Quality Assurance. Within ​ of the Effective Date, the Parties shall enter into a quality assurance agreement for the Unlabeled Product (the “Quality Agreement”). The Quality Agreement shall address the standard quality terms of supply and relevant other terms, including, terms relating to specifications, product warranties, quality testing, storage, shipment, labelling, quality controls and regulatory matters.

After a Confirmation Number is issued by the Transfer Agent to the Participant, the Participant will fax a written version of the Creation Order to the Transfer Agent. Upon receipt, the Transfer Agent should immediately telephone the Participant if the Transfer Agent believes that the Creation Order has not been completed correctly by the Participant. In addition, the Transfer Agent will telephone the Participant if the Transfer Agent is in non-receipt of the Creation Order within 15 minutes after the Creation Order has been called into the Transfer Agent.

After a Confirmation Number is issued by the Transfer Agent to the Participant, the Participant will fax a written version of the Redemption Order to the Transfer Agent. Upon receipt, the Transfer Agent should immediately telephone the Participant if the Transfer Agent believes that the Redemption Order has not been completed correctly by the Participant. In addition, the Transfer Agent will telephone the Participant if the Transfer Agent is in non-receipt of the Redemption Order within 15 minutes after the Redemption Order has been called into the Transfer Agent.

After a Confirmation Number is issued by the Transfer Agent to the Participant, the Participant will fax a written version of the Creation Order to the Transfer Agent. Upon receipt, the Transfer Agent should immediately telephone the Participant if the Transfer Agent believes that the Creation Order has not been completed correctly by the Participant. In addition, the Transfer Agent will telephone the Participant if the Transfer Agent is in non-receipt of the Creation Order within 15 minutes after the Creation Order has been called into the Transfer Agent.

After a Confirmation Number is issued by the Transfer Agent to the Participant, the Participant will fax a written version of the Redemption Order to the Transfer Agent. Upon receipt, the Transfer Agent should immediately telephone the Participant if the Transfer Agent believes that the Redemption Order has not been completed correctly by the Participant. In addition, the Transfer Agent will telephone the Participant if the Transfer Agent is in non-receipt of the Redemption Order within 15 minutes after the Redemption Order has been called into the Transfer Agent.

Quality Agreement. The Parties shall enter into a separate Quality Agreement relating to the Parties’ quality responsibilities substantially in accordance with ​, before Supplier commences the Supplier Bulk Supply and/or Packaging Services for Customer for commercial production.

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 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.

Certain identified information marked with ​ has been excluded from this exhibit because it is not material and is of the type that the registrant treats as private and confidential.