Licensed Regulatory Documentation definition

Licensed Regulatory Documentation means any and all Regulatory Documentation related to the Product or any Other Product, in each case, Controlled by AstraZeneca or any of its Affiliates as of and following the Closing, excluding the Regulatory Documentation included in the Purchased Assets.
Licensed Regulatory Documentation means all (a) regulatory filings, supporting documents, chemistry, manufacturing and control data, preclinical and clinical studies and tests and (b) records maintained under record keeping or reporting requirements of the U.S. Food and Drug Administration or any other governmental entity, in each case held by Purchaser or any of its Affiliates and related to the Product or any Improvements thereto, including the Regulatory Documentation (as defined in the Asset Purchase Agreement.)
Licensed Regulatory Documentation means all Regulatory Documentation other than the Transferred Regulatory Documentation.

Examples of Licensed Regulatory Documentation in a sentence

  • Horizon shall conduct, and shall cause its Affiliates, Sublicensees, and Third Party subcontractors and distributors to conduct, all activities concerning the Product, any Other Product, the Licensed Intellectual Property and the Licensed Regulatory Documentation in compliance with all applicable Laws.

  • AstraZeneca has the right to grant the right of reference and use under the Licensed Regulatory Documentation to Horizon in accordance with the License Agreement.

  • At the Closing Time, the Securities will be rated at least BBB by Fitch Ratings and Baa1 by Xxxxx’x Investor Service.

  • Either party may exercise its rights under this Section 2.05 upon not less than five (5) business days’ advance written notice to the other party and shall conduct any related review of the Licensed Regulatory Documentation, Transferred Regulatory Documentation or the Shire Regulatory Documentation, as applicable, only during normal business hours.

  • The general increase and widening and availability of infrastructure will in turn attract and support further foreign investments and therefore completes the cycle of interdependence.

  • For the avoidance of doubt, as between WFHC and Shire, WFHC shall have the right to use the Licensed Regulatory Documentation for all purposes and indications other than to make, have made, use, have used, offer for sale, sell, import and export the Product and Licensed Improvements within the Territory for the Indication.

  • Effective upon the Closing, WFHC, on behalf of itself and its Affiliates, hereby grants to Shire and its Affiliates an exclusive (including with respect to WFHC and its Affiliates), royalty-free, perpetual license to access and reference the Licensed Regulatory Documentation to make, have made, use, have used, offer for sale, sell, import and export the Product and Licensed Improvements within the Territory for the Indication.

  • Each party shall promptly upon another party's reasonable request deliver to such other party any Know-How and, pursuant to Section 2.03, copies of any Licensed Regulatory Documentation, licensed to such other party by such party under this Agreement.

Related to Licensed 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.

  • 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 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.

  • 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.

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

  • 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.

  • 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).

  • 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.

  • 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 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.

  • 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.

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

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

  • 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.

  • 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.

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

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

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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.

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

  • Licensed Materials means any materials that Executive utilizes for the benefit of the Company (or any Subsidiary thereof), or delivers to the Company or the Company’s Customers, which (a) do not constitute Work Product, (b) are created by Executive or of which Executive is otherwise in lawful possession and (c) Executive may lawfully utilize for the benefit of, or distribute to, the Company or the Company’s Customers.

  • 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”.

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

  • 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:

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].