Example ContractsClausesManufacturing Site
Manufacturing Site
Manufacturing Site contract clause examples

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.

Launch Site Expenses. Notwithstanding Articles 17.1 – 17.4, if a Launch is prevented or delayed other than due to actions or omissions of the Contractor, whether an Excusable Delay, breach or any other cause, at any point in time after shipment of one or more Customer Satellites to any Launch Site, Customer shall bear all expenses incurred by the Contractor.

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.

“Net Sales” - with respect to any Compound or Product, the gross invoiced sales price of such Compound or Product sold by Ovid, its Affiliates or Sub-licensees (the “Selling Party”), in bulk form or finished product form in arm’s-length transactions to Third Parties, less deductions allowed to the Third Party customer by the Selling Party, to the extent actually taken by such Third Party customer, on such sales for:

Manufacturing Responsibility. Licensee will be responsible for the manufacturing of the Licensed Compound and Licensed Product for use by Licensee, its Affiliates, and its sublicensees in the Field in the Territory.

For ACTR T-cells or SGI Antibodies (as applicable) manufactured by a Third Party, Manufacturing Costs described in [clause (a) above] will include: # the amount paid to such Third Party, to the extent treated as Manufacturing Costs pursuant to Section 10.7, including the supply price, any up-front payments, royalties, milestone payments or other payments, including payments relating to capital expenditures or the preparation or reservation of manufacturing capacity or equipment, and equipment cost depreciation, if such payments have been capitalized in accordance with GAAP, plus # the relevant manufacturing Party’s internal costs and out-of-pocket costs, incurred (including any prepayments) by the manufacturing Party, which costs are reasonably and directly allocable to Manufacturing ACTR T-cells or SGI Antibodies for use in Development or Commercialization activities and include the following types of costs: inventory write-offs, variances, manufacturing process improvements, storage, manufacturing scale-up, manufacturing site qualification, materials, quality assurance and quality control (including testing), supply chain management, capital equipment and similar activities comprising the manufacturing Party’s oversight of the manufacturing process, and any value-added tax or similar tax due on such amounts, plus # to the extent applicable, as reasonably determined by the Parties, # any royalties attributable to Manufacture of ACTR T-cells or SGI Antibodies (as applicable) due under the Unum Existing In-Licenses, SGI Existing In-License or any In-Licenses, plus # Third Party Payments to the extent to be included in Manufacturing Costs under Section 10.7.

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