EXECUTION VERSION
6.3 |
As between the Parties, Context shall bear all costs relating to all recalls and market withdrawals whether
voluntary or requested or required by Applicable Laws or by any Regulatory Authority. |
7. |
REPRESENTATIONS AND WARRANTIES |
7.1 |
Each Party hereby represents and warrants to the other Party as follows: |
(a) Such Party is a company/corporation, duly organized, validly existing and in good standing under the laws of the
jurisdiction of its incorporation or organization, is qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification
and failure to have such would prevent such Party from performing its obligations under this Agreement;
(b) The execution,
delivery and performance of this Agreement by such Party have been duly authorized by all necessary corporate or organizational action. This Agreement is a legal and valid obligation binding on such Party and enforceable in accordance with its terms
and does not (i) to such Partys knowledge, violate any law, rule, regulation, order, writ, judgment, decree, determination or award of any court, governmental body or administrative or other agency having jurisdiction over such Party, or
(ii) conflict with, or constitute a default under, any agreement, instrument or understanding, oral or written, to which such Party is a party or by which it is bound;
(c) Other than the Regulatory Approvals, such Party has obtained all necessary government authorizations, consents, approvals,
licenses, exemptions of, or filings or registrations with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Applicable Laws currently in effect in connection with, the
transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements;
(d) Such Party is (i) not, and during the Term shall not be, a Debarred Entity; and (ii) not currently using, and
will not in the future use, in any capacity, in connection with the performance of its duties or obligations hereunder, the services of any person or entity (x) debarred or subject to debarment under 21 U.S.C. § 335a or otherwise
disqualified or suspended from performing services, or (y) otherwise subject to any restrictions or sanctions by the FDA or any other regulatory agency or government, or (z) convicted of a criminal offense related to the provision of
healthcare items or services, or is subject to any such pending action (each of (x)-(z), a Debarred Entity). Such Party shall immediately notify the other Party in writing and shall cease employing, contracting with, or retaining
any such person to perform any services, as applicable, if either such Party or any person or entity who is performing services on its behalf hereunder is or becomes a Debarred Entity or if any action, claim, investigation, or other legal or
administrative proceeding is pending or, to the best of such Partys knowledge, threatened, that would make the other Party or any person or entity performing services hereunder a Debarred Entity;
(e) Such Party will not intentionally take or permit its Affiliates to take, any action to make the Program Products unfit for
commerce under any applicable regulatory requirements in the Territory (including, but not limited to, being adulterated or misbranded as defined under the FD&C Act or becoming an article that may not, under the FD&C Act, be introduced into
interstate commerce); and
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