Transferred Regulatory Documentation definition

Transferred Regulatory Documentation has the meaning set forth in Section 2.2(a)(vii).
Sample 1Sample 2Sample 3
Transferred Regulatory Documentation means (i) all Existing Regulatory Filings and (ii) all other Regulatory Documentation owned by any Seller Party or any of their Affiliates (including any copies (electronic or otherwise) thereof) that was acquired, developed, compiled, collected or generated in connection with the Lead Compound or the Additional Compound.
Sample 1Sample 2Sample 3
Transferred Regulatory Documentation means all Regulatory Documentation that relates solely and exclusively to the Licensed Compound and/or the Licensed Products.
Sample 1Sample 2

Examples of Transferred Regulatory Documentation in a sentence

  • Seller Parties shall have no obligation to deliver any copies of the Transferred Records or the Transferred Regulatory Documentation to Buyer other than electronic copies (except to the extent electronic copies of such Transferred Records or Transferred Regulatory Documentation do not exist).

  • The European Commission Directorate-General for International Partnerships financed the one-year pilot programme with a € 615,000 grant.

  • In addition, Salix and Napo will each file their respective change ownership letters relating to each IND included in the Transferred Regulatory Documentation with the FDA as soon as possible, and in any event within ten (10) business days, after the date on which Salix provides to Napo a copy of the IND and the Transferred Regulatory Documentation underlying each such letter; such letters shall comply with all FDA regulatory requirements for same.

  • From and after the Closing Date, Xxxxx will assume control of, and responsibility for all costs and Liabilities arising from or related to any Transferred Regulatory Documentation other than any Excluded Liabilities, including any commitments or obligations to any Governmental Authority involving the Transferred Assets arising solely after the Closing Date.

  • When submitted to the applicable Governmental Authorities, all Transferred Regulatory Documentation were true, complete, and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections, or modification to such Transferred Regulatory Documentation have been submitted to the applicable Governmental Authorities.

  • Salix and Napo shall each file their respective change in ownership letters in the forms substantially set forth on Schedule 4.11 with the FDA as soon as possible, and in any event within ten (10) business days, after the date on which Salix provides to Napo a copy of the NDA and the Transferred Regulatory Documentation underlying each such letter pursuant to and in accordance with Section 4.9(b).

  • From and after the Closing Date, Buyer will assume control of, and responsibility for all costs and Liabilities arising from or related to any Transferred Regulatory Documentation, including, but not limited to, any commitments or obligations to any Governmental Authority involving the Products arising after the Closing Date.

  • WFHC shall bear the risk of loss to the Transferred Regulatory Documentation and the Transferred Books and Records until they have been delivered to Shire; thereafter, Shire shall bear all risk of loss associated with such Transferred Assets and shall be solely responsible for procuring adequate insurance to protect against such loss.

  • Upon completion of the Regulatory Transfer, all Transferred Regulatory Documentation shall be the sole property and held in the name of, UGNX or its designee.

  • The Transferred Books and Records and the Transferred Regulatory Documentation shall be transferred by delivery to Shire pursuant to Section 4.05(e).


More Definitions of Transferred Regulatory Documentation

Transferred Regulatory Documentation means (a) any Regulatory Documentation owned by Mereo or its Affiliates with respect to any Drug Substance or Licensed Product in the UGNX Territory existing as of the Effective Date and (b) any Regulatory Documentation owned by Mereo or its Affiliates with respect to any Drug Substance or Licensed Product in the Mereo Territory existing as of the Effective Date that is necessary for UGNX to perform its obligations under the Core Development Plan in the Mereo Territory (including clinical trial applications), but for clarity, excluding, with respect to countries in the Mereo Territory, (i) pediatric investigation plans (“PIP”), (ii) priority medicine (“PRIME”), orphan drug and similar designations granted by the applicable Regulatory Authorities in the Mereo Territory, and (iii) all other Regulatory Documentation primarily related to Section 1.168(b)(i) & (ii) existing at any time during the Term ((i) through (iii), the “Specified EMA Documentation”).
Sample 1
Transferred Regulatory Documentation means all Regulatory Documentation that relates to Crofelemer API, the Licensed IP and/or any Licensed Product.
Sample 1
Transferred Regulatory Documentation means all Regulatory Documentation that relates exclusively to the Territory, including, without limitation, the Transferred Regulatory Documentation described as set forth in Schedule 7.
Sample 1
Transferred Regulatory Documentation means all Regulatory Documentation that is used or held for use in connection with the Licensed Products in the Galapagos Territory or related to the Transferred Clinical Trials to the extent Controlled by Gilead or any of its Affiliates.
Sample 1
Transferred Regulatory Documentation means (a) all documentation comprising the Transferred Approvals, and all reports, regulatory applications, submissions and filings in connection therewith and (b) all correspondence and reports submitted to or received from Governmental Authorities in the Regeneron Territory to the extent related to any such Approvals or to the Commercialization of any Existing Praluent Product for any Existing Indication in the Regeneron Territory, and all relevant supporting documents with respect thereto, in each case ((a) and (b)), in the possession or Control of Sanofi or any of its Affiliates as of the Transition Date. For clarity, the term “Transferred Regulatory Documentation” shall only refer to the embodiments of such documentation, reports, applications, submissions, filings or correspondence and expressly excludes any Sanofi Core Know-How or any of Sanofi’s rights in or to the Existing Joint Know-How included or referenced therein, which shall be subject to the license grants in Section 2.2. The transfer to Regeneron of the Transferred Regulatory Documentation under Section 2.6 shall not operate to vest or result in any assignment or transfer of any rights, title or interest in and to such Know-How. For the avoidance of doubt, the term “Transferred Regulatory Documentation” shall not include any Trademark or Domain Name registration documentation, prosecution or enforcement files or Trademark clearance searches or conflict or opposition records and files.
Sample 1
Transferred Regulatory Documentation means, with respect to the Product in the Territory, all (a) documentation comprising the Transferred Marketing Authorizations for the Product, (b) data exclusively related to the Product and the Territory contained in any of the Transferred Marketing Authorizations and (c) correspondence and reports exclusively related to the Product in the Territory (including all such correspondence and reports submitted to or received from Regulatory Authorities in the Territory (including minutes and official contact reports relating to any communications with any Regulatory Authority) and relevant supporting documents submitted to or received from Regulatory Authorities in the Territory with respect thereto), including final versions of advertising and promotion documents, Product Labeling used as of the Closing Date, copies of Adverse Event files and Medical Device Reports, and copies of study reports, raw data, study related documents, publications, and reports of adverse device effects, in each case, to the extent owned and maintained by, and in the possession or under the Control of, Seller or its applicable Affiliate and in the format maintained by Seller or its applicable Affiliate (but excluding any Excluded Intellectual Property contained or incorporated therein and any Excluded Books and Records). “Transition Services Agreement” means the Transition Services Agreement to be entered into at the Closing, substantially in the form of Exhibit H. “VAT” means, within the European Union, any tax imposed in compliance with the Council Directive of 28 November 2006 on the common system of value added tax (Council Directive 2006/112/EC) and, in Canada, the GST/HST and QST.
Sample 1

Related to Transferred 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.

  • 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;

  • 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.

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

  • 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.

  • 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.

  • 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”.

  • 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.

  • Instructional materials means relevant instructional

  • Instructional material means instructional content that is provided to a student, regardless of its format, including printed or representational materials, audio-visual materials, and materials in electronic or digital formats (such as materials accessible through the Internet). The term does not include academic tests or academic assessments.

  • 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.

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

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

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

  • 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.

  • Acquisition Documentation collectively, the Acquisition Agreement and all schedules, exhibits and annexes thereto and all side letters and agreements affecting the terms thereof or entered into in connection therewith.

  • 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.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • 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 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.

  • Cloud Materials means any materials provided or developed by SAP (independently or with Provider’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Consulting Services to Provider or its Customers. Cloud Materials do not include any Customer Data, Provider Confidential Information, or the SAP Cloud Service.

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