Lead Commercialization Party definition

Lead Commercialization Party has the meaning set forth in Section 5.1.
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Lead Commercialization Party means, with respect to a territory [ * ], the Party with responsibility for Commercialization activities in accordance with Section 8.2.
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Lead Commercialization Party. Lead Commercialization Party shall mean, with respect to each Product in a Co-Commercialization Country, whichever of Novartis or Idenix has been designated hereunder (or by the Joint Steering Committee) as having responsibility for the distribution and sale of such Product in such country, and with respect to each Product in a Co-Marketing Country, both Novartis and Idenix. "Lead Regulatory Party". Lead Regulatory Party shall mean, with respect to each Product, whichever of Novartis or Idenix has been designated hereunder (or by the Joint Steering Committee) as having responsibility for preparing, prosecuting and maintaining Registration Filings and Regulatory Approvals relating to such Product, and for related regulatory duties, as further set forth in Section 4.7 or Exhibit K, as applicable "LdC". LdC shall mean beta-L-deoxy-cytidine, including prodrugs (e.g., valtorcitabine), active metabolites, polymorphs, salts, hydrates, solvates, enantiomers, and/or esters having the same active moiety as beta-L-deoxy-cytidine, as more specifically described in Exhibit A to this Agreement.
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Examples of Lead Commercialization Party in a sentence

  • Genmab shall be the Lead Commercialization Party for the ROW and SGI shall be the Lead Commercialization Party for North America.

  • The Parties shall jointly own the trademarks which are specifically directed to Collaboration Products and each Party shall execute all documents and take all actions as are reasonably requested by the other Party to effectuate such joint ownership in such trademarks unless such joint ownership would not be practicable in any such jurisdiction, in which case the Lead Commercialization Party shall have sole ownership.

  • Each Commercialization Plan and updates thereof shall be prepared by the Lead Commercialization Party in the United States for such Collaboration Product, with review by and input from the other Party’s key personnel for Commercialization and Manufacturing activities, and submitted pursuant to the procedures set forth in clauses (b) and (c) below to the JCC for review and submission to the JSC for approval.

  • The Lead Commercialization Party for a particular Collaboration Product in a particular country will book sales in accordance with GAAP including handling inventory, receivables, managing relationships with the trade, returns, reimbursements, and charge-backs, trade-customer complaints and inquiries with respect to such Collaboration Product in such country.

  • The Lead Commercialization Party will own rights to any Internet domain names incorporating any Trademark for the Shared Product, or any variation or part of any such Trademark, as its URL address or any part of such address in the applicable jurisdiction.

  • Each non-Lead Commercialization Party, on behalf of itself and its Affiliates, will assign to the Lead Commercialization Party or its relevant Affiliate all right, title and interest in and to such Shared Product Trademarks and goodwill in the relevant jurisdictions.

  • The Lead Commercialization Party will own rights to any Internet domain names incorporating any Trademark for the Shared Products, or any variation or part of any such Trademark, as its URL address or any part of such address in the applicable jurisdictions.

  • Each non-Lead Commercialization Party, on behalf of itself and its Affiliates, will assign to the Lead Commercialization Party or its relevant Affiliate all right, title and interest in and to such Shared Product Trademarks and goodwill in the relevant jurisdiction.

  • The Lead Commercialization Party with respect to a jurisdiction will have sole responsibility for the conduct of Commercialization activities with respect to each Shared Product in such jurisdiction in its sole discretion, subject to compliance with the approved Global Commercialization Plan, Global Commercialization Budget and Regional Commercialization Plan(s) for such Shared Product, and the provisions of this ARTICLE 5.

  • If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in a country in the Territory, the Lead Commercialization Party shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law.


More Definitions of Lead Commercialization Party

Lead Commercialization Party has the meaning set forth in Section 4.3.
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Lead Commercialization Party has the meaning set forth in Section 10.1.
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Lead Commercialization Party. Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSC.
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Lead Commercialization Party means, with respect to a territory [ * ], the Party with responsibility for Commercialization activities in accordance with Section 8.2. 1.1.79 “Lead Regulatory Party” means, with respect to a territory [ * ], the Party with the main responsibility for carrying out regulatory activities in accordance with Article 7. 1.1.80 “Liabilities” has the meaning set forth in Section 18.1.1. 1.1.81 “Licensed Product” means any and all products utilizing or incorporating an ADC: (a) the manufacture, use, sale, offer for sale or import of which would infringe a Valid Patent Claim of any SGI Patent, Joint Patent or Genmab Patent, if not for a Party’s ownership interest or the licenses granted in this Agreement; or (b) which otherwise utilize, incorporate, derive from, relate to, are made using or are based on Genmab Technology or SGI Technology. -10-
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Related to Lead Commercialization Party

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Research Program has the meaning set forth in Section 2.1.

  • 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)).

  • Development Program means the implementation of the development plan.

  • Development Plan has the meaning set forth in Section 3.2.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Collaboration has the meaning set forth in Section 2.1.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Research Program Term has the meaning set forth in Section 2.2.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Collaboration Technology means the Collaboration Know-How and the Collaboration Patents.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Commercialise means to promote, market, distribute, sell and/or otherwise commercialise a product, and Commercialising and Commercialisation shall be construed accordingly;

  • JCC has the meaning set forth in Section 2.1.

  • Commercialized shall have corresponding meanings.

  • JDC has the meaning set forth in Section 3.2.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].