General Supply Terms. With the present agreement the limited company under corporate name “ELPEDISON POWER GENERATION SINGLE-MEMBER SOCIÉTÉ ANONYME” and distinctive title “ELPEDISON S.A.” (hereinafter “Supplier”) and the customer (hereinafter “Customer”), whose details are mentioned in the herein attached application (hereinafter “Application”), agree to electricity supply in accordance with the following terms.
General Supply Terms. The following terms are applicable to both supplies for development and commercial use. It is understood and agreed that for this Appendix D, the use of the term BULK DRUG SUBSTANCE shall mean the BULK DRUG SUBSTANCE and/or BULK DRUG TABLETS, as applicable.:
General Supply Terms. The terms and conditions set forth in this Section 7.4 may be augmented or otherwise revised as the Parties may agree in an applicable supply agreement or Quality Agreement.
General Supply Terms. Ampio shall, itself or through one or more Third Party contract manufacturers, manufacture the Products in finished form in unlabeled containers in accordance with the terms of Section 9, including the performance of all manufacturing process development and scale-up for the Products (and associated regulatory activities), and shall supply to Daewoong, and Daewoong shall purchase from Ampio, all of Daewoong and its Affiliates’ and its/their Sublicensees’ requirements of the Products for Development and Commercial activities as and to the extent set forth in this Agreement and the Supply Agreement. Daewoong shall be responsible for labelling and packaging all Products supplied by Ampio to Daewoong under this Agreement and the Supply Agreement.
General Supply Terms. Until Astellas enters into direct contractual relationships with Third Party contractors for the supply of Components:
9.3.1 Astellas and its Affiliates shall exclusively purchase all of their requirements of Components from NGX;
9.3.2 NGX shall procure Components on behalf of and as reasonably requested in writing by Astellas, consistent with NGX’s arrangements with its suppliers;
9.3.3 Components ordered by NGX from such supplier on behalf of Astellas, shall be charged to Astellas at NGX’s cost of goods as defined in the Supply Agreement; ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
9.3.4 the Components supplied to Astellas under the Supply Agreement shall be supplied in the same form as like Components are supplied to NGX (save as to artwork and text), or as otherwise established by the JSC or by agreement of the Parties, it being understood that any differences in such form requested by Astellas shall be at Astellas’ expense; and
9.3.5 in the event that NGX would be required to pay to LTS any fees under Section 3.4(c) of the LTS Agreement in order to expand the “Territory” as defined in the LTS Agreement to be commensurate in scope with the “Territory” as defined in this Agreement, Astellas shall be responsible for such fees.
General Supply Terms. After the Effective Date, except as provided below, Company shall have sole responsibility for and sole authority with respect to, at its own expense (subject to MacroGenics’ exercise of the Co-Funding Option), Manufacturing clinical and commercial supplies of the Compounds and the Products for use in the Field in the Territory. Upon Company’s request, (a) MacroGenics shall transfer to Company, at no cost, all nucleotide molecules, cell lines and protein material of Compounds, and all Products in finished form or in process on the Effective Date, in MacroGenics’ inventory on the Effective Date, provided that MacroGenics may retain reasonable quantities of such materials for [***] of such inventory; and (b) MacroGenics shall use Commercially Reasonable Efforts to Manufacture, at MacroGenics’ facility, and supply to Company (i) [***]; (ii) [***]; and (iii) based on a timeline reasonably acceptable to MacroGenics, in its sole discretion, clinical supplies of Compound for use in other [***], in each case ((i), (ii) and (iii)), at a cost equal to [***] incurred by MacroGenics in connection with such Manufacture [***] with respect to new clinical supplies Manufactured after the Execution Date for [***]). A non-binding estimate of such costs are set forth on Schedule 7.1. MacroGenics shall not be obligated to [***] in fulfilling any such Company request pursuant to clause (b) of this Section 7.1, unless otherwise agreed by the Parties. MacroGenics shall continue to conduct and complete [***] that are being conducted as of the Execution Date with respect to [***] through the [***] of the Execution Date, and Company shall reimburse MacroGenics for any reasonable Third Party Expenses and Development FTE Costs incurred by MacroGenics after the Execution Date in conducting such [***]. Promptly after the Effective Date, the Parties shall enter into good faith negotiations to conclude a clinical supply agreement (the “Clinical Supply Agreement”) and a related quality agreement within [***] after the Execution Date, which Clinical Supply Agreement shall include specifications and procedures for delivery and acceptance of Products. Such quality agreement will reflect the findings of any supply qualification audits conducted by Company of MacroGenics and any critical sub-suppliers. Company shall not have the right to [***] to be negotiated under the Clinical Supply Agreement.
General Supply Terms. During the Term, Wakamoto shall have the sole and exclusive right, at its sole expense, to Manufacture Products for Harrow by manufacturing them by itself or entrusting the manufacturing to qualified contract manufacturer, and the sole responsibility for the Manufacturing of Products, in each case for purposes of Development, Commercialization and for the conducting of Regulatory Activities.
General Supply Terms. As between the Parties Chroma will be solely responsible for the Manufacture of the Product for Development purposes in both the Licensed Territory and the ROW Territory in accordance with the terms of the Supply Agreement. As between the Parties, CTI will be solely responsible, by itself or through one or more Third Party contract manufacturers, for the Manufacture of the Product for Commercialization in the Licensed Territory. As between the Parties, Chroma will be solely responsible for the Manufacture of the Product for Commercialization in the ROW Territory.
General Supply Terms. Purchase and Supply [***] Term [***] Subcontracting [***]
General Supply Terms. Cell Genesys shall (i) itself or through one or more Third Party contract manufacturers, Manufacture the Product (as defined in Section 1.69(a)) in accordance with the terms of Sections 7.2, 7.3 and 7.4, including the performance of all manufacturing process development, scale-up, and validation for such Product (and associated regulatory activities), inventory build-up and retention, (ii) be the primary source of Product (as defined in Section 1.69(a)) required by the Parties in the Licensed Territory for Non-Clinical Studies, clinical and Commercialization activities as and to the extent set forth in this Agreement, and (iii) supply Takeda’s requirements of Product as determined in accordance with the provisions of this Article 7, Exhibit E and the Supply Agreement. Cell Genesys shall have the right to Manufacture and supply to Takeda all of its requirements for Additional Products in accordance with the terms of this Agreement. [*].
