Quality Agreement. The Parties acknowledge and agree that a quality agreement between [[Durect:Organization]] and Gilead for supply of Product pursuant to this Section 5.1 (“Quality Agreement”) shall be executed by the Parties no later than ​ after the Effective Date, or sooner if needed for purposes of Phase 1 Clinical Trials.

Quality Agreement. Within 6 months after the Effective Date, and in any event prior to the first Processing of Product hereunder, the parties shall negotiate in good faith and enter into a quality or technical agreement on Catalent’s standard template (the “Quality Agreement”). The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set out therein. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.

Quality Agreement. Within ​ following the Effective Date, the Parties shall enter into a separate quality agreement that describes the responsibilities of each Party in the area of technical cooperation and quality assurance with respect to the supply of the Licensed Compound and Licensed Products for the Territory and containing terms and conditions customary for such agreements (the “Quality Agreement”).

Quality Agreement. Within sixty (60) days of the Effective Date, Purchaser and FIS shall enter into a quality agreement for the APIs substantially in the form set forth in [Schedule 4.5] to this Agreement (the “Quality Agreement”). Each Party shall comply with its obligations set forth in the Quality Agreement. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the terms of this Agreement shall control with respect to all commercial or business matters, and the terms of the Quality Agreement shall control with respect to all quality matters. The Quality Agreement shall establish the procedure to be followed if either FIS or Purchaser desires to change any aspect of the manufacturing process for any API, including but not limited to any change in the Specifications as described in Section 4.2 above.

Quality Agreement. As soon as reasonably practicable after the Effective Date, but no later than ninety (90) days thereafter, the Parties shall negotiate in good faith and agree to the terms and conditions of a quality agreement (the “Quality Agreement”), which shall be consistent in all material respects with Dynavax’s quality agreement with its CMO, setting forth the respective responsibilities of Parties in relation to quality as required for compliance with Applicable Laws, including GMP, and including provisions # ​ and # ​. The Quality Agreement is hereby incorporated herein by reference. To the extent that the terms of this Agreement and those of the Quality Agreement are in conflict, the terms of this Agreement shall control except with respect to quality issues, which shall be governed by the Quality Agreement. Each Party agrees to comply, and to cause its Affiliates and, in the case of Dynavax, its CMOs, to comply, with such Party’s obligations under the Quality Agreement.

Quality Agreement. Concurrently with the parties entering into a Work Order pursuant to which Product will be manufactured by [[CoreRx:Organization]] or supplied to Client, the parties will enter into the Quality Agreement, which will govern the quality assurance obligations and responsibilities of the parties with respect to such Product. The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set forth therein. Notwithstanding anything to the contrary in this Agreement or in any other document or agreement, in the event of a conflict between this Agreement and the Quality Agreement in relation to issues of quality, the Quality Agreement shall control; in all other cases, the terms and conditions of this Agreement shall govern and control.

Quality Agreement. Prior to the Relay IND Transfer Date, the Parties will, and will use Commercially Reasonable Efforts to cause Relay’s CMO for the Relay Phase Ia Trial to, negotiate in good faith and enter into a quality agreement (the “Quality Agreement”) with respect to the supply of Phase Ia Product for the Relay Phase Ia Trial and to designate rights and responsibilities as between such parties to support the IND for the Relay Phase Ia Trial after the Relay IND Transfer Date. Relay acknowledges that the foregoing is a condition to completion of the Relay IND Transfer.

Quality Agreement. Both Parties shall adhere to the provisions of the applicable QAA and the Parties agree that all elements of quality assurance, quality control and the like shall be governed by the terms and conditions of the applicable QAA. In the event of a conflict between the MSA and the applicable QAA, the MSA shall prevail over those of the applicable QAA with the exception of Product quality-related matters, cGMP and related regulatory requirements in which case, the terms of the applicable QAA shall prevail. The QAA for any Product is incorporated herein, and any material breach of the QAA may constitute a breach of this MSA

The parties will execute the Quality Agreement on or prior to the Effective Date.

Quality Agreement. Responsibility for quality assurance and quality control of Product shall be allocated between Customer and Lonza as set forth in the Quality Agreement. If there is a conflict between the terms and conditions of this Agreement and the Quality Agreement, the terms and conditions of this Agreement shall prevail. Performance by Lonza of all of its obligations under the Quality Agreement will be considered covered by the Batch Price and no additional consideration is payable by Customer unless otherwise agreed between the Parties. For clarity, the foregoing does not require Lonza to provide regulatory support other than as set forth in this Agreement and the Quality Agreement.