3. Supply of Dynavax Adjuvant
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.
3.11 EXCEPT AS EXPRESSLY SET FORTH IN THE SUPPLY AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON–INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES.
7. Covenants and Warranties
7.1 In addition to any covenants made by it elsewhere in the Supply Agreement, each Party hereby covenants to the other Party that in connection with the exercise of such Party’s rights or performance of such Party’s obligations under the Supply Agreement:
(a) neither such Party nor any of its affiliates will, directly or indirectly through affiliates or third parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including such Party and its affiliates, nor will such Party or any of its affiliates directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other Person;
(b) neither such Party nor any of its affiliates (or any of their respective employees and contractors), in connection with the exercise of such Party’s rights or performance of such Party’s obligations under the Supply Agreement, shall cause the other Party to be in violation of Anti–Corruption Laws or Export Control Laws;
(c) such Party shall immediately notify the other Party if such Party has any information that there is or is likely to be a violation of Anti–Corruption Laws or Export Control Laws in connection with the exercise of such Party’s rights or performance of such Party’s obligations under the Supply Agreement; and
(d) each Party shall undertake due diligence activities appropriate to its activities under the Supply Agreement in accordance with applicable Anti–Corruption Laws and related guidance, including guidance issued by the U.S. Department of Justice Criminal Division (entitled “Evaluation of Corporate Compliance Programs”) as amended from time to time, concerning the Foreign Corrupt Practices Act (15 U.S.C. §§78dd–1, et. seq.), and issued by the U.K. Ministry of Justice concerning the UK Bribery Act 2010 as amended from time to time, such activities to include the conduct of appropriate due diligence in relation to third party contractors, and shall collaborate with the other Party to ensure such compliance.
Each Party has the right, upon reasonable notice and at its sole expense, to conduct, or have conducted by an independent third party reasonably acceptable to the other Party, no more than once every three years(except for cause), a reasonable and customary audit of the other Party for the purposes of monitoring compliance with this Section 7.1, and the other Party shall, subject to compliance with Applicable Laws, provide to such Party any relevant documents reasonably requested by such Party in relation thereto. Save in respect of such an audit for cause, the auditing Party shall reimburse the audited Party for reasonable and documented out–of–pocket costs and expenses incurred by the audited Party in complying with the foregoing audit requirements.
7.2 Dynavax warrants and represents to Customer that:
(a) it has the requisite power and authority to enter into the Supply Agreement and to perform its obligations hereunder;
(b) as of the Effective Date neither Dynavax nor any of its officers or employees has been debarred under the U.S. Food, Drug and Cosmetic Act or any equivalent foreign law, and Dynavax is not involved, nor to its knowledge are any of its officers or employees involved, in any such debarment proceeding. Dynavax agrees that it will (i) not use, and (ii) require that any third–party from whom it obtains services in connection with this Supply Agreement not use, the services of any person debarred under the U.S. Food, Drug and Cosmetic Act or any equivalent foreign law;
(c) as of the Effective Date, there (i) have not been any lawsuit(s) or dispute(s) and (ii) are no pending lawsuit(s) / dispute(s) (or any notice of any imminent lawsuit / dispute), in each case, against Dynavax or its affiliates, or, to Dynavax’s knowledge, Dynavax CMO, relating to the Dynavax Adjuvant;
(d) to the best of Dynavax’s knowledge, the manufacturing, offering for sale, selling, exporting, importing and using of the Dynavax Adjuvant shall not infringe the intellectual property rights of any third party;
(e) it and Dynavax CMO hold all authorizations, permits and licenses which are necessary to fulfil Dynavax’s obligations hereunder;
(f) there are no agreements between Dynavax and any third party that conflict with the Supply Agreement.
7.3 Customer warrants and represents to Dynavax that:
(a) it has the requisite power and authority to enter into the Supply Agreement and to perform its obligations hereunder; and
(b) there are no agreements between Customer and any third party that conflict with the Supply Agreement.
12. Compliance with Applicable Laws
12.1 In performing its obligations under the Supply Agreement, Dynavax and Customer shall comply, and shall ensure that their respective affiliates comply, and Dynavax shall ensure that the Dynavax CMO complies, with all Applicable Laws.
12.2 Dynavax or Dynavax CMO, as applicable, shall manufacture, sample, test and store all Dynavax Adjuvant and provide a COA and COC in accordance with the Quality Agreement.