Sublicensee Manufacturing Rights. The Manufacturing Agreements shall permit Arcus sublicensees to place orders for such Licensed Products on the same terms and conditions applicable to Arcus; provided that # prior to expiration of Manufacturing Exclusivity Period, each Arcus sublicensee shall be free to manufacture up to CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Manufacturing. Notwithstanding that Axsome’s grant of the license to Licensee under [Section 2.1] is not conditioned on Licensee electing to have Axsome manufacture Licensed Product for Licensee, Licensee shall have the option to have Axsome Manufacture or have Manufactured the Licensed Compound and any Licensed Products for use by Licensee. If Licensee makes such election it shall notify Axsome immediately after the Effective Date and thereafter the Parties, within thirty (30) days after the Effective Date, shall negotiate and enter into such supply agreement that contains the terms in the manufacturing term sheet attached hereto as [Schedule 3.6] the together with other material and non-material terms typically included in agreements of such type and scope (the “Supply Agreement”). In the event Licensee exercises such option and the Parties enter into the Supply Agreement, Licensee shall purchase from Axsome all requirements of any such Licensed Products at the price set forth therein.
The Transition Agreement will require the Opt-Out Party or its Affiliate to enter into a supply and quality agreement to supply or have supplied the applicable SGI Antibody or ACTR T-cells (as the case may be) in the Reversion Product to the Continuing Party until such time as the Continuing Party provides written notice to the Opt-Out Party of its decision, in its sole discretion, to cease permanently the Research, Development, and Commercialization of such Reversion Product. The cost to the Continuing Party for such supply will be the Manufacturing Costs plus a markup for the applicable SGI Antibody or ACTR T-cells (as the case may be) in the Reversion Product.
The Parties shall negotiate in good faith the terms of, and shall seek to enter into, separate clinical and commercial manufacturing agreements, and/or amendments to existing manufacturing agreements, under which WuXi would manufacture and supply Licensed Products for Arcus in the Territory (the Manufacturing Agreements). The Parties intend to enter into such Manufacturing Agreements # no later than prior to the Initiation of Phase I Clinical Studies for the first Licensed Product (for the clinical manufacturing agreement) and # no later than prior to the anticipated date of Regulatory Approval of the first Licensed Product (for the commercial manufacturing agreement).
Manufacturing. Arcus shall use Commercially Reasonable Efforts to manufacture or otherwise obtain supply of the requirements of formulated, packaged and labeled Patented Products in connection with its Development and Commercialization obligations hereunder, in accordance with all Applicable Laws, GMP (as applicable) and this Agreement.
Breach by Sublicensee. During the term of this Agreement, Licensee shall be responsible for any breach of a Sublicense agreement by a Sublicensee that results in a material breach of this Agreement. Licensee may elect # to cure such breach in accordance with [Section 6.2.2] of this Agreement or # to enforce its rights by terminating such Sublicense agreement in accordance with the terms thereof.
Manufacturing Fee. Provided that has not breached its obligations under this Agreement, shall order sufficient quantities of Product over the course of the Term such that the manufacturing fee due and owing over the Term
Manufacturing Problems. The Parties will inform each other promptly after it becomes aware of any problems or delays of any nature in performing their contractual obligations that have the potential to adversely affect the Manufacturing of the ACTR T-cells or SGI Antibodies, as the case may be. Each Party will inform the other Party of the reason for such delay and of the expected duration of its inability to Manufacture and deliver the ACTR T-cells or SGI Antibodies, as the case may be, and will keep the other Party informed on a timely basis of any developments during any such period of time.
Record Keeping by Sublicensee. Licensee shall include in each sublicense granted by it pursuant to this Agreement a provision requiring the sublicensee to make reports to Licensee, to keep and maintain records of sales made pursuant to such sublicense and to grant access to such records by an independent accountant to the same extent required of Licensee under this Agreement.
Development, Manufacturing and Commercialization. Regeneron shall have the right to grant one or more sublicenses under the licenses granted to Regeneron under [Section 4.1], in full or in part, by means of written agreement to Affiliates or Third Parties (with the right to sublicense through multiple tiers), without the prior written consent of CytomX, for the performance of Regeneron’s Development, Manufacturing and Commercialization activities related to Licensed Products or for the performance of any other activities related to the Exploitation of a Licensed Product. As a condition precedent to and requirement of any such sublicense: # Regeneron shall furnish a redacted copy of such sublicense agreement to CytomX; # any such permitted sublicense shall be consistent with and subject to the terms and conditions of this Agreement (including for the avoidance of doubt, that if sales by such Sublicensee are included in Net Sales hereunder, such Sublicensee shall permit audit rights with respect to its reporting of Net Sales that are consistent with those given by Regeneron hereunder with respect to its sales included in Net Sales); # Regeneron will continue to be responsible for full performance of its obligations under this Agreement and will be responsible for all actions of such Sublicensee as if such Sublicensee were Regeneron hereunder; and # Regeneron’s grant of any sublicense will not relieve Regeneron or its Affiliates from any of its obligations under this Agreement.
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