris Subsidiary its Subsidiaries or the conduct of business by Tigris and any Subsidiary Buyer or its Subsidiaries as currently conducted, (ii) may would be reasonably likely to have an adverse effect on TigrisBuyer’s or its Subsidiaries’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would be reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Buyer and its Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses (collectively, the “Tigris Permits”) as currently conducted. Part 3.9(b) business of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris Buyer and its Subsidiaries is as currently conducted (the “Buyer Permits”). Buyer and its Subsidiaries are in material compliance with the terms of the Tigris Buyer Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisBuyer, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Buyer Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris Buyer and its Subsidiaries holds have implemented and maintain, and since January 1, 2019 have maintained, policies, procedures, and practices governing Personal Information that comply in all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for material respects with all applicable Data Protection Laws and Buyer’s Contracts. Such policies, procedures, and practices have been followed in all material respects in the conduct of the business of Tigris Buyer and its Subsidiaries. Buyer and its Subsidiaries as currently conductedhave adopted, andand since January 1, as applicable2019 have maintained, developmentinformation security and privacy programs, clinical testingincluding commercially reasonable administrative, manufacturingphysical, marketingand technical safeguards consistent with industry standards, distribution to protect the confidentiality, integrity, availability and importation security of Sensitive Data against unauthorized access, use, modification, disclosure or exportationother misuse. (d) Since January 1, as currently conducted2019, of any of Buyer and its products or product candidates (Subsidiaries have used commercially reasonable efforts to prevent the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been introduction (i) revokedinto any software owned by Buyer or its Subsidiaries, withdrawn, suspended, cancelled or terminated or (ii) modified into the IT Systems, and, to the Knowledge of Buyer, such IT Systems do not contain, any ransomware, disabling codes or instructions, spyware, Trojan horses, worms, viruses or other software routines that permit or cause unauthorized access to, or disruption, impairment, disablement, or destruction of, software, data or other materials in any materially adverse material manner. Neither Tigris nor Buyer and its Subsidiaries has received have used commercially reasonable efforts to promptly implement material security patches that are generally available for the IT Systems. To the Knowledge of Buyer, the IT Systems have not suffered any written notice unplanned or critical failures, continued substandard performance, errors, breakdowns or other written communication from adverse events that have caused any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination material disruption or material modification of any Tigris Regulatory Permit. Except for interruption in the information and files identified in Part 3.9(d) operation of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information business of Buyer and its Subsidiaries in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and any material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authoritymanner. (e) All clinicalBuyer and its Subsidiaries are, pre-clinical and since January 1, 2019 have been, in material compliance with all applicable Data Protection Laws, Buyer’s and its Subsidiaries’ obligations under their Contracts, and Buyer and Subsidiaries privacy policies relating to Personal Information, including requirements regarding the acquisition, collection, storage, confidentiality, use, disclosure, transfer, destruction, and any other studies processing of Personal Information. Buyer and tests conducted by or on behalf ofits Subsidiaries have not received any written subpoenas, demands, or sponsored byother notices from any Governmental Body investigating, Tigris inquiring into, or a Tigris Subsidiary otherwise relating to any actual or potential material violation of any Data Protection Laws. To Buyer’s Knowledge, Buyer and its Subsidiaries are not under investigation, nor have they been threatened, by any Governmental Body for any violation of any Data Protection Laws in which Tigris any material respect. No written notice, complaint, claim, enforcement action, or a Tigris Subsidiary litigation has been served on, or, to Buyer’s Knowledge, initiated against Buyer or their respective products or product candidatesits Subsidiaries alleging violation of any Data Protection Laws. The execution of this Agreement by Buyer and the other documents contemplated hereby, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations consummation of the Drug Regulatory Agencies transactions contemplated hereunder and thereunder, do not violate any privacy policy, terms of use, Contract or applicable Law relating to the use, dissemination, transfer or other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312processing of any Sensitive Data in any material respect. (f) Neither Tigris nor any Except as set forth on Section 3.15(f) of the Buyer Disclosure Schedule, Buyer and its Subsidiaries is the subject of have not suffered any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretomaterial Security Incident. To the Knowledge of TigrisBuyer, neither Tigris nor any no service provider (in the course of its Subsidiaries has committed any acts, made any statement, providing services for or failed to make any statement, in each case in respect on behalf of its business Buyer or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or ) has suffered any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agentsSecurity Incident.

Compliance; Permits; Restrictions. (a) Each Sellas and each Sellas Subsidiary are, and since July 1, 2015 each of Tigris Sellas, and its Subsidiaries ishas been, and since January 1, 2010 has complied in all material respects with, is not in material compliance with all applicable Legal Requirements except for any non-compliance that would not constitute a Sellas Material Adverse Effect. Neither Sellas nor any Sellas Subsidiaries has received any notice of violation of, and has not received any written notices of alleged or actual material been charged with a violation with respect toof, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisSellas, threatened against Tigris Sellas or a Tigris any Sellas Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Tigris Sellas or a Tigris any Sellas Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Sellas or a Tigris any Sellas Subsidiary, any acquisition of material property by Tigris Sellas or a Tigris any Sellas Subsidiary or the conduct of business by Tigris and Sellas or any Sellas Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on TigrisSellas’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Sellas and its the Sellas Subsidiaries holds hold all Governmental Authorizations which are material to necessary for the operation of their businesses the business of Sellas (collectively, the “Tigris Sellas Permits”) as currently conducted. Part 3.9(bSection 2.12(b) of the Tigris Sellas Disclosure Schedule identifies each Tigris Sellas Permit. Each Neither Sellas nor any of Tigris the Sellas Subsidiaries is in default under or in material breach or violation of (and its no event has occurred that, with notice or the lapse of time or both, would constitute a default under or a breach or violation of) any term, condition or provision of any Sellas Permit. Sellas and the Sellas Subsidiaries have taken all necessary action to maintain all Sellas Permits in full force and effect, including the submission of timely and complete applications for renewal or reissuance of such Sellas Permits, and no such Sellas Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated; or (ii) modified in any adverse manner. Neither Sellas nor any of the Sellas Subsidiaries have received any notice or other communication from any Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Sellas Permit or (B) any revocation, withdrawal, suspension, cancelation, termination or material modification of any Sellas Permit. The rights and benefits of each material Sellas Permit will be available to the Surviving Company or Galena immediately after the Effective Time on terms substantially identical to those enjoyed by Sellas and the Sellas Subsidiaries immediately prior to the Effective Time except where the unavailability of such Sellas Permit would not constitute a Sellas Material Adverse Effect. (c) As of the date of this Agreement, each of Sellas and each Sellas Subsidiary is in material compliance with the terms of the Tigris Sellas Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisSellas, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Sellas Permit. The rights and benefits of each material Tigris Sellas Permit will be available to the Surviving Corporation Company immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Sellas and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective TimeTime except where the unavailability of such Sellas Permit would not constitute a Sellas Material Adverse Effect. (cd) There are no proceedings pending or, to the Knowledge of TigrisSellas, threatened with respect to an alleged material violation by Tigris Sellas or a Tigris Subsidiary any Sellas Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA the Public Health Services Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act or any other similar Legal Requirements promulgated by a the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”). (de) Each of Tigris Sellas and its Subsidiaries each Sellas Subsidiary holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for (i) the conduct of the business of Tigris and its Subsidiaries Sellas or such Subsidiary as currently conducted, and, as applicable, and (ii) the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Sellas Product Candidates”) (collectively, the “Tigris Sellas Regulatory Permits”) and no ). No such Tigris Sellas Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Neither Tigris nor its Subsidiaries Sellas and each Sellas Subsidiary is and, since July 1, 2015, has been in compliance in all material respects with the Sellas Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding alleging any revocation, withdrawal, suspension, cancellation, termination material violation of or failure to comply with any material modification term or requirement of any Tigris Sellas Regulatory Permit. Except To Sellas’ Knowledge, any third-party supplier, manufacturer, or contractor that is developing or manufacturing Sellas Product Candidates for the information and files identified Sellas or its Subsidiaries is in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris compliance with all Governmental Authorizations issued by a Drug Regulatory Agency applicable to such development or manufacture except for any such noncompliance that would not constitute a Sellas Material Adverse Effect. Sellas has made available to Potomac Galena all information reasonably requested by Galena in its Sellas’ or its Subsidiaries’ possession or control relating to the Tigris Sellas Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Sellas Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports reports, all material pre-clinical and material clinical study data; and investigational new drug applications submitted to any Drug Regulatory Agency; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; . The descriptions of, protocols for, and (y) similar reportsdata and other results of all clinical, material study datapre-clinical and other studies and tests conducted by or on behalf of, noticesor sponsored by, lettersSellas or its Subsidiaries that have been provided to Galena are true, filingscorrect, correspondence and meeting minutes with any other Governmental Authoritycomplete. (ef) Section 2.12(f) of the Sellas Disclosure Schedule sets forth a true, correct, and complete list of all of Sellas and its Subsidiaries products and product candidates, noting, where applicable, (i) the phase of the clinical trial or development each product or product candidate is in, and (ii) those products or product candidates where FDA or other regulatory approval, including foreign approvals, has been applied for and/or received, and listing the application made and/or the approval or decision thereon obtained. All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Sellas or a Tigris Subsidiary its Subsidiaries or in which Tigris Sellas or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidates, including the Sellas Product Candidates, have participated were were, and if still pending are being, conducted in all material respects in accordance with good clinical practices, standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 58, 312, 314 Subpart H, 316, and 312601, as applicable. Since July 1, 2015, neither Sellas nor any Sellas Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Sellas threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Sellas or any Sellas Subsidiaries or in which Sellas or any Sellas Subsidiaries or their respective current products or product candidates, including the Sellas Product Candidates, have participated. (fg) Neither Tigris Sellas nor any of its the Sellas Subsidiaries is the subject of any pending, or to the Knowledge of TigrisSellas or the Sellas Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisSellas or any of the Sellas Subsidiaries, neither Tigris Sellas nor any of its the Sellas Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Sellas Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisSellas, any Sellas Subsidiaries or to the Knowledge of its SubsidiariesSellas, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of TigrisSellas, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisSellas, any Tigris Sellas Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Except where failure would not result in a PubCo Material Adverse Effect, PubCo is, and since January 1, 2010 2020, has complied in all material respects with, is not been in material violation ofcompliance with all applicable Laws, including the FDCA, applicable provisions of the Public Health Service Act (“PHSA”), the Controlled Substances Act (“CSA”) (21 U.S.C. § 801 et seq.), and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited regulations promulgated to all applicable Legal Requirementsimplement the foregoing. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisPubCo, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the samePubCo. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Tigris or a Tigris Subsidiary PubCo which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryPubCo, any acquisition of material property by Tigris or a Tigris Subsidiary PubCo or the conduct of business by Tigris and any Subsidiary PubCo as currently conducted, or (ii) may have an adverse effect on Tigris’ ability is reasonably likely to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactionsresult in a PubCo Material Adverse Effect. (b) Each of Tigris and its Subsidiaries Except where a failure would not result in a PubCo Material Adverse Effect, PubCo: (i) holds all required Governmental Authorizations which that are material to the operation of their businesses the business of PubCo and Merger Sub as currently conducted (collectively, the “Tigris PubCo Permits”), and (ii) as currently conducted. Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is in material compliance with the terms of the Tigris PubCo Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisPubCo, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Tigris PubCo Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings Legal Proceedings pending or, to the Knowledge of TigrisPubCo, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary PubCo of the FDCA, FDA the PHSA, the CSA, the implementing regulations adopted thereunder, or any other similar Legal Requirements Law promulgated by a the FDA or other Drug Regulatory AgencyAgency that is material to the conduct of PubCo’s business. (d) Each Except where failure would not result in a PubCo Material Adverse Effect, each of Tigris and its Subsidiaries PubCo holds all required Governmental Authorizations issuable issued or granted by any Drug Regulatory Agency or other Governmental Authority which is necessary for the conduct of the business of Tigris and its Subsidiaries PubCo as currently conducted, and, as applicable, conducted and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris PubCo Product Candidates”) (collectively, the “Tigris PubCo Regulatory Permits”) and no such Tigris PubCo Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated terminated, or (ii) modified in any materially adverse manner, other than immaterial modifications. Neither Tigris nor its Subsidiaries Except where failure would not result in a PubCo Material Adverse Effect, PubCo has timely maintained and are in compliance in all material respects with the PubCo Regulatory Permits and have not received any written notice or other written communication from any Drug Regulatory Agency or other Governmental Authority regarding (A) any material violation of or failure to comply materially with any term or requirement of any PubCo Regulatory Permit, or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris PubCo Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris PubCo has made available to Potomac the Company all information requested by the Company in its or its Subsidiaries’ PubCo’s possession or control relating to the Tigris PubCo Product Candidates and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation and or exportation of the Tigris PubCo Product Candidates, including without limitation, but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; , and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects. (e) All clinicalclinical trials, pre-clinical studies and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary PubCo, or in which Tigris or a Tigris Subsidiary PubCo or their respective products or product candidates, including the PubCo Product Candidates, have participated participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. PubCo has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of PubCo threatening to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, PubCo or in which PubCo or its respective current product candidates, including the PubCo Product Candidates, have participated. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of PubCo, on behalf of PubCo has been disqualified from participating in studies involving the PubCo Product Candidates, and to the Knowledge of PubCo, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending. (f) Neither Tigris nor PubCo nor, to the Knowledge of PubCo, any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate, is the subject of any pendingpending or, or to the Knowledge of TigrisPubCo, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisPubCo, neither Tigris PubCo nor any of its Subsidiaries contract manufacturer with respect to any PubCo Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither of TigrisPubCo, and to the Knowledge of PubCo, any of its Subsidiariescontract manufacturer with respect to any PubCo Product Candidate, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a 335a, or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisPubCo, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisPubCo, and to the Knowledge of PubCo, any Tigris Subsidiary contract manufacturer with respect to any PubCo Product Candidate, or any of their respective officers, employees or agents. (g) All manufacturing operations conducted by, or to the Knowledge of PubCo, for the benefit of, PubCo in connection with any PubCo Product Candidate, since January 1, 2018, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices for human pharmaceutical products codified at 21 C.F.R. Parts 210, and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. (h) No manufacturing site owned by PubCo, and to the Knowledge of PubCo, no manufacturing site of a contract manufacturer, with respect to any PubCo Product Candidate, (i) is subject to a Drug Regulatory Agency or Governmental Authority shutdown or import or export prohibition, or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of PubCo, neither the FDA nor any other Governmental Authority is considering such action.

Compliance; Permits; Restrictions. (a) Each Advaxis and each of Tigris and its Subsidiaries isare, and since January November 1, 2010 has complied 2015 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements, including (i) the Federal Food, Drug and Cosmetic Act (“FDCA”); (ii) the Public Health Service Act (“PHSA”); (iii) all federal or state criminal or civil fraud and abuse Legal Requirements; (iv) any comparable state or local Legal Requirements; and (v) any applicable state licensing, disclosure and reporting requirements (all of the foregoing, collectively, “Healthcare Laws”). No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisAdvaxis, threatened against Tigris Advaxis or a Tigris Subsidiaryany of its Subsidiaries, nor has any Governmental Body or authority Authority indicated to Potomac Advaxis in writing an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris Advaxis or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Advaxis or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Advaxis or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Advaxis or any Subsidiary of its Subsidiaries as currently conducted, (ii) may have an adverse effect on TigrisAdvaxis’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Advaxis and its Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Advaxis (collectively, the “Tigris Advaxis Permits”) as currently conducted. Part 3.9(b2.11(b) of the Tigris Advaxis Disclosure Schedule identifies each Tigris Advaxis Permit, including the holder of the Advaxis Permit, the name of the Advaxis Permit, and the date of expiration. Each of Tigris Advaxis and its Subsidiaries is in material compliance with the terms of the Tigris Advaxis Permits and the Advaxis Permits are in full force and effect. All fees and charges with respect to the Advaxis Permits, as of the date hereof, have been paid in full, and all filing, reporting, record keeping, and maintenance obligations required under the applicable Advaxis Permits and Healthcare Laws have been completely and timely satisfied. All such reports, records, and filings were complete and accurate in all material respects, or were subsequently updated, changed, corrected, or modified. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisAdvaxis, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Tigris Advaxis Permit. The rights and benefits of each material Tigris Advaxis Permit will be available to the Surviving Corporation Company immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Advaxis and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. There have been no occurrences, events, or Legal Proceedings that are pending, under investigation, or to the Knowledge of Advaxis, threatened, nor has Advaxis received any written notice which has resulted in or would reasonably be expected to result in any material limitation, adverse modification, revocation, withdrawal, cancellation, lapse, integrity review, suspension, or any other adverse action against any Advaxis Permit. (c) There are no proceedings pending or, to the Knowledge of TigrisAdvaxis, threatened with respect to an alleged material violation by Tigris Advaxis or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA PHSA, Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by a the FDA or other comparable Governmental Authority responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”). Advaxis has not been restrained by any Governmental Authority or other Person in its ability to conduct or have conducted the manufacturing, clinical and pre-clinical investigation, handling, shipping, packaging, labeling, storage, import, export, or distribution of its Advaxis Product Candidates. (d) Each Advaxis and each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Advaxis or such Subsidiary as currently conducted, and, as to the extent applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Advaxis Product Candidates”) (collectively, the “Tigris Advaxis Regulatory Permits”) ), and no such Tigris Advaxis Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Neither Tigris nor Advaxis and each of its Subsidiaries is in compliance in all material respects with the Advaxis Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Advaxis Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Advaxis Regulatory Permit. Except for the information and files identified in Part 3.9(d2.11(d) of the Tigris Advaxis Disclosure Schedule, Tigris Advaxis has made available to Potomac Biosight all information requested by Biosight in its Advaxis’ or its Subsidiaries’ possession or control relating to the Tigris Advaxis Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Advaxis Product Candidates, including without limitation, complete copies of the following (to the extent there are any): ) (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinicalmaterial preclinical and clinical investigations conducted or sponsored by or on behalf of and intended to be submitted to a Governmental Authority to support a Governmental Authorization are being and have been conducted in compliance in all material respects with all applicable Healthcare Laws administered or issued by the applicable Governmental Authority, including, as applicable, (i) the FDA regulations for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) applicable 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 312 of the Code of Federal Regulations and (iii) applicable federal, state and foreign Healthcare Laws restricting the use and disclosure of individually identifiable health information, including HIPAA. Neither Advaxis or its Subsidiaries, nor, to the Knowledge of Advaxis, any of third party conducting a clinical or preclinical study on their behalf, has received any written notice, correspondence or other written communication from the FDA or any other Governmental Authority or from any institutional review board, ethics committee, or analogous review board (collectively “IRB”) requiring or threatening the termination, suspension, delay, restriction, rejection, or material modification of any ongoing, completed, or planned clinical or pre-clinical and other studies and tests trials conducted by by, or on behalf of, Advaxis. The study reports, protocols, and statistical analysis plans for all such material preclinical and clinical investigations, accurately, completely, and fairly reflect the results from and plans for such studies. Advaxis has no Knowledge of any other studies, the results of which are inconsistent or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with otherwise call into question the applicable regulations results of the Drug Regulatory Agencies material preclinical and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 clinical investigations. Advaxis does not have any Knowledge of any material facts or circumstances related to the safety or efficacy of the Advaxis Product Candidates that would materially and 312adversely affect its ability to receive or maintain a Governmental Authorization. (f) As of the date of this Agreement, no data generated by or on behalf of Advaxis or its Subsidiaries with respect to the Advaxis Product Candidates is the subject of any written regulatory investigation, claim, suit, proceeding, audit or other action, either pending, or to the Knowledge of Advaxis, threatened by any Governmental Authority relating to the truthfulness or scientific integrity of such data. (g) Neither Tigris nor Advaxis, any of its Subsidiaries Subsidiaries, nor, to the Knowledge of Advaxis, any Person providing services on their behalf, is the subject of any pending, or to the Knowledge of TigrisAdvaxis, threatened investigation in respect of its business or products the Advaxis Product Candidates by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereto or otherwise with respect to any other untrue or false statement or omission. To the Knowledge of TigrisAdvaxis, neither Tigris Advaxis nor any of its Subsidiaries or Persons proving services on their behalf, has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products the Advaxis Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisAdvaxis, any of its Subsidiaries, or to the Knowledge of Advaxis, any of their respective officers, employees or agents has agents, or to the Knowledge of Advaxis, any Person providing services on Advaxis’ or its Subsidiaries’ behalf, have been debarred, disqualified, or excluded, or have been convicted of any crime or engaged in any conduct that could result in a material debarment debarment, disqualification, or exclusion (i) under 21 U.S.C. Section 335a S▇▇▇▇▇▇ ▇▇▇▇, (▇▇) ▇▇▇▇▇ ▇▇ ▇.▇.▇. §▇▇▇▇▇-▇, (iii) with respect to federal procurement or non-procurement programs, including those produced by the U.S. General Services Administration, (iv) under 21 C.F.R. Parts 312, 511, or 812 or otherwise with respect to the receipt of investigational products, or (iiv) any similar applicable Legal Requirement. To the Knowledge of TigrisAdvaxis, no material debarment debarment, ineligibility, or exclusionary claims, actions, proceedings or investigations in respect of their business or products the Advaxis Product Candidates are pending or threatened against TigrisAdvaxis, any Tigris Subsidiary or of its Subsidiaries, any of their respective officers, employees or agents, or any Person providing services on behalf of Advaxis or its Subsidiaries. (h) To the Knowledge of Advaxis, no Advaxis Product Candidate manufactured or distributed by or on behalf of Advaxis or its Subsidiaries is (i) adulterated within the meaning of 21 U.S.C. §351 (or any similar Healthcare Law), (ii) misbranded within the meaning of 21 U.S.C. §352 (or any similar Healthcare Law); or (iii) otherwise prohibited from introduction into interstate commerce under applicable Legal Requirements. As of the date of this Agreement, neither the Advaxis or its Subsidiaries nor, to the Knowledge of Advaxis and with respect to services provided to Advaxis, any of their respective contractors, including, but not limited to, contract manufacturers, has received any FDA Form 483, warning letter, untitled letter, cyber letter, reprimand, regulatory letter, adverse inspectional findings, notice of integrity review or investigation, request for corrective or remedial action, deficiency notice, or other similar correspondence or written notice from the FDA or any other regulatory authority alleging or asserting material noncompliance with any applicable Healthcare Laws or Advaxis Permits issued to Advaxis or its Subsidiaries by the FDA or any other regulatory authority. No manufacturing site owned by Advaxis or its Subsidiaries, to the Knowledge of Advaxis, any of their respective contract manufacturers, is or has been subject to a shutdown or import or export prohibition imposed by FDA or another regulatory authority. (i) No Advaxis Product Candidate has been or has been requested by a regulatory authority or other Person to be recalled, withdrawn, removed, suspended, seized, the subject of a corrective action, or discontinued (whether voluntarily or otherwise) (collectively “Recall”). Neither Advaxis, its Subsidiaries, nor, to the Knowledge of Advaxis, any regulatory authority or other Person, has sought, is seeking, or, to the Knowledge of Advaxis, has or is currently threatening or contemplating any Recall of any such Advaxis Product Candidate.

Compliance; Permits; Restrictions. (a) Each Except as disclosed on Schedule 2.9 neither Synergy nor any of Tigris and its Subsidiaries is, and since January 1, 2010 has complied is in all material respects conflict with, is not or in material default or violation ofof (i) any law, and has not received any written notices of alleged or actual material violation with respect torule, any foreign, federal, state or local statute, law or regulation, includingorder, but not limited judgment or decree applicable to all applicable Legal Requirements. No investigationSynergy or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, claimor (ii) any note, suitbond, proceedingmortgage, audit indenture, contract, agreement, lease, license, permit, franchise or other action instrument or obligation to which Synergy or any of its Subsidiaries is a party or by which Synergy or any of its Subsidiaries or its or any of their respective properties is bound or affected except for those conflicts, defaults or violations which would not be reasonably expected to have a Synergy Material Adverse Effect. Except as disclosed on Schedule 2.9 to the knowledge of Synergy, no investigation or review by any Governmental Body or authority Entity is pending or, to the Knowledge of Tigris, or threatened against Tigris Synergy or a Tigris Subsidiaryits Subsidiaries, nor has any Governmental Body or authority Entity indicated to Potomac in writing an intention to conduct the samesame other than those which would not reasonably be expected to have a Synergy Material Adverse Effect. There is no agreement, judgment, injunction, order or decree binding upon Tigris Synergy or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Synergy or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Synergy or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and any Subsidiary Synergy as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Synergy and its Subsidiaries holds hold all permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material would necessary to the operation of their businesses (collectively, the “Tigris Permits”) as currently conducted. Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is in material compliance with the terms of the Tigris Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris Synergy except those the absence of which would not, individually or in the aggregate, reasonably be likely to have a Synergy Material Adverse Effect (collectively, the "Synergy Permits"). Synergy and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified are in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted compliance in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations terms of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312Synergy Permits. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Apricus and each of Tigris and its Subsidiaries isare, and since January 1, 2010 has complied 2015, have been in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding the regulations adopted thereunder, and has any other similar Law administered or promulgated by a Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not received any written notices be material to Apricus. Except as set forth in Section 3.14 of alleged or actual material violation with respect tothe Apricus Disclosure Schedule, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No no investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisApricus, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameApricus. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary Apricus which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryApricus, any acquisition of material property by Tigris or a Tigris Subsidiary Apricus or the conduct of business by Tigris and any Subsidiary Apricus as currently conducted, (ii) may is reasonably likely to have an adverse effect on TigrisApricus’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Apricus and its Subsidiaries Merger Sub holds all required Governmental Authorizations which are material to the operation of their businesses the business of Apricus and Merger Sub as currently conducted (collectively, the “Tigris Apricus Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Apricus Disclosure Schedule identifies each Tigris Apricus Permit. Each of Tigris Apricus and its Subsidiaries Merger Sub is in material compliance with the terms of the Tigris Apricus Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisApricus, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Apricus Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.43 Exhibit 2.1 (c) There are no proceedings pending or, to the Knowledge of TigrisApricus, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary Apricus of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements Law administered or promulgated by a Drug Regulatory Agency. (d) Each Apricus and each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for material to the conduct of the business of Tigris Apricus and its Subsidiaries Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Apricus Product Candidates”) (the “Tigris Apricus Regulatory Permits”) and no such Tigris Apricus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse mannermanner other than immaterial adverse modifications. Neither Tigris Each of Apricus and Merger Sub is in compliance in all material respects with the Apricus Regulatory Permits and neither Apricus nor its Subsidiaries Merger Sub has received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Apricus Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Apricus Regulatory Permit. Except for To the information and files identified in Part 3.9(d) Knowledge of the Tigris Disclosure ScheduleApricus, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reportsno facts that would be reasonably likely to result in any warning letter, notices of adverse findings, warning letters, filings and letters and untitled letter or other written correspondence to and notice of material violation letter from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authoritythe FDA. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary Apricus or in which Tigris Apricus or a Tigris Subsidiary or their its respective products or product candidates, including the Apricus Product Candidates, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. No preclinical or clinical trial conducted by or on behalf of Apricus has been terminated or suspended prior to completion for reasons of lack of safety or material non-compliance with applicable Laws. Since January 1, 2015, neither Apricus nor Merger Sub has received any written notices or correspondence, or other written communications from any Drug Regulatory Agency requiring or, to the Knowledge of Apricus, threatening to initiate, the termination, suspension or material modification of any clinical studies conducted by or on behalf of, or sponsored by, Apricus or in which Apricus or its current products or product candidates, including the Apricus Product Candidates, have participated. To the extent required, all clinical trials conducted by or on behalf of Apricus have been registered on, and trial results have been reported on, the United States National Institutes of Health Website, ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any applicable additional state and local law requirements. (f) Neither Tigris Apricus nor any of its Subsidiaries is the subject of any pendingpending or, or to the Knowledge of TigrisApricus, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisApricus, neither Tigris nor any of its Subsidiaries Apricus has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products 44 Exhibit 2.1 that has violated or would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisApricus, any Merger Sub, or, to the Knowledge of its SubsidiariesApricus, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that has resulted in or could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisApricus, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary Apricus or any of their respective its officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Nautilus is, and since January 1, 2010 2014, has complied been in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substance Act and any other similar Law administered or promulgated by a Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Nautilus. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisNautilus, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameNautilus. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary Nautilus which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryNautilus, any acquisition of material property by Tigris or a Tigris Subsidiary Nautilus or the conduct of business by Tigris and any Subsidiary Nautilus as currently conducted, (ii) may is reasonably likely to have an adverse effect on TigrisNautilus’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Nautilus and its Subsidiaries Merger Sub holds all required Governmental Authorizations which are material to the operation of their businesses the business of Nautilus and Merger Sub as currently conducted (collectively, the “Tigris Nautilus Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Nautilus Disclosure Schedule identifies each Tigris Nautilus Permit. Each of Tigris Nautilus and its Subsidiaries Merger Sub is in material compliance with the terms of the Tigris Nautilus Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisNautilus, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Nautilus Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisNautilus, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary Nautilus of the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law administered or promulgated by a Drug Regulatory Agency. (d) Each of Tigris Nautilus and its Subsidiaries Merger Sub holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for material to the conduct of the business of Tigris Nautilus and its Subsidiaries Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Nautilus Product Candidates”) (the “Tigris Nautilus Regulatory Permits”) and no such Tigris Nautilus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse mannermanner other than immaterial adverse modifications. Neither Tigris Each of Nautilus and Merger Sub is in compliance in all material respects with the Nautilus Regulatory Permits and neither Nautilus nor its Subsidiaries Merger Sub has received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Nautilus Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Nautilus Regulatory Permit. Except for the information and files identified in Part 3.9(dSection 3.14(d) of the Tigris Nautilus Disclosure Schedule, Tigris Nautilus has made available to Potomac the Company all information requested by the Company in its or its SubsidiariesNautilus’ possession or control relating to the Tigris Nautilus Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Nautilus Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) copies of all investigational new drug applications (INDs) submitted to the FDA, and all supplements to and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityBody. Each of Nautilus and Merger Sub has complied in all material respects with the ICH E9 Guidance for Industry: Statistical Principles for Clinical Trials in the management of the clinical data that have been presented to the Company. To the Knowledge of Nautilus, there are no facts that would be reasonably likely to result in any warning, untitled or notice of violation letter or Form FDA-483 from the FDA. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary Nautilus or in which Tigris Nautilus or a Tigris Subsidiary or their its respective products or product candidates, including the Nautilus Product Candidates, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. No preclinical or clinical trial conducted by or on behalf of Nautilus has been terminated or suspended prior to completion for safety or non-compliance reasons. Other than as set forth on Section 3.14(e) of the Nautilus Disclosure Schedule, since January 1, 2014, neither Nautilus nor Merger Sub has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring or, to the Knowledge of Nautilus, threatening to initiate, the termination, suspension or material modification of any clinical studies conducted by or on behalf of, or sponsored by, Nautilus or in which Nautilus or its current products or product candidates, including the Nautilus Product Candidates, have participated. To the extent required, all clinical trials conducted by or on behalf of Nautilus have been registered on, and trial results have been reported on, the United States National Institutes of Health Website, ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any applicable additional state and local law requirements. (f) Neither Tigris nor any Except as set forth on Section 3.14(f) of its Subsidiaries the Nautilus Disclosure Schedule, Nautilus has withdrawn each IND submitted to the FDA and, for each such IND, notified FDA of the withdrawal, ended all clinical investigations conducted under the IND, notified all clinical investigators, assured return or disposal of all stocks of the investigational drug and has otherwise wound down all IND-related activities in accordance with all applicable Laws. (g) Nautilus has not been and is not the subject of any pendingpending or, or to the Knowledge of TigrisNautilus, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisNautilus, neither Tigris nor any of its Subsidiaries Nautilus has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that has violated or would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisNautilus, any Merger Sub, or, to the Knowledge of its SubsidiariesNautilus, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that has resulted in or could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisNautilus, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary Nautilus or any of their respective its officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Threshold is, and since January 1, 2010 2014, each of Threshold and its Subsidiaries has complied been in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Threshold Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisThreshold, threatened against Tigris Threshold or a Tigris any Threshold Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Tigris Threshold or a Tigris any Threshold Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Threshold or a Tigris any Threshold Subsidiary, any acquisition of material property by Tigris Threshold or a Tigris any Threshold Subsidiary or the conduct of business by Tigris and Threshold or any Threshold Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on Tigris’ Threshold’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Threshold and its the Threshold Subsidiaries holds hold all Governmental Authorizations which that are material to the operation of their businesses its business (collectively, the “Tigris Threshold Permits”) as currently conducted. Part 3.9(bSection 3.12(b) of the Tigris Threshold Disclosure Schedule identifies each Tigris Threshold Permit. Each As of Tigris the date of this Agreement, each of Threshold and its the Threshold Subsidiaries is are in material compliance with the terms of the Tigris Threshold Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisThreshold, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Threshold Permit. The rights and benefits of each material Tigris Threshold Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Threshold and its the Threshold Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisThreshold, threatened with respect to an alleged material violation by Tigris Threshold or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act or any other similar Legal Requirements promulgated by a the FDA or other Drug Regulatory Agency. (d) Each Threshold and each of Tigris and its Subsidiaries holds hold all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Threshold or such Subsidiary as currently conducted, and, as applicable, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Threshold Product Candidates”) ). Threshold holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Tigris Threshold Regulatory Permits”) and no such Tigris Threshold Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries Threshold has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Tigris Threshold Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris Threshold has made available to Potomac Molecular all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Threshold Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Threshold or a Tigris Subsidiary any of the Threshold Subsidiaries or in which Tigris Threshold or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidates, services have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2014, neither Threshold nor any of the Threshold Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Threshold threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Threshold or in which Threshold Product Candidates, have participated. (f) Neither Tigris nor any To the Knowledge of Threshold, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Threshold or its Subsidiaries officers, employees or agents. Threshold is not the subject of any pending, or to the Knowledge of TigrisThreshold, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisThreshold, neither Tigris nor any of its Subsidiaries Threshold has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Threshold Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Threshold, nor to the Knowledge of TigrisThreshold, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Zordich and each of Tigris and its Subsidiaries is, and since January 1has been, 2010 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisZordich, threatened against Tigris Zordich or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Tigris Zordich or a Tigris Subsidiary any of its Subsidiaries which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Zordich or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Zordich or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Zordich or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Zordich’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Zordich and its Subsidiaries holds all required Governmental Authorizations which that are material to the operation of their businesses the business of Zordich and Merger Sub as currently conducted (collectively, the “Tigris Zordich Permits”) as currently conducted). Part 3.9(bSection 4.14(b) of the Tigris Zordich Disclosure Schedule identifies each Tigris Zordich Permit. Each of Tigris Zordich and its Subsidiaries is in material compliance with the terms of the Tigris Zordich Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisZordich, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Tigris Zordich Permit. The rights and benefits of each material Tigris Zordich Permit will be available to the Zordich and Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Zordich and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings Legal Proceedings pending or, to the Knowledge of TigrisZordich, threatened with respect to an alleged material violation by Tigris Zordich or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law promulgated by a Drug Regulatory Agency. (d) Each of Tigris Zordich and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris Zordich and its Subsidiaries Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Zordich Product Candidates”) (the “Tigris Zordich Regulatory Permits”) and no such Tigris Zordich Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse mannermanner other than immaterial adverse modifications. Neither Tigris Zordich has timely maintained and is in compliance in all material respects with the Zordich Regulatory Permits and neither Zordich nor any of its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Zordich Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Zordich Regulatory Permit. Except for the information and files identified in Part 3.9(dSection 4.14(d) of the Tigris Zordich Disclosure Schedule, Tigris Zordich has made available to Potomac the Company all information requested by the Company in its Zordich’s or its Subsidiaries’ possession or control relating to the Tigris Zordich Product Candidates and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation and or exportation of the Tigris Zordich Product Candidates, including without limitationincluding, but not limited to, complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information are accurate and complete in all material respects. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Zordich or a Tigris Subsidiary or its Subsidiaries, in which Tigris Zordich or a Tigris Subsidiary its Subsidiaries or their respective products or product candidates, including the Zordich Product Candidates, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Other than as set forth on Section 4.14(e) of the Zordich Disclosure Schedule, neither Zordich nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring or, to the Knowledge of Zordich, any action to place a clinical hold order on, or otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Zordich or any of its Subsidiaries or in which Zordich or any of its Subsidiaries or its current products or product candidates, including the Zordich Product Candidates, have participated. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of Zordich, on behalf of Zordich or any of its Subsidiaries has been disqualified from participating in studies involving the Zordich Product Candidates, and to the Knowledge of Zordich, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending. (f) Neither Tigris Zordich nor any of its Subsidiaries Subsidiaries, and to the Knowledge of Zordich, no contract manufacturer with respect to any Zordich Product Candidate is the subject of any pendingpending or, or to the Knowledge of TigrisZordich, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisZordich, neither Tigris Zordich nor any of its Subsidiaries and no contract manufacturer with respect to any Zordich Product Candidate has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisZordich, any of its Subsidiaries, and to the Knowledge of Zordich, any contract manufacturer with respect to any Zordich Product Candidate, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisZordich, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisZordich, any Tigris Subsidiary of its Subsidiaries, and to the Knowledge of Zordich, any contract manufacturer with respect to any Zordich Product Candidate, or any of their respective its officers, employees or agents. (g) All manufacturing operations conducted by, or, to the Knowledge of the Zordich, for the benefit of Zordich or its Subsidiaries in connection with any Zordich Product Candidate, since January 1, 2017, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contains in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. (h) No manufacturing site owned by Zordich or its Subsidiaries, and to the Knowledge of Zordich, no manufacturing site of a contract manufacturer, with respect to any Zordich Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not be complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of Zordich, neither the FDA nor any other Governmental Authority is considering such action.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Decoy is, and since January 1for the past 5 years has been, 2010 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisDecoy, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameDecoy. There is no agreementContract, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary Decoy which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryDecoy, any acquisition of material property by Tigris or a Tigris Subsidiary Decoy or the conduct of business by Tigris and any Subsidiary as currently conductedthe Decoy Business, (ii) may would reasonably be expected to have an adverse effect on Tigris’ Decoy’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris and its Subsidiaries holds all Governmental Authorizations which are material to the operation of their businesses (collectively, the “Tigris Permits”) as currently conducted. Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is in material compliance with the terms of the Tigris Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries Decoy holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Decoy as currently conducted, and, as applicable, and the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Decoy Product Candidates”) ). Decoy holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Tigris Regulatory Decoy Permits”), and Section ‎2.12‎(b) and no of the Decoy Disclosure Schedule identifies each Decoy Permit. No such Tigris Regulatory Decoy Permit has been been: (i) revoked, withdrawn, suspended, cancelled canceled or terminated terminated; or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries Decoy has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Tigris Regulatory Decoy Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris Decoy has made available to Potomac Intec all material information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and concerning the development, clinical testing, manufacturing, importation and exportation of the Tigris Decoy Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; . The rights and (y) similar reports, benefits of each material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityDecoy Permit will be available to Decoy immediately after the Effective Time on terms substantially identical to those enjoyed by Decoy immediately prior to the Effective Time. (ec) There are no proceedings pending or, to the Knowledge of Decoy, threatened with respect to an alleged violation by Decoy of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”). (d) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidatesDecoy were, have participated were and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor . No preclinical or clinical trial conducted by or on behalf of Decoy has been terminated or suspended prior to completion for safety or non-compliance reasons. Decoy has not received any of its Subsidiaries is the subject of notices, correspondence or other communications from any pendingDrug Regulatory Agency requiring, or to the Knowledge of TigrisDecoy threatening to initiate, threatened investigation the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by Decoy or, in respect which Decoy or its current products or product candidates, including the Decoy Product Candidates, have participated. (e) Decoy has complied in all material respects with all Legal Requirements relating to patient, medical or individual health information, including the Health Insurance Portability and Accountability Act of 1996 and its business or products by implementing regulations promulgated thereunder, all as amended from time to time (collectively “HIPAA”), including the FDA pursuant to its “Fraudstandards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Untrue Statements Subparts A and E, the standards for the protection of Material FactsElectronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, BriberySubpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and Illegal Gratuities” Final Policy the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time. Decoy has entered into, where required, and is in compliance in all material respects with the terms of all Business Associate (as defined in HIPAA) agreements to which Decoy is a party or otherwise bound. Decoy has created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and have implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. Decoy has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. All capitalized terms in this Section ‎2.12(e) not otherwise defined in this Agreement shall have the meanings set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agentsHIPAA.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries is, and Celladon since January 1, 2010 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to including all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisCelladon, threatened against Tigris or a Tigris SubsidiaryCelladon, nor has any Governmental Body or authority indicated to Potomac Celladon an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary Celladon which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryCelladon, any acquisition of material property by Tigris or a Tigris Subsidiary Celladon or the conduct of business by Tigris and any Subsidiary Celladon as currently conducted and planned to be conducted, (ii) may have an adverse effect on Tigris’ Celladon’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris and its Subsidiaries Celladon holds all Governmental Authorizations which are material to the operation of their businesses its business (collectively, the “Tigris Celladon Permits”) as currently conducted and planned to be conducted. Part 3.9(b) of the Tigris Celladon Disclosure Schedule identifies each Tigris Celladon Permit. Each of Tigris and its Subsidiaries Celladon is in material compliance with the terms of the Tigris Celladon Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisCelladon, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Celladon Permit. The rights and benefits of each material Tigris Celladon Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries Celladon as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisCelladon, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary Celladon of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries Celladon holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the its business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution testing and importation or exportation, manufacturing as currently conducted, conducted of any of its products or product candidates (the “Tigris Celladon Product Candidates”) (the “Tigris Celladon Regulatory Permits”) and no such Tigris Celladon Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries Celladon has not received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Celladon Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Celladon Disclosure Schedule, Tigris Celladon has made available to Potomac Eiger all information in its or its Subsidiaries’ possession or control relating to the Tigris Celladon Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Celladon Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary Celladon or in which Tigris Celladon or a Tigris Subsidiary or their respective its products or product candidates, candidates have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor any of its Subsidiaries Celladon is not the subject of any pending, or to the Knowledge of TigrisCelladon, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisCelladon, neither Tigris nor any of its Subsidiaries Celladon has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, Celladon or any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of TigrisCelladon, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary Celladon or any of their respective its officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Neither VFI nor any of Tigris and its Subsidiaries subsidiaries is, and since January 1in any material respect, 2010 has complied in all material respects conflict with, is not or in material default or in violation ofof any law, and has not received any written notices of alleged or actual material violation with respect torule, any foreign, federal, state or local statute, law or regulation, includingorder, but judgment or decree applicable to VFI or any of its subsidiaries or by which VFI or any of its subsidiaries or any of their respective properties is bound or affected, except for conflicts, violations and defaults that individually would not limited cause, in VFI's reasonable judgment, VFI to all applicable Legal Requirementslose benefits aggregating to $1 million or more, or to incur liabilities aggregating to $1 million or more. No investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body or authority Entity is pending or, to the Knowledge knowledge of TigrisVFI, has since January 1, 1993, been threatened in a writing delivered to VFI against Tigris VFI or a Tigris Subsidiaryany of its subsidiaries, nor nor, to VFI's knowledge, has any Governmental Body or authority Entity indicated to Potomac an intention in a writing delivered to VFI to conduct the samean investigation of VFI or any of its subsidiaries. There is no agreement, material judgment, injunction, order or decree binding upon Tigris VFI or a Tigris Subsidiary any of its subsidiaries which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris VFI or a Tigris Subsidiaryany of its subsidiaries, any acquisition of material property by Tigris VFI or a Tigris Subsidiary any of its subsidiaries or the conduct of business by Tigris and any Subsidiary VFI as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris VFI and its Subsidiaries holds subsidiaries hold, to the extent legally required, all permits, licenses, variances, exemptions, orders and approvals from a Governmental Authorizations which Entity that are material to and required for the operation of their businesses the business of VFI as currently conducted (collectively, the “Tigris "VFI PERMITS"), other than such VFI Permits”) as currently conducted, which if not held, would not result, in VFI's reasonable judgment, in a loss of material benefit to or any material liability to VFI. Part 3.9(b) VFI and its subsidiaries are in compliance in all material respects with the terms of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is VFI Permits, except where the failure to be in material compliance with the terms of the Tigris Permits. No actionVFI Permits would not result, proceedingin VFI's reasonable judgment, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, in a loss of material benefit to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agencymaterial liability to VFI. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Biosight and each of Tigris and its Subsidiaries isare, and since January November 1, 2010 has complied 2015 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements, including all Healthcare Laws. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisBiosight, threatened against Tigris Biosight or a Tigris Subsidiaryany of its Subsidiaries, nor has any Governmental Body or authority Authority indicated to Potomac Biosight in writing an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris Biosight or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Biosight or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Biosight or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Biosight or any Subsidiary of its Subsidiaries as currently conducted, (ii) may have an adverse effect on Tigris’ Biosight’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Biosight and its Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Biosight (collectively, the “Tigris Biosight Permits”) as currently conducted. Part 3.9(b3.11(b) of the Tigris Biosight Disclosure Schedule identifies each Tigris Biosight Permit, including the holder of the Biosight Permit, the name of the Biosight Permit, and the date of expiration. Each of Tigris Biosight and its Subsidiaries is in material compliance with the terms of the Tigris Biosight Permits and the Biosight Permits are in full force and effect. All fees and charges with respect to the Biosight Permits, as of the date hereof, have been paid in full, and all filing, reporting, record keeping, and maintenance obligations required under the applicable Biosight Permits and Healthcare Laws have been completely and timely satisfied. All such reports, records, and filings were complete and accurate in all material respects, or were subsequently updated, changed, corrected, or modified. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisBiosight, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Tigris Biosight Permit. The rights and benefits of each material Tigris Biosight Permit will be available to the Surviving Corporation Company immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Biosight and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. There have been no occurrences, events, or Legal Proceedings that are pending, under investigation, or to the Knowledge of Biosight, threatened, nor has Biosight received any written notice which has resulted in or would reasonably be expected to result in any material limitation, adverse modification, revocation, withdrawal, cancellation, lapse, integrity review, suspension, or any other adverse action against any Biosight Permit. (c) There are no proceedings pending or, to the Knowledge of TigrisBiosight, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, Biosight or any other similar of its Subsidiaries of any Legal Requirements promulgated by a any Drug Regulatory Agency. Biosight has not been restrained by any Governmental Authority or other Person in its ability to conduct or have conducted the manufacturing, clinical and pre-clinical investigation, handling, shipping, packaging, labeling, storage, import, export, or distribution of its Biosight Product Candidates. (d) Each Biosight and each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Biosight or such Subsidiary as currently conducted, and, as to the extent applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Biosight Product Candidates”) (collectively, the “Tigris Biosight Regulatory Permits”) ), and no such Tigris Biosight Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Neither Tigris nor Biosight and each of its Subsidiaries is in compliance in all material respects with the Biosight Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Biosight Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Biosight Regulatory Permit. Except for the information and files identified in Part 3.9(d3.11(d) of the Tigris Biosight Disclosure Schedule, Tigris Biosight has made available to Potomac Advaxis all information requested by Biosight in its Biosight’s or its Subsidiaries’ possession or control relating to the Tigris Biosight Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Biosight Product Candidates, including without limitation, complete copies of the following (to the extent there are any): ) (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinicalmaterial preclinical and clinical investigations conducted or sponsored by or on behalf of and intended to be submitted to a Governmental Authority to support a Governmental Authorization are being and have been conducted in compliance in all material respects with all applicable Healthcare Laws administered or issued by the applicable Governmental Authority, including, as applicable, (i) the FDA regulations for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) applicable 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 312 of the Code of Federal Regulations and (iii) applicable federal, state and foreign Healthcare Laws restricting the use and disclosure of individually identifiable health information, including HIPAA. Neither Biosight or its Subsidiaries, nor, to the Knowledge of Biosight, any of third party conducting a clinical or preclinical study on their behalf, has received any written notice, correspondence or other written communication from the FDA or any other Governmental Authority or from IRB requiring or threatening the termination, suspension, delay, restriction, rejection, or material modification of any ongoing, completed, or planned clinical or pre-clinical and other studies and tests trials conducted by by, or on behalf of, Biosight. The study reports, protocols, and statistical analysis plans for all such material preclinical and clinical investigations, accurately, completely, and fairly reflect the results from and plans for such studies. Biosight has no Knowledge of any other studies, the results of which are inconsistent or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with otherwise call into question the applicable regulations results of the Drug Regulatory Agencies material preclinical and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 clinical investigations. Biosight does not have any Knowledge of any material facts or circumstances related to the safety or efficacy of the Biosight Product Candidates that would materially and 312adversely affect its ability to receive or maintain a Governmental Authorization. (f) As of the date of this Agreement, no data generated by or on behalf of Biosight or its Subsidiaries with respect to the Biosight Product Candidates is the subject of any written regulatory action, either pending, or to the Knowledge of Biosight, threatened by any Governmental Authority relating to the truthfulness or scientific integrity of such data. (g) Neither Tigris nor Biosight, any of its Subsidiaries Subsidiaries, nor, to the Knowledge of Biosight, any Person providing services on their behalf, is the subject of any pending, or to the Knowledge of TigrisBiosight, threatened investigation in respect of its business or products the Biosight Product Candidates by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereto or otherwise with respect to any other untrue or false statement or omission. To the Knowledge of TigrisBiosight, neither Tigris Biosight nor any of its Subsidiaries or Persons proving services on their behalf, has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products the Biosight Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisBiosight, any of its Subsidiaries, or to the Knowledge of Biosight, any of their respective officers, employees or agents has agents, or to the Knowledge of Biosight, any Person providing services on Biosight’s or its Subsidiaries’ behalf, have been debarred, disqualified, or excluded, or have been convicted of any crime or engaged in any conduct that could result in a material debarment debarment, disqualification, or exclusion (i) under 21 U.S.C. Section 335a S▇▇▇▇▇▇ ▇▇▇▇, (▇▇) ▇▇▇▇▇ ▇▇ ▇.▇.▇. §▇▇▇▇▇-▇, (iii) with respect to federal procurement or non-procurement programs, including those produced by the U.S. General Services Administration, (iv) under 21 C.F.R. Parts 312, 511, or 812 or otherwise with respect to the receipt of investigational products, or (iiv) any similar applicable Legal Requirement. To the Knowledge of TigrisBiosight, no material debarment debarment, ineligibility, or exclusionary claims, actions, proceedings or investigations in respect of their business or products the Biosight Product Candidates are pending or threatened against TigrisBiosight, any Tigris Subsidiary or of its Subsidiaries, any of their respective officers, employees or agents, or any Person providing services on behalf of Biosight or its Subsidiaries. (h) To the Knowledge of Biosight, no Biosight Product Candidate manufactured or distributed by or on behalf of Biosight or its Subsidiaries is (i) adulterated within the meaning of 21 U.S.C. §351 (or any similar Healthcare Law), (ii) misbranded within the meaning of 21 U.S.C. §352 (or any similar Healthcare Law); or (iii) otherwise prohibited from introduction into interstate commerce under applicable Legal Requirements. As of the date of this Agreement, neither the Biosight or its Subsidiaries nor, to the Knowledge of Biosight and with respect to services provided to Biosight, any of their respective contractors, including, but not limited to, contract manufacturers, has received any FDA Form 483, warning letter, untitled letter, cyber letter, reprimand, regulatory letter, adverse inspectional findings, notice of integrity review or investigation, request for corrective or remedial action, deficiency notice, or other similar correspondence or written notice from the FDA or any other regulatory authority alleging or asserting material noncompliance with any applicable Healthcare Laws or Biosight Permits issued to Biosight or its Subsidiaries by the FDA or any other regulatory authority. No manufacturing site owned by Biosight or its Subsidiaries, to the Knowledge of Biosight, any of their respective contract manufacturers, is or has been subject to a shutdown or import or export prohibition imposed by FDA or another regulatory authority. (i) No Biosight Product Candidate has been or has been requested by a regulatory authority or other Person to be Recalled. Neither Biosight, its Subsidiaries, nor, to the Knowledge of Biosight, any regulatory authority or other Person, has sought, is seeking, or, to the Knowledge of Biosight, has or is currently threatening or contemplating any Recall of any such Biosight Product Candidate.

Compliance; Permits; Restrictions. (a) Each of Tigris Arrow and its Subsidiaries isOTI are, and since January 1, 2010 has complied 2013 have been in compliance in all material respects with, is not in with all material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority Governmental Authority is pending or, to the Knowledge of TigrisArrow, threatened against Tigris Arrow or a Tigris SubsidiaryOTI, nor has any Governmental Body or authority Governmental Authority indicated to Potomac Arrow or OTI in writing an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris Arrow or a Tigris Subsidiary OTI which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Arrow or a Tigris SubsidiaryOTI, any acquisition of material property by Tigris Arrow or a Tigris Subsidiary OTI or the conduct of business by Tigris Arrow and any Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on Tigris’ Arrow’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may would reasonably be expected to have the effect of preventing, materially delaying, making illegal or otherwise interfering with the Merger Mergers or any of the Contemplated Transactions. (b) Each of Tigris Arrow, OTI, and its Subsidiaries Merger Subs holds all Governmental Authorizations which are material to the operation of their businesses (collectively, the “Tigris Arrow Permits”) as currently conducted. Part 3.9(b3.14(b) of the Tigris Arrow Disclosure Schedule identifies each Tigris Arrow Permit. Each of Tigris Arrow, OTI, and its Subsidiaries Merger Subs is in material compliance with the terms of the Tigris Arrow Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisArrow, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Arrow Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisArrow, threatened with respect to an alleged material violation by Tigris Arrow or a Tigris Subsidiary OTI of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris Arrow, OTI, and its Subsidiaries Merger Subs holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris Arrow, OTI, and its Subsidiaries Merger Subs as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Arrow Product Candidates”) (the “Tigris Arrow Regulatory Permits”) and no such Tigris Arrow Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris Arrow nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Arrow Regulatory Permit. Except for the information and files identified in Part 3.9(d3.14(d) of the Tigris Arrow Disclosure Schedule, Tigris has Arrow and OTI have made available to Potomac the Company all information in its or its Subsidiaries’ possession or control relating to the Tigris Arrow Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Arrow Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Arrow or a Tigris Subsidiary OTI or in which Tigris or a Tigris Subsidiary Arrow, OTI, or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris Arrow nor any of its Subsidiaries OTI is the subject of any pending, or to the Knowledge of TigrisArrow, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisArrow, neither Tigris Arrow nor any of its Subsidiaries OTI has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisArrow, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of TigrisArrow, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisArrow, any Tigris Subsidiary OTI, or any of their respective officers, employees or agents. (g) Other than in connection with the winding down of its operations, Arrow has filed with the FDA, EMA, any other Governmental Body, and any institutional review board or comparable body, all required notices, supplemental applications, and annual or other reports, including adverse experience reports, with respect to each investigational new drug application or any comparable foreign regulatory application, related to the manufacture, testing, study, or sale of any of its products or product candidates, as applicable.

Compliance; Permits; Restrictions. (a) Each Parent and each of Tigris and its Subsidiaries isare, and since January 1, 2010 has complied 2020, have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws, including the FDCA, the FDA regulations adopted thereunder, the Public Health Service Act and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened against Tigris Parent or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order or decree by or with a Drug Regulatory Agency binding upon Tigris Parent or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Parent or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Parent and its Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Parent and its Subsidiaries as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each of Tigris Parent and its Subsidiaries is hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisParent’s Knowledge, threatened with respect to an alleged material violation by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Legal Requirements Law administered or promulgated by a any Drug Regulatory Agency. (d) Each of Tigris Parent is not currently conducting or addressing, and its Subsidiaries holds all to Parent’s Knowledge there is no basis to expect that it will be required Governmental Authorizations issuable by to conduct or address, any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conductedcorrective actions, andincluding, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; product recalls or clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authorityholds. (e) All clinical, pre-clinical and other studies and tests conducted by or or, to Parent’s Knowledge, on behalf of, or sponsored by, Tigris Parent or a Tigris Subsidiary any of its Subsidiaries, or in which Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or their respective current products or product candidatescandidates have participated, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2020, neither Parent nor any of its Subsidiaries have received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated. (f) Neither Tigris Parent nor any of its Subsidiaries is are the subject of any pendingpending or, or to the Knowledge of TigrisParent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisParent’s Knowledge, neither Tigris Parent nor any of its Subsidiaries has have committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisParent, any of its Subsidiaries, Subsidiaries or any of their respective officers, employees or agents has have been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisParent’s Knowledge, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisParent, any Tigris Subsidiary of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris Celldex and its Subsidiaries is, and since January 1, 2010 has complied subsidiaries are not in all material respects conflict with, is not or in material default or violation ofof (i) any law, and has not received any written notices of alleged or actual material violation with respect torule, any foreign, federal, state or local statute, law or regulation, includingorder, but judgment or decree applicable to them or by which their properties are bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Celldex or any of its subsidiaries is a party or by which Celldex or any of its subsidiaries or their properties are bound or affected, except for any conflicts, defaults or violations which, individually or in the aggregate, would not limited reasonably be expected to all applicable Legal Requirementshave a Celldex Material Adverse Effect. No investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body governmental or regulatory body or authority is pending or, to the Knowledge knowledge of TigrisCelldex and its subsidiaries, threatened against Tigris Celldex or a Tigris Subsidiaryits subsidiaries, nor has any Governmental Body governmental or regulatory body or authority indicated to Potomac Celldex or its subsidiaries an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris Subsidiary, any acquisition of material property by Tigris or a Tigris Subsidiary or the conduct of business by Tigris and any Subsidiary as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Celldex and its Subsidiaries holds subsidiaries hold all Governmental Authorizations permits, licenses, variances, exemptions, orders and approvals from governmental authorities which are material to the operation of their businesses the business of Celldex and its subsidiaries (collectively, the “Tigris Celldex Permits”) as currently conducted). Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris Celldex and its Subsidiaries is subsidiaries are in material compliance with the terms of the Tigris Celldex Permits, except where the failure to so comply would not reasonably be expected to have a Celldex Material Adverse Effect. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge knowledge of TigrisCelldex and its subsidiaries, threatened, which seeks to revokerevoke or limit any Celldex Permit. A true, limit, suspend, or materially modify any Tigris Permitcomplete and correct list of the material Celldex Permits is set forth in Section 2.11(b) of the Celldex Disclosure Schedule. The rights and benefits of each material Tigris Celldex Permit will be available to the Surviving Corporation or its subsidiaries immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Celldex and its Subsidiaries as of the date of this Agreement and subsidiaries immediately prior to the Effective Time. (c) There All biological and drug products being manufactured, distributed, developed or tested by or on behalf of Celldex or its subsidiaries (“Celldex Products”) that are no proceedings pending or, subject to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary jurisdiction of the Food and Drug Administration (“FDA”) are being manufactured, labeled, stored, tested, distributed, and marketed in compliance in all material respects with all applicable requirements under the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA the Public Health Service Act (“PHSA”), their applicable implementing regulations, and all comparable federal and state laws and regulations adopted thereunderincluding, or any other similar Legal Requirements promulgated by a Drug Regulatory Agencybut not limited to, those relating to investigational use, premarket clearance, good manufacturing practices, labeling, advertising, promotional activities, record keeping, filing of reports and security. (d) Each All clinical trials conducted by or on behalf of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its Celldex or its Subsidiaries’ possession or control subsidiaries are being conducted in material compliance with the applicable requirements of Good Clinical Practice, Informed Consent, and all applicable requirements relating to the Tigris Product Candidates protection of human subjects contained in 21 CFR Parts 50, 54, and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority56. (e) All clinical, pre-clinical and other studies and tests manufacturing operations for Celldex Products conducted by or on behalf offor the benefit of Celldex or its subsidiaries are being conducted in accordance, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects respects, with the FDA’s current Good Manufacturing Practices for drug and biological products. In addition, Celldex and its subsidiaries are in accordance with standard medical and scientific research procedures and in material compliance with the all applicable regulations of the Drug Regulatory Agencies registration and other listing requirements set forth in 21 U.S.C. Section 360 and 21 CFR Part 207 and all similar applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 laws and 312regulations. (f) Neither Tigris Celldex or its subsidiaries, nor any representative of Celldex or its Subsidiaries is subsidiaries, nor, to the subject knowledge of Celldex or its subsidiaries, any of Celldex’s or its subsidiaries’ licensees or assignees of Celldex IP Rights has received any notice that the FDA or any other Governmental Authority has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application sponsored by Celldex or its subsidiaries or otherwise restrict the preclinical research on or clinical study of any pendingCelldex Product or any biological or drug product being developed by any licensee or assignee of Celldex IP Rights based on such intellectual property, or to recall, suspend or otherwise restrict the Knowledge development or manufacture of Tigrisany Celldex Product, threatened investigation except for such terminations, suspensions or restrictions which, individually or in respect the aggregate, would not reasonably be expected to have a Celldex Material Adverse Effect. (g) Neither Celldex or its subsidiaries nor, to the knowledge of Celldex or its business subsidiaries, any of their officers, key employees (as set forth on Section 2.17(a) of the Celldex Disclosure Schedule), agents or products by clinical investigators acting for Celldex or its subsidiaries, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA pursuant to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereof. To the Knowledge knowledge of TigrisCelldex, Celldex and its subsidiaries are not, and have not been, in material violation of the Federal Anti-Kickback Act, any Federal conspiracy statutes, the Prescription Drug Marketing Act (“PDMA”), Federal False Claims Act, Federal ▇▇▇▇▇ Law or any other federal, foreign or state statute related to sales and marketing practices of pharmaceutical manufacturers and others involved in the purchase and sale of pharmaceutical products. Additionally, neither Tigris Celldex or its subsidiaries, nor any to the knowledge of Celldex or its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigrissubsidiaries, any officer, key employee or agent of Celldex or its Subsidiaries, or any of their respective officers, employees or agents subsidiaries has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a material debarment or exclusion (i) debarment under 21 U.S.C. Section 335a or any similar state law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation. (h) All human clinical trials, animal studies or other preclinical tests performed in connection with or as the basis for any regulatory approval required for the Celldex Products (1) either (x) have been conducted in accordance, in all material respects, with applicable Legal RequirementGood Laboratory Practice requirements contained in 21 CFR Part 58, or (y) were not required to be conducted in accordance with Good Laboratory Practice requirements contained in 21 CFR Part 58 and (2) have employed the experimental protocols, procedures and controls generally used by qualified experts in human, animal or preclinical study of products comparable to those being developed by Celldex or its subsidiaries. (i) Celldex and its subsidiaries have made available to AVANT copies of any and all written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA, which indicate or suggest lack of compliance with the regulatory requirements of the FDA. To Celldex and its subsidiaries have made available to AVANT for review all correspondence to or from the Knowledge FDA, FDCA and PHSA, including minutes of Tigrismeetings, no material debarment written reports of phone conversations, visits or exclusionary claimsother contact with the FDA, actionsFDCA or PHSA, proceedings notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or investigations from the FDA, FDCA or PHSA, or prepared by the FDA, FDCA and PHSA or which bear in respect any way on Celldex’s and its subsidiaries’ compliance with regulatory requirements of their business the FDA, FDCA and PHSA, or products are pending on the likelihood of timing of approval of any Celldex Products, including, but not limited to, copies of (i) all warning letters and untitled letters, notices of adverse findings and similar correspondence received in the last three years, (ii) all FDA 483s and other audit reports performed during the last three years, and (iii) any document concerning any significant oral or threatened against Tigris, written communication received from the FDA and comparable foreign governmental entities in the last three years. Neither Celldex nor any Tigris Subsidiary agent or representative of Celldex has received any notices or correspondence from the FDA or any of their respective officersother governmental agency requiring the termination, employees suspension or agents.modification (other than such modifications as are normal in the regulatory

Compliance; Permits; Restrictions. (a) Each of Tigris Eiger and its Subsidiaries iseach Eiger Subsidiary are, and since January 1, 2010 has complied have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisEiger, threatened against Tigris Eiger or a Tigris any Eiger Subsidiary, nor has any Governmental Body or authority indicated to Potomac Eiger an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris Eiger or a Tigris any Eiger Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Eiger or a Tigris any Eiger Subsidiary, any acquisition of material property by Tigris Eiger or a Tigris any Eiger Subsidiary or the conduct of business by Tigris and Eiger or any Eiger Subsidiary as currently conducted, (ii) may have an adverse effect on Tigris’ Eiger’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Eiger and its the Eiger Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Eiger (collectively, the “Tigris Eiger Permits”) as currently conducted. Part 3.9(b2.11(b) of the Tigris Eiger Disclosure Schedule identifies each Tigris Eiger Permit. Each of Tigris Eiger and its Subsidiaries each Eiger Subsidiary is in material compliance with the terms of the Tigris Eiger Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisEiger, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Eiger Permit. The rights and benefits of each material Tigris Eiger Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Eiger and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, or threatened with respect to an alleged material violation by Tigris Eiger or a Tigris Subsidiary any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by a the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”). (d) Each Eiger and each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Eiger or such Subsidiary as currently conducted, and, as applicable, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Eiger Product Candidates”) (collectively, the “Tigris Eiger Regulatory Permits”) ), and no such Tigris Eiger Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Neither Tigris nor its Subsidiaries Eiger and each Eiger Subsidiary is in compliance in all material respects with the Eiger Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Eiger Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Eiger Regulatory Permit. Except for the information and files identified in Part 3.9(d2.11(d) of the Tigris Eiger Disclosure Schedule, Tigris Eiger has made available to Potomac Celladon all information requested by Celladon in its Eiger’s or its Subsidiaries’ possession or control relating to the Tigris Eiger Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Eiger Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Eiger or a Tigris Subsidiary its Subsidiaries or in which Tigris Eiger or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated were were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2010, neither Eiger nor any of its Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Eiger threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Eiger or any of its Subsidiaries or in which Eiger or any of its Subsidiaries or their respective current products or product candidates, including the Eiger Product Candidates, have participated. (f) Neither Tigris Eiger nor any of its the Eiger Subsidiaries is the subject of any pending, or to the Knowledge of TigrisEiger or the Eiger Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisEiger or any of the Eiger Subsidiaries, neither Tigris Eiger nor any of its the Eiger Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisEiger, any of its Subsidiaries, Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of TigrisEiger, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisEiger, any Tigris Eiger Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Parent and each of Tigris and its Subsidiaries isare, and since January November 1, 2010 has complied 2018 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisParent, threatened against Tigris Parent or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Tigris Parent or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Parent or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Parent and its Subsidiaries holds hold all required Governmental Authorizations which that are material to the operation of their businesses the business of Parent and its Subsidiaries as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted). Part 3.9(bSection 3.15(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each of Tigris Parent and its Subsidiaries is in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Parent Permit will be available to the Parent and Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings Legal Proceedings pending or, to the Knowledge of TigrisParent, threatened with respect to an alleged material violation by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, thereunder or any other applicable similar Legal Requirements Law promulgated by a Drug Regulatory Agency. (d) Each Parent and each of Tigris and its Subsidiaries holds all required material Governmental Authorizations issuable issued by any Drug Regulatory Agency that are necessary for the conduct of the business of Tigris and its Subsidiaries Parent or such Subsidiary as currently conducted, and, as applicable, and the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Parent Product Candidates”) (collectively, the “Tigris Parent Regulatory Permits”) ). All such Parent Regulatory Permits are in full force and effect. Parent and each of its Subsidiaries have fulfilled and performed all of its material obligations with respect to the Parent Regulatory Permits and, to the Knowledge of Parent, no such Tigris Regulatory Permit event has been (i) revokedoccurred which allows, withdrawnor after notice or lapse of time would allow, suspended, cancelled revocation or terminated termination thereof or (ii) modified results in any materially adverse mannerother material impairment of the rights of the holder of any Parent Regulatory Permit. Neither Tigris Parent and each of its Subsidiaries are in compliance in all material respects with the terms of the Parent Regulatory Permits and neither Parent nor any of its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any of Legal Proceedings relating to the revocation, withdrawaltermination, suspension, cancellation, termination suspension or material modification of any Tigris Parent Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Parent or a Tigris Subsidiary its Subsidiaries, or in which Tigris Parent or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidates, including the Parent Product Candidates, have participated participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Laws governing the privacy of patient medical records and other Personal Data. No clinical trial conducted by or, on behalf of, Parent or any of its Subsidiaries has been terminated or suspended by any Drug Regulatory Agencies. Other than as set forth in Section 3.14(e) of the Parent Disclosure Schedule, since January 1, 2018, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Drug Regulatory Agency requiring, or to the Knowledge of Parent, threatening to initiate, the termination or suspension or investigation of, or place a clinical hold order on or otherwise delay or materially restrict, any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries. With respect to each Parent Product Candidate, Parent has made available to the Company complete and accurate copies of all material clinical and preclinical data in the possession of Parent and its Subsidiaries and all material written correspondence that exists as of the date of this Agreement between Parent or its Subsidiaries and the applicable Drug Regulatory Agencies. (f) Neither Tigris Parent nor any of its Subsidiaries is the subject of any pendingpending or, or to the Knowledge of TigrisParent, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy final policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisParent, neither Tigris Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policyfinal policy, and any amendments thereto. None of TigrisParent, any of its SubsidiariesSubsidiaries or, or to the Knowledge of Parent, any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisParent, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisParent, any Tigris Subsidiary of its Subsidiaries or any of their respective officers, employees or agents. (g) Parent and each of its Subsidiaries have complied in all material respects with all applicable security and privacy standards regarding protection of health information under applicable Laws.

Compliance; Permits; Restrictions. (a) Each of Tigris Merger Partner and its Subsidiaries iseach Merger Partner Subsidiary are, and since January 1, 2010 has complied 2005 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisMerger Partner, threatened against Tigris Merger Partner or a Tigris any Merger Partner Subsidiary, nor has any Governmental Body or authority indicated to Potomac Merger Partner an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris Merger Partner or a Tigris any Merger Partner Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Merger Partner or a Tigris any Merger Partner Subsidiary, any acquisition of material property by Tigris Merger Partner or a Tigris any Merger Partner Subsidiary or the conduct of business by Tigris and Merger Partner or any Merger Partner Subsidiary as currently conducted, (ii) may have an adverse effect on Tigris’ Merger Partner’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Merger Partner and its the Merger Partner Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Merger Partner (collectively, the “Tigris Merger Partner Permits”) as currently conducted. Part 3.9(b2.11(b) of the Tigris Merger Partner Disclosure Schedule identifies each Tigris Merger Partner Permit. Each of Tigris Merger Partner and its Subsidiaries each Merger Partner Subsidiary is in material compliance with the terms of the Tigris Merger Partner Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisMerger Partner, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Merger Partner Permit. The rights and benefits of each material Tigris Merger Partner Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Merger Partner and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, or threatened with respect to an alleged material violation by Tigris Merger Partner or a Tigris Subsidiary any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by a the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”). (d) Each of Tigris and its Subsidiaries Merger Partner holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Merger Partner as currently conducted, and, as applicable, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates candidates, including Intermezzo and TO-2060 (the “Tigris Merger Partner Product Candidates”) (the “Tigris Merger Partner Regulatory Permits”) and no such Tigris Merger Partner Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Neither Tigris nor its Subsidiaries Merger Partner is in compliance in all material respects with the Merger Partner Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Merger Partner Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Merger Partner Regulatory Permit. Except for the information and files identified in Part 3.9(d2.11(d) of the Tigris Merger Partner Disclosure Schedule, Tigris Merger Partner has made available to Potomac Pivot all information requested by Pivot in its or its Subsidiaries’ Merger Partner’s possession or control relating to the Tigris Merger Partner Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Merger Partner Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary Merger Partner or in which Tigris Merger Partner or a Tigris Subsidiary or their respective its current products or product candidates, including the Merger Partner Product Candidates, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2005, Merger Partner has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Merger Partner, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Merger Partner or in which Merger Partner or its current products or product candidates, including the Merger Partner Product Candidates, have participated. (f) Neither Tigris Merger Partner nor any of its the Merger Partner Subsidiaries is the subject of any pending, or to the Knowledge of TigrisMerger Partner or the Merger Partner Subsidiaries, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisMerger Partner or any of the Merger Partner Subsidiaries, neither Tigris Merger Partner nor any of its the Merger Partner Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, Neither Merger Partner nor any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of TigrisMerger Partner, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary Merger Partner or any of their respective its officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Except as disclosed on Schedule 2.9 neither FlexSCAN nor any of Tigris and its Subsidiaries is, and since January 1, 2010 has complied is in all material respects conflict with, is not or in material default or violation ofof (i) any law, and has not received any written notices of alleged or actual material violation with respect torule, any foreign, federal, state or local statute, law or regulation, includingorder, but not limited judgment or decree applicable to all applicable Legal Requirements. No investigationFlexSCAN or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, claimor (ii) any note, suitbond, proceedingmortgage, audit indenture, contract, agreement, lease, license, permit, franchise or other action instrument or obligation to which FlexSCAN or any of its Subsidiaries is a party or by which FlexSCAN or any of its Subsidiaries or its or any of their respective properties is bound or affected except for those conflicts, defaults or violations which would not be reasonably expected to have a FlexSCAN Material Adverse Effect. Except as disclosed on Schedule 2.9 to the knowledge of FlexSCAN, no investigation or review by any Governmental Body or authority Entity is pending or, to the Knowledge of Tigris, or threatened against Tigris FlexSCAN or a Tigris Subsidiaryits Subsidiaries, nor has any Governmental Body or authority Entity indicated to Potomac in writing an intention to conduct the samesame other than those which would not reasonably be expected to have a FlexSCAN Material Adverse Effect. There is no agreement, judgment, injunction, order or decree binding upon Tigris FlexSCAN or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris FlexSCAN or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris FlexSCAN or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and any Subsidiary FlexSCAN as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris FlexSCAN and its Subsidiaries holds hold all permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material would necessary to the operation of their businesses (collectively, the “Tigris Permits”) as currently conducted. Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is in material compliance with the terms of the Tigris Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris FlexSCAN except those the absence of which would not, individually or in the aggregate, reasonably be likely to have a FlexSCAN Material Adverse Effect (collectively, the "FlexSCAN Permits"). FlexSCAN and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified are in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted compliance in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations terms of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312FlexSCAN Permits. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Apricus and each of Tigris and its Subsidiaries isare, and since January 1, 2010 has complied 2015, have been in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding the regulations adopted thereunder, and has any other similar Law administered or promulgated by a Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not received any written notices be material to Apricus. Except as set forth in Section 3.14 of alleged or actual material violation with respect tothe Apricus Disclosure Schedule, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No no investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisApricus, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameApricus. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary Apricus which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryApricus, any acquisition of material property by Tigris or a Tigris Subsidiary Apricus or the conduct of business by Tigris and any Subsidiary Apricus as currently conducted, (ii) may is reasonably likely to have an adverse effect on TigrisApricus’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Apricus and its Subsidiaries Merger Sub holds all required Governmental Authorizations which are material to the operation of their businesses the business of Apricus and Merger Sub as currently conducted (collectively, the “Tigris Apricus Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Apricus Disclosure Schedule identifies each Tigris Apricus Permit. Each of Tigris Apricus and its Subsidiaries Merger Sub is in material compliance with the terms of the Tigris Apricus Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisApricus, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Apricus Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisApricus, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary Apricus of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements Law administered or promulgated by a Drug Regulatory Agency. (d) Each Apricus and each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for material to the conduct of the business of Tigris Apricus and its Subsidiaries Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Apricus Product Candidates”) (the “Tigris Apricus Regulatory Permits”) and no such Tigris Apricus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse mannermanner other than immaterial adverse modifications. Neither Tigris Each of Apricus and Merger Sub is in compliance in all material respects with the Apricus Regulatory Permits and neither Apricus nor its Subsidiaries Merger Sub has received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Apricus Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Apricus Regulatory Permit. Except for To the information and files identified in Part 3.9(d) Knowledge of the Tigris Disclosure ScheduleApricus, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reportsno facts that would be reasonably likely to result in any warning letter, notices of adverse findings, warning letters, filings and letters and untitled letter or other written correspondence to and notice of material violation letter from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authoritythe FDA. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary Apricus or in which Tigris Apricus or a Tigris Subsidiary or their its respective products or product candidates, including the Apricus Product Candidates, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. No preclinical or clinical trial conducted by or on behalf of Apricus has been terminated or suspended prior to completion for reasons of lack of safety or material non-compliance with applicable Laws. Since January 1, 2015, neither Apricus nor Merger Sub has received any written notices or correspondence, or other written communications from any Drug Regulatory Agency requiring or, to the Knowledge of Apricus, threatening to initiate, the termination, suspension or material modification of any clinical studies conducted by or on behalf of, or sponsored by, Apricus or in which Apricus or its current products or product candidates, including the Apricus Product Candidates, have participated. To the extent required, all clinical trials conducted by or on behalf of Apricus have been registered on, and trial results have been reported on, the United States National Institutes of Health Website, ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any applicable additional state and local law requirements. (f) Neither Tigris Apricus nor any of its Subsidiaries is the subject of any pendingpending or, or to the Knowledge of TigrisApricus, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisApricus, neither Tigris nor any of its Subsidiaries Apricus has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that has violated or would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisApricus, any Merger Sub, or, to the Knowledge of its SubsidiariesApricus, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that has resulted in or could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisApricus, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary Apricus or any of their respective its officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Parent and each of Tigris and its Subsidiaries isare, and since January 1, 2010 has complied 2020 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws, including the FDCA, the FDA regulations adopted thereunder and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened against Tigris Parent or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Tigris Parent or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Parent or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Parent and its Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Parent and its Subsidiaries as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each of Tigris Parent and its Subsidiaries is hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There To Parent’s Knowledge, there are no proceedings pending or, to the Knowledge of Tigris, or threatened with respect to an alleged material violation by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Legal Requirements Law administered or promulgated by a any Drug Regulatory Agency. (d) Each of Tigris Parent is not currently conducting or addressing, and its Subsidiaries holds all to Parent’s Knowledge there is no basis to expect that it will be required Governmental Authorizations issuable by to conduct or address, any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conductedcorrective actions, andincluding, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; product recalls or clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authorityholds. (e) All clinical, pre-clinical and other studies and tests conducted by or or, to Parent’s Knowledge, on behalf of, or sponsored by, Tigris Parent or a Tigris Subsidiary any of its Subsidiaries, or in which Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or their respective current products or product candidatescandidates have participated, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2020, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated. (f) Neither Tigris Parent nor any of its Subsidiaries is the subject of any pendingpending or, or to the Knowledge of TigrisParent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisParent’s Knowledge, neither Tigris Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisParent, any of its Subsidiaries, Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisParent’s Knowledge, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisParent, any Tigris Subsidiary of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris Except as would not, individually or in the aggregate, reasonably be expected to be material to Sipex and its Subsidiaries istaken as a whole or prevent or materially delay consummation of the Merger or the other transactions contemplated by this Agreement, and since January 1, 2010 has complied neither Sipex nor any of its Subsidiaries is in all material respects conflict with, or in default or violation of (i) any Legal Requirement applicable to Sipex or any of its Subsidiaries or by which its or any of their respective properties is not in material violation ofbound or affected, and has not received or (ii) any written notices Contract to which Sipex or any of alleged its Subsidiaries is a party or actual material violation with respect to, by which Sipex or any foreign, federal, state of its Subsidiaries or local statute, law its or regulation, including, but not limited to all applicable Legal Requirementsany of their respective properties is bound or affected. No investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body or authority Entity is pending or, to the Knowledge of TigrisSipex’s knowledge, threatened against Tigris Sipex or a Tigris Subsidiaryits Subsidiaries, nor to Sipex’s knowledge has any Governmental Body or authority Entity indicated to Potomac an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Tigris Sipex or a Tigris Subsidiary any of its Subsidiaries which (i) has or could reasonably be expected to have the effect of materially prohibiting or materially impairing any business practice of Tigris Sipex or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Sipex or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and any Subsidiary Sipex as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Sipex and its Subsidiaries holds hold all material permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material to the operation of their businesses the business of Sipex (collectively, the “Tigris Sipex Permits”) as currently conducted). Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris Sipex and its Subsidiaries is are in compliance in all material compliance respects with the terms of the Tigris Sipex Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Neither OrthoNetx nor any of Tigris and its Subsidiaries is, and since January 1, 2010 has complied is in all material respects conflict with, is not or in material default or violation ofof (i) any law, and has not received any written notices of alleged or actual material violation with respect torule, any foreign, federal, state or local statute, law or regulation, includingorder, but not limited judgment or decree applicable to all applicable Legal Requirements. No investigationOrthoNetx or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, claimor (ii) any note, suitbond, proceedingmortgage, audit indenture, contract, agreement, lease, license, permit, franchise or other action instrument or obligation to which OrthoNetx or any of its Subsidiaries is a party or by which OrthoNetx or any of its Subsidiaries or its or any of their respective properties is bound or affected except for those conflicts, defaults or violations which would not be reasonably expected to have an OrthoNetx Material Adverse Effect. To the knowledge of OrthoNetx, no investigation or review by any Governmental Body or authority Entity is pending or, to the Knowledge of Tigris, or threatened against Tigris OrthoNetx or a Tigris Subsidiaryits Subsidiaries, nor has any Governmental Body or authority Entity indicated to Potomac in writing an intention to conduct the samesame other than those which would not reasonably be expected to have an OrthoNetx Material Adverse Effect. There is no agreement, judgment, injunction, order or decree binding upon Tigris OrthoNetx or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris OrthoNetx or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris OrthoNetx or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and any Subsidiary OrthoNetx as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris OrthoNetx and its Subsidiaries holds hold all permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material would necessary to the operation of their businesses (collectively, the “Tigris Permits”) as currently conducted. Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is in material compliance with the terms of the Tigris Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris OrthoNetx except those the absence of which would not, individually or in the aggregate, reasonably be likely to have an OrthoNetx Material Adverse Effect (collectively, the "OrthoNetx Permits"). OrthoNetx and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified are in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted compliance in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations terms of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312OrthoNetx Permits. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Frequency and each of Tigris and its Subsidiaries is, and since January 1, 2010 2020, has complied in all material respects with, is not been in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisFrequency, threatened against Tigris Frequency or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Tigris Frequency or a Tigris Subsidiary any of its Subsidiaries which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Frequency or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Frequency or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Frequency or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Frequency’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Frequency and its Subsidiaries holds all required Governmental Authorizations which that are material to the operation of their businesses the business of Frequency and Merger Sub as currently conducted (collectively, the “Tigris Frequency Permits”) as currently conducted). Part 3.9(bSection 4.14(b) of the Tigris Frequency Disclosure Schedule identifies each Tigris Frequency Permit. Each of Tigris Frequency and its Subsidiaries is in material compliance with the terms of the Tigris Frequency Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisFrequency, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Tigris Frequency Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings Legal Proceedings pending or, to the Knowledge of TigrisFrequency, threatened with respect to an alleged material violation by Tigris Frequency or a Tigris Subsidiary any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act or any other similar Legal Requirements Law promulgated by a Drug Regulatory Agency. (d) Each of Tigris Frequency and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris Frequency and its Subsidiaries Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Frequency Product Candidates”) (collectively, the “Tigris Frequency Regulatory Permits”) and no such Tigris Frequency Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially material, adverse manner. Neither Tigris Frequency has timely maintained and is in compliance in all material respects with the Frequency Regulatory Permits and neither Frequency nor any of its Subsidiaries has has, since January 1, 2020, received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Frequency Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Frequency Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinicalclinical trials, pre-clinical preclinical studies and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Frequency or a Tigris Subsidiary or its Subsidiaries, in which Tigris or a Tigris Subsidiary or their respective products or product candidatesthe Frequency Product Candidates have participated, have participated were and, if still pending, are being conducted in compliance in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Other than as set forth on Section 4.14(e) of the Frequency Disclosure Schedule, neither Frequency nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to the Knowledge of Frequency, any action to place a clinical hold order on, or otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Frequency or any of its Subsidiaries or in which the Frequency Product Candidates have participated. (f) Neither Tigris Frequency nor any of its Subsidiaries has, and, to the Knowledge of Frequency, any contract manufacturer with respect to any Frequency Product Candidate, is the subject of any pendingpending or, or to the Knowledge of TigrisFrequency, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any other applicable Law. To the Knowledge of TigrisFrequency, neither Tigris Frequency nor any of its Subsidiaries nor any contract manufacturer with respect to any Frequency Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its Frequency’s business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto, or any other applicable Law. None of TigrisFrequency, any of its Subsidiaries, and to the Knowledge of Frequency, any contract manufacturer with respect to any Frequency Product Candidate, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) 42 U.S.C. § 1320a-7, or (iii) any similar other applicable Legal RequirementLaw. To the Knowledge of TigrisFrequency, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisFrequency, any Tigris Subsidiary of its Subsidiaries, and to the Knowledge of the Frequency, any contract manufacturer with respect to any Frequency Product Candidate, or any of their respective its officers, employees or agents. Neither Frequency nor any of its Subsidiaries is a party to or has any reporting obligations under any corporate integrity agreements, monitoring agreements, deferred or non-prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority. (g) All manufacturing operations conducted by, or to the Knowledge of Frequency, for the benefit of, Frequency or its Subsidiaries in connection with any Frequency Product Candidate, since January 1, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. (h) No laboratory or manufacturing site owned by Frequency or its Subsidiaries, and to the Knowledge of Frequency, no manufacturing site of a contract manufacturer or laboratory, with respect to any Frequency Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has since January 1, 2020, received any unresolved Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Law, and, to the Knowledge of Frequency, neither the FDA nor any other Governmental Authority is considering such action.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Caladrius is, and since January 1, 2010 2019, has complied been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisCaladrius, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameCaladrius. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary Caladrius which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryCaladrius, any acquisition of material property by Tigris or a Tigris Subsidiary ▇▇▇▇▇▇▇▇▇ or the conduct of business by Tigris and any Subsidiary ▇▇▇▇▇▇▇▇▇ as currently conducted, (ii) may is reasonably likely to have an adverse effect on TigrisCaladrius’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Caladrius and its Subsidiaries ▇▇▇▇▇▇ Sub holds all required Governmental Authorizations which that are material to the operation of their businesses the business of Caladrius and Merger Sub as currently conducted (collectively, the “Tigris Caladrius Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Caladrius Disclosure Schedule identifies each Tigris Caladrius Permit. Each of Tigris Caladrius and its Subsidiaries Merger Sub is in material compliance with the terms of the Tigris Caladrius Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisCaladrius, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Caladrius Permit. The rights and benefits of each material Tigris Caladrius Permit will be available to the Caladrius and Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris ▇▇▇▇▇▇▇▇▇ and its Subsidiaries Merger Sub as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisCaladrius, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary Caladrius of the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law promulgated by a Drug Regulatory Agency. (d) Each of Tigris Caladrius and its Subsidiaries Merger Sub holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris Caladrius and its Subsidiaries Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Caladrius Product Candidates”) (the “Tigris Caladrius Regulatory Permits”) and no such Tigris Caladrius Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse mannermanner other than immaterial adverse modifications. Neither Tigris Caladrius is in compliance in all material respects with the Caladrius Regulatory Permits and neither Caladrius nor its Subsidiaries Merger Sub has received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any revocation, withdrawal, suspension, cancellation, termination material violation of or material modification failure to comply materially with any term or requirement of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.Caladrius (e) All clinical, pre-clinical and other studies and tests conducted by or or, to the Knowledge of Caladrius, on behalf of, or sponsored by, Tigris or a Tigris Subsidiary Caladrius or in which Tigris Caladrius or a Tigris Subsidiary or their its respective products or product candidates, including the Caladrius Product Candidates, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and ethics and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. . Since January 1, 2019, neither ▇▇▇▇▇▇▇▇▇ nor Merger Sub has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring or, to the Knowledge of Caladrius, threatening to initiate, the termination or suspension of any clinical trials conducted by or on behalf of, or sponsored by, Caladrius or in which Caladrius or its current products or product candidates, including the Caladrius Product Candidates, have participated. (f) Neither Tigris nor any of its Subsidiaries Caladrius is not the subject of any pendingpending or, or to the Knowledge of TigrisCaladrius, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any other Drug Regulatory Agency pursuant to any similar Laws or regulations promulgated or enforced thereby. To the Knowledge of TigrisCaladrius, neither Tigris nor any of its Subsidiaries ▇▇▇▇▇▇▇▇▇ has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto, or any other Drug Regulatory Agency pursuant to any similar Laws or regulations promulgated or enforced thereby. None of TigrisCaladrius, any of its SubsidiariesMerger Sub, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisCaladrius, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary Caladrius or any of their respective its officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Parent and each of Tigris and its Subsidiaries isare, and since January 1, 2010 has complied 2021, have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws, including applicable provisions of the FDCA, the FDA regulations adopted thereunder, the PHSA and any other similar Law administered or promulgated by the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parent. No investigation, claim, suit, proceeding, audit or, to Parent’s Knowledge, investigation or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened against Tigris Parent or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Tigris Parent or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Parent or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Parent and its Subsidiaries holds hold all required Governmental Authorizations which that are material to the operation of their businesses the business of Parent and its Subsidiaries as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each Parent and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear of Tigris any Encumbrance. Parent and each of its Subsidiaries is in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisParent’s Knowledge, threatened with respect to an alleged material violation by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries of the FDCA, the FDA regulations adopted thereunder, the PHSA or any other similar Legal Requirements Law administered or promulgated by a any Drug Regulatory Agency. Neither Parent nor any of its Subsidiaries is currently conducting or addressing, and, to Parent’s Knowledge, there is no basis to expect that it will be required to conduct or address, any corrective actions, including product recalls or clinical holds. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical nonclinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Parent or a Tigris Subsidiary any of its Subsidiaries, or in which Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or their respective current products or product candidatescandidates have participated, have participated were and, if still pending, are being conducted in compliance in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2021, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring or, threatening to initiate the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current product candidates have participated. (fe) Neither Tigris Parent nor any of its Subsidiaries is the subject of any pending, pending or to the Knowledge of TigrisParent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisParent’s Knowledge, neither Tigris Parent nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisParent, any of its Subsidiaries, Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) under 42 U.S.C. §§ 1320a-7 or 1320a-7a or any similar applicable Legal RequirementLaw. To the Knowledge of Tigris, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending pending, or to Parent’s Knowledge, threatened against TigrisParent, any Tigris Subsidiary of its Subsidiaries or any of their respective officers, employees or or, to the Parent’s Knowledge, agents.

Compliance; Permits; Restrictions. (a) Each Parent and each of Tigris and its Subsidiaries isare, and since January 1, 2010 has complied 2022, have been, in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding the FTC, CPSC, and has CPSIA, and regulations adopted thereunder and any other similar Law administered or promulgated by the FTC, CPSC, CPSIA, or other Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not received any written notices of alleged or actual be material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsParent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened against Tigris Parent or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Tigris Parent or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Parent or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Parent and its Subsidiaries holds hold all required Governmental Authorizations which are material to the operation of their businesses the business of Parent and its Subsidiaries as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each of Tigris Parent and its Subsidiaries is hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Parent Permit will be available to the Surviving Corporation Parent and its Subsidiaries immediately after the Effective Time on terms substantially identical similar to those enjoyed by Tigris Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisParent’s Knowledge, threatened with respect to an alleged material violation by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries of the FDCAFTC, FDA CPSC, or CPSIA, or any regulations adopted thereunder, or any other similar Legal Requirements Law administered or promulgated by a Drug any Regulatory Agency. (d) Each of Tigris Parent is not currently conducting or addressing, and its Subsidiaries holds all to Parent’s Knowledge there is no basis to expect that it will be required Governmental Authorizations issuable by to conduct or address, any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirementscorrective actions, including, without limitation, 21 C.F.R. Parts 50product recalls. (e) Parent and its Subsidiaries have made available to Company true and complete copies of all material notices, 54correspondence or other communications received by the Parent and each of its Subsidiaries from any Regulatory Agency, 56, 58 and 312if any. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or or, to Parent’s Knowledge, threatened against TigrisParent, any Tigris Subsidiary of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Except for any conflicts, defaults or violations which would not reasonably be expected to have a Material Adverse Effect on Raven, neither Raven nor any of Tigris and its Subsidiaries is, and since January 1, 2010 has complied subsidiaries is in all material respects conflict with, is not or in material default or violation ofof (i) any law, and has not received any written notices of alleged or actual material violation with respect torule, any foreign, federal, state or local statute, law or regulation, includingorder, but not limited judgment or decree applicable to all applicable Legal RequirementsRaven or any of its subsidiaries or by which its or any of their respective properties is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument or obligation to which Raven or any of its subsidiaries is a party or by which Raven or any of its subsidiaries or its or any of their respective properties is bound or affected. No investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body governmental or regulatory body or authority is pending or, to the Knowledge knowledge of TigrisRaven, threatened against Tigris Raven or a Tigris Subsidiaryits subsidiaries, nor nor, to Raven's knowledge, has any Governmental Body governmental or regulatory body or authority indicated to Potomac an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris Subsidiary, any acquisition of material property by Tigris or a Tigris Subsidiary or the conduct of business by Tigris and any Subsidiary as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Except where the failure to hold a permit, license, variance, exemption, order or approval from governmental authorities would be reasonably expected to have a Material Adverse Effect on Raven, Raven and its Subsidiaries holds subsidiaries hold all Governmental Authorizations permits, licenses, variances, exemptions, orders and approvals from governmental authorities which are material necessary to the operation of their businesses the business of Raven and its subsidiaries taken as a whole (collectively, the “Tigris "Raven Permits”) as currently conducted"). Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris Raven and its Subsidiaries is subsidiaries are in material compliance with the terms of the Tigris Raven Permits, except where the failure to so comply would not have a Material Adverse Effect on Raven. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge knowledge of TigrisRaven, threatened, which seeks to revoke, limit, suspend, revoke or materially modify limit any Tigris Raven Permit. The rights A true, complete and benefits correct list of each the Raven Permits is set forth in Section 2.10(b) of the Raven Disclosure Schedule, which further sets forth all material Tigris Permit will consents required to be obtained in order for such Raven Permits to continue in place or to be available to the Surviving Corporation Entity immediately after following the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective TimeClosing. (c) There All biological and drug products being manufactured, distributed or developed by or on behalf of Raven ("Raven Pharmaceutical Products") that are no proceedings pending or, subject to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary jurisdiction of the Food and Drug Administration ("FDA") are being manufactured, labeled, stored, tested, distributed, and marketed in compliance in all respects with all applicable requirements under the Federal Food, Drug, and Cosmetic Act ("FDCA"), FDA regulations adopted thereunderthe Public Health Service Act, or any other similar Legal Requirements promulgated by their applicable implementing regulations, and all comparable state laws and regulations, except as would not reasonably be expected to have a Drug Regulatory AgencyMaterial Adverse Effect on Raven. (d) Each All clinical trials conducted by or on behalf of Tigris Raven have been, and its Subsidiaries holds are being conducted in compliance with the applicable requirements of Good Clinical Practice, Informed Consent, and all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control applicable requirements relating to the Tigris Product Candidates protection of human subjects contained in 21 CFR Parts 50, 54, and the development56, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (except as would not reasonably be expected to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authorityhave a Material Adverse Effect on Raven. (e) All clinical, pre-clinical and other studies and tests manufacturing operations for drug products conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, for the benefit of Raven have participated were been and are being conducted in all material respects in accordance with standard medical the FDA's current Good Manufacturing Practices for drug and scientific research procedures and biological products, except as would not reasonably be expected to have a Material Adverse Effect on Raven. In addition, Raven is in compliance with the all applicable regulations of the Drug Regulatory Agencies registration and other listing requirements set forth in 21 U.S.C. Section 360 and 21 CFR Part 207 and all similar applicable Legal Requirementslaws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312except as would not reasonably be expected to have a Material Adverse Effect on Raven. (f) Neither Tigris Raven nor any representative of Raven, nor to the knowledge of Raven, any of its Subsidiaries is licensees or assignees of Raven IP Rights has received any notice that the subject FDA or any other Governmental Entity has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application sponsored by Raven or otherwise restrict the preclinical research on or clinical study of any pendingRaven Pharmaceutical Product or any biological or drug product being developed by any licensee or assignee of Raven IP Rights based on such intellectual property, or to recall, suspend or otherwise restrict the Knowledge manufacture of Tigrisany Raven Pharmaceutical Product. (g) Neither Raven nor, threatened investigation in respect to the knowledge of Raven, any of its business officers, key employees, agents or products by clinical investigators acting for Raven, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA pursuant to invoke its “policy with respect to "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy " set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereof. To the Knowledge of TigrisAdditionally, neither Tigris Raven, nor any to the knowledge of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisRaven, any officer, key employee or agent of its Subsidiaries, or any of their respective officers, employees or agents Raven has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a material debarment or exclusion (i) debarment under 21 U.S.C. Section 335a or any similar state law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation. (h) All animal studies or other preclinical tests performed in connection with or as the basis for any regulatory approval required for the Raven Pharmaceutical Products (1) either (x) have been conducted in accordance, in all material respects, with applicable Legal RequirementGood Laboratory Practice requirements contained in 21 CFR Part 58, or (y) were not required to be conducted in accordance with Good Laboratory Practice requirements contained in 21 CFR Part 58 and (2) have employed the procedures and controls generally used by qualified experts in animal or preclinical study of products comparable to those being developed by Raven. (i) Raven has made available to Parent copies of any and all notices of inspectional observations, establishment inspection reports and any other documents received from the FDA, that indicate or suggest lack of compliance with the regulatory requirements of the FDA. To Raven has made available to Parent for review all correspondence to or from the Knowledge FDA, minutes of Tigrismeetings, no material debarment written reports of phone conversations, visits or exclusionary claimsother contact with the FDA, actionsnotices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from the FDA, or prepared by the FDA or which bear in any way on Raven's compliance with regulatory requirements of the FDA, or on the likelihood of timing of approval of any Raven Pharmaceutical Products. (j) Raven has not been notified in writing of any proceedings or investigations in pending with respect to a violation by Raven of their business or products are pending or threatened against Tigristhe FDCA, any Tigris Subsidiary FDA regulations adopted thereunder, the Controlled Substance Act or any of their respective officers, employees other legislation or agentsregulation promulgated by any other United States governmental entity.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries TapImmune is, and since January 1, 2010 2015, each of TapImmune and its Subsidiaries has complied been in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a TapImmune Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisTapImmune, threatened against Tigris TapImmune or a Tigris any TapImmune Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Tigris TapImmune or a Tigris any TapImmune Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris TapImmune or a Tigris any TapImmune Subsidiary, any acquisition of material property by Tigris TapImmune or a Tigris any TapImmune Subsidiary or the conduct of business by Tigris and TapImmune or any TapImmune Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on Tigris’ TapImmune’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris TapImmune and its the TapImmune Subsidiaries holds hold all Governmental Authorizations which that are material to the operation of their businesses its business (collectively, the “Tigris TapImmune Permits”) as currently conducted. Part 3.9(bSection 3.12(b) of the Tigris TapImmune Disclosure Schedule identifies each Tigris TapImmune Permit. Each As of Tigris the date of this Agreement, each of TapImmune and its the TapImmune Subsidiaries is are in material compliance with the terms of the Tigris TapImmune Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisTapImmune, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris TapImmune Permit. The rights and benefits of each material Tigris TapImmune Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris TapImmune and its the TapImmune Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisTapImmune, threatened with respect to an alleged material violation by Tigris TapImmune or a Tigris Subsidiary any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act or any other similar Legal Requirements promulgated by a the FDA or other Drug Regulatory Agency. (d) Each TapImmune and each of Tigris and its Subsidiaries holds hold all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries TapImmune or such Subsidiary as currently conducted, and, as applicable, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris TapImmune Product Candidates”) ). TapImmune holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Tigris TapImmune Regulatory Permits”) and no such Tigris TapImmune Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries TapImmune has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Tigris TapImmune Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris TapImmune has made available to Potomac Marker all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris TapImmune Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) copies of all investigational new drug applications (INDs) submitted to the FDA, and all supplements to and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityBody. Each of TapImmune and each of its Subsidiaries has complied in all material respects with the ICH E9 Guidance for Industry: Statistical Principles for Clinical Trials in the management of the clinical data that have been presented to TapImmune. To the Knowledge of TapImmune, there are no facts that would be reasonably likely to result in any warning, untitled or notice of violation letter or Form FDA-483 from the FDA. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris TapImmune or a Tigris Subsidiary any of the TapImmune Subsidiaries or in which Tigris TapImmune or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidates, services have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. No preclinical or clinical trial conducted by or on behalf of TapImmune has been terminated or suspended prior to completion for safety or non-compliance reasons. Since January 1, 2015, neither TapImmune nor any of the TapImmune Subsidiaries has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of TapImmune threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, TapImmune or in which TapImmune Product Candidates, have participated. To the extent required, all clinical trials conducted by or on behalf of TapImmune have been registered on, and trial results have been reported on, the United States National Institutes of Health Website, w▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any applicable additional state and local law requirements. (f) Neither Tigris nor any To the Knowledge of TapImmune, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TapImmune or its Subsidiaries officers, employees or agents. TapImmune is not the subject of any pending, or to the Knowledge of TigrisTapImmune, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisTapImmune, neither Tigris nor any of its Subsidiaries TapImmune has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products TapImmune Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither TapImmune, nor to the Knowledge of TigrisTapImmune, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Parent and each of Tigris and its Subsidiaries is, and since January 1, 2010 2023, has complied been in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws, except for such non-compliance that would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. No investigation, claim, suit, proceeding, audit audit, Order or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisParent, threatened against Tigris Parent or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Tigris Parent or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Parent or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Parent or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Parent and its Subsidiaries holds all required Governmental Authorizations which are material related to the operation of their businesses the business of Parent and Merger Sub as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted), except for any Parent Permits for which the failure to obtain or hold would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Part 3.9(bSection 4.14(b) of the Tigris Parent Disclosure Schedule Letter identifies each Tigris Parent Permit. Each of Tigris Parent and its Subsidiaries is in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent, threatened, which seeks to revoke, substantially limit, suspend, suspend or materially modify any Tigris Parent Permit, except for any such limitation, suspension or modification which would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. The rights and benefits of each material Tigris Permit Parent Permit, if any, will be available to the Parent and Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There The Parent is in compliance in all material respects with (i) the Trading with the Enemy Act, as amended, and each of the economic sanctions regulations of the United States Treasury Department’s Office of Foreign Assets Control (31 CFR, Subtitle B, Chapter V, as amended) and any other enabling legislation or executive order relating thereto and/or administered by OFAC, and (ii) the Uniting And Strengthening America By Providing Appropriate Tools Required To Intercept And Obstruct Terrorism (USA Patriot Act of 2001) and regulations promulgated thereunder, as applicable. (d) The operations of the Parent are and have been conducted at all times in compliance, in all material respects, with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, federal, state or foreign anti-money laundering statutes, the rules and regulations thereunder and any related or similar Applicable Laws, issued, administered or enforced by any Governmental Entity and no proceedings Proceeding by or before any Governmental Entity involving the Parent with respect to such laws is pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary knowledge of the FDCAParent, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authoritythreatened. (e) All clinicalThe operations of the Parent are and have been conducted at all times in compliance, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted in all material respects in accordance respects, with standard medical applicable financial laws and scientific research procedures regulations, including without limitation the Fair Credit Reporting Act, ▇▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Act, Credit Repair Organizations Act, ▇▇▇▇-▇▇▇▇▇ ▇▇▇▇ Street Reform and in compliance with the applicable regulations of the Drug Regulatory Agencies Consumer Protection Act, Federal Trade Commission Act, Electronic Fund Transfer Act, Telemarketing Sales Rule, federal securities laws, analogous or related state financial services and other applicable Legal Requirementsfinancial privacy laws, includingstate insurance laws, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 state credit services organization laws and 312state debt management services laws. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Cellect is, and since January 1, 2010 2016, each of Cellect and its Subsidiaries has complied in all material respects with, is not been in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsRequirements except for any non-compliance that would not constitute a Cellect Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisCellect, threatened against Tigris Cellect or a Tigris any Cellect Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Tigris Cellect or a Tigris any Cellect Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Cellect or a Tigris any Cellect Subsidiary, any acquisition of material property by Tigris Cellect or a Tigris any Cellect Subsidiary or the conduct of business by Tigris and Cellect or any Cellect Subsidiary as currently conducted, (ii) may would reasonably be expected to have an adverse effect on Tigris’ Cellect’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may would reasonably be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each To the Knowledge of Tigris Cellect, Cellect and its the Cellect Subsidiaries holds hold all required Governmental Authorizations which that are material to the operation of their businesses the business of Cellect (collectively, the “Tigris Cellect Permits”) as currently conducted. Part 3.9(bSection 3.12(b) of the Tigris Cellect Disclosure Schedule identifies each Tigris Cellect Permit. Each As of Tigris and its Subsidiaries the date of this Agreement, Cellect is in material compliance with the terms of the Tigris Cellect Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of TigrisCellect, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Cellect Permit. The rights and benefits of each material Tigris Cellect Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Cellect and its the Cellect Subsidiaries as of the date of this Agreement and immediately prior to the Effective TimeTime except where the unavailability of such Cellect Permit would not constitute a Cellect Material Adverse Effect. (c) There are no proceedings pending or, to the Knowledge of TigrisCellect, threatened with respect to an alleged material violation by Tigris Cellect or a Tigris any Cellect Subsidiary of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act or any other similar Legal Requirements promulgated by a the FDA or other Drug Regulatory Agency. (d) Each To the Knowledge of Tigris Cellect, Cellect and each of its Subsidiaries holds hold all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Cellect or such Subsidiary as currently conducted, and, as applicable, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Cellect Product Candidates”) ). Cellect holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Tigris Cellect Regulatory Permits”) and no such Tigris Cellect Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries Cellect has not received any written notice or other written communication from any Drug Regulatory Agency Governmental Body regarding any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Tigris Cellect Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris Cellect has made available to Potomac Quoin all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Cellect Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All To the Knowledge of Cellect, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Cellect or a Tigris any Cellect Subsidiary or in which Tigris Cellect or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidates, services have participated were were, and if still pending are being, conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2012, neither Cellect nor any Cellect Subsidiary has received any notices, correspondence or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of Cellect threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Cellect or in which Cellect or Cellect Product Candidates, have participated. (f) Neither Tigris nor any of its Subsidiaries Cellect is not the subject of any pending, or to the Knowledge of TigrisCellect, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisCellect, neither Tigris nor any of its Subsidiaries Cellect has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Cellect Product Candidates that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None Neither Cellect, nor to the Knowledge of TigrisCellect, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could would reasonably be expected to result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of TigrisCellect, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary Cellect or any of their respective its officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Carnivale is, and since January 1, 2010 2012 has complied been in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws, except for any noncompliance, either individually or in the aggregate, which would not result in a Carnivale Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of TigrisCarnivale, threatened against Tigris or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameCarnivale. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary Carnivale which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris SubsidiaryCarnivale, any acquisition of material property by Tigris or a Tigris Subsidiary Carnivale or the conduct of business by Tigris and any Subsidiary Carnivale as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Carnivale’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, delaying or making illegal or otherwise interfering with the Merger Transaction or any of the Contemplated Transactions. (b) Each of Tigris and its Subsidiaries Carnivale holds all required Governmental Authorizations which are material to for the operation of their its businesses (collectively, the “Tigris Carnivale Permits”) as currently conducted, except for any failure to hold any such Governmental Authorizations, either individually or in the aggregate, which would not result in a Carnivale Material Adverse Effect. Part 3.9(b3.14(b) of the Tigris Carnivale Disclosure Schedule identifies each Tigris Carnivale Permit. Each of Tigris and its Subsidiaries Carnivale is in material compliance with the terms of the Tigris Carnivale Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisCarnivale, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Carnivale Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of TigrisCarnivale, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary Carnivale of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements Laws promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries Carnivale holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Carnivale as currently conducted, and, as applicable, for the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Carnivale Product Candidates”) (the “Tigris Carnivale Regulatory Permits”) and no such Tigris Carnivale Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither Tigris nor its Subsidiaries Carnivale has not received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Carnivale Regulatory Permit. Except for the information and files identified in Part 3.9(d3.14(d) of the Tigris Carnivale Disclosure Schedule, Tigris Carnivale has made available to Potomac the Company all information requested by the Company in its or its Subsidiaries’ Carnivale’s possession or control relating to the Tigris Carnivale Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Carnivale Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary Carnivale or in which Tigris Carnivale or a Tigris Subsidiary or their respective its products or product candidates, have participated were conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaws, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Neither Tigris nor any of its Subsidiaries Carnivale is not the subject of any pending, or to the Knowledge of TigrisCarnivale, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisCarnivale, neither Tigris nor any of its Subsidiaries Carnivale has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, Carnivale or any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisCarnivale, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary Carnivale or any of their respective its officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each Milan and each of Tigris and its Subsidiaries isare, and since January 1, 2010 has complied 2016, have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisMilan, threatened against Tigris Milan or a Tigris Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Tigris Milan or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Milan or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Milan or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and Milan or any Subsidiary of its Subsidiaries as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Milan’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Milan and its Subsidiaries holds all required Governmental Authorizations which that are material to the operation of their businesses the business of Milan and its Subsidiaries as currently conducted (collectively, the “Tigris Milan Permits”) as currently conducted). Part 3.9(bSection 3.14(b) of the Tigris Milan Disclosure Schedule identifies each Tigris Milan Permit. Each of Tigris Milan and its Subsidiaries is in material compliance with the terms of the Tigris Milan Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisMilan, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Milan Permit. The rights and benefits of each material Tigris Milan Permit will be available to the Milan and Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Milan and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings Legal Proceedings pending or, to the Knowledge of TigrisMilan, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary Milan of the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law promulgated by a Drug Regulatory Agency. (d) Each Milan and each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries Milan or such Subsidiary as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Milan Product Candidates”) (, and such required Governmental Authorizations, the “Tigris Milan Regulatory Permits”) and no such Tigris Milan Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse mannermanner other than immaterial adverse modifications. Neither Tigris Milan and each of its Subsidiaries are in compliance in all material respects with the Milan Regulatory Permits and neither Milan nor any of its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Milan Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Milan Regulatory Permit. Except for the information and files identified in Part 3.9(dSection 3.14(d) of the Tigris Milan Disclosure Schedule, Tigris Milan has made available to Potomac the Company all information requested by the Company in its Milan’s or its Subsidiaries’ possession or control relating to the Tigris Milan Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Milan Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) serious adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority, in each case to the extent material. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Milan or a Tigris Subsidiary its Subsidiaries or in which Tigris Milan or a Tigris Subsidiary its Subsidiaries or their respective current products or product candidates, including the Milan Product Candidates, have participated were have been, since the date of Milan’s acquisition of such product or product candidate and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Other than as set forth on Section 3.14(e) of the Milan Disclosure Schedule, since January 1, 2016, neither Milan nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring or, to the Knowledge of Milan, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Milan or any of its Subsidiaries or in which Milan or any of its Subsidiaries or their respective current products or product candidates, including the Milan Product Candidates, have participated since the date of Milan’s acquisition of such product or product candidate. (f) Neither Tigris Milan nor any of its Subsidiaries is the subject of any pendingpending or, or to the Knowledge of TigrisMilan, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of TigrisMilan, neither Tigris Milan nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisMilan, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisMilan, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, Milan or any Tigris Subsidiary of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. Except as disclosed on Schedule 3.9, (a) Each Neither Callisto nor any of Tigris and its Subsidiaries is, and since January 1, 2010 has complied is in all material respects conflict with, is not or in material default or violation ofof (i) any law, and has not received any written notices of alleged or actual material violation with respect torule, any foreign, federal, state or local statute, law or regulation, includingorder, but not limited judgment or decree applicable to all applicable Legal Requirements. No investigationCallisto or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, claimor (ii) any note, suitbond, proceedingmortgage, audit indenture, contract, agreement, lease, license, permit, franchise or other action instrument or obligation to which Callisto or any of its Subsidiaries is a party or by which Callisto or any of its Subsidiaries or its or any of their respective properties is bound or affected except for those conflicts, defaults or violations which would not be reasonably expected to have a Callisto Material Adverse Effect. Except as disclosed on Schedule 3.9 to the knowledge of Callisto, no investigation or review by any Governmental Body or authority Entity is pending or, to the Knowledge of Tigris, or threatened against Tigris Callisto or a Tigris Subsidiaryany of its Subsidiaries, nor has any Governmental Body or authority Entity indicated to Potomac in writing an intention to conduct the same; other than those which would not reasonably be expected to have a Callisto Material Adverse Effect. There is no agreement, judgment, injunction, order or decree binding upon Tigris Callisto or a Tigris Subsidiary any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Callisto or a Tigris Subsidiaryany of its Subsidiaries, any acquisition of material property by Tigris Callisto or a Tigris Subsidiary any of its Subsidiaries or the conduct of business by Tigris and any Subsidiary Callisto as currently conducted, (ii) may have an adverse effect on Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each of Tigris Callisto and its Subsidiaries holds hold all permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material necessary to the operation of their businesses (collectively, the “Tigris Permits”) as currently conducted. Part 3.9(b) of the Tigris Disclosure Schedule identifies each Tigris Permit. Each of Tigris and its Subsidiaries is in material compliance with the terms of the Tigris Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Tigris Permit. The rights and benefits of each material Tigris Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigris, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris Callisto except those the absence of which would not, individually or in the aggregate, be reasonably likely to have a Callisto Material Adverse Effect, (collectively, the "Callisto Permits"). Callisto and its Subsidiaries as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Regulatory Permits”) and no such Tigris Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified are in any materially adverse manner. Neither Tigris nor its Subsidiaries has received any written notice or other written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidates, have participated were conducted compliance in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations terms of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312Callisto Permits. (f) Neither Tigris nor any of its Subsidiaries is the subject of any pending, or to the Knowledge of Tigris, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigris, neither Tigris nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigris, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Each of Tigris Parent and its Subsidiaries isSubsidiary are, and since January 1March 31, 2010 has complied in all material respects with2023, is not have been in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order or other Legal Proceeding or action by any Governmental Body or authority Authority is pending or, to the Knowledge of TigrisParent, threatened against Tigris Parent or a Tigris its Subsidiary, nor has any Governmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Tigris Parent or a Tigris its Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris Parent or a Tigris its Subsidiary, any acquisition of material property by Tigris Parent or a Tigris its Subsidiary or the conduct of business by Tigris and any Parent or its Subsidiary as currently conducted, (ii) may is reasonably likely to have an adverse effect on Tigris’ Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) may is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Each Except for matters regarding the FDA or other Drug/Device Regulatory Agency, each of Tigris Parent and its Subsidiaries Subsidiary holds all required Governmental Authorizations which that are material to the operation of their businesses the business of Parent and Merger Sub as currently conducted (collectively, the “Tigris Parent Permits”) as currently conducted). Part 3.9(bSection 4.14(b) of the Tigris Parent Disclosure Schedule identifies each Tigris Parent Permit. Each of Tigris Parent and its Subsidiaries Subsidiary is in material compliance with the terms of the Tigris Parent Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of TigrisParent, threatened, which seeks to revoke, substantially limit, suspend, suspend or materially modify any Tigris Parent Permit. The rights and benefits of each material Tigris Permit Parent Permit, if any, will be available to the Parent and Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris Parent and its Subsidiaries Subsidiary as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings Legal Proceedings pending or, to the Knowledge of TigrisParent, threatened with respect to an alleged material violation by Tigris Parent or a Tigris its Subsidiary of the FDCA, PHSA or FDA regulations adopted thereunder, the Controlled Substances Act or any other similar Legal Requirements Law promulgated by a Drug Drug/Device Regulatory Agency. (d) Each of Tigris Parent and its Subsidiaries Subsidiary holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of Tigris Parent and its Subsidiaries Merger Sub as currently conducted, and, as applicable, the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Parent Product Candidates”) (collectively, the “Tigris Parent Regulatory Permits”) and no such Tigris Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse mannermanner other than immaterial adverse modifications. Neither Tigris Section 4.14(d) of the Parent Disclosure Schedule identifies and lists each Parent Regulatory Permit. Parent has timely maintained and is in compliance in all material respects with the Parent Regulatory Permits and neither Parent nor its Subsidiaries has Subsidiary has, since March 31, 2023, received any written notice or correspondence or, to the Knowledge of Parent, other written communication from any Drug Drug/Device Regulatory Agency regarding (w) any material violation of or failure to comply materially with any term or requirement of any Parent Regulatory Permit or (x) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Parent Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Tigris Disclosure Schedule, Tigris Parent has made available to Potomac the Company all information requested by the Company in its Parent’s or its Subsidiaries’ Subsidiary’s possession or control relating to the Tigris material Parent Product Candidates and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation and or exportation of the Tigris Parent Product Candidates, including without limitationincluding, but not limited to, complete copies of the following (to the extent there are any): (xy) adverse event reports; pre-clinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Drug/Device Regulatory Agency; and meeting minutes with any Drug Drug/Device Regulatory Agency; Agency and (yz) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris Parent or a Tigris Subsidiary or its Subsidiary, in which Tigris Parent or a Tigris its Subsidiary or their respective products or product candidates, including the Parent Product Candidates, have participated were were, since March 31, 2023, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, and in compliance in all material respects with the applicable regulations of the Drug Drug/Device Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Other than as set forth on Section 4.14(e) of the Parent Disclosure Schedule, since March 31, 2023, neither Parent nor its Subsidiary has received any written notices, correspondence, or other communications from any Drug/Device Regulatory Agency requiring or, to the Knowledge of Parent, any action to place a clinical hold order on, or otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or its Subsidiaries or in which Parent or any of its Subsidiaries or its current product candidates, including the Parent Product Candidates, have participated. Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of Parent, on behalf of Parent or its Subsidiary has been disqualified from participating in studies involving the Parent Product Candidates, and to the Knowledge of Parent, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending. (f) Neither Tigris nor Parent, its Subsidiary nor, to the Knowledge of Parent, any of its Subsidiaries contract manufacturer with respect to any Parent Product Candidate is the subject of any pendingpending or, or to the Knowledge of TigrisParent, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To Neither Parent, its Subsidiary nor, to the Knowledge of TigrisParent, neither Tigris any contract manufacturer, nor their respective officers, employees or agents, with respect to any of its Subsidiaries Parent Product Candidate has committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of TigrisParent, its Subsidiary, and, to the Knowledge of Parent, any of its Subsidiariescontract manufacturer with respect to any Parent Product Candidate, or any of their respective officers, employees or agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of TigrisParent, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against TigrisParent, its Subsidiary, and to the Knowledge of the Parent, any Tigris Subsidiary contract manufacturer with respect to any Parent Product Candidate, or any of their respective its officers, employees or agents. (g) All manufacturing operations conducted by, or to the Knowledge of Parent, for the benefit of, Parent or its Subsidiary in connection with any Parent Product Candidate, since March 31, 2023, have been and are being conducted in compliance and in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211 and 600-610 and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. (h) None of Parent, its Subsidiary, and to the Knowledge of Parent, any manufacturing site of a contract manufacturer or laboratory, with respect to any Parent Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, reviews (including data integrity reviews) or similar correspondence or notice from the FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Drug/Device Regulatory Agency, and, to the Knowledge of Parent, neither the FDA nor any other Drug/Device Regulatory Agency is considering such action.

Compliance; Permits; Restrictions. (a) Each of Tigris and its Subsidiaries Except as set forth in Schedule 3.11(a), the Acquiror is, and since January 1, 2010 2008 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, any foreign, federal, state or local statute, law or regulation, including, but not limited to all applicable Legal Requirements. No Except as set forth in Schedule 3.11(a), no investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of Tigristhe Acquiror, threatened against Tigris or a Tigris Subsidiarythe Acquiror, nor has any Governmental Body or authority indicated to Potomac the Acquiror an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Tigris or a Tigris Subsidiary the Acquiror which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Tigris or a Tigris Subsidiarythe Acquiror, any acquisition of material property by Tigris or a Tigris Subsidiary the Acquiror or the conduct of business by Tigris and any Subsidiary as currently conductedthe Acquiror Business, (ii) may could reasonably be expected to have an a material adverse effect on Tigris’ the Acquiror’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) may could reasonably be expected to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions. (b) Each of Tigris and its Subsidiaries The Acquiror holds all required Governmental Authorizations which are material to the operation of their businesses the Acquiror Business (collectively, the “Tigris Acquiror Permits”) as currently conducted). Part 3.9(bSchedule 3.11(b) of the Tigris Acquiror Disclosure Schedule Letter identifies each Tigris Acquiror Permit. Each of Tigris and its Subsidiaries The Acquiror is in material compliance with the terms of the Tigris Acquiror Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Tigristhe Acquiror, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Tigris Acquiror Permit. The rights and benefits of each material Tigris Acquiror Permit will continue to be available to the Surviving Corporation Acquiror immediately after the Effective Time on terms substantially identical to those enjoyed by Tigris and its Subsidiaries the Acquiror as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of Tigristhe Acquiror, threatened with respect to an alleged material violation by Tigris or a Tigris Subsidiary the Acquiror of the FDCA, the FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by a Drug Regulatory Agency. (d) Each of Tigris and its Subsidiaries The Acquiror holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Tigris and its Subsidiaries as currently conductedAcquiror Business, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Tigris Product Candidates”) (the “Tigris Acquiror Regulatory Permits”) and no such Tigris Acquiror Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. Neither Tigris nor its Subsidiaries The Acquiror is in compliance in all material respects with the Acquiror Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Acquiror Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Tigris Acquiror Regulatory Permit. Except for the information and files identified in Part 3.9(dSchedule 3.11(d) of the Tigris Acquiror Disclosure ScheduleLetter, Tigris the Acquiror has made available to Potomac all information in its or its Subsidiaries’ possession or control relating to the Tigris Product Candidates Company true and the development, clinical testing, manufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Tigris or a Tigris Subsidiary or in which Tigris or a Tigris Subsidiary or their respective products or product candidatesthe Acquiror were and, have participated were if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the Acquiror has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Acquiror, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Acquiror. (f) Neither Tigris nor any of its Subsidiaries The Acquiror is not the subject of any pending, or to the Knowledge of Tigristhe Acquiror, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Tigristhe Acquiror, neither Tigris nor any of its Subsidiaries the Acquiror has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Tigris, Neither the Acquiror nor any of its Subsidiaries, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of Tigristhe Acquiror, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Tigris, any Tigris Subsidiary the Acquiror or any of their respective its officers, employees or agents.