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 QAA shall further include provisions obligating Ardelyx to report to AstraZeneca any regulatory compliance issues with its suppliers as well as any critical quality non-conformances relating to the Lead Licensed Compound or Lead Licensed Product.

  • 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 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.

  • After the Effective Date, and promptly following AstraZeneca’s request to do so, Ardelyx shall transfer to AstraZeneca copies of all of the “Essential Documents” as defined in Chapter 8 of ICH-GCP that are Controlled by Ardelyx relating to the Lead Licensed Compound and Lead Licensed Product (the “Essential Documents”).

  • 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 Parties shall also enter into a separate Quality Assurance Agreement (“QAA”) that shall define the manufacturing and supply quality responsibilities of the Parties for the Lead Licensed Compound and the Lead Licensed Product.

  • Notwithstanding the foregoing, if KKC requests Ardelyx to supply to KKC the Lead Licensed Product and placebos that are manufactured for the US market in order for KKC to conduct the CMC Development of the Lead Licensed Product and placebos by KKC in the Territory, the Parties shall discuss KKC’s request in good faith.

  • AstraZeneca shall ensure that the incentives offered to its sales representatives in connection with sales of the Lead Licensed Product [***] with the sale of [***], if any.

  • 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.