Example ContractsClausescommercial supply agreementVariants
Commercial Supply Agreement
Commercial Supply Agreement contract clause examples

​ of RTGel Component to be supplied by UroGen hereunder. The initial supply order for RTGel Components to be supplied by UroGen to Allergan will consist of at least ​ of sterile, GMP grade RTGel Component and its Certificate of Analysis (“CofA”) that shall be delivered, notwithstanding any other provision of this Agreement, by UroGen to Allergan no later than ​ (the “Initial Supply” and such initial supply terms, the “Initial Supply Terms”). UroGen shall Manufacture (or have Manufactured) all such RTGel Components in accordance with Applicable Law, including cGMP for clinical supply. All RTGel Component supplied to Allergan under this Agreement will meet the acceptance criteria for all the tests on the CofA. The supply price for an RTGel Component payable by Allergan to UroGen under this Agreement or the supply agreement described in Section 5.1.2 shall be equal to the direct out-of-pocket costs incurred by UroGen in either the Manufacture or procurement from a Third Party, as applicable, of each RTGel Component ​. Except as otherwise set forth in this Section 5.1, Allergan shall have the sole right, at its expense, to Manufacture (or have Manufactured) and supply the Licensed Products for Exploitation in the Territory by Allergan and its Affiliates and its or their Sublicensees. In no event shall Allergan be obligated to procure supply of RTGel Components exclusively from UroGen or meet any minimum quantity order requirements. For clarity, UroGen has no obligation to supply Allergan with any RTGel Component for Phase III Clinical Trials or for the launch or commercial use of the Licensed Product. Notwithstanding anything to the contrary in this Section 5.1.1, in the event an RTGel Component is an Allergan RTGel Improvement for which the manufacturing process materially differs from the manufacturing process for the RTGel Product as of the Effective Date, then # the Parties shall, at Allergan’s request, discuss and implement in good faith a commercially reasonable plan under which UroGen can manufacture and supply such RTGel Component for Allergan in accordance with this Agreement, which shall include # reimbursement by Allergan to UroGen for its reasonably incurred and documented costs in implementing the different manufacturing process (to the extent such process will be used to supply RTGel Components to Allergan under this Agreement) and # the technology transfer described in Section 5.3, and (b) (i) Section 5.1.3 shall cease to apply with respect to any failure or delay in the supply of a RTGel Component reasonably stemming from implementation by UroGen or its Third Party supplier of such different manufacturing process for such RTGel Component and # in the event such change in RTGel Component applies to the Initial Supply, then the Initial Supply Terms shall cease to apply.

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.

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