Commercial Supply. Celgene shall Manufacture and supply all Commercial Supplies.
Commercial Supply. Unless otherwise agreed in any definitive agreement executed by the Parties pursuant to Section 2.10, Licensee shall have the sole right, responsibility and decision-making authority for the manufacture, in accordance with good manufacturing practice, and supply of commercial quantities of Licensed Product in the Territory after receipt of Regulatory Approval therefor in the applicable jurisdiction or jurisdictions.
Commercial Supply. As part of each Commercialization Plan for each Collaboration Product, the JSC shall determine which Party, or Third Party(ies), shall be responsible for manufacturing the Collaboration Product and the components thereof for commercial sale in the Territory [ * ].
Commercial Supply. Licensee will be solely responsible, at its own expense, for the Manufacture and supply of Licensee’s entire requirements of supplies of POZEN Product for Commercialization in the Territory.
Commercial Supply. Nuvios shall be solely and exclusively responsible for the manufacture, in accordance with good manufacturing practice, and supply of commercial quantities of Licensed Product in the Territory (including France) and Japan after receipt of Regulatory Approval therefore in the applicable jurisdiction or jurisdictions. With respect to Japan: Nuvios shall supply commercial quantities of finished and fully labeled Licensed Product (and shall provide any clinical supplies that may be required after obtaining Regulatory Approval) to Ipsen for Teijin in Japan at a supply price equal to 10% of net sales in Japan. Should the manufacturing costs be anticipated to exceed 10% of net sales in Japan, as evidenced by Nuvios, then the Parties shall discuss in good faith to define a new supply price which shall be no less than a supply price equal to such manufacturing costs plus a reasonable markup (not to exceed [*] percent of such manufacturing costs). With respect to France if Ipsen has elected to co-market Licensed Product in France: Nuvios shall supply commercial quantities of finished and fully labeled Licensed Product (and shall provide any clinical supplies that may be required after obtaining Regulatory Approval) to Ipsen for France at a supply price equal to (i) for commercial supplies, Nuvios’ Manufacturing Cost plus a [*] percent ([*] %) margin, and (ii) for clinical supplies, Nuvious Manufacturing Cost. The Parties, with respect to the supply of Licensed Product for France and for Japan contemplated pursuant to this Section 9.3, shall agree on the terms of a commercial supply agreement and a technical agreement no later than the date of first NDA filing for Licensed Product in the corresponding country. It shall be a condition precedent to Nuvios’ supply obligations under this Section 9.3 that the Parties shall have agreed upon the terms of, and executed and delivered to each other, such supply agreement and such technical agreement. Without limiting the foregoing provisions of this paragraph, such agreements should provide standard provisions commonly used in the industry, including: · that Ipsen or Teijin shall provide binding forecasts of the clinical and commercial quantities of Licensed Product required for Japan, · that Nuvios or its contractor shall manufacture in accordance with good manufacturing practice and supply Licensed Product compliant to specifications, · that disruption of supply shall be remedied by equitable sharing of available stock, · th...
Commercial Supply. The Parties shall use Reasonable Commercial Efforts to sign the Manufacturing Agreement no later than [***] ([***]) months prior to the anticipated first Launch of the Product in the Territory. The Manufacturing Agreement shall contain the terms set forth in this Clause 6.2 through Clause 6.6 and such other commercially reasonable and customary terms and conditions to be mutually agreed by the Parties (including the right of DESITIN to audit ZOGENIX’s (or its Third Party contract manufacturer’s) manufacturing facilities and a forecasting mechanism which will permit ZOGENIX to properly manage its supply chain for the Product on a worldwide basis) and such other terms as are reasonable and customary in the commercial supply of pharmaceutical compounds; provided that the Manufacturing Agreement shall be subject to the terms of any manufacturing agreement which ZOGENIX puts into place with respect to the commercial supply of Product in the Other Territories
Commercial Supply. GSK shall have the right to conduct a new contractor assessment of Liquidia to determine, in its sole discretion, that Liquidia is acceptable to GSK for the purposes of supplying PRINT Materials, Liquidia Respiratory Product, Research Products and Inhaled Products (but only if Inhaled Products are the same as Research Products and do not require further formulation or other work in order to be considered appropriate for commercial supply and development requiring commercial grade supply) for clinical trials requiring commercial grade supply and, if applicable, for further formulation work by GSK or a Third Party as Inhaled Products for commercialization on a worldwide basis. Such assessment of Liquidia’s manufacturing capabilities will be conducted at the appropriate time to allow for technology transfer, if required, prior to manufacture of pivotal clinical trial material.
Commercial Supply. Roche shall be solely and exclusively responsible at its own expense for the manufacture and supply of Product for sale in the Territory, either by itself or through Third Parties.
Commercial Supply. In the event that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance of the launch of the first Licensed Product in the Territory, or at such earlier or later date as may be mutually agreed in writing, the Parties will negotiate in good faith and enter into an agreement for commercial supply by Epizyme to Hutchmed of Drug Substance or Drug Product, as applicable, and a related quality agreement, each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the “Commercial Supply Agreement”). The Commercial Supply Agreement contain commercially reasonable terms including terms addressing forecasting, ordering, delivery, acceptance and rejection procedures, indemnification, limitations of liability, and quality assurance and control. From and after the execution of the Commercial Supply Agreement and until Manufacturing Technology Transfer Completion under Section 7.2, and subject to the terms of such Commercial Supply Agreement and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply Hutchmed with Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products in the Field in the Territory by the Hutchmed Entities in accordance with the Commercialization Plan and the terms of this Agreement. Hutchmed Entities shall not use any quantity of Drug Product supplied by Epizyme for any purpose other than Commercialization in the Field and Territory in accordance with the Commercialization Plan and the terms of this Agreement, and Epizyme shall not be obligated under the Commercial Supply Agreement to supply quantities of Drug Product in excess of the forecasted quantity that Hutchmed notifies Epizyme, and Epizyme reasonably agrees, is needed to perform the Commercialization activities in the Territory. In addition, in no event shall Epizyme supply to Hutchmed under the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed for purposes of Commercialization of Licensed Products in the Field in the Territory, Hutchmed shall pay to Epizyme the Commercial Supply Price for such quantity, payable within [**] after receipt of an invoice therefor.
Commercial Supply. ARES TRADING shall be responsible for manufacturing and supplying Products for Commercialization in the Field in the Territory, provided that ARES TRADING may request Intrexon to conduct such manufacture and supply as follows: At least 18 months prior to the anticipated filing of the first MAA for the first Indication with respect to a Product, ARES TRADING shall notify Intrexon in writing whether it desires to consider Intrexon for Commercial manufacture and supply of such Product. If Intrexon is interested in conducting such manufacture and supply, ARES TRADING and Intrexon shall Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
