Provision Language
Definitions
“Quality Agreement” means the quality agreement between Customer and Dynavax setting out the responsibilities of the Parties in relation to quality of the Dynavax Adjuvant supplied hereunder as required for compliance with cGMP of the applicable country or jurisdictions.
3. Supply of Dynavax Adjuvant
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3.5 Customer and Dynavax shall enter into a Quality Agreement and Pharmacovigilance Agreement, each in a form reasonable and typical for the industry, within thirty (30) days of the Effective Date. The Quality Agreement shall include provisions covering inter alia recalls of Customer Product(s), and Dynavax Adjuvant and the respective responsibilities of the Parties.
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3.9 Dynavax represents and warrants to Customer that all Dynavax Adjuvant delivered by Dynavax hereunder (whether directly or upon CEPI’s direction as set forth in Section 3.4) will, as of the date of delivery: (a) conform to the applicable Specifications then in effect and Applicable Laws; (b) have been manufactured, labelled, packaged, stored, handled and shipped in accordance with the Quality Agreement, cGMP and other Applicable Laws; (c) not be adulterated or misbranded within the meaning of the United States Food, Drug and Cosmetic Act, as amended, and any regulations promulgated thereunder (the “Act”); (d) not be articles that, under the provisions of the Act, may not be introduced into interstate commerce; and (e) be free and clear of any lien or encumbrance.
12. Compliance with Applicable Laws
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12.3 On reasonable prior notice, Dynavax shall provide all reasonable co–operation to any inspection by any Regulatory Authority, and shall permit such Regulatory Authority access to the Dynavax or Dynavax CMO manufacturing site, as applicable, and all relevant records necessary or reasonably desirable, in each case, in support of the use of the Dynavax Adjuvant as expressly permitted by the Supply Agreement and shall share the results of such inspection promptly with Customer, in writing.
12.4 If any Regulatory Authority notifies Dynavax CMO or Dynavax of a violation or deficiency in compliance which would impact the use of the Dynavax Adjuvant as expressly permitted by the Supply Agreement, Dynavax shall share such notification with Customer within three (3) days of receipt of the same. [***].