Target Product Profiles Clause Samples

The Target Product Profiles clause defines the specific characteristics, features, and performance criteria that a product must meet during its development. In practice, this clause outlines measurable benchmarks such as safety standards, efficacy requirements, and intended uses, serving as a reference point for both parties throughout the project. Its core function is to ensure mutual understanding and alignment on product expectations, thereby reducing the risk of disputes and facilitating efficient product development.
Target Product Profiles. For each Collaboration Target, GSK shall establish and submit an aspirational Target Product Profile for adoption by the JSC. The JSC shall review and approve such Target Product Profile for Collaboration Compounds directed against each Collaboration Target. Upon nomination of a Development Candidate, such aspirational TPP shall be updated, amended or modified to specifically address the particular qualities and features of such Development Candidate. In the event of a disagreement at the JSC, GSK shall have the final say on the content of the Target Product Profile. It is understood and agreed that the Target Product Profile is aspirational in nature, and that any given Development Candidate may not meet all targeted features and requirements of a given TPP, and that certain features of the TPP may only apply to later stages of Development of a given Development Candidate (such as development of a sustained release formulation, etc.).
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Target Product Profiles. For each Program, a draft Target Product Profile shall be prepared by [********] and provided to [********] not later than [********] following the nomination by Targacept of a Development Candidate for such Program. [********] shall thereafter revise such TPP, in consultation with [********], in order to prepare the TPP for presentation to the JSC for adoption at its next scheduled meeting, subject to Section 2.3.4(b); provided that the TPP for each Program shall (i) be consistent with and not include or contemplate a target or profile different from the Indication and Protein Target Profile applicable for such Program and (ii) set as the objective for the Program [********], but not necessarily [********] to pharmaceutical commercialization. [********] may, in consultation with [********], update any TPP from time to time to specifically address the particular qualities and features of a particular Development Candidate or otherwise to reflect any material event or change; provided that no such TPP shall be changed after [********] following [********] receipt of notice of [********] completion of [********] a Development Candidate in such Program in any manner that would, in any material respect, increase the obligations of Targacept hereunder or make such obligations more costly or difficult to satisfy. It is understood and agreed that (A) the Target Product Profile is aspirational in nature, (B) any given Development Candidate may not meet [********] of a TPP, and (C) certain features of the TPP may only apply to [********] of a given Development Candidate (such as [********] of a [********] etc.).
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Related to Target Product Profiles

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Product Sales Subject to Sections 10.3(c) and 10.3(d), Licensee agrees that it will not sell, offer for sale, or assist third parties (including Affiliates) in selling Product except for the sale and offer for sale of (A) TAF Product, TAF Combination Product, TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF-TAF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad Product for use in the Field and in the countries of the EVG-Quad Territory.‌ (i) Licensee agrees that during the period in which the Patents are valid and enforceable (on a Product-by-Product basis) it will prohibit its Distributors from selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field. (ii) Licensee agrees that it will not administer the TAF Quad to humans, or sell the TAF Quad until Gilead has obtained marketing approval for the TAF Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for an EVG Product from the FDA. Licensee agrees that it will not administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for a COBI Product from the FDA. Licensee agrees that it will not administer TAF to humans, or sell Products containing TAF until Gilead has obtained marketing approval for a TAF Product from the FDA. If Gilead obtains marketing approval from the FDA for any Quad Product or a Combination Product containing TAF, COBI or EVG (“Approved Combination Product”) prior to obtaining marketing approval for a TAF Product, EVG Product or COBI Product from the FDA, then Licensee will be allowed to administer such Quad Product or such Approved Combination Product to humans, and sell such Quad Product or such Approved Combination Product from and after the date of such marketing approval from the FDA, but will not (A) administer to humans or sell Combination Products containing EVG other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for an EVG Product, or (B) administer to humans or sell Combination Products containing COBI other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a COBI Product or (C) administer to humans or sell Combination Products containing TAF other than such Quad Product or such Approved Combination Product until Gilead has obtained marketing approval from the FDA for a TAF Product.

  • Product Prices Product prices and validity of product prices are stated in the Offer and/or in the Individual Agreement.

  • Loss Leader; Recycled Products Contractor shall not sell or use any article or product as a “loss leader” as defined in Section 17030 of the Business and Professions Code. If Contractor will sell to the Judicial Council, or use in the performance of this Agreement, goods specified in PCC 12207 (for example, certain paper products, office supplies, mulch, glass products, lubricating oils, plastic products, paint, antifreeze, tires and tire-derived products, and metal products), then with respect to those goods: (i) Contractor shall use recycled products in the performance of this Agreement to the maximum extent doing so is economically feasible, and (ii) upon request, Contractor shall certify in writing under penalty of perjury, the minimum, if not exact, percentage of post consumer material as defined in the PCC 12200, in such goods regardless of whether the goods meet the requirements of PCC 12209.