Manufacturing and Supply. (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D.
(b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties):
(i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period;
(ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law;
(iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer;
(iv) Depomed shall [***];
(v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);
Manufacturing and Supply. (a) For a period to be established by the JSC and agreed to by Ambit, such agreement not to be unreasonably withheld, which period is intended to support the orderly completion of the manufacturing technology transfer to Astellas to enable the First Commercial Sale in the Territory, Ambit shall continue to have primary operational responsibility for manufacturing and supply to Astellas of Clinical Trial supplies of the Lead Product (including manufacturing any intermediary or any Licensed Compound or other material contained therein for purpose of such supply), and all other activities in support of preparation of the Chemistry, Manufacturing and Controls sections of any Regulatory Materials or Regulatory Approval necessary to support receipt of Regulatory Approval of the Lead Product in the Joint Development Territory. At and after the end of the foregoing period, Astellas shall have sole responsibility and decision making authority on (i) all manufacturing activities and regulatory activities designed to support preparation of the Chemistry, Manufacturing and Controls sections of any Regulatory Materials or Regulatory Approval, pharmaceutical process development (provided that such process development activities shall be overseen by the JSC), and (ii) manufacturing of Clinical Trial supplies and commercial manufacturing for the Lead Product and each other Product developed or commercialized under this Agreement (including any intermediate of any Licensed Compound or other material contained therein) in the Territory. For clarity, nothing in this Section 3.6.2 or any other term or condition of this Agreement is intended to or shall be construed to limit Astellas’s right and license, as provided in Section 3.1, to make and have made any Product (including any intermediary or any Licensed Compound or other material contained therein) at any time during the Term.
(b) Each Party shall have the following obligations with respect to costs and expenses incurred in connection with the manufacturing activities described in clause (a): (i) costs incurred by either Party in pharmaceutical development and the Manufacturing Costs of any quantities of Clinical Trial supplies required to carry out the Development Program shall constitute Development Costs; (ii) the Manufacturing Costs with respect to the commercialization of Co-Promoted Products to be commercialized in the U.S. shall be included in the Annual U.S. Profit/Loss calculation; and (iii) all other Manufacturi...
Manufacturing and Supply. Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.
Manufacturing and Supply. 3.5.1 Licensor shall supply Company with 100% of Company’s (and its Affiliates’ and Sublicensees’) requirements for clinical supplies of Product and at least 75% of Company’s (and its Affiliates’ and Sublicensees’) requirements for commercial supplies of Products, in each case at a cost not to exceed Licensor’s documented COGS plus [*]% in accordance with the terms and conditions of a manufacture and supply agreement between the parties (the “Supply Agreement”). Company and Licensor will enter into the Supply Agreement in the form to be agreed within forty five days of the date of this Agreement. If Licensor is unwilling or unable, subject to the terms of the applicable Supply Agreement, to perform all of its obligations under the Supply Agreement, Company may elect to have Product made by a second source contract manufacturer (the “Contract Manufacturer”) during the term of such unwillingness or inability, as applicable, pursuant to the terms and conditions of this Section 3.5. Additionally and for avoidance of doubt, at all times Company is entitled to use a Contract Manufacturer for up to 25% of Company’s (and its Affiliates’ and Sublicensees’) requirements for commercial supplies of Products.
3.5.2 Notwithstanding Company’s obligation to purchase 75% of commercial supplies of Products as set forth in Section 3.5.1, and subject to the approval rights in Section 3.5.3 below, if Company delivers to Licensor a bona fide arms length quote from a Contractor Manufacturer to produce the Product at price less than Licensor’s price under the Supply Agreement (the “Quote”) and provided that all other terms of the Quote (including but not limited to supply quantities, delivery terms and Product quality control) are substantially similar to the terms of the Supply Agreement, then Licensor shall have [*] ([*]) days to either agree to match the terms provided in the Quote for the quantity of Product specified, or waive its right to provide such Product. Notwithstanding the foregoing, this waiver shall be effective only with respect to the quantities included in the Quote and shall not waive any future rights of Licensor to manufacture the Product under the terms of the Supply Agreement. Notwithstanding the foregoing or the price or other terms of any Quote, Licensor shall have the right to supply a minimum of at least 25% of Company’s (and its Affiliates’ and Sublicensees’) aggregate requirements for commercial supplies of Products at a cost not to exceed Licensor’s ...
Manufacturing and Supply. Before finalizing a partnership with its manufacturing and/or commercial partner(s), Icosavax will ensure that its agreement(s) with these manufacturing and/or commercial partner(s) have appropriate provisions to support the furtherance of Global Access for the Charitable Purpose, including assurances that the Covid Vaccine will be provided at the Price Commitment and Annual Volume Commitment outlined above consistent with this Agreement.
Manufacturing and Supply. During the Collaboration Term, Ionis will supply up to [***] solely for Praxis to conduct studies under the Research Plan. Except as set forth in this Section 3.4, and subject to Section 3.6.1, Praxis is responsible for supplying all API and finished drug product for the Parties’ activities under this Agreement.
Manufacturing and Supply. EYETECH is exclusively authorized and responsible for the manufacture and supply of all Development Compound and/or Compound Product as necessary for the conduct of the EYETECH Development Program and for all commercial purposes in the Territory. Further, EYETECH is exclusively authorized and responsible for formulation, packaging and labeling including but not limited to package inserts and leaflets for Compound Products.
Manufacturing and Supply. Genentech and/or its sublicensee(s) shall be responsible for, and shall bear all associated costs of, manufacturing all preclinical, clinical and commercial forms of such Lead Products, including the bulk drug substance and finished drug product forms thereof. Genentech shall keep Curis reasonably informed of manufacturing and supply related activity.
Manufacturing and Supply. The Parties shall agree upon responsibility for Manufacture of Compound and Product for Development and Commercialization activities hereunder. The Parties intend to determine whether they will use Lilly's pen technology by [...***...], and to finalize appropriate manufacturing and supply agreements for all aspects of manufacturing by [...***...].
Manufacturing and Supply. Subject to the terms and conditions of this Agreement, Licensee shall have the exclusive right to manufacture the Licensed Compounds and the Licensed Products itself or through one or more Third Party subcontractor(s) selected by Licensee.
