Common use of Compliance; Permits; Restrictions Clause in Contracts

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws, 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 is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, 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 Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. Except as disclosed on Schedule 3.9 or described in a Parent SEC Report filed prior to the date hereof: (a) Neither Parent and each nor any of its Subsidiaries areis in conflict with, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws, 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 aggregatedefault or violation of (i) any law, which would not be material rule, regulation, order, judgment or decree applicable to Parent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledge, threatened against Parent 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 Parent or any of its Subsidiaries is a party or by which Parent 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 Parent Material Adverse Effect. Except as disclosed on Schedule 3.9 to the knowledge of Parent, no investigation or review by any Governmental Entity is pending or threatened against Parent or its Subsidiaries, nor has any Governmental Entity indicated in writing an intention to conduct the same other than those which would not reasonably be expected to have a Parent Material Adverse Effect. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material would necessary to the operation conduct of the business of Parent except those the absence of which would not, individually or in the aggregate, reasonably be likely to have a Parent Material Adverse Effect or prevent or materially burden or materially impair the ability of Parent to consummate the Merger and its Subsidiaries as currently conducted the other transactions contemplated by this Agreement (collectively, the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) terms 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 anyPermits. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Homology and each of its Subsidiaries areis, and since January 1, 2020 have been2020, has been in material compliance in all material respects with all applicable Laws, 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 audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Homology, threatened against Parent Homology or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent Homology or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Homology or any of its Subsidiaries, any acquisition of material property by Parent Homology or any of its Subsidiaries or the conduct of business by Parent Homology or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on ParentHomology’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Each of Homology and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent Homology and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Homology Permits”). Section 3.14(b4.14(b) of the Parent Homology Disclosure Schedule identifies each Parent Homology Permit. Parent Each of Homology and its Subsidiaries 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 is in material compliance with the terms of the Parent Homology Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Homology, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent Homology Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledgethe Knowledge of Homology, threatened in writing with respect to an alleged material violation by Parent Homology or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent Each of Homology and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Homology and Merger Sub as currently conducted, and, as applicable, the research, development, testing, manufacturing, packaging, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Homology Product Candidates”) (collectively, the “Homology Regulatory Permits”) and no such Homology Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any material, adverse manner. Homology has timely maintained and is not currently conducting in compliance in all material respects with the Homology Regulatory Permits and neither Homology nor any of its Subsidiaries has, since January 1, 2020, received any written notice or addressingother 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 Homology Regulatory Permit or (B) any revocation, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct withdrawal, suspension, cancellation, termination or address, material modification of any corrective actions, including, without limitation, product recalls or clinical holdsHomology Regulatory Permit. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Homology or any of its Subsidiaries, or in which Parent Homology or any of its Subsidiaries or their respective current products or product candidates candidates, including the Homology 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 any applicable the Drug Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except Other than as set forth in on Section 3.14(e4.14(e) of the Parent Homology Disclosure Schedule, since January 1, 2020, neither Parent Homology nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledgethe Knowledge of Homology, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent Homology or any of its Subsidiaries or in which Parent Homology or any of its Subsidiaries or their respective its current products or product candidates candidates, including the Homology 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 Parent Homology nor any of its Subsidiaries has, and, to the Knowledge of Homology, any contract manufacturer with respect to any Homology Product Candidate, is the subject of any pending or, to Parent’s Knowledgethe Knowledge of Homology, 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 Parent’s Knowledgethe Knowledge of Homology, neither Parent Homology nor any of its Subsidiaries nor any contract manufacturer with respect to any Homology Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its Homology’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 ParentHomology, any of its Subsidiaries nor Subsidiaries, and to the Knowledge of Homology, any contract manufacturer with respect to any Homology 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 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 Law. No To the Knowledge of Homology, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against ParentHomology, any of its Subsidiaries Subsidiaries, and to the Knowledge of the Homology, any contract manufacturer with respect to any Homology Product Candidate, or any of their respective its officers, employees or agents. Neither Homology 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 Homology, for the benefit of, Homology or its Subsidiaries in connection with any Homology 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, 211, 600-680 and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States. (h) No laboratory or manufacturing site owned by Homology or its Subsidiaries, and to the Knowledge of Homology, no manufacturing site of a contract manufacturer or laboratory, with respect to any Homology 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 Homology, neither the FDA nor any other Governmental Authority is considering such action.

Compliance; Permits; Restrictions. (a) Parent and each Neither Acquirer nor any of its Subsidiaries areis in conflict with, and since January 1or in default or in violation of any law, 2020 have beenrule, in compliance in all material respects with all regulation, order, judgment or decree applicable Laws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act and to Acquirer or any other similar Law administered of its Subsidiaries or promulgated by the FDA which Acquirer or other Drug Regulatory Agencyany of its Subsidiaries or any of their respective properties is bound or affected, except for any noncompliance, either conflicts and violations that (individually or in the aggregate, which ) would not be material reasonably likely to Parenthave an Acquirer Material Adverse Effect. No investigation, claim, suit, proceeding, audit investigation or other action review by any Governmental Body Entity is pending or, to Parent’s KnowledgeAcquirer's knowledge, has been threatened in a writing delivered to Acquirer against Parent Acquirer or any of its Subsidiariesthe Material Acquirer Subsidiaries (except for threats delivered prior to January 1, 1995 regarding matters which were subsequently resolved or are no longer pending). There is no material agreement, judgment, injunction, order or decree binding upon Parent Acquirer or any of its the Material Acquirer Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Acquirer or any of its the Material Acquirer Subsidiaries, any acquisition of material property by Parent Acquirer or any of its the Material Acquirer Subsidiaries or the conduct of business by Parent Acquirer or any of its the Material Acquirer Subsidiaries as currently conducted. (b) Acquirer and the Material Acquirer Subsidiaries hold, (ii) is to the extent legally required, all 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 adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this AgreementAcquirer Target Adverse Effect (collectively, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent "Acquirer Permits”"). Section 3.14(b) of Acquirer and the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Material Acquirer Subsidiaries are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) terms of the Parent Disclosure ScheduleAcquirer Permits, since January 1, 2020, neither Parent nor any except where the failure to be in compliance with the terms of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, the Acquirer Permits would not be reasonably likely 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 anya Acquirer Material Adverse Effect. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Each of Tigris and each of its Subsidiaries areis, and since January 1, 2020 have been, in compliance 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 Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Tigris, threatened against Parent Tigris or a Tigris Subsidiary, nor has any of its SubsidiariesGovernmental Body or authority indicated to Potomac an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Tigris or any of its Subsidiaries a Tigris Subsidiary which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Tigris or any of its Subsidiariesa Tigris Subsidiary, any acquisition of material property by Parent Tigris or any of its Subsidiaries a Tigris Subsidiary or the conduct of business by Parent or Tigris and any of its Subsidiaries Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on Parent’s Tigris’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Parent Each of Tigris and its Subsidiaries hold holds all required Governmental Authorizations which are material to the operation of their businesses (collectively, the business of Parent and its Subsidiaries “Tigris Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(bPart 3.9(b) of the Parent Tigris Disclosure Schedule identifies each Parent Tigris Permit. Parent Each of Tigris and its Subsidiaries 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 is in material compliance with the terms of the Parent Tigris Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Tigris, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Tigris Permit. The rights and benefits of each Parent material Tigris Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Tigris, threatened with respect to an alleged material violation by Parent Tigris or any of its Subsidiaries a Tigris Subsidiary of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by any a Drug Regulatory Agency. (d) Parent is not 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 conducting conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or addressingexportation, 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 Parent’s Knowledge there is no basis Potomac all information in its or its Subsidiaries’ possession or control relating to expect that it will be required to conduct or addressthe Tigris Product Candidates and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the Tigris Product Candidates, including without limitation, product recalls or complete copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy 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, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Tigris or any of its Subsidiaries, a Tigris Subsidiary or in which Parent Tigris or any of its Subsidiaries a Tigris Subsidiary or their respective current products or product candidates 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 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 Parent Tigris nor any of its Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe 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 Parent’s Knowledgethe Knowledge of Tigris, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of ParentTigris, any of its Subsidiaries nor 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 LawLegal Requirement. No 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, to Parent’s Knowledge, or threatened against ParentTigris, any of its Subsidiaries Tigris Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries areis, and since January 1February 26, 2020 have been2014, each of Parent and its Subsidiaries has been in material compliance in all material respects with all applicable Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its SubsidiariesParent. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesParent, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely 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) Parent and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the its business of Parent and its Subsidiaries as currently conducted (collectively, the “Parent Permits”)) as currently conducted. Section 3.14(b3.12(b) of the Parent Disclosure Schedule identifies each Parent Permit. As of the date of this Agreement, Parent and its Subsidiaries 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 is in material compliance with the terms of the Parent Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each material Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar identical to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation Parent holds all required Governmental Authorizations issuable by Parent or any Governmental Body necessary for the conduct of its Subsidiaries business as currently conducted (the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Parent has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Parent Regulatory AgencyPermit. (d) To the Knowledge of Parent, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against Parent or its officers, employees or agents. 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, 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 Parent nor any of its Subsidiaries is the subject of any pending orpending, or to the Knowledge of Parent’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 Parent’s Knowledge, neither Parent 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 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 Parent, any of its Subsidiaries nor 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, Legal Requirement. (e) There are no proceedings or investigations in respect of their business or products are pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent, with respect to an alleged violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act or any 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 their respective officersthe Drug Regulatory Agencies and other applicable Legal Requirements, employees including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2013, Parent has not received any notices, correspondence or agentsother 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) Parent and each of its Subsidiaries areSubsidiaries, and since January 1, 2020 2019 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act 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 ParentParent 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 is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each Parent Permit is valid and in full force and effect, and Parent and its Subsidiaries hold all right, title and interest in and to all holding Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by Parent 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) . 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. (ed) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, 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 Since January 1, 20202019, 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 made available no liability for failure to comply with the Company true and complete copies of all material noticesFDCA, correspondence PHSA, or other communications received by Parent from 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 Drug Regulatory Agencycivil, if anycriminal 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 Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its Subsidiaries nor 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 (i) debarment or exclusion (i) under 21 U.S.C. Section 335a or 335a, as amended; (ii) any similar applicable Lawdisqualification 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. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Parent’s Knowledge, threatened against Parent, any 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) Parent and each of its Subsidiaries are, and since January 1, 2020 2022, have been, in compliance in all material respects with all applicable Laws, including the FDCAFTC, the FDA CPSC, and CPSIA, and regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act thereunder and any other similar Law administered or promulgated by the FDA FTC, CPSC, CPSIA, 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 is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCAFTC, FDA CPSC, or CPSIA, or any regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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 holdsrecalls. (e) All clinical, pre-clinical Parent and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, 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 the Parent and each of its Subsidiaries from any Drug Regulatory Agency, if any. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries are, and since January November 1, 2020 2018 have been, in compliance in all material respects with all applicable Laws, 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 Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries as currently conducted (collectively, the “Parent Permits”). Section 3.14(b3.15(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each of Parent and its Subsidiaries 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 is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and Surviving Corporation or its Subsidiaries Subsidiaries, as applicable, immediately after the Effective Time on terms substantially similar identical to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act thereunder or any other applicable similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent is not and each of its Subsidiaries holds all material Governmental Authorizations issued by any Drug Regulatory Agency that are necessary for the conduct of the business of Parent or such Subsidiary as currently conducting or addressingconducted, and the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Parent Product Candidates”) (collectively, the “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’s Knowledge there is , no basis event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Parent Regulatory Permit. 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 of Legal Proceedings relating to expect that it will be required to conduct the revocation, termination, suspension or address, material modification of any corrective actions, including, without limitation, product recalls or clinical holdsParent Regulatory Permit. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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 candidates, including the Parent 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 any applicable the Drug Regulatory Agency Agencies and other applicable Law, 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. Except 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, 20202018, 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, or to the Knowledge of Parent’s Knowledge, threatening to initiate, the termination or suspension of 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 or in which Subsidiaries. With respect to each Parent or any of its Subsidiaries or their respective current products or product candidates have participated. Product Candidate, Parent has made available to the Company true complete and complete accurate copies of all material notices, 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 other communications received by Parent from any its Subsidiaries and the applicable Drug Regulatory Agency, if anyAgencies. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of Parent’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 final policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of Parent’s Knowledge, neither 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 Parent, any of its Subsidiaries nor 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To the Knowledge of Parent, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, any 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) Parent and each of its Subsidiaries areNautilus is, and since January 1, 2020 have been2014, has been in compliance in all material respects with all applicable Laws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act and any other similar Law administered or promulgated by the FDA or other a Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to ParentNautilus. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledgethe Knowledge of Nautilus, threatened against Parent or any of its SubsidiariesNautilus. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Nautilus which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesNautilus, any acquisition of material property by Parent or any of its Subsidiaries Nautilus or the conduct of business by Parent or any of its Subsidiaries Nautilus as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s Nautilus’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Each of Nautilus and its Subsidiaries hold Merger Sub holds all required Governmental Authorizations which are material to the operation of the business of Parent Nautilus and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Nautilus Permits”). Section 3.14(b) of the Parent Nautilus Disclosure Schedule identifies each Parent Nautilus Permit. Parent Each of Nautilus and its Subsidiaries 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 Merger Sub is in material compliance with the terms of the Parent Nautilus Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Nautilus, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Nautilus Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledgethe Knowledge of Nautilus, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Nautilus of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent Each of Nautilus and Merger Sub holds all required Governmental Authorizations issuable by any Drug Regulatory Agency material to the conduct of the business of Nautilus and 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 “Nautilus Product Candidates”) (the “Nautilus Regulatory Permits”) and no such Nautilus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Each of Nautilus and Merger Sub is not currently conducting in compliance in all material respects with the Nautilus Regulatory Permits and neither Nautilus nor Merger Sub has received any written notice or addressingother 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 Nautilus Regulatory Permit. Except for the information and files identified in Section 3.14(d) of the Nautilus Disclosure Schedule, Nautilus has made available to the Company all information requested by the Company in Nautilus’ possession or control relating to the Nautilus Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Nautilus Product Candidates, including 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 Parent’s and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; 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 notices, letters, filings, correspondence and meeting minutes with any other Governmental Body. 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 is are no basis facts that would be reasonably likely to expect that it will be required to conduct result in any warning, untitled or address, any corrective actions, including, without limitation, product recalls notice of violation letter or clinical holdsForm FDA-483 from the FDA. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its Subsidiaries, Nautilus or in which Parent Nautilus or any of its Subsidiaries or their respective current products or product candidates candidates, including the Nautilus 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except 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 in on Section 3.14(e) of the Parent Nautilus Disclosure Schedule, since January 1, 20202014, neither Parent Nautilus nor any of its Subsidiaries Merger Sub has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledgethe Knowledge of Nautilus, threatening to initiate, the termination termination, suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Nautilus or in which Parent Nautilus or any of its Subsidiaries or their respective current products or product candidates candidates, including the Nautilus Product Candidates, have participated. Parent has made available to To the Company true extent required, all clinical trials conducted by or on behalf of Nautilus have been registered on, and complete copies trial results have been reported on, the United States National Institutes of all material noticesHealth Website, correspondence or other communications received by Parent from xxx.xxxxxxxxxxxxxx.xxx, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any Drug Regulatory Agency, if anyapplicable additional state and local law requirements. (f) Neither Parent 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 pending or, to Parent’s Knowledgethe Knowledge of Nautilus, 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 Parent’s Knowledgethe Knowledge of Nautilus, neither Parent 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 ParentNautilus, any Merger Sub, or, to the Knowledge of its Subsidiaries nor Nautilus, 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To the Knowledge of Nautilus, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Nautilus or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Apricus and each of its Subsidiaries are, and since January 1, 2020 2015, have been, been in compliance in all material respects with all applicable Laws, 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 a Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to ParentApricus. No Except as set forth in Section 3.14 of the Apricus Disclosure Schedule, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledgethe Knowledge of Apricus, threatened against Parent or any of its SubsidiariesApricus. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Apricus which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesApricus, any acquisition of material property by Parent or any of its Subsidiaries Apricus or the conduct of business by Parent or any of its Subsidiaries Apricus as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s Apricus’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Each of Apricus and its Subsidiaries hold Merger Sub holds all required Governmental Authorizations which are material to the operation of the business of Parent Apricus and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Apricus Permits”). Section 3.14(b) of the Parent Apricus Disclosure Schedule identifies each Parent Apricus Permit. Parent Each of Apricus and its Subsidiaries 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 Merger Sub is in material compliance with the terms of the Parent Apricus Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Apricus, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Apricus Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Apricus, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Apricus of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent Apricus and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency material to the conduct of the business of Apricus and 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 “Apricus Product Candidates”) (the “Apricus Regulatory Permits”) and no such Apricus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Each of Apricus and Merger Sub is not currently conducting in compliance in all material respects with the Apricus Regulatory Permits and neither Apricus nor Merger Sub has received any written notice or addressingother 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, and withdrawal, suspension, cancellation, termination or material modification of any Apricus Regulatory Permit. To the Knowledge of Apricus, there are no facts that would be reasonably likely to Parent’s Knowledge there is no basis to expect that it will be required to conduct result in any warning letter, untitled letter or address, any corrective actions, including, without limitation, product recalls or clinical holdsother written notice of material violation letter from the FDA. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its Subsidiaries, Apricus or in which Parent Apricus or any of its Subsidiaries or their respective current products or product candidates candidates, including the Apricus 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) No preclinical or clinical trial conducted by or on behalf of the Parent Disclosure Schedule, since 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, 20202015, neither Parent Apricus nor any of its Subsidiaries Merger Sub has received any notices, written notices or correspondence, or other written communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledgethe Knowledge of Apricus, threatening to initiate, the termination termination, suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Apricus or in which Parent Apricus or any of its Subsidiaries or their respective current products or product candidates candidates, including the Apricus Product Candidates, have participated. Parent has made available to To the Company true extent required, all clinical trials conducted by or on behalf of Apricus have been registered on, and complete copies trial results have been reported on, the United States National Institutes of all material noticesHealth Website, correspondence or other communications received by Parent from xxx.xxxxxxxxxxxxxx.xxx, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any Drug Regulatory Agency, if anyapplicable additional state and local law requirements. (f) Neither Parent Apricus nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledgethe Knowledge of Apricus, 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 Parent’s Knowledgethe Knowledge of Apricus, neither Parent 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 ParentApricus, any Merger Sub, or, to the Knowledge of its Subsidiaries nor Apricus, 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To the Knowledge of Apricus, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Apricus or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Arrow and each of its Subsidiaries OTI are, and since January 1, 2020 2013 have been, been in compliance in all material respects with all applicable Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or Governmental Authority is pending or, to Parent’s Knowledgethe Knowledge of Arrow, threatened against Parent Arrow or OTI, nor has any of its SubsidiariesGovernmental Body or Governmental Authority indicated to Arrow or OTI in writing an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Arrow or any of its Subsidiaries OTI which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Arrow or any of its SubsidiariesOTI, any acquisition of material property by Parent Arrow or any of its Subsidiaries OTI or the conduct of business by Parent or Arrow and any of its Subsidiaries Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentArrow’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, materially delaying, making illegal or otherwise interfering with the Mergers or any of the Contemplated Transactions. (b) Parent Each of Arrow, OTI, and its Subsidiaries hold Merger Subs holds all required Governmental Authorizations which are material to the operation of their businesses (collectively, the business of Parent and its Subsidiaries “Arrow Permits”) as currently conducted (the “Parent Permits”)conducted. Section Part 3.14(b) of the Parent Arrow Disclosure Schedule identifies each Parent Arrow Permit. Parent Each of Arrow, OTI, and its Subsidiaries 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 Merger Subs is in material compliance with the terms of the Parent Arrow Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Arrow, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Arrow Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledgethe Knowledge of Arrow, threatened with respect to an alleged material violation by Parent Arrow or any of its Subsidiaries OTI of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by any a Drug Regulatory Agency. (d) Parent is not currently conducting or addressingEach of Arrow, OTI, and Merger Subs holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Arrow, OTI, and 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 “Arrow Product Candidates”) (the “Arrow Regulatory Permits”) and no such Arrow Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Neither 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 Arrow Regulatory Permit. Except for the information and files identified in Part 3.14(d) of the Arrow Disclosure Schedule, Arrow and OTI have made available to Parent’s Knowledge the Company all information in its or its Subsidiaries’ possession or control relating to the Arrow Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Arrow Product Candidates, including complete copies of the following (to the extent there is no basis 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 expect that it will be required to conduct or addressand 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 corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Arrow or any of its Subsidiaries, OTI or in which Parent or any of its Subsidiaries Arrow, OTI, or their respective current products or product candidates 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, 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 Parent Arrow nor any of its Subsidiaries OTI is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Arrow, 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 Parent’s Knowledgethe Knowledge of Arrow, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of ParentArrow, any of its Subsidiaries nor 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 LawLegal Requirement. No To the Knowledge of Arrow, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against ParentArrow, any of its Subsidiaries 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) Parent and each of its Subsidiaries are, and since January 1, 2020 2020, have been, in compliance in all material respects with all applicable Laws, 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 is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree by or with a Drug Regulatory Agency binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, 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 Since January 1, 2020, neither Parent nor any of its Subsidiaries has 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. 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 Parent nor any of its Subsidiaries is are the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its Subsidiaries nor 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To Parent’s Knowledge, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Axonyx and each of its Subsidiaries Axonyx Subsidiary are, and since January 1, 2020 2003 have been, in compliance in all material respects with all applicable Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Axonyx, threatened against Parent Axonyx or any of its Axonyx Subsidiaries, nor has any Governmental Body or authority indicated to Axonyx an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Axonyx or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Axonyx or any of its SubsidiariesAxonyx Subsidiary, any acquisition of material property by Parent Axonyx or any of its Subsidiaries Axonyx Subsidiary or the conduct of business by Parent or Axonyx and any of its Subsidiaries Subsidiary as currently conducted, conducted (ii) is reasonably likely to may have an adverse effect on ParentAxonyx’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Parent Axonyx and its the Axonyx Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted their businesses (collectively, the “Parent Axonyx Permits”). Section 3.14(bPart 3.11(b) of the Parent Axonyx Disclosure Schedule identifies each Parent Axonyx Permit. Parent and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear Each of any Encumbrance. Parent Axonyx and each of its Subsidiaries are Axonyx Subsidiary is in material compliance with the terms of the Parent Axonyx Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Axonyx, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Axonyx Permit. The rights and benefits of each Parent material Axonyx Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent Axonyx 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 Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent Axonyx or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or Legal Requirements promulgated by any other Drug Regulatory Agency. (d) Parent Axonyx holds all Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Axonyx as currently conducted and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including Phenserine, Posiphen and Bisnorcymserine (the “Axonyx Product Candidates”) (the “Axonyx Regulatory Permits”) and no such Axonyx Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Axonyx is in compliance in all material respects with the Axonyx Regulatory Permits and has not currently conducting received any written notice or addressingother 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 Axonyx Regulatory Permit or (ii) any actual or possible revocation, withdrawal, suspension, cancellation, termination or material modification of any Axonyx Regulatory Permit. Except for the information and files identified in Part 3.11(d) of the Axonyx Disclosure Schedule, Axonyx has made available to Parent’s Knowledge there is no basis TorreyPines all information in its possession or control relating to expect that it will be required to conduct or addressthe Axonyx Product Candidates and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the Axonyx Product Candidates, including without limitation, product recalls or complete and correct copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, 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, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its Subsidiaries, Axonyx or in which Parent Axonyx or any of its Subsidiaries or their respective current products or product candidates candidates, including the Axonyx 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 38 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 Axonyx has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiringrequiring the termination, or, to Parent’s Knowledge, threatening to initiate, the termination suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Axonyx or in which Parent Axonyx or any of its Subsidiaries or their respective current products or product candidates candidates, including the Axonyx 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 Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. Except as disclosed on Schedule 3.9, (a) Parent and each Neither Callisto nor any of its Subsidiaries areis in conflict with, and since January 1or in default or violation of (i) any law, 2020 have beenrule, in compliance in all material respects with all regulation, order, judgment or decree applicable Lawsto Callisto or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, including the FDCAor (ii) any note, the FDA regulations adopted thereunderbond, the Controlled Substances Actmortgage, the Public Health Service Act and any other similar Law administered or promulgated by the FDA indenture, contract, agreement, lease, license, permit, franchise or other Drug Regulatory Agency, 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 any noncompliancethose conflicts, either individually defaults or in the aggregate, violations which would not be material reasonably expected to Parenthave a Callisto Material Adverse Effect. No investigationExcept as disclosed on Schedule 3.9 to the knowledge of Callisto, claim, suit, proceeding, audit no investigation or other action review by any Governmental Body Entity is pending or, to Parent’s Knowledge, or threatened against Parent Callisto or any of its Subsidiaries, nor has any Governmental Entity indicated 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 Parent Callisto or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Callisto or any of its Subsidiaries, any acquisition of material property by Parent Callisto or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries Callisto as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Callisto and its Subsidiaries hold all required permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material necessary to the operation conduct of the business of Parent 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 (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) terms 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 anyCallisto Permits. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries areAlcobra is, and since January 1, 2020 have been2014, each of Alcobra and its Subsidiaries has been in material compliance in all material respects with all applicable Laws, 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, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parentconstitute and Alcobra Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Alcobra, threatened against Parent Alcobra or any of its SubsidiariesAlcobra Subsidiary. There is no agreementContract, judgment, injunction, order or decree binding upon Parent Alcobra or any of its Subsidiaries Alcobra Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Alcobra or any of its SubsidiariesAlcobra Subsidiary, any acquisition of material property by Parent Alcobra or any of its Subsidiaries Alcobra Subsidiary or the conduct of business by Parent Alcobra or any of its Subsidiaries Alcobra Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentAlcobra’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Parent Alcobra and its the Alcobra Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries Alcobra (collectively, the “Alcobra Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b3.12(b) of the Parent Alcobra Disclosure Schedule identifies each Parent Alcobra Permit. Parent and its Subsidiaries hold all rightAs of the date of this Agreement, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries are Alcobra is in material compliance with the terms of the Parent Alcobra Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Alcobra, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Alcobra Permit. The rights and benefits of each Parent material Alcobra Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent Alcobra and its the Alcobra Subsidiaries as of the date of this Agreement and immediately prior to the Effective TimeTime except where the unavailability of such Alcobra Permit would not constitute an Alcobra Material Adverse Effect. (c) There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Alcobra, threatened with respect to an alleged material violation by Parent Alcobra or any of its Subsidiaries Alcobra Subsidiary of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by any the FDA or other Drug Regulatory Agency. (d) Parent is not To the Knowledge of Alcobra, Alcobra and each of its Subsidiaries hold all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Alcobra or such Subsidiary as currently conducting or addressingconducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “Alcobra Product Candidates”). Alcobra holds all required Governmental Authorizations issuable by any Governmental Body necessary for the conduct of its business as currently conducted (the “Alcobra Regulatory Permits”) and no such Alcobra Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. Alcobra has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any Alcobra Regulatory Permit. Alcobra has made available to Parent’s Knowledge Arcturus all information in its possession or control relating to the development, clinical testing, manufacturing, importation and exportation of the Alcobra Product Candidates, including complete copies of the following (to the extent there is no basis are any): adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to expect that it will be required to conduct or address, and from any corrective actions, including, without limitation, product recalls or clinical holdsDrug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency. (e) All To the Knowledge of Alcobra, all clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Alcobra or any of its Subsidiaries, Alcobra Subsidiary or in which Parent Alcobra or any of its Subsidiaries or their respective current products or product candidates services have participatedparticipated were, were and, and if still pendingpending are being, 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, 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 Since January 1, 20202012, neither Parent Alcobra nor any of its Subsidiaries Alcobra Subsidiary has received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Alcobra 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 Alcobra or in which Parent Alcobra or any of its Subsidiaries or their respective current products or product candidates Alcobra 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 Parent nor any of its Subsidiaries Alcobra is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Alcobra, 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 Parent’s Knowledgethe Knowledge of Alcobra, neither Parent nor any of its Subsidiaries Alcobra has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products Alcobra 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 Alcobra, nor to the Knowledge of ParentAlcobra, any of its Subsidiaries nor 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable LawLegal Requirement. No To the Knowledge of Alcobra, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, any of Alcobra or its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries are, and Celladon since January 1, 2020 have been, in compliance 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 all applicable Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Celladon, threatened against Parent Celladon, nor has any Governmental Body or any of its Subsidiariesauthority indicated to Celladon an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Celladon which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesCelladon, any acquisition of material property by Parent or any of its Subsidiaries Celladon or the conduct of business by Parent or any of its Subsidiaries Celladon as currently conducted and planned to be conducted, (ii) is reasonably likely to may have an adverse effect on ParentCelladon’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Parent and its Subsidiaries hold Celladon holds all required Governmental Authorizations which are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “Celladon Permits”) as currently conducted (the “Parent Permits”)and planned to be conducted. Section 3.14(bPart 3.9(b) of the Parent Celladon Disclosure Schedule identifies each Parent Celladon Permit. Parent and its Subsidiaries 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 Celladon is in material compliance with the terms of the Parent Celladon Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Celladon, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Celladon Permit. The rights and benefits of each Parent material Celladon Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Celladon, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Celladon of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by any a Drug Regulatory Agency. (d) Parent is Celladon holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of its business as currently conducted, and, as applicable, development, clinical testing and manufacturing as currently conducted of any of its product candidates (the “Celladon Product Candidates”) (the “Celladon Regulatory Permits”) and no such Celladon Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Celladon has not currently conducting received any written notice or addressingother written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Celladon Regulatory Permit. Except for the information and files identified in Part 3.9(d) of the Celladon Disclosure Schedule, Celladon has made available to Parent’s Knowledge Eiger all information in its possession or control relating to the Celladon Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Celladon Product Candidates, including complete copies of the following (to the extent there is no basis 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 expect that it will be required to conduct or addressand 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 corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its Subsidiaries, Celladon or in which Parent Celladon or any of its Subsidiaries or their respective current products or 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, 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 Parent nor any of its Subsidiaries Celladon is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Celladon, 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 Parent’s Knowledgethe Knowledge of Celladon, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parent, Celladon or any of its 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 LawLegal Requirement. No To the Knowledge of Celladon, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Celladon or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent TorreyPines and each of its Subsidiaries TorreyPines Subsidiary are, and since January 1, 2020 2003 have been, in compliance in all material respects with all applicable Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of TorreyPines, threatened against Parent TorreyPines or any of its SubsidiariesTorreyPines Subsidiary, nor has any Governmental Body or authority indicated to TorreyPines an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent TorreyPines or any of its Subsidiaries TorreyPines Subsidiary which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent TorreyPines or any of its SubsidiariesTorreyPines Subsidiary, any acquisition of material property by Parent TorreyPines or any of its Subsidiaries TorreyPines Subsidiary or the conduct of business by Parent TorreyPines or any of its Subsidiaries TorreyPines Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on Parent’s TorreyPines’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Parent TorreyPines and its the TorreyPines Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted TorreyPines (collectively, the “Parent TorreyPines Permits”). Section 3.14(bPart 2.11(b) of the Parent TorreyPines Disclosure Schedule identifies each Parent TorreyPines Permit. Parent and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear Each of any Encumbrance. Parent TorreyPines and each of its Subsidiaries are TorreyPines Subsidiary is in material compliance with the terms of the Parent TorreyPines Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of TorreyPines, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent TorreyPines Permit. The rights and benefits of each Parent material TorreyPines Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent TorreyPines or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or Legal Requirements promulgated by any 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) Parent TorreyPines holds all Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of TorreyPines as currently conducted and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including NXX-000, XXX-000, XXX-000 and NGX-292 (the “TorreyPines Product Candidates”) (the “TorreyPines Regulatory Permits”) and no such TorreyPines Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. TorreyPines is in compliance in all material respects with the TorreyPines Regulatory Permits and has not currently conducting received any written notice or addressingother 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 TorreyPines Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the TorreyPines Disclosure Schedule, TorreyPines has made available to Parent’s Knowledge there is no basis Axonyx all information in its possession or control relating to expect that it will be required to conduct or addressthe TorreyPines Product Candidates and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the TorreyPines Product Candidates, including without limitation, product recalls or complete and correct copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, 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, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its Subsidiaries, TorreyPines or in which Parent TorreyPines or any of its Subsidiaries or their respective current products or product candidates candidates, including the TorreyPines 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 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 TorreyPines has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiringrequiring the termination, or, to Parent’s Knowledge, threatening to initiate, the termination suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries TorreyPines or in which Parent TorreyPines or any of its Subsidiaries or their respective current products or product candidates candidates, including the TorreyPines 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 Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Merger Partner and each of its Subsidiaries Merger Partner Subsidiary are, and since January 1, 2020 2005 have been, in compliance in all material respects with all applicable Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Merger Partner, threatened against Parent Merger Partner or any of its SubsidiariesMerger Partner Subsidiary, nor has any Governmental Body or authority indicated to Merger Partner an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Merger Partner or any of its Subsidiaries Merger Partner Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Merger Partner or any of its SubsidiariesMerger Partner Subsidiary, any acquisition of material property by Parent Merger Partner or any of its Subsidiaries Merger Partner Subsidiary or the conduct of business by Parent Merger Partner or any of its Subsidiaries Merger Partner Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on ParentMerger Partner’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Parent Merger Partner and its the Merger Partner Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries Merger Partner (collectively, the “Merger Partner Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(bPart 2.11(b) of the Parent Merger Partner Disclosure Schedule identifies each Parent Merger Partner Permit. Parent and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear Each of any Encumbrance. Parent Merger Partner and each of its Subsidiaries are Merger Partner Subsidiary is in material compliance with the terms of the Parent Merger Partner Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Merger Partner, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Merger Partner Permit. The rights and benefits of each Parent material Merger Partner Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent Merger Partner or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or Legal Requirements promulgated by any 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) Parent is not Merger Partner holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Merger Partner as currently conducting or addressingconducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including Intermezzo and TO-2060 (the “Merger Partner Product Candidates”) (the “Merger Partner Regulatory Permits”) and no such Merger Partner Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. 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 Parentcomply 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 Merger Partner Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Merger Partner Disclosure Schedule, Merger Partner has made available to Pivot all information requested by Pivot in Merger Partner’s Knowledge there is no basis possession or control relating to expect that it will be required to conduct or addressthe Merger Partner Product Candidates and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the Merger Partner Product Candidates, including without limitation, product recalls or complete copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy 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, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its Subsidiaries, Merger Partner or in which Parent Merger Partner or any of its Subsidiaries or their respective current products or product candidates candidates, including the Merger Partner 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 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 Since January 1, 20202005, neither Parent nor any of its Subsidiaries Merger Partner has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledgethe Knowledge of Merger Partner, 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 Merger Partner or in which Parent Merger Partner or any of its Subsidiaries or their respective current products or product candidates candidates, including the Merger Partner 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 Parent Merger Partner nor any of its the Merger Partner Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Merger 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 Parent’s Knowledgethe Knowledge of Merger Partner or any of the Merger Partner Subsidiaries, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parent, Neither Merger Partner nor any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable LawLegal Requirement. No To the Knowledge of Merger Partner, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Merger Partner or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Celldex and each its subsidiaries are not in conflict with, or in default or violation of (i) any law, rule, regulation, order, 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 are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act and subsidiaries is a party or by which Celldex or any other similar Law administered of its subsidiaries or promulgated by the FDA their properties are bound or other Drug Regulatory Agencyaffected, except for any noncomplianceconflicts, either defaults or violations which, individually or in the aggregate, which would not reasonably be material expected to Parenthave 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 Parent’s Knowledgethe knowledge of Celldex and its subsidiaries, threatened against Parent Celldex or its subsidiaries, nor has any of governmental or regulatory body or authority indicated to Celldex or its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected subsidiaries an intention to have conduct the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionssame. (b) Parent Celldex and its Subsidiaries subsidiaries hold all required Governmental Authorizations permits, licenses, variances, exemptions, orders and approvals from governmental authorities which are material to the operation of the business of Parent Celldex and its Subsidiaries as currently conducted subsidiaries (collectively, the “Parent Celldex Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent Celldex and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries subsidiaries are in material compliance with the terms of the Parent Celldex Permits, except where the failure to so comply would not reasonably be expected to have a Celldex Material Adverse Effect. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe knowledge of Celldex and its subsidiaries, threatened, which seeks to revokerevoke or limit any Celldex Permit. A true, limit, suspend, or materially modify any Parent 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 Parent material Celldex Permit will be available to Parent and the Surviving Corporation or its Subsidiaries subsidiaries immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries the jurisdiction of the FDCAFood and Drug Administration (“FDA”) are being manufactured, FDA regulations adopted thereunderlabeled, the Controlled Substances Actstored, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) Parent is not currently conducting or addressingtested, distributed, 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and marketed in compliance in all material respects with all applicable requirements under the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), their applicable implementing regulations, and all comparable federal and state laws and regulations including, but 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) All clinical trials conducted by or on behalf of Celldex or its subsidiaries are being conducted in material compliance with the applicable regulations requirements of any Good Clinical Practice, Informed Consent, and all applicable Drug Regulatory Agency and other applicable Law, including requirements relating to protection of human subjects contained in 21 C.F.R. CFR Parts 50, 54, and 56. (e) All manufacturing operations for Celldex Products conducted by or for the benefit of Celldex or its subsidiaries are being conducted in accordance, 58 in all material respects, with the FDA’s current Good Manufacturing Practices for drug and 312biological products. Except as In addition, Celldex and its subsidiaries are in material compliance with all applicable registration and listing requirements set forth in 21 U.S.C. 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 360 and complete copies of 21 CFR Part 207 and all material notices, correspondence or other communications received by Parent from any Drug Regulatory Agency, if anysimilar applicable laws and regulations. (f) Neither Parent 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 pending orCelldex 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 development or manufacture of any Celldex Product, except for such terminations, suspensions or restrictions which, individually or in the aggregate, would not reasonably be expected to have a Celldex Material Adverse Effect. (g) Neither Celldex or its subsidiaries nor, to Parent’s Knowledgethe knowledge of Celldex or its subsidiaries, threatened investigation in respect any of their officers, key employees (as set forth on Section 2.17(a) of the Celldex Disclosure Schedule), agents or clinical investigators acting for Celldex or its business subsidiaries, has committed any act, made any statement or products by 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 Parent’s Knowledgethe knowledge of Celldex, 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 Xxxxx 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 Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parentsubsidiaries, any officer, key employee or agent of Celldex or its Subsidiaries nor 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 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 LawGood 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. No debarment Celldex and its subsidiaries have made available to AVANT for review all correspondence to or exclusionary claimsfrom the FDA, actionsFDCA and PHSA, proceedings including minutes of meetings, written reports of phone conversations, visits or investigations other contact with the FDA, FDCA or PHSA, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or 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 oron the likelihood of timing of approval of any Celldex Products, to Parent’s Knowledgeincluding, threatened against Parentbut 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 written communication received from the FDA and comparable foreign governmental entities in the last three years. Neither Celldex nor any agent or representative of its Subsidiaries 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) Parent and each of its Subsidiaries areTapImmune is, and since January 1, 2020 have been2015, each of TapImmune and its Subsidiaries has been in compliance in all material respects with all applicable Laws, 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, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parentconstitute a TapImmune Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of TapImmune, threatened against Parent TapImmune or any of its SubsidiariesTapImmune Subsidiary. There is no agreementContract, judgment, injunction, order or decree binding upon Parent TapImmune or any of its Subsidiaries TapImmune Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent TapImmune or any of its SubsidiariesTapImmune Subsidiary, any acquisition of material property by Parent TapImmune or any of its Subsidiaries TapImmune Subsidiary or the conduct of business by Parent TapImmune or any of its Subsidiaries TapImmune Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on ParentTapImmune’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Parent TapImmune and its the TapImmune Subsidiaries hold all required Governmental Authorizations which that are material to the operation of its business (collectively, the business of Parent and its Subsidiaries “TapImmune Permits”) as currently conducted (the “Parent Permits”)conducted. Section 3.14(b3.12(b) of the Parent TapImmune Disclosure Schedule identifies each Parent TapImmune Permit. Parent and its Subsidiaries hold all rightAs of the date of this Agreement, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its TapImmune and the TapImmune Subsidiaries are in material compliance with the terms of the Parent TapImmune Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of TapImmune, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent TapImmune Permit. The rights and benefits of each Parent material TapImmune Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of TapImmune, threatened with respect to an alleged material violation by Parent TapImmune or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by any the FDA or other Drug Regulatory Agency. (d) Parent is not TapImmune and each of its Subsidiaries hold all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of TapImmune or such Subsidiary as currently conducting or addressingconducted, and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates (the “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 “TapImmune Regulatory Permits”) and no such TapImmune Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any materially adverse manner. TapImmune has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any TapImmune Regulatory Permit. TapImmune has made available to Parent’s Marker all information in its possession or control relating the development, clinical testing, manufacturing, importation and exportation of the TapImmune Product Candidates, including 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; 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 notices, letters, filings, correspondence and meeting minutes with any other Governmental Body. 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 is are no basis facts that would be reasonably likely to expect that it will be required to conduct result in any warning, untitled or address, any corrective actions, including, without limitation, product recalls notice of violation letter or clinical holdsForm FDA-483 from the FDA. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent TapImmune or any of its Subsidiaries, the TapImmune Subsidiaries or in which Parent TapImmune or any of its Subsidiaries or their respective current products or product candidates services 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) No preclinical or clinical trial conducted by or on behalf of the Parent Disclosure Schedule, since TapImmune has been terminated or suspended prior to completion for safety or non-compliance reasons. Since January 1, 20202015, neither Parent TapImmune nor any of its the TapImmune Subsidiaries has received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of TapImmune 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 TapImmune or in which Parent or any of its Subsidiaries or their respective current products or product candidates TapImmune Product Candidates, have participated. Parent has made available to To the Company true extent required, all clinical trials conducted by or on behalf of TapImmune have been registered on, and complete copies trial results have been reported on, the United States National Institutes of all material noticesHealth Website, correspondence or other communications received by Parent from wxx.xxxxxxxxxxxxxx.xxx, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any Drug Regulatory Agency, if anyapplicable additional state and local law requirements. (f) Neither Parent 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 orpending, or to Parent’s Knowledgethe Knowledge of TapImmune, 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 Parent’s Knowledgethe Knowledge of TapImmune, neither Parent 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 ParentTapImmune, any of its Subsidiaries nor 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agentsLegal Requirement.

Compliance; Permits; Restrictions. (a) Parent Advaxis and each of its Subsidiaries are, and since January November 1, 2020 2015 have been, in compliance in all material respects with all applicable LawsLegal Requirements, including (i) the Federal Food, Drug and Cosmetic Act (“FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, ”); (ii) the Public Health Service Act (“PHSA”); (iii) all federal or state criminal or civil fraud and abuse Legal Requirements; (iv) any other similar Law administered comparable state or promulgated by local Legal Requirements; and (v) any applicable state licensing, disclosure and reporting requirements (all of the FDA or other Drug Regulatory Agencyforegoing, except for any noncompliancecollectively, either individually or in the aggregate, which would not be material to Parent“Healthcare Laws”). No investigation, claim, suit, proceeding, audit or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Advaxis, threatened against Parent Advaxis or any of its Subsidiaries, nor has any Governmental Authority indicated to Advaxis in writing an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Advaxis or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Advaxis or any of its Subsidiaries, any acquisition of material property by Parent Advaxis or any of its Subsidiaries or the conduct of business by Parent Advaxis or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to may have an adverse effect on Parent’s Advaxis’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Merger or any of the Transactions. (b) Parent Advaxis and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Advaxis (the “Parent Advaxis Permits”)) as currently conducted. Section 3.14(bPart 2.11(b) of the Parent Advaxis Disclosure Schedule identifies each Parent Advaxis Permit, including the holder of the Advaxis Permit, the name of the Advaxis Permit, and the date of expiration. Parent Each of Advaxis and its Subsidiaries 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 is in material compliance with the terms of the Parent 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 Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Advaxis, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Parent Advaxis Permit. The rights and benefits of each Parent material Advaxis Permit will be available to Parent and its Subsidiaries the Surviving Company immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Advaxis, threatened with respect to an alleged material violation by Parent Advaxis or any of its Subsidiaries of the FDCA, FDA PHSA, Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or Legal Requirements promulgated by any 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) Parent is not Advaxis and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Advaxis or such Subsidiary as currently conducting or addressingconducted, 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. (e) All clinical, pre-clinical and other studies and tests conducted by orand, to Parent’s Knowledgethe extent applicable, on behalf ofdevelopment, clinical testing, manufacturing, marketing, distribution and importation or sponsored byexportation, Parent or as currently conducted, of any of its Subsidiaries, or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated(the “Advaxis Product Candidates”) (collectively, were andthe “Advaxis Regulatory Permits”), if still pendingand no such Advaxis Regulatory Permit has been (i) revoked, are being conducted withdrawn, suspended, cancelled or terminated or (ii) modified in all material respects in accordance with standard medical any adverse manner, other than immaterial adverse modifications. Advaxis and scientific research procedures and each of its Subsidiaries is in compliance in all material respects with the applicable regulations of any applicable Drug Advaxis Regulatory Agency Permits and other applicable Law, 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 not received any notices, correspondence, written notice or other communications written communication from any Drug Regulatory Agency requiringregarding (A) any material violation of or failure to comply materially with any term or requirement of any Advaxis Regulatory Permit or (B) any revocation, orwithdrawal, suspension, cancellation, termination or material modification of any Advaxis Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Advaxis Disclosure Schedule, Advaxis has made available to Biosight all information requested by Biosight in Advaxis’ or its Subsidiaries’ possession or control relating to the Advaxis Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Advaxis Product Candidates, including complete copies of the following (to the extent there are any) (x) adverse event reports; clinical study reports and material study data; 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 material 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 Parent’s Knowledgethe 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 to initiatethe termination, the termination suspension, delay, restriction, rejection, or suspension material modification of any ongoing, completed, or planned clinical studies or pre-clinical 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, Parent otherwise call into question the results of the material preclinical and clinical investigations. Advaxis does not have any Knowledge of any material facts 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 circumstances related to the Company true safety or efficacy of the Advaxis Product Candidates that would materially and complete copies of all material notices, correspondence adversely affect its ability to receive or other communications received by Parent from any Drug Regulatory Agency, if anymaintain a Governmental Authorization. (f) Neither Parent nor any 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 pending orwritten 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 Advaxis, any of its Subsidiaries, nor, to Parent’s Knowledgethe Knowledge of Advaxis, any Person providing services on their behalf, is the subject of any pending, or to the Knowledge of Advaxis, 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 Parent’s Knowledgethe Knowledge of Advaxis, neither Parent 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 ParentAdvaxis, any of its Subsidiaries nor Subsidiaries, 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 debarment debarment, disqualification, or exclusion (i) under 21 U.S.C. Section 335a Sxxxxxx 000x, (xx) xxxxx 00 X.X.X. §0000x-0, (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 LawLegal Requirement. No debarment To the Knowledge of Advaxis, no debarment, ineligibility, or exclusionary claims, actions, proceedings or investigations in respect of their business or products the Advaxis Product Candidates are pending or, to Parent’s Knowledge, or threatened against ParentAdvaxis, any of its Subsidiaries or 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) Parent Biosight and each of its Subsidiaries are, and since January November 1, 2020 2015 have been, in compliance in all material respects with all applicable LawsLegal Requirements, 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 Parentall Healthcare Laws. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Biosight, threatened against Parent Biosight or any of its Subsidiaries, nor has any Governmental Authority indicated to Biosight in writing an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Biosight or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Biosight or any of its Subsidiaries, any acquisition of material property by Parent Biosight or any of its Subsidiaries or the conduct of business by Parent Biosight or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to may have an adverse effect on ParentBiosight’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Merger or any of the Transactions. (b) Parent Biosight and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Biosight (the “Parent Biosight Permits”)) as currently conducted. Section 3.14(bPart 3.11(b) of the Parent Biosight Disclosure Schedule identifies each Parent Biosight Permit, including the holder of the Biosight Permit, the name of the Biosight Permit, and the date of expiration. Parent Each of Biosight and its Subsidiaries 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 is in material compliance with the terms of the Parent 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 Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Biosight, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Parent Biosight Permit. The rights and benefits of each Parent material Biosight Permit will be available to Parent and its Subsidiaries the Surviving Company immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Biosight, threatened with respect to an alleged material violation by Parent Biosight or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by 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) Parent is not Biosight and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Biosight or such Subsidiary as currently conducting or addressingconducted, 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. (e) All clinical, pre-clinical and other studies and tests conducted by orand, to Parent’s Knowledgethe extent applicable, on behalf ofdevelopment, clinical testing, manufacturing, marketing, distribution and importation or sponsored byexportation, Parent or as currently conducted, of any of its Subsidiaries, or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated(the “Biosight Product Candidates”) (collectively, were andthe “Biosight Regulatory Permits”), if still pendingand no such Biosight Regulatory Permit has been (i) revoked, are being conducted withdrawn, suspended, cancelled or terminated or (ii) modified in all material respects in accordance with standard medical any adverse manner, other than immaterial adverse modifications. Biosight and scientific research procedures and each of its Subsidiaries is in compliance in all material respects with the applicable regulations of any applicable Drug Biosight Regulatory Agency Permits and other applicable Law, 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 not received any notices, correspondence, written notice or other communications written communication from any Drug Regulatory Agency requiringregarding (A) any material violation of or failure to comply materially with any term or requirement of any Biosight Regulatory Permit or (B) any revocation, orwithdrawal, suspension, cancellation, termination or material modification of any Biosight Regulatory Permit. Except for the information and files identified in Part 3.11(d) of the Biosight Disclosure Schedule, Biosight has made available to Advaxis all information requested by Biosight in Biosight’s or its Subsidiaries’ possession or control relating to the Biosight Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Biosight Product Candidates, including complete copies of the following (to the extent there are any) (x) adverse event reports; clinical study reports and material study data; 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 material 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 Parent’s Knowledgethe 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 to initiatethe termination, the termination suspension, delay, restriction, rejection, or suspension material modification of any ongoing, completed, or planned clinical studies or pre-clinical 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, Parent otherwise call into question the results of the material preclinical and clinical investigations. Biosight does not have any Knowledge of any material facts 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 circumstances related to the Company true safety or efficacy of the Biosight Product Candidates that would materially and complete copies of all material notices, correspondence adversely affect its ability to receive or other communications received by Parent from any Drug Regulatory Agency, if anymaintain a Governmental Authorization. (f) Neither Parent nor any 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 pending orwritten 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 Biosight, any of its Subsidiaries, nor, to Parent’s Knowledgethe Knowledge of Biosight, any Person providing services on their behalf, is the subject of any pending, or to the Knowledge of Biosight, 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 Parent’s Knowledgethe Knowledge of Biosight, neither Parent 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 ParentBiosight, any of its Subsidiaries nor Subsidiaries, 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 debarment debarment, disqualification, or exclusion (i) under 21 U.S.C. Section 335a Sxxxxxx 000x, (xx) xxxxx 00 X.X.X. §0000x-0, (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 LawLegal Requirement. No debarment To the Knowledge of Biosight, no debarment, ineligibility, or exclusionary claims, actions, proceedings or investigations in respect of their business or products the Biosight Product Candidates are pending or, to Parent’s Knowledge, or threatened against ParentBiosight, any of its Subsidiaries or 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) Parent and each of its Subsidiaries are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act 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 is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by Parent 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 Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, 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 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 Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its Subsidiaries nor 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To Parent’s Knowledge, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each Except as disclosed on Schedule 2.9 neither Synergy nor any of its Subsidiaries areis in conflict with, and since January 1or in default or violation of (i) any law, 2020 have beenrule, in compliance in all material respects with all regulation, order, judgment or decree applicable Lawsto Synergy or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, including the FDCAor (ii) any note, the FDA regulations adopted thereunderbond, the Controlled Substances Actmortgage, the Public Health Service Act and any other similar Law administered or promulgated by the FDA indenture, contract, agreement, lease, license, permit, franchise or other Drug Regulatory Agency, 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 any noncompliancethose conflicts, either individually defaults or in the aggregate, violations which would not be material reasonably expected to Parenthave a Synergy Material Adverse Effect. No investigationExcept as disclosed on Schedule 2.9 to the knowledge of Synergy, claim, suit, proceeding, audit no investigation or other action review by any Governmental Body Entity is pending or, to Parent’s Knowledge, or threatened against Parent Synergy or any of its Subsidiaries, nor has any Governmental Entity indicated in writing an intention to conduct the same 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 Parent Synergy or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Synergy or any of its Subsidiaries, any acquisition of material property by Parent Synergy or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries Synergy as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Synergy and its Subsidiaries hold all required permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material would necessary to the operation conduct of the business of Parent 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 (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) terms 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 anySynergy Permits. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Zordich and each of its Subsidiaries areis, and since January 1, 2020 have has been, in material compliance in all material respects with all applicable Laws, 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 audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Zordich, threatened against Parent Zordich or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent Zordich or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Zordich or any of its Subsidiaries, any acquisition of material property by Parent Zordich or any of its Subsidiaries or the conduct of business by Parent Zordich or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on ParentZordich’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Each of Zordich and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent Zordich and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Zordich Permits”). Section 3.14(b4.14(b) of the Parent Zordich Disclosure Schedule identifies each Parent Zordich Permit. Parent Each of Zordich and its Subsidiaries 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 is in material compliance with the terms of the Parent Zordich Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Zordich, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent Zordich Permit. The rights and benefits of each Parent Zordich Permit will be available to Parent Zordich and its Subsidiaries Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Zordich, threatened with respect to an alleged material violation by Parent Zordich or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent Each of Zordich and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Zordich and Merger Sub as currently conducted, and, as applicable, the development, 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 “Zordich Product Candidates”) (the “Zordich Regulatory Permits”) and no such Zordich Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Zordich has timely maintained and is not currently conducting 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 addressingother 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 Zordich Regulatory Permit. Except for the information and files identified in Section 4.14(d) of the Zordich Disclosure Schedule, Zordich has made available to Parentthe Company all information requested by the Company in Zordich’s Knowledge there is no basis or its Subsidiaries’ possession or control relating to expect that it will be required to conduct the Zordich Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or address, any corrective actionsexportation of the Zordich Product Candidates, including, without limitationbut not limited to, product recalls or complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical holdsand other study reports and material study data; 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 are accurate and complete in all material respects. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Zordich or any of its Subsidiaries, or in which Parent Zordich or any of its Subsidiaries or their respective current products or product candidates candidates, including the Zordich 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 any applicable the Drug Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except Other than as set forth in on Section 3.14(e4.14(e) of the Parent Zordich Disclosure Schedule, since January 1, 2020, neither Parent Zordich nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledgethe Knowledge of Zordich, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent Zordich or any of its Subsidiaries or in which Parent Zordich or any of its Subsidiaries or their respective its current products or product candidates candidates, including the Zordich Product Candidates, have participated. Parent has made available Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Company true 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 complete copies to the Knowledge of all material noticesZordich, correspondence no such administrative action to disqualify such clinical investigators, researchers or other communications received by Parent from any Drug Regulatory Agency, if anyclinical staff has been threatened or is pending. (f) Neither Parent 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 pending or, to Parent’s Knowledgethe Knowledge of Zordich, 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 Parent’s Knowledgethe Knowledge of Zordich, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of ParentZordich, any of its Subsidiaries nor 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 Law. No To the Knowledge of Zordich, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against ParentZordich, any of its Subsidiaries 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) Parent and each of its Subsidiaries areCarnivale is, and since January 1, 2020 have been, 2012 has been in compliance in all material respects with all applicable Laws, 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 Parentresult 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 Parent’s Knowledgethe Knowledge of Carnivale, threatened against Parent or any of its SubsidiariesCarnivale. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Carnivale which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesCarnivale, any acquisition of material property by Parent or any of its Subsidiaries Carnivale or the conduct of business by Parent or any of its Subsidiaries Carnivale as currently conducted, (ii) is reasonably likely to have an adverse effect on ParentCarnivale’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, delaying or making illegal the Transaction or otherwise interfering with any of the Contemplated Transactions. (b) Parent and its Subsidiaries hold Carnivale holds all required Governmental Authorizations which are material to for the operation of its businesses (collectively, the business of Parent and its Subsidiaries “Carnivale Permits”) as currently conducted (conducted, except for any failure to hold any such Governmental Authorizations, either individually or in the “Parent Permits”)aggregate, which would not result in a Carnivale Material Adverse Effect. Section Part 3.14(b) of the Parent Carnivale Disclosure Schedule identifies each Parent Carnivale Permit. Parent and its Subsidiaries 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 Carnivale is in material compliance with the terms of the Parent Carnivale Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Carnivale, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Carnivale Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledgethe Knowledge of Carnivale, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Carnivale of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or Laws promulgated by any a Drug Regulatory Agency. (d) Parent is Carnivale holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of 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 “Carnivale Product Candidates”) (the “Carnivale Regulatory Permits”) and no such Carnivale Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. Carnivale has not currently conducting received any written notice or addressingother written communication from any Drug Regulatory Agency regarding any revocation, withdrawal, suspension, cancellation, termination or material modification of any Carnivale Regulatory Permit. Except for the information and files identified in Part 3.14(d) of the Carnivale Disclosure Schedule, Carnivale has made available to Parentthe Company all information requested by the Company in Carnivale’s Knowledge possession or control relating to the Carnivale Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Carnivale Product Candidates, including complete copies of the following (to the extent there is no basis 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 expect that it will be required to conduct or addressand 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 corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its Subsidiaries, Carnivale or in which Parent Carnivale or any of its Subsidiaries or their respective current products or product candidates 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLaws, 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 Parent nor any of its Subsidiaries Carnivale is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Carnivale, 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 Parent’s Knowledgethe Knowledge of Carnivale, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parent, Carnivale or any of its 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 Law. No To the Knowledge of Carnivale, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Carnivale or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws, 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 Except for any noncomplianceconflicts, either individually defaults or in the aggregate, violations which would not reasonably be material expected to Parenthave a Material Adverse Effect on Raven, neither Raven nor any of its subsidiaries is in conflict with, or in default or violation of (i) any law, rule, regulation, order, judgment or decree applicable to Raven 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 Parent’s Knowledgethe knowledge of Raven, threatened against Parent Raven or its subsidiaries, nor, to Raven's knowledge, has any of its Subsidiaries. There is no agreement, judgment, injunction, order governmental or decree binding upon Parent regulatory body or any of its Subsidiaries which (i) has or would reasonably be expected authority indicated an intention to have conduct the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionssame. (b) Parent 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 subsidiaries hold all required Governmental Authorizations permits, licenses, variances, exemptions, orders and approvals from governmental authorities which are material necessary to the operation of the business of Parent Raven and its Subsidiaries subsidiaries taken as currently conducted a whole (collectively, the “Parent "Raven Permits”"). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent Raven and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear of any Encumbrance. Parent and each of its Subsidiaries subsidiaries are in material compliance with the terms of the Parent Raven Permits, except where the failure to so comply would not have a Material Adverse Effect on Raven. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe knowledge of Raven, threatened, which seeks to revoke, limit, suspend, revoke or materially modify limit any Parent Raven Permit. The rights A true, complete and benefits correct list of each Parent Permit will the Raven Permits is set forth in Section 2.10(b) of the Raven Disclosure Schedule, which further sets forth all material consents required to be obtained in order for such Raven Permits to continue in place or to be available to Parent and its Subsidiaries the Surviving Entity immediately after following the Effective Time on terms substantially similar to those enjoyed by Parent 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries the 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 thereunder, the Controlled Substances Act"), the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory AgencyAct, their applicable implementing regulations, and all comparable state laws and regulations, except as would not reasonably be expected to have a Material Adverse Effect on Raven. (d) Parent is not currently conducting All clinical trials conducted by or addressingon behalf of Raven have been, and are being conducted in compliance with the applicable requirements of Good Clinical Practice, Informed Consent, and all applicable requirements relating to Parent’s Knowledge there is no basis protection of human subjects contained in 21 CFR Parts 50, 54, and 56, except as would not reasonably be expected to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdshave a Material Adverse Effect on Raven. (e) All clinical, pre-clinical and other studies and tests manufacturing operations for drug products conducted by or, to Parent’s Knowledge, on behalf of, or sponsored by, Parent or any for the benefit of its Subsidiaries, or in which Parent or any of its Subsidiaries or their respective current products or product candidates Raven have participated, were and, if still pending, 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 in with all material respects with the applicable regulations of any applicable Drug Regulatory Agency registration and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as listing requirements set forth in 21 U.S.C. Section 3.14(e) of the Parent Disclosure Schedule360 and 21 CFR Part 207 and all similar applicable laws and regulations, 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, except as would not reasonably be expected to Parent’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or have a Material Adverse Effect 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 anyRaven. (f) Neither Parent 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 pending orRaven 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 manufacture of any Raven Pharmaceutical Product. (g) Neither Raven nor, to Parent’s Knowledgethe knowledge of Raven, threatened investigation in respect 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 Parent’s KnowledgeAdditionally, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of ParentRaven, any officer, key employee or agent of its Subsidiaries nor 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 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 LawGood 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. No debarment Raven has made available to Parent for review all correspondence to or exclusionary claimsfrom the FDA, actionsminutes of meetings, written reports of phone conversations, visits or other contact with the FDA, notices 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 orthe FDCA, to Parent’s KnowledgeFDA regulations adopted thereunder, threatened against Parent, any of its Subsidiaries 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) Parent and each of its Subsidiaries areExcept where failure would not result in a PubCo Material Adverse Effect, PubCo is, and since January 1, 2020 have been2020, has been in material compliance in all material respects with all applicable Laws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, applicable provisions of the Public Health Service Act (“PHSA”), the Controlled Substances Act (“CSA”) (21 U.S.C. § 801 et seq.), and any other similar Law administered or regulations promulgated by to implement the FDA or other Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to Parentforegoing. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened against Parent or any of its SubsidiariesPubCo. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries PubCo which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesPubCo, any acquisition of material property by Parent or any of its Subsidiaries PubCo or the conduct of business by Parent or any of its Subsidiaries PubCo as currently conducted, or (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionsresult in a PubCo Material Adverse Effect. (b) Parent and its Subsidiaries hold 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 the business of Parent PubCo and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent PubCo Permits”). Section 3.14(b, and (ii) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 is in material compliance with the terms of the Parent PubCo Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent PubCo Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledgethe Knowledge of PubCo, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries PubCo of the FDCA, FDA the PHSA, the CSA, the implementing regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any the FDA or other Drug Regulatory AgencyAgency that is material to the conduct of PubCo’s business. (d) Parent Except where failure would not result in a PubCo Material Adverse Effect, each of PubCo holds all required Governmental Authorizations issued or granted by any Drug Regulatory Agency or other Governmental Authority which is necessary for the conduct of the business of PubCo as currently conducted and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “PubCo Product Candidates”) (collectively, the “PubCo Regulatory Permits”) and no such PubCo Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated, or (ii) modified in any adverse manner, other than immaterial modifications. Except where failure would not currently conducting 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 addressingother 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 PubCo Regulatory Permit. PubCo has made available to the Company all information requested by the Company in PubCo’s possession or control relating to the PubCo Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the PubCo Product Candidates, including 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; 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 to Parent’s Knowledge there (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdsaccurate and complete in all material respects. (e) All clinicalclinical trials, pre-clinical studies and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its SubsidiariesPubCo, or in which Parent or any of its Subsidiaries PubCo or their respective current products or product candidates candidates, including the PubCo 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 any applicable the Drug Regulatory Agency Agencies and other applicable Law, 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 PubCo has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of PubCo threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries PubCo or in which Parent PubCo or any of its Subsidiaries or their respective current products or product candidates candidates, including the PubCo Product Candidates, have participated. Parent has made available Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Company true Knowledge of PubCo, on behalf of PubCo has been disqualified from participating in studies involving the PubCo Product Candidates, and complete copies to the Knowledge of all material noticesPubCo, correspondence no such administrative action to disqualify such clinical investigators, researchers or other communications received by Parent from any Drug Regulatory Agency, if anyclinical staff has been threatened or is pending. (f) Neither Parent 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 pending or, to Parent’s Knowledgethe Knowledge of PubCo, 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 Parent’s Knowledgethe Knowledge of PubCo, neither Parent 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 ParentPubCo, and to the Knowledge of PubCo, any of its Subsidiaries nor contract 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 debarment or exclusion under (i) under 21 U.S.C. Section 335a 335a, or (ii) any similar applicable Law. No To the Knowledge of PubCo, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against ParentPubCo, and to the Knowledge of PubCo, any of its Subsidiaries 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) Parent and each of its Subsidiaries areis, and since January 1, 2020 have been2016, has been in compliance in all material respects with all applicable Laws, 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 is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its SubsidiariesParent. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesParent, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Each of Parent and its Subsidiaries hold Merger Sub holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Permits”). Section 3.14(b3.13(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each of Parent and its Subsidiaries 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 Merger Sub is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Each of Parent and Merger Sub holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Parent and 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 “Parent Product Candidates”) (collectively, the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, canceled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Parent is not currently conducting in compliance in all material respects with the Parent Regulatory Permits and neither Parent nor Merger Sub has received any written notice or addressingother 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 Parent Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Parent Regulatory Permit. Except for the information and files identified in Section 3.13(d) of the Parent Disclosure Schedule, Parent has made available to the Company all information requested by the Company in Parent’s Knowledge possession or control relating to the Parent Product Candidates and, as applicable, the development, clinical testing, manufacturing, importation and exportation of the Parent Product Candidates, including complete copies of the following (to the extent there is no basis are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to expect that it will be required to conduct or addressand from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar material reports, material study data, notices, letters, filings, correspondence and meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Body. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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 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 in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except Other than as set forth in on Section 3.14(e3.13(e) of the Parent Disclosure Schedule, since January 1, 20202016, neither Parent nor any of its Subsidiaries Merger Sub has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to the Knowledge of 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 candidates, including the Parent 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 Parent nor any of its Subsidiaries is not the subject of any pending or, to the Knowledge of Parent’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 Parent’s Knowledge, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parent, any Merger Sub, or, to the Knowledge of its Subsidiaries nor 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 Law. No To the Knowledge of Parent, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Parent or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Vibrant and each of its Subsidiaries are, and since January 1, 2020 2021, have been, been in material compliance in all material respects with all applicable Laws, 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 audit, Order, or other Legal Proceeding or action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Vibrant, threatened against Parent Vibrant or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent Vibrant or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesVibrant, any acquisition of material property by Parent Vibrant or any of its Subsidiaries or the conduct of business by Parent Vibrant or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an a material adverse effect on ParentVibrant’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Except for matters regarding the FDA, each of Vibrant and its Subsidiaries hold holds all required Governmental Authorizations which are material to the operation of the business of Parent Vibrant and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Vibrant Permits”). Section 3.14(b4.14(b) of the Parent Vibrant Disclosure Schedule identifies each Parent Vibrant Permit. Parent Each of Vibrant and its Subsidiaries 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 is in material compliance with the terms of the Parent Vibrant Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Vibrant, threatenedthreatened in writing, which seeks to revoke, substantially limit, suspend, or materially modify any Parent Vibrant Permit. The rights and benefits of each Parent Vibrant Permit will be available to Parent Vibrant and its Subsidiaries Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent Vibrant 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 Parent’s Knowledgethe Knowledge of Vibrant, threatened with respect to an actual or alleged material violation by Parent Vibrant or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted promulgated thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar applicable Law administered or promulgated by any Drug a Drug/Device Regulatory Agency. (d) Parent Each of Vibrant and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Vibrant and Merger Sub as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Vibrant Product Candidates”) (the “Vibrant Regulatory Permits”) and no such Vibrant Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Vibrant has timely maintained and is not currently conducting in compliance in all material respects with the Vibrant Regulatory Permits and neither Vibrant nor or addressingany of its Subsidiaries has, since January 1, 2021, received any written notice or other communication (in writing or otherwise) from any Drug/Device Regulatory Agency regarding (A) any material violation of or failure to comply materially with any term or requirement of any Vibrant Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Vibrant Regulatory Permit. Except for the information and files identified in Section 4.14(d) of the Vibrant Disclosure Schedule, Vibrant has made available to Parentthe Company all information requested by the Company in Vibrant’s Knowledge there is no basis or its Subsidiaries’ possession or control relating to expect that it will be required to conduct the Vibrant Product Candidates and the development, testing, manufacturing, processing, storage, labeling, distribution and importation or address, any corrective actionsexportation of the Vibrant Product Candidates, including, without limitationbut not limited to, product recalls or complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical holdsand other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device 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 clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Vibrant or any of its Subsidiaries, or in which Parent Vibrant or any of its Subsidiaries or their respective current products or product candidates candidates, including the Vibrant Product Candidates, have participatedparticipated were, were if completed, conducted and wound down, and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures procedures, in compliance with the applicable protocols, and in compliance in all material respects with the applicable regulations of any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 11, 50, 54, 56, 58 and 312, the applicable requirements of good laboratory practices and good clinical practices, including the applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects (including “Informed Consent” as such term or similar term is defined under applicable Law) and applicable Law governing the privacy of patient medical records and other personal information, data and biological specimens, and no such informed consent documents would prevent the transfer of such personal information, data and biological specimens to the Company. Except Other than as set forth in on Section 3.14(e4.14(e) of the Parent Vibrant Disclosure Schedule, since January 1, 2020, neither Parent Vibrant nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Drug/Device Regulatory Agency requiringAgency, Governmental Authority, IRB, ethics committee or safety monitoring committee requiring or, to Parent’s Knowledgethe Knowledge of Vibrant, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent Vibrant or any of its Subsidiaries or in which Parent Vibrant or any of its Subsidiaries or their respective its current products product candidates, including the Vibrant Product Candidates, are participating or have participated (collectively, the “Vibrant Clinical Studies”). For all completed Vibrant Clinical Studies, no study subjects remain on any study drug comprising any product candidates of Vibrant or its Subsidiaries, including the Vibrant Product Candidates, and no study subjects have participatedrequested ongoing administration of any such study drug. Parent Further, no clinical investigator, researcher, or clinical staff participating in any Vibrant Clinical Study has made available been disqualified from participating in studies involving the Vibrant Product Candidates, and to the Company true and complete copies Knowledge of all material noticesVibrant, correspondence no such administrative action to disqualify such clinical investigators, researchers or other communications received by Parent from any Drug Regulatory Agency, if anyclinical staff has been threatened or is pending. (f) Neither Parent Vibrant nor any of its Subsidiaries Subsidiaries, nor, to the Knowledge of Vibrant, any contract manufacturer with respect to any Vibrant Product Candidate is the subject of any pending or, to Parent’s Knowledgethe Knowledge of Vibrant, 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 Parent’s KnowledgeNeither Vibrant, neither Parent nor any of its Subsidiaries Subsidiaries, or, to the Knowledge of Vibrant, any contract manufacturer with respect to any Vibrant 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of ParentVibrant, any of its Subsidiaries nor or any contract manufacturer with respect to any Vibrant Product Candidate, or any of their respective officers, directors, 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 Law, or is or has ever been debarred or excluded. No material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledgethe Knowledge of Vibrant, threatened against ParentVibrant, any of its Subsidiaries or, to the Knowledge of Vibrant, any contract manufacturer with respect to any Vibrant Product Candidate, or any of their respective officers, directors, employees or agents. (g) All manufacturing operations conducted by, or to the Knowledge of Vibrant, for the benefit of, Vibrant or its Subsidiaries in connection with any Vibrant Product Candidate, since January 1, 2021, 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 manufacturing site owned by Vibrant or its Subsidiaries, and to the Knowledge of Vibrant, no manufacturing site of a contract manufacturer, with respect to any Vibrant 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, 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 Vibrant, neither the FDA nor any other Governmental Authority is considering such action. (i) Since January 1, 2021, Vibrant has operated in compliance with all Health Care Laws and has timely filed all material reports, applications, statements, documents, registrations, filings, corrections, updates, amendments, supplements, and submissions required to be filed by them under applicable Health Care Laws. Each such filing was true and correct in all material respects as of the date of submission, or was corrected in or supplemented by a subsequent filing, and any material and legally necessary or required updates, changes, corrections, amendments, supplements, or modifications to such filings have been submitted to the applicable governmental authorities. (j) Except as set forth on Section 4.14(j) of the Vibrant Disclosure Schedule, all payments have been made and there are no remaining payment obligations under any Contract with a Third Party relating to Vibrant Clinical Studies, including any contract research organization or study site. (k) There are no Legal Proceedings pending or, to the Knowledge of Vibrant, threatened with respect to claims arising from (i) any Vibrant Clinical Studies; or (ii) actual or alleged breach by Vibrant or it Subsidiaries of any Contract with a Third Party relating to any Vibrant Clinical Studies.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries areExcept as set forth in Schedule 3.11(a), the Acquiror is, and since January 1, 2020 have been, in compliance 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, all applicable LawsLegal Requirements. Except as set forth in Schedule 3.11(a), 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 no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledgethe Knowledge of the Acquiror, threatened against Parent or the Acquiror, nor has any of its SubsidiariesGovernmental Body indicated to the Acquiror an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries the Acquiror which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiariesthe Acquiror, any acquisition of material property by Parent or any of its Subsidiaries the Acquiror or the conduct of business by Parent or any of its Subsidiaries as currently conductedthe Acquiror Business, (ii) is could reasonably likely be expected to have an a material adverse effect on Parentthe Acquiror’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is could reasonably likely 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) Parent and its Subsidiaries hold The Acquiror holds all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Acquiror Business (collectively, the “Parent Acquiror Permits”). Section 3.14(bSchedule 3.11(b) of the Parent Acquiror Disclosure Schedule Letter identifies each Parent Acquiror Permit. Parent and its Subsidiaries 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 The Acquiror is in material compliance with the terms of the Parent Acquiror Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of the Acquiror, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Parent Acquiror Permit. The rights and benefits of each Parent Acquiror Permit will continue to be available to Parent and its Subsidiaries the Acquiror immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of the Acquiror, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries the Acquiror of the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or Legal Requirements promulgated by any a Drug Regulatory Agency. (d) Parent The Acquiror holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the Acquiror 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 “Acquiror Regulatory Permits”) and no such Acquiror Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Acquiror is in compliance in all material respects with the Acquiror Regulatory Permits and has not currently conducting received any written notice or addressingother 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 Acquiror Regulatory Permit. Except for the information and files identified in Schedule 3.11(d) of the Acquiror Disclosure Letter, the Acquiror has made available to Parent’s Knowledge the Company true and complete copies of the following (to the extent there is no basis 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 expect that it will be required to conduct or addressand 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 corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, the Acquiror 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 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 Since January 1, 20202008, neither Parent nor any of its Subsidiaries the Acquiror has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledgethe Knowledge of the Acquiror, 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 anyAcquiror. (f) Neither Parent nor any of its Subsidiaries The Acquiror is not the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of the 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 Parent’s Knowledgethe Knowledge of the Acquiror, neither Parent 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 the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parent, Neither the Acquiror nor any of its 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 LawLegal Requirement. No To the Knowledge of the Acquiror, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, the Acquiror or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each Neither OrthoNetx nor any of its Subsidiaries areis in conflict with, and since January 1or in default or violation of (i) any law, 2020 have beenrule, in compliance in all material respects with all regulation, order, judgment or decree applicable Lawsto OrthoNetx or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, including the FDCAor (ii) any note, the FDA regulations adopted thereunderbond, the Controlled Substances Actmortgage, the Public Health Service Act and any other similar Law administered or promulgated by the FDA indenture, contract, agreement, lease, license, permit, franchise or other Drug Regulatory Agency, 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 any noncompliancethose conflicts, either individually defaults or in the aggregate, violations which would not be material reasonably expected to Parenthave an OrthoNetx Material Adverse Effect. No investigationTo the knowledge of OrthoNetx, claim, suit, proceeding, audit no investigation or other action review by any Governmental Body Entity is pending or, to Parent’s Knowledge, or threatened against Parent OrthoNetx or any of its Subsidiaries, nor has any Governmental Entity indicated in writing an intention to conduct the same 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 Parent OrthoNetx or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent OrthoNetx or any of its Subsidiaries, any acquisition of material property by Parent OrthoNetx or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries OrthoNetx as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent OrthoNetx and its Subsidiaries hold all required permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material would necessary to the operation conduct of the business of Parent 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 (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) terms 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 anyOrthoNetx Permits. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each Except as disclosed on Schedule 2.9 neither FlexSCAN nor any of its Subsidiaries areis in conflict with, and since January 1or in default or violation of (i) any law, 2020 have beenrule, in compliance in all material respects with all regulation, order, judgment or decree applicable Lawsto FlexSCAN or any of its Subsidiaries or by which its or any of their respective properties is bound or affected, including the FDCAor (ii) any note, the FDA regulations adopted thereunderbond, the Controlled Substances Actmortgage, the Public Health Service Act and any other similar Law administered or promulgated by the FDA indenture, contract, agreement, lease, license, permit, franchise or other Drug Regulatory Agency, 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 any noncompliancethose conflicts, either individually defaults or in the aggregate, violations which would not be material reasonably expected to Parenthave a FlexSCAN Material Adverse Effect. No investigationExcept as disclosed on Schedule 2.9 to the knowledge of FlexSCAN, claim, suit, proceeding, audit no investigation or other action review by any Governmental Body Entity is pending or, to Parent’s Knowledge, or threatened against Parent FlexSCAN or any of its Subsidiaries, nor has any Governmental Entity indicated in writing an intention to conduct the same 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 Parent FlexSCAN or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent FlexSCAN or any of its Subsidiaries, any acquisition of material property by Parent FlexSCAN or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries FlexSCAN as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent FlexSCAN and its Subsidiaries hold all required permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material would necessary to the operation conduct of the business of Parent 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 (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) terms 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 anyFlexSCAN Permits. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Buyer and each of its Subsidiaries Buyer Subsidiary are, and since January 1, 2020 2014 have been, in compliance in all material respects with all applicable Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Buyer, threatened in writing against Parent Buyer or any of its SubsidiariesBuyer Subsidiary. There is no agreement, judgment, injunction, order or decree binding upon Parent Buyer or any of its Subsidiaries Buyer Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Buyer or any of its SubsidiariesBuyer Subsidiary, any acquisition of material property by Parent Buyer or any of its Subsidiaries Buyer Subsidiary or the conduct of business by Parent Buyer or any of its Subsidiaries Buyer Subsidiary as currently conducted, (ii) is reasonably likely to may have an adverse effect on ParentBuyer’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to may have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent 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 hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Buyer (the “Parent Buyer Permits”)) as currently conducted. Section 3.14(bPart 2.11(b) of the Parent Buyer Disclosure Schedule identifies each Parent Buyer Permit. Parent and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear Each of any Encumbrance. Parent Buyer and each of its Subsidiaries are Buyer Subsidiary is in material compliance with the terms of the Parent Buyer Permits, except as would not reasonably be expected to have a Buyer Material Adverse Effect. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Buyer, threatenedthreatened in writing, which seeks to revoke, limit, suspend, or materially modify any Parent Buyer Permit. The rights and benefits of each Parent material Buyer Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Buyer, threatened in writing with respect to an alleged material violation by Parent Buyer or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or Legal Requirements promulgated by any 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) Parent is Buyer and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of 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 (the “Buyer Products”) (collectively, the “Buyer Regulatory Permits”), except as would not currently conducting or addressingreasonably be expected to have a Buyer Material Adverse Effect, and no such Buyer Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner. 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/Device Regulatory Agency regarding (A) any material violation of or failure to Parentcomply materially with any term or requirement of any Buyer Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Buyer Regulatory Permit. Except for the information and files identified in Part 2.11(d) of the Buyer Disclosure Schedule, Buyer has made available to Lpath all information requested by Lpath in Buyer’s Knowledge or its Subsidiaries’ possession or control relating to the Buyer Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Buyer Product Candidates, including complete copies of the following (to the extent there is no basis are any): (x) adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to expect that it will be required to conduct or addressand from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any corrective actions, including, without limitation, product recalls or clinical holdsother Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Buyer or any of its Subsidiaries, Subsidiaries or in which Parent Buyer or any of its Subsidiaries or their respective current products or product candidates candidates, including the Buyer Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, 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 any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable LawLegal Requirements, 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 Parent Buyer nor any of its the Buyer Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Buyer 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 Parent’s Knowledgethe Knowledge of Buyer or any of the Buyer Subsidiaries, neither Parent 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 ParentBuyer, any of its Subsidiaries nor 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable LawLegal Requirement. No To the Knowledge of Buyer, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against ParentBuyer, any of its Subsidiaries Buyer Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule, Corautus and each of its Subsidiaries Corautus Subsidiary are, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws, including the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act Legal Requirements and has not received any other similar Law administered written notice of violation or promulgated by the FDA or other Drug Regulatory Agency, except for alleged violation of any noncompliance, either individually or in the aggregate, which would not be material to Parentapplicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Corautus, threatened against Parent Corautus or any of its SubsidiariesCorautus Subsidiary, nor has any Governmental Body or authority indicated to Corautus an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon Parent Corautus or any of its Subsidiaries Corautus Subsidiary which (i) has had or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionsa Corautus Material Adverse Effect. (b) Parent Except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule: (i) Corautus and its the Corautus Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Corautus (collectively, the “Parent Corautus Permits”). Section 3.14(b3.11(b) of the Parent Corautus Disclosure Schedule identifies each Parent Corautus Permit, each of which is in full force and effect. Parent and its Subsidiaries hold all right, title and interest in and to all Parent Permits free and clear Each of any Encumbrance. Parent Corautus and each of its Subsidiaries are Corautus Subsidiary is in material compliance with the terms of the Parent Corautus Permits. No Legal Proceeding 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 Parent’s Knowledgethe Knowledge of Corautus, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Corautus Permit. The ; and (ii) the rights and benefits of each Parent Corautus Permit will be available to Parent and its Subsidiaries the Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledge, or threatened with respect to an alleged material violation by Parent Corautus or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Substance Act, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by any the FDA or other Drug Regulatory Agency. (d) Parent is Except for such Governmental Authorizations listed in Section 3.11(d) of the Corautus Disclosure Schedule, Corautus and its Subsidiaries holds (or at the relevant time, held) all Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business as currently conducted and development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its existing products (the “Corautus Products”) (the “Corautus Regulatory Permits”) and, except as set forth on Section 3.11(d) of the Corautus Disclosure Schedule, no such Corautus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. 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 currently conducting received any written notice or addressingother 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 Corautus Regulatory Permit. Except for the information and files identified in Section 3.11(d) of the Corautus Disclosure Schedule, Corautus has made available to Parent’s Knowledge there is no basis VIA all information in its possession or control relating to expect that it will be required to conduct or addressthe Corautus Products and the development, any corrective actionsclinical testing, includingmanufacturing, importation and exportation of the Corautus Products, including without limitation, product recalls or complete and correct copies of the following (to the extent there are any): (x) adverse event reports; clinical holdsstudy reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, 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, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Corautus or any of its Subsidiaries, Corautus Subsidiary or in which Parent Corautus or any of Corautus Subsidiary or its Subsidiaries or their respective current products or product candidates candidates, including the Corautus Products, have participated, 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 in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth for such notices listed in Section 3.14(e3.11(e) of the Parent Corautus Disclosure Schedule, since January 1, 2020, neither Parent Corautus nor any of its Subsidiaries Corautus Subsidiary has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiringrequiring the termination, or, to Parent’s Knowledge, threatening to initiate, the termination suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent Corautus or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates candidates, including the Corautus Products, have participated. Parent has made available Except for such material obligations listed in Section 3.11(e) of the Corautus Disclosure Schedule, Corautus and its Subsidiaries have fulfilled and performed all of their material obligations with respect 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 Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, BriberyCorautus Studies, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither Parent nor any of its Subsidiaries no event has committed any acts, made any statementoccurred which causes, or failed after notice or lapse of time would reasonably be expected to make any statementcause, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of a Corautus Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agentsAdverse Effect.

Compliance; Permits; Restrictions. (a) Parent Buyer and each of its Subsidiaries are, and since January 1, 2020 2019 have been, in compliance in all material respects with all applicable Laws. Except as set forth on Section 3.15(a) of the Buyer Disclosure Schedule, 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 no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending oris, to Parent’s Knowledgethe Knowledge of Buyer, pending or threatened against Parent Buyer or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent Buyer or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Buyer or any of its Subsidiaries, any acquisition of material property by Parent Buyer or any of its Subsidiaries or the conduct of business by Parent Buyer or any of its Subsidiaries as currently conducted, (ii) is would be reasonably likely to have an adverse effect on ParentBuyer’s or its Subsidiaries’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would be reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Buyer and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent Buyer and its Subsidiaries as currently conducted (the “Parent Buyer Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent Buyer and its Subsidiaries 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 Parent Buyer Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Buyer, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Buyer Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending orBuyer and its Subsidiaries have implemented and maintain, and since January 1, 2019 have maintained, policies, procedures, and practices governing Personal Information that comply in all 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 Buyer and its Subsidiaries. Buyer and its Subsidiaries have adopted, and since January 1, 2019 have maintained, information security and privacy programs, including commercially reasonable administrative, physical, and technical safeguards consistent with industry standards, to Parent’s Knowledgeprotect the confidentiality, threatened with respect to an alleged material violation by Parent integrity, availability and security of Sensitive Data against unauthorized access, use, modification, disclosure or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agencymisuse. (d) Parent is Since January 1, 2019, Buyer and its Subsidiaries have used commercially reasonable efforts to prevent the introduction (i) into any software owned by Buyer or its Subsidiaries, or (ii) into the IT Systems, and, to the Knowledge of Buyer, such IT Systems do not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or addresscontain, any corrective actionsransomware, includingdisabling codes or instructions, without limitationspyware, product recalls Trojan horses, worms, viruses or clinical holdsother software routines that permit or cause unauthorized access to, or disruption, impairment, disablement, or destruction of, software, data or other materials in any material manner. Buyer and its Subsidiaries 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 unplanned or critical failures, continued substandard performance, errors, breakdowns or other adverse events that have caused any material disruption or interruption in the operation of the business of Buyer and its Subsidiaries in any material manner. (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 its Subsidiaries have not received any written subpoenas, demands, or other notices from any Governmental Body investigating, inquiring into, or 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 any material respect. No written notice, complaint, claim, enforcement action, or litigation has been served on, or, to ParentBuyer’s Knowledge, initiated against Buyer or its Subsidiaries alleging violation of any Data Protection Laws. The execution of this Agreement by Buyer and the other documents contemplated hereby, and the consummation of the 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 processing of any Sensitive Data in any material respect. (f) Except as set forth on Section 3.15(f) of the Buyer Disclosure Schedule, Buyer and its Subsidiaries have not suffered any material Security Incident. To the Knowledge of Buyer, no service provider (in the course of providing services for or on behalf of, or sponsored by, Parent of Buyer or any of its Subsidiaries, or in which Parent or ) has suffered any of its Subsidiaries or their respective current products or 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 any applicable Drug Regulatory Agency and other applicable Law, 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 anySecurity Incident. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Except where failure would not result in a PubCo Material Adverse Effect, PubCo and each of its Subsidiaries areis, and since January 1, 2020 have been2018, has been in material compliance in all material respects with all applicable Laws, 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 audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened against Parent PubCo or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent PubCo or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent PubCo or any of its Subsidiaries, any acquisition of material property by Parent PubCo or any of its Subsidiaries or the conduct of business by Parent PubCo or any of its Subsidiaries as currently conducted, or (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactionsresult in a PubCo Material Adverse Effect. (b) Parent Except where a failure would not result in a PubCo Material Adverse Effect, each of PubCo and its Subsidiaries hold Subsidiaries: (i) holds all required Governmental Authorizations which that are material to the operation of the business of Parent PubCo and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent PubCo Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 (ii) is in material compliance with the terms of the Parent PubCo Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of PubCo, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent PubCo Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledgethe Knowledge of PubCo, threatened with respect to an alleged material violation by Parent PubCo or any of its Subsidiaries of the FDCA, the PHSA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any the FDA or other Drug Regulatory AgencyAgency which is material to the conduct of PubCo’s business. (d) Parent Except where failure would not result in a PubCo Material Adverse Effect, each of PubCo and its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency or Governmental Authority which is necessary for the conduct of the business of PubCo as currently conducted and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “PubCo Product Candidates”) (collectively, the “PubCo Regulatory Permits”) and no such PubCo Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial modifications. Except where failure would not currently conducting result in a PubCo Material Adverse Effect, PubCo and its Subsidiaries have timely maintained and are in compliance in all material respects with the PubCo Regulatory Permits and have not received any written notice or addressingother written communication from any Drug Regulatory Agency or 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 PubCo Regulatory Permit. PubCo has made available to the Company all information requested by the Company in PubCo’s or its Subsidiaries’ possession or control relating to the PubCo Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the PubCo Product Candidates, including but not limited to Parent’s Knowledge 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; 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 no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdsaccurate and complete in all material respects. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its SubsidiariesPubCo, or in which Parent or any of its Subsidiaries PubCo or their respective current products or product candidates candidates, including the PubCo 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 any applicable the Drug Regulatory Agency Agencies and other applicable Law, 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 PubCo has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of PubCo threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries PubCo or in which Parent PubCo or any of its Subsidiaries or their respective current products or product candidates candidates, including the PubCo Product Candidates, have participated. Parent has made available Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Company true Knowledge of PubCo, on behalf of PubCo has been disqualified from participating in studies involving the PubCo Product Candidates, and complete copies to the Knowledge of all material noticesPubCo, correspondence no such administrative action to disqualify such clinical investigators, researchers or other communications received by Parent from any Drug Regulatory Agency, if anyclinical staff has been threatened or is pending. (f) Neither Parent 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 pending or, to Parent’s Knowledgethe Knowledge of PubCo, 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 Parent’s Knowledgethe Knowledge of PubCo, neither Parent 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 ParentPubCo, and to the Knowledge of PubCo, any of its Subsidiaries nor contract 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 debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To the Knowledge of PubCo, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against ParentPubCo, and to the Knowledge of PubCo, any of its Subsidiaries 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, including applicable requirements contained in 21 C.F.R. Parts 210, 211, 600-680, and 1271, 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) Parent The Company and each of its Subsidiaries are, and since January 1, 2020 the Relevant Date have been, in compliance in all material respects with all applicable Laws, 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 is pending oris, to Parent’s Knowledgethe Knowledge of the Company, pending or threatened against Parent the Company or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent the Company or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent the Company or any of its Subsidiaries, any acquisition of material property by Parent the Company or any of its Subsidiaries or the conduct of business by Parent the Company or any of its Subsidiaries as currently conducted, (ii) is would be reasonably likely to have an adverse effect on Parentthe Company’s or its Subsidiaries’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would be reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent The Company and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of Parent the Company and its Subsidiaries as currently conducted (the “Parent Company Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent The Company and its Subsidiaries 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 Parent Company Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of the Company, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Company Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending orThe Company and its Subsidiaries have implemented and maintain policies, procedures, and practices governing Personal Information that comply in all material respects with all applicable Data Protection Laws and the Company’s Contracts. Such policies, procedures, and practices have been followed in all material respects in the conduct of the business of the Company and its Subsidiaries. The Company and its Subsidiaries have adopted information security and privacy programs, including commercially reasonable administrative, physical, and technical safeguards, consistent with industry standards, to Parent’s Knowledgeprotect the confidentiality, threatened with respect to an alleged material violation by Parent integrity, availability and security of Sensitive Data against unauthorized access, use, modification, disclosure or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agencymisuse. (d) Parent is The Company and its Subsidiaries have used commercially reasonable efforts to prevent the introduction (i) into any software owned by the Company or its Subsidiaries, or (ii) into the IT Systems, and, to the Knowledge of the Company, such IT Systems do not currently conducting or addressing, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct or addresscontain, any corrective actionsransomware, includingdisabling codes or instructions, without limitationspyware, product recalls Trojan horses, worms, viruses or clinical holdsother software routines that permit or cause unauthorized access to, or disruption, impairment, disablement, or destruction of, software, data or other materials in any material manner. The Company and its Subsidiaries have used commercially reasonable efforts to promptly implement material security patches that are generally available for the IT Systems. To the Knowledge of the Company, the IT Systems have not suffered any unplanned or critical failures, continued substandard performance, errors, breakdowns or other adverse events that have caused any material disruption or interruption in the operation of the business of the Company and its Subsidiaries in any material manner. (e) All clinicalThe Company and its Subsidiaries are, pre-clinical and since the Relevant Date have been, in material compliance with all applicable Data Protection Laws, the Company’s and Subsidiaries’ obligations under Contracts, and the Company 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. The Company and tests conducted its Subsidiaries have not received any written subpoenas, demands, or other notices from any Governmental Body investigating, inquiring into, or otherwise relating to any actual or potential material violation of any Data Protection Laws. To the Company’s Knowledge, the Company and its Subsidiaries are not under investigation by any Governmental Body for any violation of any Data Protection Laws in any material respect. No written notice, complaint, claim, enforcement action, or litigation has been served on, or, to Parentthe Company’s Knowledge, initiated against the Company or its Subsidiaries alleging violation of any Data Protection Laws. The execution of this Agreement by the Company and the other documents contemplated hereby, and the consummation of the 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 processing of any Sensitive Data in any material respect. (f) The Company and its Subsidiaries have not suffered any material Security Incident. To the Knowledge of the Company, no service provider (in the course of providing services for or on behalf of, or sponsored by, Parent of the Company or any of its Subsidiaries, or in which Parent or ) has suffered any of its Subsidiaries or their respective current products or 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 any applicable Drug Regulatory Agency and other applicable Law, 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 anySecurity Incident. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries areDecoy is, and since January 1, 2020 have for the past 5 years has been, in material compliance in all material respects with all applicable Laws, 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 ParentLegal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Decoy, threatened against Parent or any of its SubsidiariesDecoy. There is no agreementContract, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Decoy which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesDecoy, any acquisition of material property by Parent or any of its Subsidiaries Decoy or the conduct of business by Parent or any of its Subsidiaries as currently conductedthe Decoy Business, (ii) is would reasonably likely be expected to have an adverse effect on ParentDecoy’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Merger or any of the Transactions. (b) Parent and its Subsidiaries hold Decoy holds all required Governmental Authorizations which are material to issuable by any Drug Regulatory Agency necessary for the operation conduct of the business of Parent Decoy as currently conducted, and the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its Subsidiaries products or product candidates (the “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 “Parent Decoy Permits”). , and Section 3.14(b‎2.12‎(b) of the Parent Decoy Disclosure Schedule identifies each Parent Decoy Permit. Parent and its Subsidiaries hold all rightNo such Decoy Permit has been: (i) revoked, title and interest withdrawn, suspended, canceled or terminated; or (ii) modified in and to all Parent Permits free and clear any materially adverse manner. Decoy has not received any written notice or other written communication from any Governmental Body regarding any revocation, withdrawal, suspension, cancelation, termination or material modification of any EncumbranceDecoy Permit. Parent Decoy has made available to Intec all material information in its possession or control concerning the development, clinical testing, manufacturing, importation and each of its Subsidiaries are in material compliance with the terms exportation of the Parent Permits. No Legal Proceeding is pending orDecoy Product Candidates, including complete copies of the following (to Parent’s Knowledgethe extent there are any): adverse event reports; clinical study reports and material study data; inspection reports, threatenednotices of adverse findings, which seeks warning letters, filings and letters and other written correspondence to revoke, limit, suspend, or materially modify and from any Parent PermitDrug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency. The rights and benefits of each Parent material Decoy Permit will be available to Parent and its Subsidiaries Decoy immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent and its Subsidiaries as of the date of this Agreement and Decoy immediately prior to the Effective Time. (c) There are no proceedings pending or, to Parent’s Knowledgethe Knowledge of Decoy, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Decoy of the Federal Food, Drug, and Cosmetic Act (“FDCA”), FDA the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by any 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) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its SubsidiariesDecoy were, or in which Parent or any of its Subsidiaries or their respective current products or product candidates have participated, were and, and if still pendingpending are being, 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 any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) No preclinical or clinical trial conducted by or on behalf of the Parent Disclosure Schedule, since January 1, 2020, neither Parent nor any of its Subsidiaries Decoy has been terminated or suspended prior to completion for safety or non-compliance reasons. Decoy has not received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Decoy threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored byby Decoy or, Parent or any of its Subsidiaries or in which Parent Decoy or any of its Subsidiaries or their respective current products or product candidates candidates, including the Decoy 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. (fe) Neither Parent nor 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 implementing regulations promulgated thereunder, all as amended from time to time (collectively “HIPAA”), including the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart 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 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 of its Subsidiaries is the subject other Governmental Body of any pending or, allegation regarding its failure to Parent’s Knowledge, threatened investigation 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 respect of its business or products by this Section ‎2.12(e) not otherwise defined in this Agreement shall have the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy meanings set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agentsHIPAA.

Compliance; Permits; Restrictions. (a) Parent Sellas and each of its Subsidiaries Sellas Subsidiary are, and since January July 1, 2020 have 2015 each of Sellas, and its Subsidiaries has been, in material compliance in all material respects with all applicable Laws, 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, Legal Requirements except for any noncompliance, either individually or in the aggregate, which non-compliance that would not be material to Parentconstitute a Sellas Material Adverse Effect. Neither Sellas nor any Sellas Subsidiaries has received any notice of violation of, or been charged with a violation of, any applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to Parent’s Knowledgethe Knowledge of Sellas, threatened against Parent Sellas or any of its SubsidiariesSellas Subsidiary. There is no agreementContract, judgment, injunction, order or decree binding upon Parent Sellas or any of its Subsidiaries Sellas Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Sellas or any of its SubsidiariesSellas Subsidiary, any acquisition of material property by Parent Sellas or any of its Subsidiaries Sellas Subsidiary or the conduct of business by Parent Sellas or any of its Subsidiaries Sellas Subsidiary as currently conducted, (ii) is would reasonably likely be expected to have an adverse effect on Parent’s Sellas’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is would reasonably likely be expected to have the effect of preventing, delaying, making illegal or otherwise interfering with the Merger or any of the Contemplated Transactions. (b) Parent Sellas and its the Sellas Subsidiaries hold all required Governmental Authorizations which are material to necessary for the operation of the business of Parent and its Subsidiaries as currently conducted Sellas (the “Parent Sellas Permits”)) as currently conducted. Section 3.14(b2.12(b) of the Parent Sellas Disclosure Schedule identifies each Parent Sellas Permit. Parent Neither Sellas nor any of the Sellas Subsidiaries is in default under or in material breach or violation of (and its Subsidiaries hold all rightno event has occurred that, title and interest in and to all Parent Permits free and clear 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 EncumbranceSellas Permit. Parent 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 of its Subsidiaries are Sellas Subsidiary is in material compliance with the terms of the Parent Sellas Permits. No Legal Proceeding action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to Parent’s Knowledgethe Knowledge of Sellas, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Sellas Permit. The rights and benefits of each Parent material Sellas Permit will be available to Parent and its Subsidiaries the Surviving Company immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Sellas, threatened with respect to an alleged material violation by Parent Sellas or any of its 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, the Public Health Service Act or any other similar Law administered or Legal Requirements promulgated by any 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) 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”). (e) Sellas and each Sellas Subsidiary holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for (i) the conduct of the business of Sellas or such Subsidiary as currently conducted, 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 “Sellas Product Candidates”) (collectively, the “Sellas Regulatory Permits”). No such 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. 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 alleging any material violation of or failure to comply with any material term or requirement of any Sellas Regulatory Permit. To Sellas’ Knowledge, any third-party supplier, manufacturer, or contractor that is developing or manufacturing Sellas Product Candidates for Sellas or its Subsidiaries is in 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 Galena all information reasonably requested by Galena in Sellas’ or its Subsidiaries’ possession or control relating to the Sellas Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Sellas Product Candidates, including complete copies of the following (to the extent there are any): adverse event reports; clinical study reports, all material pre-clinical and material clinical study data; 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 data and other results of all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Sellas or its Subsidiaries that have been provided to Galena are true, correct, and complete. (f) 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, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Sellas or any of its Subsidiaries, Subsidiaries or in which Parent Sellas or any of its Subsidiaries or their respective current products or product candidates candidates, including the Sellas Product Candidates, have participatedparticipated were, were and, and if still pendingpending are being, are being conducted in all material respects in accordance with good clinical practices, standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable LawLegal Requirements, including 21 C.F.R. Parts 50, 54, 56, 58 58, 312, 314 Subpart H, 316, and 312601, as applicable. Except as set forth in Section 3.14(e) of the Parent Disclosure Schedule, since January Since July 1, 20202015, neither Parent Sellas nor any of its Sellas Subsidiaries has received any notices, correspondence, correspondence or other communications from any Drug Regulatory Agency requiring, or, or to Parent’s Knowledge, the Knowledge of Sellas threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent Sellas or any of its Sellas Subsidiaries or in which Parent Sellas or any of its Sellas Subsidiaries or their respective current products or product candidates candidates, including the Sellas 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. (fg) Neither Parent Sellas nor any of its the Sellas Subsidiaries is the subject of any pending orpending, or to Parent’s Knowledgethe Knowledge of Sellas 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 Parent’s Knowledgethe Knowledge of Sellas or any of the Sellas Subsidiaries, neither Parent 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 ParentSellas, any Sellas Subsidiaries or to the Knowledge of its Subsidiaries nor Sellas, 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable LawLegal Requirement. No To the Knowledge of Sellas, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against ParentSellas, any of its Subsidiaries Sellas Subsidiary or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Apricus and each of its Subsidiaries are, and since January 1, 2020 2015, have been, been in compliance in all material respects with all applicable Laws, 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 a Drug Regulatory Agency, except for any noncompliance, either individually or in the aggregate, which would not be material to ParentApricus. No Except as set forth in Section 3.14 of the Apricus Disclosure Schedule, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to Parent’s Knowledgethe Knowledge of Apricus, threatened against Parent or any of its SubsidiariesApricus. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Apricus which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesApricus, any acquisition of material property by Parent or any of its Subsidiaries Apricus or the conduct of business by Parent or any of its Subsidiaries Apricus as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s Apricus’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Each of Apricus and its Subsidiaries hold Merger Sub holds all required Governmental Authorizations which are material to the operation of the business of Parent Apricus and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Apricus Permits”). Section 3.14(b) of the Parent Apricus Disclosure Schedule identifies each Parent Apricus Permit. Parent Each of Apricus and its Subsidiaries 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 Merger Sub is in material compliance with the terms of the Parent Apricus Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Apricus, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Apricus Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledgethe Knowledge of Apricus, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Apricus of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent Apricus and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency material to the conduct of the business of Apricus and 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 “Apricus Product Candidates”) (the “Apricus Regulatory Permits”) and no such Apricus Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Each of Apricus and Merger Sub is not currently conducting in compliance in all material respects with the Apricus Regulatory Permits and neither Apricus nor Merger Sub has received any written notice or addressingother 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, and withdrawal, suspension, cancellation, termination or material modification of any Apricus Regulatory Permit. To the Knowledge of Apricus, there are no facts that would be reasonably likely to Parent’s Knowledge there is no basis to expect that it will be required to conduct result in any warning letter, untitled letter or address, any corrective actions, including, without limitation, product recalls or clinical holdsother written notice of material violation letter from the FDA. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its Subsidiaries, Apricus or in which Parent Apricus or any of its Subsidiaries or their respective current products or product candidates candidates, including the Apricus 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) No preclinical or clinical trial conducted by or on behalf of the Parent Disclosure Schedule, since 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, 20202015, neither Parent Apricus nor any of its Subsidiaries Merger Sub has received any notices, written notices or correspondence, or other written communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledgethe Knowledge of Apricus, threatening to initiate, the termination termination, suspension or suspension material modification of any clinical studies conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Apricus or in which Parent Apricus or any of its Subsidiaries or their respective current products or product candidates candidates, including the Apricus Product Candidates, have participated. Parent has made available to To the Company true extent required, all clinical trials conducted by or on behalf of Apricus have been registered on, and complete copies trial results have been reported on, the United States National Institutes of all material noticesHealth Website, correspondence or other communications received by Parent from xxx.xxxxxxxxxxxxxx.xxx, in accordance with 42 U.S.C. § 282(j), and are listed in accordance with any Drug Regulatory Agency, if anyapplicable additional state and local law requirements. (f) Neither Parent Apricus nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledgethe Knowledge of Apricus, 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 Parent’s Knowledgethe Knowledge of Apricus, neither Parent 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 ParentApricus, any Merger Sub, or, to the Knowledge of its Subsidiaries nor Apricus, 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To the Knowledge of Apricus, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Apricus or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries areExcept as would not, and since January 1, 2020 have been, in compliance in all material respects with all applicable Laws, 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 reasonably be expected to be material to ParentSipex and its Subsidiaries taken as a whole or prevent or materially delay consummation of the Merger or the other transactions contemplated by this Agreement, neither Sipex nor any of its Subsidiaries is in 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 bound or affected, or (ii) any Contract to which Sipex or any of its Subsidiaries is a party or by which Sipex 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 Entity is pending or, to ParentSipex’s Knowledgeknowledge, threatened against Parent Sipex or any of its Subsidiaries, nor to Sipex’s knowledge has any Governmental Entity indicated an intention to conduct the same. There is no agreementContract, judgment, injunction, order or decree binding upon Parent Sipex or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of materially prohibiting or materially impairing any business practice of Parent Sipex or any of its Subsidiaries, any acquisition of material property by Parent Sipex or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries Sipex as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Sipex and its Subsidiaries hold all required material permits, licenses, variances, exemptions, orders and approvals from Governmental Authorizations Entities which are material to the operation of the business of Parent and its Subsidiaries as currently conducted Sipex (collectively, the “Parent Sipex Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent Sipex and its Subsidiaries 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 Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) 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. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except as set forth in Section 3.14(e) terms 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 anySipex Permits. (f) Neither Parent nor any of its Subsidiaries is the subject of any pending or, to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent Frequency and each of its Subsidiaries areis, and since January 1, 2020 have been2020, has been in material compliance in all material respects with all applicable Laws, 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 audit, Order, or other action by any Governmental Body Authority is pending or, to Parent’s Knowledgethe Knowledge of Frequency, threatened against Parent Frequency or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent Frequency or any of its Subsidiaries which (i) has or would could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Frequency or any of its Subsidiaries, any acquisition of material property by Parent Frequency or any of its Subsidiaries or the conduct of business by Parent Frequency or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on ParentFrequency’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Each of Frequency and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent Frequency and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Frequency Permits”). Section 3.14(b4.14(b) of the Parent Frequency Disclosure Schedule identifies each Parent Frequency Permit. Parent Each of Frequency and its Subsidiaries 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 is in material compliance with the terms of the Parent Frequency Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Frequency, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Parent Frequency Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledgethe Knowledge of Frequency, threatened with respect to an alleged material violation by Parent Frequency or any of its Subsidiaries of the FDCA, PHSA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent Each of Frequency and its Subsidiaries holds all required material Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Frequency and Merger Sub as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Frequency Product Candidates”) (collectively, the “Frequency Regulatory Permits”) and no such Frequency Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any material, adverse manner. Frequency has timely maintained and is not currently conducting in compliance in all material respects with the Frequency Regulatory Permits and neither Frequency nor any of its Subsidiaries has, since January 1, 2020, received any written notice or addressingother 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, and to Parent’s Knowledge there is no basis to expect that it will be required to conduct withdrawal, suspension, cancellation, termination or address, material modification of any corrective actions, including, without limitation, product recalls or clinical holdsFrequency Regulatory Permit. (e) All clinicalclinical trials, pre-clinical preclinical studies and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Frequency or any of its Subsidiaries, or in which Parent or any of its Subsidiaries or their respective current products or product candidates the Frequency 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 any applicable the Drug Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except Other than as set forth in on Section 3.14(e4.14(e) of the Parent Frequency Disclosure Schedule, since January 1, 2020, neither Parent Frequency nor any of its Subsidiaries has received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to Parent’s Knowledgethe Knowledge of Frequency, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, Parent Frequency or any of its Subsidiaries or in which Parent or any of its Subsidiaries or their respective current products or product candidates the Frequency 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 Parent 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 pending or, to Parent’s Knowledgethe Knowledge of Frequency, 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 Parent’s Knowledgethe Knowledge of Frequency, neither Parent 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 ParentFrequency, any of its Subsidiaries nor 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 Law. No To the Knowledge of Frequency, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against ParentFrequency, any of its Subsidiaries 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) Parent and each of its Subsidiaries are, and since January 1, 2020 2021, have been, in compliance in all material respects with all applicable Laws, including applicable provisions of the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act 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 is pending or, to Parent’s Knowledge, threatened against Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its Subsidiaries, any acquisition of material property by Parent or any of its Subsidiaries or the conduct of business by Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent and its Subsidiaries hold all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries as currently conducted (the “Parent Permits”). Section 3.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Parent and its Subsidiaries 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 is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to Parent’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Permit. The rights and benefits of each Parent Permit will be available to Parent and its Subsidiaries immediately after the Effective Time on terms substantially similar to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries of the FDCA, the FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act PHSA or any other similar Law administered or promulgated by any Drug Regulatory Agency. (d) . Neither Parent nor any of its Subsidiaries is not currently conducting or addressing, and and, to Parent’s Knowledge Knowledge, there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, including product recalls or clinical holds. (ed) All clinical, pre-clinical nonclinical and other studies and tests conducted by or, to Parent’s Knowledge, 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, 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 any applicable Drug Regulatory Agency and other applicable Law, 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 Since January 1, 20202021, neither Parent nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledge, threatening to initiate, 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. (fe) Neither Parent nor any of its Subsidiaries is the subject of any pending or, or to Parent’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 Parent’s Knowledge, neither 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 Parent, any of its Subsidiaries nor 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 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 Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending orpending, or to Parent’s Knowledge, threatened against Parent, any of its Subsidiaries or any of their respective officers, employees or or, to the Parent’s Knowledge, agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries Subsidiary are, and since January 1March 31, 2020 2023, have been, been in material compliance in all material respects with all applicable Laws, 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 audit, Order or other Legal Proceeding or action by any Governmental Body Authority is pending or, to the Knowledge of Parent’s Knowledge, threatened against Parent or any of its SubsidiariesSubsidiary. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent or any of its Subsidiaries Subsidiary which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesSubsidiary, any acquisition of material property by Parent or any of its Subsidiaries Subsidiary or the conduct of business by Parent or any of its Subsidiaries Subsidiary as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Except for matters regarding the FDA or other Drug/Device Regulatory Agency, each of Parent and its Subsidiaries hold Subsidiary holds all required Governmental Authorizations which that are material to the operation of the business of Parent and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Permits”). Section 3.14(b4.14(b) of the Parent Disclosure Schedule identifies each Parent Permit. Each of Parent and its Subsidiaries 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 Subsidiary is in material compliance with the terms of the Parent Permits. No Legal Proceeding is pending or, to the Knowledge of Parent’s Knowledge, threatened, which seeks to revoke, substantially limit, suspend, suspend or materially modify any Parent Permit. The rights and benefits of each Parent Permit Permit, if any, will be available to Parent and its Subsidiaries Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by 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 Parent’s Knowledge, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Subsidiary of the FDCA, PHSA or FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Act or any other similar Law administered or promulgated by any Drug a Drug/Device Regulatory Agency. (d) Each of Parent and its Subsidiary holds all required Governmental Authorizations issuable by any Drug/Device Regulatory Agency necessary for the conduct of the business of Parent and Merger Sub as currently conducted, and, as applicable, the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its product candidates (the “Parent Product Candidates”) (collectively, the “Parent Regulatory Permits”) and no such Parent Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Section 4.14(d) of the Parent Disclosure Schedule identifies and lists each Parent Regulatory Permit. Parent has timely maintained and is not currently conducting in compliance in all material respects with the Parent Regulatory Permits and neither Parent nor its Subsidiary has, since March 31, 2023, received any written notice or addressingcorrespondence or, and to the Knowledge of Parent, other communication from any 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 Parent Regulatory Permit. Parent has made available to the Company all information requested by the Company in Parent’s Knowledge there is no basis or its Subsidiary’s possession or control relating to expect that it will be required to conduct material Parent Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or address, any corrective actionsexportation of the Parent Product Candidates, including, without limitationbut not limited to, product recalls or complete copies of the following (to the extent there are any): (y) adverse event reports; pre-clinical, clinical holdsand other study reports and material study data; inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug/Device Regulatory Agency; and meeting minutes with any Drug/Device Regulatory Agency and (z) 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, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent or any of its SubsidiariesSubsidiary, or in which Parent or any of its Subsidiaries Subsidiary or their respective current products or product candidates candidates, including the Parent Product Candidates, have participatedparticipated 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 any applicable Drug the Drug/Device Regulatory Agency Agencies and other applicable Law, including including, without limitation, 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Except Other than as set forth in on Section 3.14(e4.14(e) of the Parent Disclosure Schedule, since January 1March 31, 20202023, neither Parent nor any of its Subsidiaries Subsidiary has received any written notices, correspondence, or other communications from any Drug Drug/Device Regulatory Agency requiring, requiring or, to the Knowledge of Parent’s Knowledge, threatening any action to initiateplace a clinical hold order on, the termination or suspension of otherwise terminate, delay or suspend 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 its current products or product candidates candidates, including the Parent Product Candidates, have participated. Parent has made available Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Company true Knowledge of Parent, on behalf of Parent or its Subsidiary has been disqualified from participating in studies involving the Parent Product Candidates, and complete copies to the Knowledge of all material noticesParent, correspondence no such administrative action to disqualify such clinical investigators, researchers or other communications received by Parent from any Drug Regulatory Agency, if anyclinical staff has been threatened or is pending. (f) Neither Parent, its Subsidiary nor, to the Knowledge of Parent, any contract manufacturer with respect to any Parent nor any of its Subsidiaries Product Candidate is the subject of any pending or, to the Knowledge of Parent’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 theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To Neither Parent’s Knowledge, neither its Subsidiary nor, to the Knowledge of Parent, any contract manufacturer, nor their respective officers, employees or agents, with respect to any Parent nor any of its Subsidiaries 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 Parent, its Subsidiary, and, to the Knowledge of Parent, any of its Subsidiaries nor contract 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 Law. No To the Knowledge of Parent, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, its Subsidiary, and to the Knowledge of the Parent, any contract manufacturer with respect to any Parent Product Candidate, or any of its Subsidiaries or any of their respective 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) Parent Milan and each of its Subsidiaries are, and since January 1, 2020 2016, have been, in compliance in all material respects with all applicable Laws, 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 Authority is pending or, to Parent’s Knowledgethe Knowledge of Milan, threatened against Parent Milan or any of its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon Parent Milan or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent Milan or any of its Subsidiaries, any acquisition of material property by Parent Milan or any of its Subsidiaries or the conduct of business by Parent Milan or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on ParentMilan’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Each of Milan and its Subsidiaries hold holds all required Governmental Authorizations which that are material to the operation of the business of Parent Milan and its Subsidiaries as currently conducted (collectively, the “Parent Milan Permits”). Section 3.14(b) of the Parent Milan Disclosure Schedule identifies each Parent Milan Permit. Parent Each of Milan and its Subsidiaries 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 is in material compliance with the terms of the Parent Milan Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Milan, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Milan Permit. The rights and benefits of each Parent Milan Permit will be available to Parent Milan and Surviving Corporation or its Subsidiaries Subsidiaries, as applicable, immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent 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 Parent’s Knowledgethe Knowledge of Milan, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Milan of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent is not Milan and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Milan or such Subsidiary as currently conducting conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or addressingexportation, as currently conducted, of any of its products or product candidates (the “Milan Product Candidates”, and such required Governmental Authorizations, the “Milan Regulatory Permits”) and no such Milan Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. 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 Parentcomply materially with any term or requirement of any Milan Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Milan Regulatory Permit. Except for the information and files identified in Section 3.14(d) of the Milan Disclosure Schedule, Milan has made available to the Company all information requested by the Company in Milan’s Knowledge or its Subsidiaries’ possession or control relating to the Milan Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Milan Product Candidates, including complete copies of the following (to the extent there is no basis are any): (x) serious adverse event reports; clinical study reports and material study data; inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to expect that it will be required 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 conduct or address, any corrective actions, including, without limitation, product recalls or clinical holdsthe extent material. (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledge, or on behalf of, or sponsored by, Parent Milan or any of its Subsidiaries, Subsidiaries or in which Parent Milan or any of its Subsidiaries or their respective current products or product candidates candidates, including the Milan Product Candidates, have participatedparticipated have been, were 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 any applicable the Drug Regulatory Agency Agencies and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except Other than as set forth in on Section 3.14(e) of the Parent Milan Disclosure Schedule, since January 1, 20202016, neither Parent Milan nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledgethe Knowledge of Milan, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, Parent Milan or any of its Subsidiaries or in which Parent Milan or any of its Subsidiaries or their respective current products or product candidates candidates, including the Milan Product Candidates, have participated. Parent has made available to participated since the Company true and complete copies date of all material notices, correspondence Milan’s acquisition of such product or other communications received by Parent from any Drug Regulatory Agency, if anyproduct candidate. (f) Neither Parent Milan nor any of its Subsidiaries is the subject of any pending or, to Parent’s Knowledgethe Knowledge of Milan, 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 Parent’s Knowledgethe Knowledge of Milan, neither Parent 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 ParentMilan, any of its Subsidiaries nor 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To the Knowledge of Milan, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Milan or any of its Subsidiaries or any of their respective officers, employees or agents.

Compliance; Permits; Restrictions. (a) Parent and each of its Subsidiaries areCaladrius is, and since January 1, 2020 have 2019, has been, in compliance in all material respects with all applicable Laws, 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 is pending or, to Parent’s Knowledgethe Knowledge of Caladrius, threatened against Parent or any of its SubsidiariesCaladrius. There is no agreement, judgment, injunction, order or decree binding upon Parent or any of its Subsidiaries Caladrius which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Parent or any of its SubsidiariesCaladrius, any acquisition of material property by Parent or any of its Subsidiaries Xxxxxxxxx or the conduct of business by Parent or any of its Subsidiaries Xxxxxxxxx as currently conducted, (ii) is reasonably likely to have an adverse effect on Parent’s Caladrius’ ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. (b) Parent Each of Caladrius and its Subsidiaries hold Xxxxxx Sub holds all required Governmental Authorizations which that are material to the operation of the business of Parent Caladrius and its Subsidiaries Merger Sub as currently conducted (collectively, the “Parent Caladrius Permits”). Section 3.14(b) of the Parent Caladrius Disclosure Schedule identifies each Parent Caladrius Permit. Parent Each of Caladrius and its Subsidiaries 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 Merger Sub is in material compliance with the terms of the Parent Caladrius Permits. No Legal Proceeding is pending or, to Parent’s Knowledgethe Knowledge of Caladrius, threatened, which seeks to revoke, limit, suspend, or materially modify any Parent Caladrius Permit. The rights and benefits of each Parent Caladrius Permit will be available to Parent Caladrius and its Subsidiaries Surviving Corporation immediately after the Effective Time on terms substantially similar identical to those enjoyed by Parent Xxxxxxxxx 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 Parent’s Knowledgethe Knowledge of Caladrius, threatened with respect to an alleged material violation by Parent or any of its Subsidiaries Caladrius of the FDCA, FDA regulations adopted thereunder, the Controlled Substances Act, the Public Health Service Substance Act or any other similar Law administered or promulgated by any a Drug Regulatory Agency. (d) Parent Each of Caladrius and Merger Sub holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of Caladrius and 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 “Caladrius Product Candidates”) (the “Caladrius Regulatory Permits”) and no such Caladrius Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner other than immaterial adverse modifications. Caladrius is not currently conducting in compliance in all material respects with the Caladrius Regulatory Permits and neither Caladrius nor Merger Sub has received any written notice or addressing, and other written communication from any Drug Regulatory Agency regarding (A) any material violation of or failure to Parent’s Knowledge there is no basis to expect that it will be required to conduct comply materially with any term or address, requirement of any corrective actions, including, without limitation, product recalls or clinical holds.Caladrius (e) All clinical, pre-clinical and other studies and tests conducted by or, to Parent’s Knowledgethe Knowledge of Caladrius, on behalf of, or sponsored by, Parent or any of its Subsidiaries, Caladrius or in which Parent Caladrius or any of its Subsidiaries or their respective current products or product candidates candidates, including the Caladrius 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 ethics and in compliance in all material respects with the applicable regulations of any applicable the Drug Regulatory Agency Agencies and other applicable Law, including including, without limitation, 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 Since January 1, 20202019, neither Parent Xxxxxxxxx nor any of its Subsidiaries Merger Sub has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or, to Parent’s Knowledgethe Knowledge of Caladrius, threatening to initiate, the termination or suspension of any clinical studies trials conducted by or on behalf of, or sponsored by, Parent or any of its Subsidiaries Caladrius or in which Parent Caladrius or any of its Subsidiaries or their respective current products or product candidates candidates, including the Caladrius 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 Parent nor any of its Subsidiaries Caladrius is not the subject of any pending or, to Parent’s Knowledgethe Knowledge of Caladrius, 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 Parent’s Knowledgethe Knowledge of Caladrius, neither Parent nor any of its Subsidiaries Xxxxxxxxx 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 the 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 ParentCaladrius, any of its Subsidiaries nor Merger 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 debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No To the Knowledge of Caladrius, no debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to Parent’s Knowledge, or threatened against Parent, Caladrius or any of its Subsidiaries or any of their respective officers, employees or agents.