AstraZeneca Regulatory Documentation definition

AstraZeneca Regulatory Documentation means Regulatory Documentation Controlled by AstraZeneca or any of its Affiliates as of the Effective Date relating exclusively to the Licensed Compound(s) in the Field in the Territory.
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AstraZeneca Regulatory Documentation has the meaning set forth in Section 5.1.1.
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AstraZeneca Regulatory Documentation means Regulatory Documentation Controlled by AstraZeneca or any of its Affiliates as of the Effective Date [***] the Licensed Compounds or the Licensed Products in the Field. The AstraZeneca Regulatory Documentation is listed on Schedule 1.13 (AstraZeneca Regulatory Documentation).
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Examples of AstraZeneca Regulatory Documentation in a sentence

  • Except as expressly provided herein and without limiting the foregoing, AstraZeneca grants no other right or license, including any rights or licenses to the AstraZeneca Patents, the AstraZeneca Know-How, the AstraZeneca Regulatory Documentation or any other Patent or other intellectual property rights not otherwise expressly granted herein.

  • Except as expressly provided herein and without limiting the foregoing, AstraZeneca grants no other right or license, including any rights or licenses to the AstraZeneca Patents, the AstraZeneca Know-How, the AstraZeneca Regulatory Documentation, the AstraZeneca Corporate Names or any other Patent, Trademark or other intellectual property rights not otherwise expressly granted herein.

  • Except as expressly provided herein and without limiting the foregoing, AstraZeneca grants no other right or license, including any rights or licenses to the AstraZeneca Patents, the AstraZeneca Know-How, the AstraZeneca Regulatory Documentation or any other Patent or other intellectual property rights.

  • In addition, AstraZeneca and its Affiliates expressly retain the rights under the AstraZeneca Patents, AstraZeneca Improvement Patents, AstraZeneca Corporate Names, Product Trademarks, the AstraZeneca Regulatory Documentation Regulatory Approvals or Controlled by AstraZeneca, the Manufacturing Know-How, and any other Patent or intellectual property rights, to perform all its obligations pursuant to this Agreement.

  • AstraZeneca further represents and warrants to Licensee, as of the Effective Date, (a) AstraZeneca Controls the AstraZeneca Patents and the AstraZeneca Regulatory Documentation as of the Effective Date and has the right to grant the licenses specified herein; and (b) AstraZeneca has not received any written claim or demand alleging that the Development or Commercialization of the Licensed Products as contemplated herein infringes any Patent owned by any Third Party.

  • Within the time period set forth in the Transitional Services Agreement, AstraZeneca shall provide Licensee with an electronic copy of the AstraZeneca Regulatory Documentation existing as of the Execution Date.

  • For the avoidance of doubt, all Information contained in the AstraZeneca Regulatory Documentation constitutes AstraZeneca Know-How and AstraZeneca’s Confidential Information and shall remain as such notwithstanding the transfer of the Existing Approvals to Licensee.

  • Except as expressly provided herein and without limiting the foregoing, AstraZeneca grants no other right or license, including any rights or licenses to the AstraZeneca Patents, the [***] Combination Patents, the Combination Data, the AstraZeneca Know-How, the AstraZeneca Regulatory Documentation, the AstraZeneca Corporate Names, or any other Patent, Trademark or other intellectual property rights not expressly granted herein.

Related to AstraZeneca 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 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, 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.

  • 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 documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).