Quality Agreement. The Parties shall enter into a Quality Agreement with respect to the Manufacture of Drug Substance within ​ of the Effective Date, but in any event prior to the Manufacture of Drug Substance for commercial purposes. Upon execution, such Quality Agreement shall be appended to this Agreement as [Appendix B].

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. No later than the date of the first shipment of Nektar Compound to BioXcel for use in the Combined Therapy Trials, the Parties shall enter into a quality agreement (the “Quality Agreement”). The Quality Agreement shall outline the additional roles and responsibilities relative to the quality of BioXcel Compound and Nektar Compound in support of the Combined Therapy Trials. The Quality Agreement shall include the responsibility for quality elements including, by way of example, audits & inspections, sub-contractors and suppliers, change control, OOS results, deviations and investigations required to conduct the Combined Therapy Trials. In addition, the Quality Agreement shall detail the documentation required for each shipment of Nektar Compound supplied to BioXcel or its designee for use in the Combined Therapy Trials. The Quality Agreement shall also indicate whether any required transfer from Nektar to BioXcel of analytical methods will be necessary to support identity testing by BioXcel of the Nektar Compound supplied to BioXcel under this Agreement.

Quality Agreement. The Parties shall enter into a Quality Agreement within ​.

Quality Agreement. All further provisions regarding audits and inspections, Product complaints and recall management are set forth in the Quality Agreement applicable to the Products. The Parties acknowledge and agree that no Products shall be manufactured under this Agreement until the applicable Quality Agreement is effective.

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. Within 120 days 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 Products for the Territory and containing terms and conditions customary for such agreements (the “Quality Agreement”).

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. 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. The Parties shall enter into separate quality agreement regarding supply of the Materials by Licensor to Licensee, incorporating provisions that are standard in the pharmaceutical field within ​ days after Effective Date, and in any event prior to any delivery of Materials, as set forth in more details in EXHIBIT 6.