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.
Sample 1Sample 2Sample 3
Licensee Regulatory Documentation has the meaning set forth in Section 3.12.1(ii) (Licensee Regulatory Documentation).
Sample 1
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).
Sample 1

Examples of Licensee Regulatory Documentation in a sentence

  • 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 [***].

  • 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.

  • 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 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.

  • Licensee shall use reasonable efforts to give AstraZeneca at least [***] prior written notice of any planned variations or other amendments to the Existing Approvals or such other Licensee Regulatory Documentation that would require a new CPP to be issued.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


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.
Sample 1

Related to Licensee Regulatory Documentation

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • 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 or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Third Party Material means software, software development tools, methodologies, ideas, methods, processes, concepts and techniques owned by, or licensed to a third party and used by the Service Provider in the performance of the Services;

  • Third Party Materials means materials and information, in any form or medium, including any software, documents, data, content, specifications, products, equipment or components of or relating to the Services that are not proprietary to NCIT.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Product Know-How means Know-How to the extent related to the properties, manufacture or use of any products.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

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

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Licensed Know-How means any and all unpatented and/or non-patentable technical data, documents, materials, samples and other information and know‐how that is Controlled by LICENSOR or any of its Affiliates as of the Effective Date or thereafter during the Term that relates to, or is otherwise reasonably necessary or reasonably useful for, the use, Development, manufacture, or Commercialization of the Product. Licensed Know-How shall not include Licensed Patents.

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

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • Program Know-How means Information, whether or not patentable, that is conceived, generated, discovered, or created by one or both Parties or their Affiliates, or by any Third Party working on behalf of one or both Parties or their Affiliates, at any time during the Research Program Term as a direct result of the performance of the activities under the Research Program. Program Know-How shall include Results and Program Inventions and shall exclude Program Patents.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • IP Materials has the meaning given to it in clause E8.1 (Intellectual Property Rights).

  • Licensor Know-How means any and all Know-How that (a) is Controlled by Licensor or any of its Affiliates as of the Effective Date or at any time thereafter during the Term and (b) pertains to the Manufacture, use or sale of Licensed Products, including Research Inventions (other than Research Patents).

  • Product Documentation means the specific materials listed under “Documentation” at

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • Licensed Material means the artistic or literary work, database, or other material to which the Licensor applied this Public License.

  • Licensor Technology means the Licensor Patents, the Licensor Know-How, Licensor Materials, and Non-Patent Rights Controlled by Licensor or its Affiliates embodied in Licensor Know-How or Licensor Materials.