Lead Manufacturing Party definition

Lead Manufacturing Party has the meaning set forth in Section 6.1.

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Lead Manufacturing Party means the Party responsible for taking the lead on manufacturing activities, including arranging for Third Party or internal manufacture, as specified in or pursuant to Article 7.

Lead Manufacturing Party means: (a) the Lead Development Party with respect to the manufacture of preclinical and clinical materials for a Collaboration Compound; and (b) the Lead Marketing Party with respect to the commercial manufacture of a Collaboration Product.

Examples of Lead Manufacturing Party in a sentence

• Trubion shall be the initial Lead Manufacturing Party for TRU-016.

• The JSC shall select the lead manufacturing Party (“Lead Manufacturing Party”) for each Collaboration Product and the Lead Manufacturing Party shall be responsible for the supply of the Parties’ entire requirements of such Collaboration Product in accordance with the terms set forth below.

• Pursuant to the schedule approved by the JSC, or upon request of the JDC, the Lead Manufacturing Party shall conduct an inspection or audit of the facilities of such Third Party contract manufacturers.

• The Lead Manufacturing Party shall be responsible for negotiating the terms of such agreement, with the other Party having consultation and review rights on the terms of such Third Party agreement.

• The Lead Manufacturing Party shall ensure that all finished Collaboration Product supplied pursuant to the Development Plan shall, when delivered, have been manufactured, handled and stored in compliance with all agreed-upon specifications, then-current GMP requirements and applicable Laws, including without limitation prohibitions on misbranding and adulteration.

• The Lead Manufacturing Party shall reasonably determine the process for quantity orders, timing for delivery and shipping terms to permit the Parties to fulfill their obligations under the Development Plan.

• The Lead Manufacturing Party with respect to a particular Collaboration Product shall, by itself or through its Third Party contract manufacturers, timely supply all quantities of such Collaboration Product agreed upon by the JDC as required by the Parties to carry out all Development activities (pre-clinical and clinical) for such Collaboration Product pursuant to the Development Plan.

• The Lead Manufacturing Party shall have the flexibility to adjust the actual Joint Product volume using its good faith judgment to meet the ongoing demand for Joint Product supply while minimizing the quantity of unusable Joint Product.

• In the event that the Unilateral Product is also a Joint Product in a Profit Share Region and the Non- Participating Party for the Unilateral Product in the Royalty Region is the Lead Manufacturing Party for such Product in the Profit Share Region, the Participating Party for such Product shall have the right to request such Lead Manufacturing Party to supply such Product for the Development or Commercialization of such Product in the Royalty Region.

• In the event the Lead Manufacturing Party exercises or is deemed to have exercised its Opt-Out Option pursuant to Article 7, Section 8.5 or Section 14.2(b), then Sections 7.5(b)(iii) and 7.5(b)(x) shall apply.

More Definitions of Lead Manufacturing Party

Lead Manufacturing Party means, with respect to the Licensed Product, SeaGen (unless otherwise determined by the JSC or otherwise expressly set forth in this Agreement); provided that (a) where a Party acts as a second source for supply in accordance with Section 7.4.4 or otherwise takes over responsibility for Manufacturing Licensed Product in accordance with this Agreement (or the applicable Ancillary Agreement), and, as such, Manufactures the Licensed Product, such Party shall be the “Lead Manufacturing Party” with respect to the quantities of Licensed Product Manufactured by it and (b) without limiting the foregoing sub-clause (a), certain specific Manufacturing responsibilities for the Licensed Product as set forth in the Manufacturing Plan (e.g., secondary packaging and labeling) may be designated to the other Party, in which case such other Party shall be the “Lead Manufacturing Party” to the extent of such assigned responsibilities as set forth in the Manufacturing Plan. 1.75 “Lead Patent Party” means, (a) SeaGen, with respect to the SeaGen Product- Specific Patents and Joint Program Patents, and (b) Merck, with respect to the Merck Product- Specific Patents, in each case, except as otherwise expressly set forth in this Agreement. 1.76 “Lead Regulatory Party” means, (a) with respect to the Licensed Product in the US Collaboration Territory, SeaGen (unless otherwise determined by the JSC), (b) with respect to the Licensed Product in the European Collaboration Territory, Merck (unless otherwise determined by the JSC), (c) with respect to the Licensed Product in the SeaGen Territory, SeaGen (unless otherwise determined by the JSC), and (d) with respect to the Licensed Product in the Merck Territory, Merck (unless otherwise determined by the JSC), in each case (a), (b), (c) and (d), except as otherwise expressly set forth in this Agreement. 1.77 “Lead Study Party” means, with respect to a given Clinical Trial for the Licensed Product, the Party that is designated by the JSC as the “Lead Study Party” for such Clinical Trial as set forth in the Development Plan, in each case, except as otherwise expressly set forth in this Agreement. 1.78 “Lead Trademark Party” means, with respect to a given country in the Territory, unless otherwise determined by the JCC, the Party that is the “Lead Distribution Party” for such country, as set forth in this Agreement. 1.79 “Licensed Compound” means (a) SGN-LIV-1-A, (b) any Next Generation Compound for which Merck has delivered (or is deemed to ...