Lead Licensed Product definition

Lead Licensed Product means a Licensed Product containing the Lead Licensed Compound as an active ingredient.
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Lead Licensed Product means the product consisting of Protein Targets that are Omega Controllers and associated Human Genome Target(s) identified on Appendix 1.46 hereto, where such product is derived from, incorporates, or utilizes any LNP Technology that is Controlled by Acuitas or its Affiliates as of the License Agreement Effective Date or at any time during the Term. Upon replacement of the Lead Licensed Product with a Backup Licensed Product, the Backup Licensed Product will become the Lead Licensed Product hereunder. For the avoidance of doubt, any product consisting of Protein Targets that are Omega Controllers that have at least [***] percent ([***]%) amino acid sequence identity to the Protein Targets that are Omega Controllers identified on Appendix 1.46 (or to the Protein Targets that are Omega Controllers in any Backup Licensed Product that becomes the Lead Licensed Product) will also be a Lead Licensed Product if such product is derived from, incorporates, or utilizes any LNP Technology that is Controlled by Acuitas or its Affiliates as of the License Agreement Effective Date or at any time during the Term.
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Lead Licensed Product means the Licensed Product that is [***].
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Examples of Lead Licensed Product in a sentence

  • The Initial Supply shall include, unless otherwise determined by the DCC, those quantities of Lead Licensed Product and Lead Licensed Compound and those activities described on Exhibit J.

  • Ardelyx will use subcontractors to manufacture and supply Lead Licensed Product and Lead Licensed Compound for use by the Parties under the Main Agreement, and Ardelyx shall enter into, or maintain contractual relationships with its subcontractors that are consistent with the provisions set forth herein.

  • The Initial Supply from Ardelyx to AstraZeneca, or to Ardelyx internally where Ardelyx has been assigned (either by the DCC or under the terms of the Agreement) the lead responsibility for the conduct of the Clinical Trial for which the supply is intended, shall include those GMP quantities of Lead Licensed Compound or Lead Licensed Product, and those development activities, in either case, approved by the DCC.

  • The IBS-C Study will include a minimum of [***] with the Lead Licensed Product (subject to any extension which the DCC agrees should apply) and shall include at least one arm with [***].

  • The Parties acknowledge and agree that additional development will be required to obtain approval of a Drug Approval Application for the Lead Licensed Product in the Territory.

  • Upon [***] reasonable request, MAP or AstraZeneca shall provide [***] samples of promotional material used by MAP or AstraZeneca in connection with promotion of the Lead Licensed Product.

  • If AstraZeneca believes that the Lead Licensed Product has failed to meet the Target Product Characteristics in the Key Trials conducted pursuant to the Initial Development Plan, as may be amended for any additional Phase III Clinical Trial, then AstraZeneca shall notify MAP in writing of such conclusions prior to the filing of the Drug Approval Application for the Lead Licensed Product in the United States.

  • Under the direction and supervision of the JPT, with respect to the United States, AstraZeneca shall use Commercially Reasonable Efforts to develop (a) the Lead Licensed Product and to obtain Health Registration Approvals from the FDA for the Lead Licensed Product for use in humans, and (b) the NextGen Product and to obtain Health Registration Approvals from the FDA for such products for use in humans.

  • MAP shall have the right and obligation to co-promote the Lead Licensed Product in the United States pursuant to a co-promotion agreement (the “Co-Promotion Agreement”) to be entered into between the Parties.

  • Such designation shall not limit AstraZeneca’s diligence obligations under the other provisions of this Article 5 with respect to the former Lead Licensed Product prior to the effective date of such designation.

Related to Lead Licensed Product

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • 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.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Licensed Compound means [***].

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Licensed Territory means worldwide.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Licensed Field means all fields of use.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

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

  • Licensed Services means all functions performed by the Licensed System.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

  • Third Party Product means a product (whether hardware, software or services) supplied to you by a third party;

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Hemp products means all products made from industrial hemp,

  • 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;

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • 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.

  • Licensed Field of Use means all fields.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • End product means those articles, materials, and supplies to be acquired under the contract for public use.