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. Subject to the oversight of the JMC as described in Section 3.4, SeaGen or its Affiliates shall Manufacture and supply the commercial requirements for the Licensed Product in fully packaged and labelled, finished form (except as may otherwise set forth in the European Collaboration Territory Distribution Agreement or as otherwise set forth in the Manufacturing Plan) in accordance with the terms hereof (and the SeaGen Supply Agreement contemplated by Section 7.4.2, as applicable) for Commercialization worldwide by each Party; provided that Merck shall be responsible for any specific Manufacturing responsibilities for the Licensed Product as set forth in and designated to Merck in the Manufacturing Plan. For clarity, such Licensed Product shall be labelled in accordance with the labelling specifications provided by Merck for the Merck Territory, provided by SeaGen for the SeaGen Territory and as agreed upon between the Parties for the Collaboration Territory. With respect to the Licensed Product for sale in a given country: (a) in the Merck Territory, Merck shall be responsible for ensuring that such labelling complies with the approved label and Applicable Laws for the applicable country in the Merck Territory; (b) in the SeaGen Territory, SeaGen shall be responsible for ensuring that such labelling complies with the approved label and Applicable Laws for the applicable country in the SeaGen Territory; (c) in the US Collaboration Territory, SeaGen shall be responsible for ensuring that such labelling complies with the approved label and Applicable Laws in the US Collaboration Territory; and (d) in the European Collaboration Territory, each Party shall be responsible for ensuring that such labelling complies with the approved label and Applicable Laws for the applicable country in the European Collaboration -85- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED
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.
