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Assigned Regulatory Documentation definition

Assigned Regulatory Documentation has the meaning set forth in Section 3.5.2.
Assigned Regulatory Documentation. Section 3.3.1‎(iii) “Auditor” Section ‎‎7.11.1
Assigned Regulatory Documentation shall have the meaning set forth in Section 6.2.

Examples of Assigned Regulatory Documentation in a sentence

  • Notwithstanding the foregoing, MedImmune shall be permitted to retain copies of the Assigned Regulatory Documentation for purposes of Exploiting the AstraZeneca Product and otherwise.

  • Power was not restored until December 21, 2002.When ratepayers and DHS officials telephoned the Respondents on December 16, no answering machine or answering service was available.

  • All such Assigned Regulatory Documentation will be owned by and held in the name of X4.

  • Except to the extent specifically included in the Technical Services or expressly set forth in the preceding provisions of this Section 3.1 or the last sentence of Section 5.2.2, MedImmune shall have no obligation to provide transition or other support with respect to the Technical Transfer Documents, the Licensed Patents, the Licensed Know-How, the Assigned Regulatory Documentation, any Licensed Compound or Licensed Product or otherwise.

  • 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.

  • Sanofi hereby grants to Lexicon a non-exclusive, royalty-free (sub)license and right of reference, without the right to grant sublicenses or further rights of reference (except to permitted subcontractors as provided in Section 3.1.5), under the Sanofi Patents, the Sanofi Know-How and the Assigned Regulatory Documentation and Sanofi’s interests in the Joint Intellectual Property Rights, to perform Lexicon’s obligations as set forth herein or in the Ancillary Agreements.

  • Subject to the terms and conditions of this Agreement, as of the Effective Date, Allergan, on behalf of itself and its Affiliates, hereby grants to Assembly, and Assembly hereby accepts, a non-exclusive, royalty-free, sublicensable (solely to permitted subcontractors under this Agreement) license and right of reference under Allergan’s right, title and interest in and to the Allergan Collaboration IP and the Assigned Regulatory Documentation solely to carry out Assembly’s activities under the R&D Plan.

  • 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.

  • Issued on November 30, 1993 - This PSD modification was performed to increase the steel production rate from 160 tons per hour to 260 tons per hour.


More Definitions of Assigned Regulatory Documentation

Assigned Regulatory Documentation has the meaning set forth in Section 7.2.1(b).

Related to Assigned 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 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.

  • 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.

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

  • 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).

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

  • 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;

  • 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.

  • 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 Information has the meaning specified in Section 10.12(a).

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • SAP Materials means any materials (including statistical reports) provided, developed or made available by SAP (independently or with Customer’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Professional Services to Customer. SAP Materials do not include the Customer Data, Customer Confidential Information or the Cloud Service. SAP Materials may also be referred to in the Agreement as “Cloud Materials”.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

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

  • 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.

  • 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.

  • 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.

  • Controlled technical information means technical information with military or space application that is subject to controls on the access, use, reproduction, modification, performance, display, release, disclosure, or dissemination. Controlled technical information would meet the criteria, if disseminated, for distribution statements B through F using the criteria set forth in DoD Instruction 5230.24, Distribution Statements on Technical Documents. The term does not include information that is lawfully publicly available without restrictions.

  • 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.

  • 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.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

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

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Technical Information means technical data or computer software, as those terms are defined in the clause at DFARS 252.227-7013, Rights in Technical Data-Non Commercial Items, regardless of whether or not the clause is incorporated in this solicitation or contract. Examples of technical information include research and engineering data, engineering drawings, and associated lists, specifications, standards, process sheets, manuals, technical reports, technical orders, catalog-item identifications, data sets, studies and analyses and related information, and computer software executable code and source code.

  • Marketing Materials has the meaning ascribed thereto in NI 41-101;