Common use of Regulatory Matters; Products and Product Candidates Clause in Contracts

Regulatory Matters; Products and Product Candidates. Except as described in the Registration Statement and the Prospectus or as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of the Company and its subsidiaries (i) is, and at all times has been, in compliance with applicable provisions of the Health Care Laws (as defined below) of the U.S. Food and Drug Administration (“FDA”) and all statutes, rules and regulations of any other comparable federal, state, local or foreign governmental and regulatory authorities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product currently in development by the Company (collectively, the “Applicable Laws”; (ii) has not received any correspondence or written notice from any governmental or regulatory authority alleging or asserting non-compliance with (x) any Applicable Laws or (y) any licenses, exemptions, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Regulatory Authorizations”); and (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted, and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Regulatory Authorizations.

Regulatory Matters; Products and Product Candidates. Except as described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus or as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of the Company and its subsidiaries (i) is, and at all times has been, in compliance with applicable provisions of the Health Care Laws (as defined below) of the U.S. Food and Drug Administration (“FDA”) and all statutes, rules and regulations of any other comparable federal, state, local or foreign governmental and regulatory authorities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any product currently in development by the Company (collectively, the “Applicable Laws”; (ii) has not received any correspondence or written notice from any governmental or regulatory authority alleging or asserting non-compliance with (x) any Applicable Laws or (y) any licenses, exemptions, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Regulatory Authorizations”); and (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted, and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Regulatory Authorizations.

Regulatory Matters; Products and Product Candidates. Except as described in the Registration Statement and the Prospectus or Prospectus, the Company (collectively with its subsidiaries) and except, in each case, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, each of the Company and its subsidiaries : (i) is, has operated and at all times has been, currently operates its business in compliance with applicable provisions of the all Health Care Laws (as defined below) of the U.S. Food and Drug Administration (“FDA”) and all statutes, rules and regulations of any other comparable federal, state, local or foreign governmental and regulatory authorities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s or its subsidiaries’ product currently in development candidates or any product manufactured or distributed by the Company (collectively, the “Applicable Laws”Company; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (xA) any Applicable Health Care Laws or (yB) any licenses, exemptions, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Health Care Laws (“Regulatory Authorizations”); and (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted, and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Regulatory Authorizations.and