Elimination of Certain Commercial Restrictions. Article V of the Purchase Agreement is hereby amended to include a new [Section 5.20], which shall read in its entirety as follows:
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 Allergans 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.
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 Agreement also provides for the license of Coya 301, Coya’s low dose IL-2 to Dr. Reddy’s to permit the commercialization by Dr. Reddy’s of Coya 302 in territories not otherwise granted to Coya. Coya will receive royalties on Net Sales by Dr. Reddy’s in their territories based on the same tiered structure as Coya owes Dr. Reddy’s. The Agreement also allows Dr. Reddy’s and Coya to enter into a mutually satisfactory commercial supply agreement at an appropriate time.
Ovid shall have the right to terminate the Supply Agreement, and if Ovid terminates the Supply Agreement, Lundbeck shall undertake the technology transfer contemplated by [Section 3.3].
the Purchaser and the Seller shall execute and deliver a manufacturing and supply agreement in substantially the form attached hereto as Exhibit D (the “Manufacturing and Supply Agreement”);
The terms under which Unum will supply clinical supplies of ACTR T-cells to SGI for use as part of the Development Candidates in the Territory 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 ACTR T-cell Clinical Supply Agreement). Such ACTR T-cell Clinical Supply Agreement will contain customary terms and conditions, including quality, and otherwise be consistent with this Agreement.
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 Agreement - see the recitals.
The Parties hereby agree to terminate the License and Supply Agreement in its entirety as of the Termination Agreement Effective Date. As of the Termination Agreement Effective Date, all rights and obligations of the Parties under the License and Supply Agreement, and all sublicenses under the ARS Intellectual Property Rights granted by Recordati (if any), shall be, and hereby are, automatically terminated. For clarity, on execution of this Agreement, unless otherwise specified in this Agreement, all provisions of the License and Supply Agreement, including any which are expressly stated in the License and Supply Agreement as surviving its termination, or which might otherwise have done so by implication, are terminated.
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