Clinical Supply and Quality Agreement. Within ​ days of the Effective Date, the Parties shall enter into a clinical supply agreement setting forth any additional terms and conditions of such supply and quality with respect thereto, including a reasonable and customary quality assurance agreement that shall set forth the terms and conditions upon which UroGen will conduct its quality activities in connection with such supply. Such agreements shall be negotiated and agreed by the Parties in good faith.

Following depletion of the Current Compound Inventory Ovid is free to purchase its Compound requirement from a Third Party and/or from Lundbeck, provided however that Lundbeck shall not be obligated to manufacture Compound to Ovid once the Current Compound Inventory is depleted. If Ovid and Lundbeck agree on a continued supply of Compound, Lundbeck shall sell Compound to Ovid at the Fully Burdened Cost plus a manufacturing royalty subject to [Section 4.18].

The terms under which SGI will supply clinical supplies of SGI Antibodies to Unum for use as part of the Development Candidates in the Territory under the Late Clinical Development Plan will be set forth in a supply agreement to be entered into between the Parties no later than ​ days prior to the date of initiation of a Clinical Trial of the first Development Candidate in the Territory (the “SGI Antibodies Clinical Supply Agreement”). Such SGI Antibodies Clinical Supply Agreement will contain terms and conditions that are consistent with this Agreement.

Supply. Subject to the terms and conditions of this Agreement, from and after the Effective Date, during the Term of a Product: # TRIS shall use Commercially Reasonable Efforts to manufacture, or have manufactured, Label and Package, and supply to AYTU, all of AYTU’s and its Subsidiaries’ and/or sublicensees’ requirements of such Product and # except as expressly provided in [Section 6.9, TRIS] shall not manufacture such Product for, or supply a Product to, any Third Party for sale in the Territory without the prior written consent of AYTU. Subject to the terms and conditions of this Agreement, and without limiting any other restrictions contained in this Agreement, from and after the Effective Date, during the Term of a Product AYTU shall purchase all of AYTU’s and its Subsidiaries’ requirements of such Product from TRIS (except as otherwise set forth in this Agreement).

Supply. For the Initial Development Activities, ​ shall supply pre-clinical and clinical requirements, including the requirement for the initial Phase 3 campaign, of the Licensed Compounds or Licensed Products and placebo or other comparators for use by ​ in the Development of Licensed Compounds or Licensed Products as contemplated in the Initial Development Plan and Budget; provided, that ​ agrees [[Organization A:Organization]] (or its Affiliate) shall have a right of first negotiation to Manufacture the Licensed Compounds or Licensed Products and placebo or other comparators for the initial Phase 3 campaign and the Parties shall negotiate in good faith the terms and conditions on which [[Organization A:Organization]] (or its Affiliate) would supply such requirements. In the event, despite good faith negotiations, the Parties are unable to agree upon the terms and conditions of the supply arrangement for the initial Phase 3 campaign, then ​ would be free to negotiate and enter into a supply arrangement with a Third Party. After [[Organization A:Organization]] proceeds with the In-Licensing and for Development activities CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...​...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

“SGI Antibodies Clinical Supply Agreement” has the meaning set forth in Section 9.3(c)(i).

“ACTR T-cell Clinical Supply Agreement” has the meaning set forth in Section 9.2(d)(i).

President, Clinical Development & Pharma Supply

Supply Chain Management. Unless otherwise determined by the Parties, # Unum will assume primary responsibility for the ACTR T-cell supply chain for clinical and commercial supply of Research Candidates, Development Candidates, and Products in the Territory, and # SGI will assume primary responsibility for the SGI Antibody supply chain for clinical and commercial supply of Research Candidates, Development Candidates, and Products in the Territory.

Transferred Clinical Trials. Without limiting its obligations under Section 3.2.1, Licensee shall be solely responsible, at its own cost and expense, for conducting and completing all Transferred Clinical Trials and any other trial to satisfy post-marketing commitments necessary or desirable to obtain or maintain Regulatory Approval of and enable and support the Manufacture and Commercialization of Licensed Products in the Territory. Axsome and Licensee shall undertake all actions reasonably necessary to transfer Axsome’s responsibilities and obligations under the Transferred Clinical Trials to Licensee and to assign to Licensee those clinical trial agreements listed in [Schedule 3.3.1], which are in existence as of the Effective Date and under which such Transferred Clinical Trials are being conducted.