Test and Regulatory Data definition

Test and Regulatory Data means any and all pre-clinical and clinical test data, test designs and protocols, results and data from pre-clinical and clinical studies, information contained in or submitted in government licenses and applications therefor, government certifications and findings, and related materials, data from pre-clinical and clinical experiments demonstrating or supporting bioavailability, bioequivalence, data concerning any adverse drug reactions; “[***] Field Product” means any [***] Field Product for the treatment of [***] and which incorporates [***] and is to be further developed in whole pursuant to the [***];
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Test and Regulatory Data means any and all pre-clinical and clinical test data, test designs and protocols, results and data from pre-clinical and clinical studies, information contained in or submitted in government licenses and applications therefor, government certifications and findings, and related materials, data from pre-clinical and clinical experiments demonstrating or supporting bioavailability, bioequivalence, data concerning any adverse drug reactions;
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Test and Regulatory Data any and all test data, test designs and protocols, preclinical and clinical studies and results thereof, government licences and applications therefor, government certifications and findings, and related materials, information and rights (including without limitation information regarding bioavailability, bioequivalence and any adverse drug reactions) developed, commissioned or otherwise obtained by Dexo and/or Uluru during the term of this Agreement for the uses intended by this Agreement relating to the Products;
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Examples of Test and Regulatory Data in a sentence

  • Penwest will, throughout the License Term and solely for use within the scope of the license stated in this section, promptly provide to Mylan copies of all of the Penwest Test and Regulatory Data in or coming into Penwest's possession or otherwise reasonably available to it.

  • Mylan hereby consents to Penwest's and its Affiliates' and sublicensees' cross-referencing, in any filings that are essentially the equivalent of the sorts of filings that are termed "ANDA" or "NDA" filings if made with the FDA, made by them within the scope of such license, any ANDA or NDA filing made or FDA master file created by Mylan or its Affiliates or sublicensees relating to or containing any of the Mylan Test and Regulatory Data.

  • Mylan will, throughout the License Term and solely for use within the scope of the license stated in this section, promptly provide to Penwest copies of all of the Deliverable Portion of the Mylan Test and Regulatory Data in or coming into Mylan's possession or otherwise reasonably available to it.

  • Schw▇▇▇ ▇▇▇rma hereby consents to TIMERx Technologies' and its sublicensees' cross-referencing, in any ANDA or NDA filings made by them within the scope of such license, any ANDA or NDA filing made or FDA master file created by Schw▇▇▇ ▇▇▇rma or its Affiliates relating to or containing any of the Schw▇▇▇ ▇▇▇rma Test and Regulatory Data.

  • Schw▇▇▇ ▇▇▇rma will, throughout the License Term and solely for use within the scope of the license stated in this section, provide to TIMERx Technologies on request access to all of the Schw▇▇▇ ▇▇▇rma Test and Regulatory Data in or coming into Schw▇▇▇ ▇▇▇rma's possession or otherwise reasonably available to it.

  • TIMERx Technologies will, throughout the License Term and solely for use within the scope of the license stated in this section, provide to Schw▇▇▇ ▇▇▇rma on request access to all of the TIMERx Technologies Test and Regulatory Data in or coming into TIMERx Technologies' possession or otherwise reasonably available to it.

  • Penwest hereby consents to Mylan's and its Affiliates' and such sublicensees' cross-referencing, in any ANDA or NDA filings made by them within the scope of such license, any ANDA or NDA filing made or FDA master file created by Penwest or its Affiliates relating to or containing any of the Penwest Test and Regulatory Data.

  • Such license shall be on a paid-up, royalty-free basis as to Penwest and its Affiliates, and as to any of the Available Portion of the Mylan Test and Regulatory Data (whether as to Penwest or others), but shall ************************************************ if any but the Available Portion is used by any other party under a sublicense from Penwest or its Affiliate.

  • Upon the disclosure of such Test and Regulatory Data to Autolus, the GD2 Licence shall automatically be extended to include a licence to the GD2 Clinical Study Results and the GD2 Program IP shall be deemed to include GD2 Clinical Study Results.

  • Penwest hereby consents to Mylan's and its Affiliates' and such sublicensees, cross-referencing, in any ANDA or NDA filings made by them within the scope of such license, any ANDA or NDA filing made or FDA master file created by Penwest or its Affiliates relating to or containing any of the Penwest Test and Regulatory Data.

Related to Test and Regulatory Data

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • 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.

  • Licensed Data means the data licensed by the LME to the Licensee set out in the Order Form and further defined in Schedule 1 (Licensed Data);

  • 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.

  • Study Data shall have the meaning set forth in Section 8.1.