Lead Manufacturing Party definition

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

Examples of Lead Manufacturing Party in a sentence

  • 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.

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

  • 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 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.

  • 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 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.

  • 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 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.

  • Corgentech shall be the Lead Manufacturing Party with respect to the manufacture of Intermediate for use in the Territory.


More Definitions of Lead Manufacturing Party

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.

Related to Lead Manufacturing Party

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Process means any process for—

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Third Party Manufacturer means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product by such Third Party for Licensee or such sublicensee.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Good Manufacturing Practices or “GMP” means the then-current good manufacturing practice standards, practices, and procedures promulgated or endorsed by the applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time-to-time.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.