Licensee Regulatory Documentation definition

Licensee Regulatory Documentation means Regulatory Documentation Controlled by Licensee or any of its Affiliates with respect to a Licensed Compound or a Licensed Product at any time during the Term.
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Licensee Regulatory Documentation has the meaning set forth in Section 3.12.1(ii) (Licensee Regulatory Documentation).
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Licensee Regulatory Documentation means the Regulatory Documentation Controlled by Licensee or any of its Affiliates as of the Effective Date relating to the Compound in the Field in the Territory. LML means a local manufacture license under the Chinese DAL and its relevant regulation and rules. Losses has the meaning set forth in Clause 9.1 (Indemnification of ArQule).
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Examples of Licensee Regulatory Documentation in a sentence

  • Except as expressly provided herein, Licensee grants no other right or license, including any rights or licenses to the PhaseBio Know-How, PhaseBio Patents, Licensee Termination Patents, Licensee Termination Know-How, the Assigned Regulatory Documentation, the Licensee Regulatory Documentation, the Product Trademarks, or any other Patent, Trademark or other intellectual property rights not otherwise expressly granted herein.

  • No rights or licenses are required under the Licensee Technology or Licensee Regulatory Documentation for Mersana to Develop, Manufacture or Commercialize Licensed Products as contemplated herein other than those granted under Article 2.

  • For clarity, Mersana shall not reference or otherwise use clinical data or Licensee Regulatory Documentation generated in connection with any Independent Development of Licensee unless and until Mersana [***], and Licensee shall not reference or otherwise use clinical data or Mersana Regulatory Documentation generated in connection with any Independent Development of Mersana unless and until Licensee [***].

  • Except as expressly provided herein, Licensee grants no other right or license, including any rights or licenses to the Licensee Patents, the Licensee Know-How, Licensee’s interest in the Joint Patents and the Joint Know-How, the Licensee Regulatory Documentation or any other Patent or intellectual property rights not otherwise expressly granted herein.

  • Except as expressly provided herein, Licensee grants no other right or license, including any rights or licenses to the Licensee Know-How, Licensee Patents, Licensee Improvements, Assigned Regulatory Documentation, the Licensee Regulatory Documentation or any other Patent, Trademark or other intellectual property rights not otherwise expressly granted herein.

  • With respect to such Licensee Regulatory Documentation, if elected by AstraZeneca, Licensee will submit to the applicable Health Authority, within [***] after the effective date of such termination, a letter (with a copy to AstraZeneca) notifying the applicable Health Authority of such transfer.

  • In the event of termination of this Agreement in its entirety or with respect to one or more Terminated Countries (except for termination caused by Licensee pursuant to Section 17.3.1), upon request of AstraZeneca, Licensee shall promptly transfer and assign to AstraZeneca any and all right, title, and interest in the Existing Approvals, Existing Applications and any and all Licensee Regulatory Documentation in the Licensed Territory in its entirety or such Terminated Countries, as applicable.

  • Except as expressly provided herein, the Licensee grants no other right or license, including any rights or licenses to the Licensee Technology, the Licensee Regulatory Documentation, the Licensee Trademarks or any other Intellectual Property Rights.

  • Each Party shall use commercially reasonable efforts to timely communicate to the other Party all Nabriva Development Data and Nabriva Regulatory Documentation (with respect to Nabriva as the obligor) or Licensee Development Data and Licensee Regulatory Documentation (with respect to Licensee as the obligor).

  • Except as required by a Health Authority or by Applicable Law, Licensee shall not withdraw or permit to be withdrawn, any Existing Approval, any CPP or any other Licensee Regulatory Documentation without the prior written consent of AstraZeneca, and on request of AstraZeneca, in lieu of such a withdrawal, shall transfer any such Existing Approval or other Licensee Regulatory Documentation to AstraZeneca solely for purposes of Exploiting Licensed Products in the AstraZeneca Territory.


More Definitions of Licensee Regulatory Documentation

Licensee Regulatory Documentation means (a) all Regulatory Documentation transferred to the Licensee under this Agreement, including Eisai Existing Regulatory Documentation for the Licensee Territory and (b) all Regulatory Documentation Controlled by the Licensee or any of its Affiliates created after the Original Effective Date which relates to the Licensed Compound or Licensed Products.
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Related to Licensee Regulatory Documentation

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all clinical studies and tests, including the manufacturing batch records, relating to the Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.

  • Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Trust to Fund shareholders.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).