Clinical Studies. All Clinical Studies were and, if still pending, are in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Laws and Authorizations. [Schedule 4.7] sets forth a detailed description of the Clinical Studies conducted by Seller prior to the execution hereof. The descriptions of the results of such studies, tests and trials contained in [Schedule 4.7] are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; Seller is not aware of any studies, tests or trials the results of which call into question the Clinical Studies set forth in [Schedule 4.7] when viewed in the context in which such results are described and the clinical state of development; and Seller has not received any notices or correspondence from any Regulatory Agency or any other governmental authority requiring the termination, suspension or material modification of any Clinical Studies conducted by or on behalf of Seller.

subsequent to the Initial Development Activities, [[Organization A:Organization]] shall supply pre-clinical and clinical requirements of the Licensed Compounds or Licensed Products and placebo or other comparators for use by [[Organization A:Organization]] in the Development of Licensed Compounds or Licensed Products as contemplated in the Development Plan. If the Parties are unable to agree upon a supply arrangement for the initial Phase 3 campaign pursuant to the right of first negotiation set forth in this Section 3.5.1 and in order to ensure the continuity of Development of the Licensed Compound, as reasonably requested by [[Organization A:Organization]], ​ shall and shall use Commercially Reasonable Efforts to cause its Third Party Providers to enter into supply and any other relevant agreements with [[Organization A:Organization]] to facilitate the transition of clinical supply responsibility to [[Organization A:Organization]] after [[Organization A:Organization]] proceeds with the In-Licensing, which agreements shall provide for Phase 3 and commercial clinical supply materials. Due to the lead-time for manufacturing, the initial Phase 3 clinical supply materials and associated manufacturing activities are set forth and included in the Initial Development Plan and Budget.

The terms under which SGI will supply Research and clinical supplies of SGI Antibodies to Unum for use as part of the Research Candidates and Development Candidates in the Territory under the Research Plan and Early Clinical Development Plan will be set forth in a supply agreement to be entered into between the Parties no later than ​ days after the Effective Date (the “SGI Antibodies Manufacturing Services Agreement”). Such SGI Antibodies Manufacturing Services Agreement will contain terms and conditions that are consistent with this Agreement.

Manufacturing and Supply. Denali shall be responsible for manufacturing Licensed Products for clinical use and commercial sale, using due care and commercially sound approaches.

General Terms. UroGen shall, at Allergan’s request, supply pre-clinical and clinical quantities (for Phase I Clinical Trials and Phase II Clinical Trials only) of the RTGel Component for the Development of Licensed Products by Allergan in accordance with this Agreement and any purchase order delivered by Allergan to UroGen for such RTGel Component (such purchase order, other than the initial supply orders, to include a required delivery date for the ordered quantities no less than ​ days from the date of the purchase order); provided that, for the initial Phase II Clinical Trial to be conducted by Allergan with respect to a Licensed Product, in no event shall Allergan request, without UroGen’s prior consent, more than ​ = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.

As soon as it becomes apparent to TRIS that circumstances resulting in any failure or delay in delivery of the Product will continue for more than thirty (30) days, it shall promptly notify AYTU in writing and as soon as possible thereafter confer with AYTU to discuss the alternatives, and cooperate with AYTU as AYTU may reasonably request for AYTU to obtain a source of supply of the Product during the continuance of such circumstances, provided however, that in no event shall TRIS be required to transfer manufacturing to another manufacturer or facility or cooperate with respect thereto.

Ability to Supply. During the Term, SELLER shall commit to supply Product that meets the Specifications.

Guaranty of Supply. In the event the Supplier is unable or otherwise fails or will fail, for any reason (including an event of force majeure) to supply the Hemp Extracts in accordance with the quantities and/or delivery dates specified by Buyer in a Purchase Order, the Supplier shall promptly inform Buyer verbally with a confirmation in writing. If Supplier is able to supply some but not all of Buyer's orders for the Hemp Extracts, then Supplier shall supply such partial quantities of the Hemp Extracts. Supplier will use commercially reasonable efforts to source Hemp Extracts from third parties to be delivered to Buyer, provided such Hemp Extracts conforms to the Buyer’s Specifications. Alternatively, Buyer may elect and shall have the sole right to obtain Hemp Extracts itself from another supplier. If Supplier is unable to provide any replacement Hemp Extracts or if Buyer elects to obtain Hemp Extracts from a different supplier but only to the extent of fulfilling the Purchase Order for which Supplier was unable to meet the Purchase Order requirements. In such event, this Agreement shall remain in full force and effect and the Supplier shall not be liable to the Buyer for any additional costs, damages or fees of any kind in connection with the Buyer seeking an alternative source of supply.

Supply Chain Security. The Customs-Trade Partnership Against Terrorism (“C-TPAT”) program of the U.S. Customs and Border Protection, the Authorized Economic Operator for Security program of the European Union (“EU AEO”) and similar World Customs Organization SAFE Framework of Standards (collectively, “SAFE Framework”) programs are designed to improve the security of shipments in international trade. C-TPAT applies only to Sellers with non-U.S. locations that are involved in the manufacture, warehousing or shipment of goods to Buyer or to a customer or supplier of Buyer located in the U.S. EU AEO applies only to Sellers that are involved in the manufacture, warehousing or shipment of goods originating in, transported through or destined for the EU. Seller agrees that it will review the C-TPAT requirements for foreign manufacturers as outlined at: http://www.cbp.gov/xp/cgov/trade/cargo_security/ctpat/ctpat_application_material/ctpat_security_guidelines/ and the EU AEO and other SAFE Framework requirements appropriate for its business and that it will maintain and implement a written plan for security procedures in accordance with them as applicable (“Security Plan”). The Security Plan shall address security criteria such as: container security and inspection, physical access controls, personnel security, procedural security, security training and threat awareness, and information technology security. Upon request of Buyer, Seller shall:

Supply of VDC. To the extent any tangible supply of VDC is necessary for Legacy to comply with its obligations under [Section 3.2(d)] of the Existing Ag Agreement, is explicitly requested by Legacy in writing for such purpose, has previously been synthesized by Primary, and is in Primary’s possession or control, such VDC shall be supplied by Primary to Legacy, within fifteen (15) business days of such request, in reasonably sufficient quantities (no more than 5 milligrams) for such purpose.