Common use of Compliance with Applicable Law; Permits Clause in Contracts

Compliance with Applicable Law; Permits. (a) With respect to the conduct or operation of the Business and the ownership or use of the Purchased Assets, (i) Seller and each of its Subsidiaries are, and have been, in compliance with all Applicable Laws in all material respects, (ii) neither Seller nor any of its Subsidiaries has received any written notice, Order, complaint or other communication that Seller or any of its Subsidiaries has any material Liability under any Applicable Law which has not been fully discharged or extinguished, or that Seller or any of its Subsidiaries is not, or has not been, in material compliance with any Applicable Law and, to the Knowledge of Seller, there is no reasonable basis therefor, and (iii) neither Seller nor any of its Subsidiaries has received any written notice of, and, to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any investigation or review by any Governmental Entity with respect to Seller regarding a violation of any Applicable Law by Seller or any of its Subsidiaries, which has subjected, or is reasonably likely to subject, Seller or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor. (b) Seller and each of its Subsidiaries are in possession of, and in compliance with all material Permits necessary or appropriate for Seller or its Subsidiaries to lawfully own, lease and operate the Purchased Assets and to lawfully carry on the Business as currently conducted consistent with past practice (the “Seller Permits”), a complete and correct list of which is set forth, as of the date hereof, in Section 2.4(b) of the Seller Disclosure Schedule. Each Transferred Permit is valid and in full force and effect. Neither Seller nor any of its Subsidiaries has received any written notice of, and to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any suspension, cancellation, modification, revocation or nonrenewal of any Seller Permit which has subjected, or is reasonably likely to subject, Seller or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor.

Compliance with Applicable Law; Permits. (a) With respect to the conduct or operation of the Business and the ownership or use of the Purchased Assets, (i) Seller and each of its Subsidiaries are, and have been, in compliance with all Applicable Laws relating to the ownership, distribution, development, use or operation (as applicable) by Seller or its Subsidiaries of any of the Purchased Assets in all material respects. Neither Seller, (ii) neither Seller nor any of its Subsidiaries has received any written notice, Order, complaint or other communication that Seller or any of its Subsidiaries has any material Liability relating to the Purchased Assets under any such Applicable Law which has not been fully discharged or extinguished, extinguished or that Seller or any of its Subsidiaries is not, or has not been, in material compliance with any such Applicable Law and, relating to the Knowledge of Purchased Assets. Neither Seller, there is no reasonable basis therefor, and (iii) neither Seller nor any of its Subsidiaries Subsidiaries, has received any written notice of, and, to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any investigation or review by any Governmental Entity with respect to Seller or any of its Subsidiaries regarding a violation of any Applicable Law by Seller or any of its SubsidiariesSubsidiaries relating to the ownership, which has subjecteddistribution, development, use or is reasonably likely to subject, operation (as applicable) by Seller or its Subsidiaries of any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis thereforPurchased Assets. (b) Seller and each of its Subsidiaries are in possession of, and in compliance with has all material Permits necessary or appropriate for Seller or its Subsidiaries to lawfully own, lease distribute, develop, use and operate (as applicable) the Purchased Assets and to lawfully carry on in the Business as currently conducted consistent with past practice (the “Seller Permits”), a complete and correct list of manner in which is set forth, as of the date hereof, in Section 2.4(b) of the Seller Disclosure Schedule. Each Transferred Permit is valid and in full force and effect. Neither Seller nor any of its Subsidiaries has received any written notice ofown, distribute, develop, use and to operate (as applicable) the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any suspension, cancellation, modification, revocation or nonrenewal of any Seller Permit which has subjected, or is reasonably likely to subject, Seller or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis thereforPurchased Assets.

Compliance with Applicable Law; Permits. (a) With respect Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, (a) the Company and its Subsidiaries hold all permits, licenses, approvals, certificates and other authorizations of and from, and have made all notifications, registrations, certifications, declarations and filings with, all Governmental Entities necessary or advisable for the lawful conduct or operation of the Business their respective businesses as presently conducted, and the ownership or use lease of their properties and assets, including without limitation all Laws enforced by the FDA, (b) all such permits, licenses, approvals, certificates and other authorizations are in full force and effect, (c) the businesses of the Purchased Assets, (i) Seller Company and each of its Subsidiaries are, have been and have been, are now being operated in compliance with all Applicable applicable Laws of all Governmental Entities and (d) there is no action, suit or proceeding pending or, to the Company’s knowledge, threatened in all writing by any Governmental Entity that claims any material respects, (ii) neither Seller nor any of its Subsidiaries has received any written notice, Order, complaint or other communication that Seller violation by the Company or any of its Subsidiaries has any material Liability under any Applicable Law which has of applicable Law. (b) Except as would not been fully discharged have or extinguishedreasonably be expected to have, individually or that Seller or any in the aggregate, a Company Material Adverse Effect, none of its Subsidiaries is not, or has not been, in material compliance with any Applicable Law and, to the Knowledge of Seller, there is no reasonable basis therefor, and (iii) neither Seller nor any of its Subsidiaries has received any written notice of, and, to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any investigation or review by any Governmental Entity with respect to Seller regarding a violation of any Applicable Law by Seller Company or any of its Subsidiaries, or, to the knowledge of the Company, any of their respective directors, employees, agents or subcontractors, has been convicted of any crime or engaged in any conduct which has subjectedcould result in debarment or disqualification by the FDA or any comparable Governmental Entity, and there are no proceedings pending or, to the knowledge of the Company, threatened that reasonably might be expected to result in criminal liability or is reasonably likely to subject, Seller debarment or disqualification by the FDA or any comparable Governmental Entity. Each product candidate of the Company or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor. (b) Seller and each of its Subsidiaries are in possession of, and in compliance with all material Permits necessary or appropriate for Seller or its Subsidiaries to lawfully own, lease and operate the Purchased Assets and to lawfully carry on the Business as currently conducted consistent with past practice (the “Seller Permits”), a complete and correct list of which is set forth, clinical trials as of the date hereofhereof is and has been developed, in Section 2.4(b) tested, manufactured and stored by or on behalf of the Seller Disclosure Schedule. Each Transferred Permit is valid and in full force and effect. Neither Seller nor any of its Subsidiaries has received any written notice of, and to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any suspension, cancellation, modification, revocation or nonrenewal of any Seller Permit which has subjected, or is reasonably likely to subject, Seller Company or any of its Subsidiaries in compliance in all material respects with the U.S. Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations promulgated thereunder, and all applicable similar Laws, including those requirements relating to any material Liability and“good manufacturing practice,” “good laboratory practice” and “good clinical practice,” as defined by the FDA, to the Knowledge of Seller, there is no reasonable basis thereforand all applicable Law.

Compliance with Applicable Law; Permits. (a) With respect Each of the Acquired Companies, including the Acquired Business is not, and since the Lookback Date has not been, in violation of any Law applicable to the conduct Acquired Companies, except for violations that would not be reasonably be expected to be, individually or operation of in the Business and aggregate, material to the ownership or use of the Purchased AssetsAcquired Business, (i) Seller taken as a whole, and each of its Subsidiaries arethe Acquired Companies has obtained, maintained in full force and effect and is, and have since the Lookback Date has been, in compliance with all Applicable Laws in all material respectsPermits, (ii) neither Seller nor any of its Subsidiaries has received any written noticeexemptions, Orderorders and franchises from Governmental Entities required to conduct the Acquired Business and own, complaint or other communication that Seller or any of its Subsidiaries has any material Liability under any Applicable Law which has not been fully discharged or extinguished, or that Seller or any of its Subsidiaries is not, or has not been, in material compliance with any Applicable Law and, lease and operate their respective assets and properties related to the Knowledge Acquired Business as conducted by the Acquired Companies, except for (x) any such licenses the absence of Sellerwhich or (y) any noncompliance with which would not be reasonably expected to be, there is no reasonable basis thereforindividually or in the aggregate, and (iii) neither Seller nor any of its Subsidiaries has received any written notice of, and, material to the Knowledge of SellerAcquired Business, there has not occurredtaken as a whole (collectively, is not pending and is not threatened, any investigation or review by any Governmental Entity with respect to Seller regarding a violation of any Applicable Law by Seller or any of its Subsidiaries, which has subjected, or is reasonably likely to subject, Seller or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor“Material Permits”). (b) Seller and each of its Subsidiaries are in possession of, and in compliance with all material Permits necessary or appropriate for Seller or its Subsidiaries to lawfully own, lease and operate the Purchased Assets and to lawfully carry on the Business as currently conducted consistent with past practice (the “Seller Permits”), a complete and correct list of which is set forth, as of the date hereof, in Section 2.4(bSchedule 3.6(b) of the Seller Disclosure ScheduleLetter sets forth a true, correct and complete list of all Material Permits, true, correct and complete copies of which have been made available to Purchaser. Each Transferred Permit is valid and in full force and effect. Neither Seller nor any of its Subsidiaries has received any written notice of, and to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any No suspension, cancellation, modification, revocation or nonrenewal of any Seller Material Permit which has subjected, or is reasonably likely to subject, Seller or any of its Subsidiaries to any material Liability andpending or, to the Knowledge of SellerSeller or any of the Acquired Companies, there threatened, except for where such suspension, cancellation, revocation or nonrenewal would not reasonably be expected to be, individually or in the aggregate, material to the Acquired Business, taken as a whole. (c) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Acquired Business, taken as a whole, since the Lookback Date none of the Acquired Companies or any director, officer, or employee of any of the Acquired Companies, or, to the Knowledge of Seller or any of the Acquired Companies, any agent, third party advisor, employee or other Person acting on behalf of any of the Acquired Companies, (i) is no reasonable basis thereforor has been in violation of any provision of the Anti-Corruption Laws with respect to the Acquired Business or (ii) has directly or indirectly made, offered, agreed, requested or taken any other act in furtherance of an offer, promise or authorization of any unlawful bribe, rebate, payoff, influence payment, kickback or other similar unlawful payment in violation of any of the Anti-Corruption Laws with respect to the Acquired Business. Seller has instituted and maintains policies and procedures reasonably designed to ensure compliance with the Anti-Corruption Laws. (d) Except as would not, individually or in the aggregate, be material to the Acquired Business, taken as a whole, since the Lookback Date each of the Acquired Companies has been in full compliance with the U.S. International Traffic in Arms Regulations (22 C.F.R. §§ 120 – 130) and the Export Administration Regulations (15 C.F.R. §§ 730 – 780).

Compliance with Applicable Law; Permits. (a) With Solely with respect to the conduct or operation of the ECM Business and the ownership or use of the Purchased Assetssince January 1, 2015: (i) each member of Seller Group and each of its Subsidiaries are, McKesson is and have been, has been in compliance with all Applicable Laws in all material respects, respects with all Laws; (ii) neither no member of Seller Group nor any of its Subsidiaries McKesson has received any written notice, Order, complaint or other communication that Seller or any of its Subsidiaries has any material Liability under any Applicable Law which has not been fully discharged or extinguished, or that Seller or any of its Subsidiaries is not, or has not been, in material compliance with any Applicable Law and(or, to the Knowledge of SellerSeller Group, there oral) notice or Order, or to the Knowledge of Seller Group, a threatened claim, that any member of Seller Group is no reasonable basis therefor, in material violation of any applicable Law; and (iii) neither no member of Seller Group nor any of its Subsidiaries McKesson has received any written notice of, and(or, to the Knowledge of SellerSeller Group, oral) notice of, and there has not occurred, is not pending and and, to the Knowledge of Seller Group, is not threatenedthreatened in writing, any investigation or review by any Governmental Entity with respect to Seller regarding a violation of any Applicable Law by Seller or any of its Subsidiaries, which has subjected, or is reasonably likely to subject, Seller or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis thereforapplicable Law. (b) Seller Group is and each of its Subsidiaries are has been in possession of, and in compliance with of all material Permits necessary or appropriate for Seller or its Subsidiaries to lawfully own, lease the ownership and operate operation of the Purchased Assets and to lawfully carry on the ECM Business as currently conducted consistent with past practice (the “Seller Group Permits”), except where a complete failure to possess such Permits would not be material to the ECM Business. Seller Group is and correct list has been in material compliance with all Seller Group Permits. No member of which is set forth, as of the date hereof, in Section 2.4(b) of the Seller Disclosure Schedule. Each Transferred Permit is valid and in full force and effect. Neither Seller Group nor any of its Subsidiaries McKesson has received any written notice of, and to the Knowledge of Seller, there has not occurred, is not pending and to the Knowledge of Seller Group, there is not threatened, any suspension, cancellation, modification, revocation or nonrenewal of any Seller Group Permit which that would be material to the ECM Business. (c) Solely with respect to the ECM Business and since the McKesson Transaction Closing Date, neither Seller Group nor any predecessor has subjectedreceived written notice of any use of funds to offer or provide any unlawful contribution, payment, kickback, bribe, gift, gratuity, or entertainment. Seller Group is reasonably likely in compliance in all material respects with, and solely with respect to subjectthe ECM Business and since January 1, 2015, Seller Group and McKesson have during all periods for which any applicable statute of limitations has not expired, complied in all material respects with, the applicable provisions of the U.S. Foreign Corrupt Practices Act of 1977, as amended, and any other applicable U.S. or any of its Subsidiaries to any material Liability and, non-U.S. anti-corruption or anti-bribery laws and regulations. (d) Notwithstanding anything herein to the Knowledge of Sellercontrary, there the representations and warranties contained in Section 2.5(a)(i) will not apply with respect to: (i) compliance with applicable Laws with respect to employee, labor and employee-benefits matters, which is no reasonable basis thereforexclusively addressed in the representations and warranties contained in Section 2.7 and Section 2.8, as applicable; (ii) compliance with applicable Laws with respect to intellectual property matters, which is exclusively addressed in the representations and warranties in Section 2.9; (iii) compliance with applicable Laws with respect to data privacy matters, which is exclusively addressed in the representations and warranties in Section 2.17; and (iv) compliance with applicable Laws with respect to healthcare regulatory compliance matters, which is exclusively addressed in the representations and warranties in Section 2.18.

Compliance with Applicable Law; Permits. (ai) With respect Except as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) Parent and its Subsidiaries hold all permits, licenses, approvals, certificates and other authorizations of and from all, and have made all notifications, registrations, certifications, declarations and filings with, Governmental Entities necessary or advisable for the lawful conduct or operation of the Business their respective businesses as presently conducted, and the ownership or use lease of their properties and assets, including without limitation all Laws enforced by the Purchased AssetsFDA, (iii) Seller all such permits, licenses, approvals, certificates and each other authorizations are in full force and effect, (iii) the businesses of Parent and its Subsidiaries are, have been and have been, are now being operated in compliance with all Applicable applicable Laws of all Governmental Entities and (iv) there is no action, suit or proceeding pending or, to Parent’s knowledge, threatened in all writing by any Governmental Entity that claims any material respects, (ii) neither Seller nor any of its Subsidiaries has received any written notice, Order, complaint or other communication that Seller violation by Parent or any of its Subsidiaries has any material Liability under any Applicable Law which has of applicable Law. (ii) Except as would not been fully discharged have or extinguishedreasonably be expected to have, individually or that Seller or any in the aggregate, a Parent Material Adverse Effect, none of its Subsidiaries is not, or has not been, in material compliance with any Applicable Law and, to the Knowledge of Seller, there is no reasonable basis therefor, and (iii) neither Seller nor any of its Subsidiaries has received any written notice of, and, to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any investigation or review by any Governmental Entity with respect to Seller regarding a violation of any Applicable Law by Seller Parent or any of its Subsidiaries, or, to the knowledge of Parent, any of their respective directors, employees, agents or subcontractors, has been convicted of any crime or engaged in any conduct which has subjectedcould result in debarment or disqualification by the FDA or any comparable Governmental Entity, and there are no proceedings pending or, to the knowledge of Parent, threatened that reasonably might be expected to result in criminal liability or is reasonably likely to subject, Seller debarment or disqualification by the FDA or any comparable Governmental Entity. Each product candidate of Parent or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor. (b) Seller and each of its Subsidiaries are in possession of, and in compliance with all material Permits necessary or appropriate for Seller or its Subsidiaries to lawfully own, lease and operate the Purchased Assets and to lawfully carry on the Business as currently conducted consistent with past practice (the “Seller Permits”), a complete and correct list of which is set forth, clinical trials as of the date hereofhereof is and has been developed, in Section 2.4(b) tested, manufactured and stored by or on behalf of the Seller Disclosure Schedule. Each Transferred Permit is valid and in full force and effect. Neither Seller nor any of its Subsidiaries has received any written notice of, and to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any suspension, cancellation, modification, revocation or nonrenewal of any Seller Permit which has subjected, or is reasonably likely to subject, Seller Parent or any of its Subsidiaries in compliance in all material respects with the U.S. Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations promulgated thereunder, and all applicable similar Laws, including those requirements relating to any material Liability and“good manufacturing practice,” “good laboratory practice” and “good clinical practice,” as defined by the FDA, to the Knowledge of Seller, there is no reasonable basis thereforand all applicable Law.

Compliance with Applicable Law; Permits. (a) With respect to the conduct or operation of the Business and the ownership or use of the Purchased Assets, (i) Seller The Company and each of its Subsidiaries are, and since the Applicable Date have been, in compliance in all material respects with all Applicable Laws except for such non-compliance as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, and except that if any representation or warranty contained in this Article IV with respect to the Company’s and its Subsidiaries’ compliance with any particular areas of Applicable Law is qualified by the Company’s Knowledge, then the representation and warranty set forth in this Section 4.8(a) shall be deemed qualified by Knowledge with respect to such particular area of Applicable Law to the same extent as set forth in such other representation and warranty; (ii) since the Applicable Date, the Company and its Subsidiaries have not received any notices, complaints or other communications (in writing or, to the Knowledge of the Company, otherwise) from any Person, or been subject to any order, regarding any actual or alleged material violation of any Applicable Law; and (iii) no material Proceedings have been filed, or to the Knowledge of the Company, threatened, against the Company and its Subsidiaries alleging a material violation of any Applicable Law. (b) The Company and its Subsidiaries hold, own or possess all material Permits necessary for the lawful ownership, operation and use of the material properties and assets and the conduct of the businesses of the Company and its Subsidiaries as currently conducted, and the Company and its Subsidiaries are in compliance with their respective material obligations under such Permits, in each case except where failure to have such Permits would not reasonably be expected to result in a Material Adverse Effect. Section 4.8(b) of the Company Disclosure Schedule sets forth a true and complete list of all material Permits held by the Company and each of its Subsidiaries, including (i) the jurisdiction in which the Permit is held and (ii) if not reasonably apparent from the Permit, the purpose of such Permit. None of such Permits has been revoked, suspended, restricted, cancelled, modified, impaired or non-renewed, and no statement or notice regarding any violation or failure to comply with, or intention to revoke, suspend, restrict, cancel, modify, impair or fail to renew, any such Permit has been received in writing during the Applicable Period by any of the Company or its Subsidiaries; provided, however, that this Section 4.8(b) shall not apply to any matter related to Taxes, which shall be governed by Section 4.10. (c) Except as set forth in Section 4.8(c) of the Company Disclosure Schedule, since the Applicable Date the Company and its Subsidiaries have complied in all material respectsrespects with their obligations to submit all filings required to be submitted by the Company and its Subsidiaries with any Governmental Authority except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. All such filings were in compliance in all material respects with Applicable Law when filed or as amended or supplemented, and no material deficiencies have been asserted in writing or, to the Knowledge of the Company, orally, by any Governmental Authority with respect to such filings that have not been resolved to the satisfaction of such Governmental Authority. (iid) neither Seller Neither the Company nor any of its Subsidiaries has received any written notice, Order, complaint or other communication that Seller or any of its Subsidiaries has any material Liability under any Applicable Law which has not been fully discharged or extinguished, or that Seller or any of its Subsidiaries is not, or has not been, in material compliance with any Applicable Law andor, to the Knowledge of Sellerthe Company, there is no reasonable basis thereforany other Persons acting on their behalf has, and (i) used any corporate or other funds for unlawful contributions, payments, gifts or entertainment, or made any unlawful expenditures relating to political activity to government officials, candidates or members of political parties or organizations, or established or maintained any unlawful or unrecorded funds in violation of Section 104 of the United States Foreign Corrupt Practices Act of 1977, as amended, or any other similar Law, (ii) paid, accepted or received any unlawful contributions, payments, expenditures or gifts, or (iii) neither Seller nor violated or operated in noncompliance with any of its Subsidiaries has received any written notice ofexport restrictions, andanti-boycott regulations, to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any investigation embargo regulations or review by any Governmental Entity with respect to Seller regarding a violation of any other similar Applicable Law by Seller or any of its Subsidiaries, which has subjected, or is reasonably likely to subject, Seller or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis thereforLaws. (b) Seller and each of its Subsidiaries are in possession of, and in compliance with all material Permits necessary or appropriate for Seller or its Subsidiaries to lawfully own, lease and operate the Purchased Assets and to lawfully carry on the Business as currently conducted consistent with past practice (the “Seller Permits”), a complete and correct list of which is set forth, as of the date hereof, in Section 2.4(b) of the Seller Disclosure Schedule. Each Transferred Permit is valid and in full force and effect. Neither Seller nor any of its Subsidiaries has received any written notice of, and to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any suspension, cancellation, modification, revocation or nonrenewal of any Seller Permit which has subjected, or is reasonably likely to subject, Seller or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor.

Compliance with Applicable Law; Permits. (a) With respect Except as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (a) Parent and its Subsidiaries hold all permits, licenses, approvals, certificates and other authorizations of and from all, and have made all notifications, registrations, certifications, declarations and filings with, Governmental Entities necessary or advisable for the lawful conduct or operation of the Business their respective businesses as presently conducted, and the ownership or use lease of their properties and assets, including without limitation all Laws enforced by the Purchased AssetsFDA, (ib) Seller all such permits, licenses, approvals, certificates and each other authorizations are in full force and effect, (c) the businesses of Parent and its Subsidiaries are, have been and have been, are now being operated in compliance with all Applicable applicable Laws of all Governmental Entities and (d) there is no action, suit or proceeding pending or, to Parent’s knowledge, threatened in all writing by any Governmental Entity that claims any material respects, (ii) neither Seller nor any of its Subsidiaries has received any written notice, Order, complaint or other communication that Seller violation by Parent or any of its Subsidiaries has any material Liability under any Applicable Law which has of applicable Law. (b) Except as would not been fully discharged have or extinguishedreasonably be expected to have, individually or that Seller or any in the aggregate, a Parent Material Adverse Effect, none of its Subsidiaries is not, or has not been, in material compliance with any Applicable Law and, to the Knowledge of Seller, there is no reasonable basis therefor, and (iii) neither Seller nor any of its Subsidiaries has received any written notice of, and, to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any investigation or review by any Governmental Entity with respect to Seller regarding a violation of any Applicable Law by Seller Parent or any of its Subsidiaries, or, to the knowledge of Parent, any of their respective directors, employees, agents or subcontractors, has been convicted of any crime or engaged in any conduct which has subjectedcould result in debarment or disqualification by the FDA or any comparable Governmental Entity, and there are no proceedings pending or, to the knowledge of Parent, threatened that reasonably might be expected to result in criminal liability or is reasonably likely to subject, Seller debarment or disqualification by the FDA or any comparable Governmental Entity. Each product candidate of Parent or any of its Subsidiaries to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor. (b) Seller and each of its Subsidiaries are in possession of, and in compliance with all material Permits necessary or appropriate for Seller or its Subsidiaries to lawfully own, lease and operate the Purchased Assets and to lawfully carry on the Business as currently conducted consistent with past practice (the “Seller Permits”), a complete and correct list of which is set forth, clinical trials as of the date hereofhereof is and has been developed, in Section 2.4(b) tested, manufactured and stored by or on behalf of the Seller Disclosure Schedule. Each Transferred Permit is valid and in full force and effect. Neither Seller nor any of its Subsidiaries has received any written notice of, and to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any suspension, cancellation, modification, revocation or nonrenewal of any Seller Permit which has subjected, or is reasonably likely to subject, Seller Parent or any of its Subsidiaries in compliance in all material respects with the U.S. Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations promulgated thereunder, and all applicable similar Laws, including those requirements relating to any material Liability and“good manufacturing practice,” “good laboratory practice” and “good clinical practice,” as defined by the FDA, to the Knowledge of Seller, there is no reasonable basis thereforand all applicable Law.

Compliance with Applicable Law; Permits. (a) With Solely with respect to the conduct or operation of the Business and the ownership or use of the Purchased AssetsInterconnect Program, (i) Seller and each of its the Related Subsidiaries are, and have been, in compliance with all Applicable Laws in all material respects, (ii) neither Seller nor any of its Subsidiaries Related Subsidiary has received any written notice, Order, complaint or other communication that either Seller or any of its Subsidiaries has Related Subsidiary have any material Liability under any Applicable Law which has not been fully discharged or extinguished, or that either Seller or any of its Subsidiaries is Related Subsidiary are not, or has have not been, in material compliance with any Applicable Law and, to the Knowledge of Seller, there is no reasonable basis therefor, and (iii) neither Seller nor any of its Subsidiaries Related Subsidiary has received any written notice of, and, to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any investigation or review by any Governmental Entity with respect to either Seller or any Related Subsidiary regarding a violation of any Applicable Law by either Seller or any of its SubsidiariesRelated Subsidiary, which has subjected, or is reasonably likely to subject, either Seller or any of its Subsidiaries Related Subsidiary to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor. (b) Seller and each of its the Related Subsidiaries are in possession of, and in compliance with all material Permits necessary or appropriate for Seller or its and the Related Subsidiaries to lawfully own, lease and operate the Purchased Assets and to lawfully carry on the Business as currently conducted consistent with past practice (the “Seller Permits”), a complete and correct list of which is set forth, as of the date hereof, in Section 2.4(b) of the Seller Disclosure Schedule. Each Transferred Permit is valid and in full force and effect. Neither Seller nor any of its Subsidiaries Related Subsidiary has received any written notice of, and to the Knowledge of Seller, there has not occurred, is not pending and is not threatened, any suspension, cancellation, modification, revocation or nonrenewal of any Seller Permit which has subjected, or is reasonably likely to subject, either Seller or any of its Subsidiaries Related Subsidiary to any material Liability and, to the Knowledge of Seller, there is no reasonable basis therefor.