PENWEST TEST AND REGULATORY DATA definition

PENWEST TEST AND REGULATORY DATA means any and all test data, test designs and protocols, clinical studies and results thereof, government licenses and applications therefor, government certifications and findings, and related materials, information and rights (including without limitation information regarding bioavailability and bioequivalence, and any adverse drug reactions), developed, commissioned or otherwise obtained by Penwest or any of its Affiliates during the term of this Agreement relating to TIMERx, Penwest Patents, TIMERx Production Technology, and/or Penwest's Confidential Technology, together with all intellectual property and other rights and interests of Penwest and its Affiliates thereto and therein in the Territory.
PENWEST TEST AND REGULATORY DATA means any and all test data, test designs and protocols, clinical studies and results thereof, government licenses and applications therefor, government certifications and findings, and related materials, information and rights (including without limitation information regarding bioavailability and any adverse drug reactions), developed, commissioned or otherwise obtained by Penwest or any of its Affiliates during the term of this Agreement relating to TIMERx, Penwest Patents, Penwest Technology, and/or Penwest's Confidential Information, together with all intellectual property and other rights and interests of Penwest and its Affiliates thereto and therein in the Territory.
PENWEST TEST AND REGULATORY DATA means any and all test data, test designs and protocols, clinical studies and results thereof, government licenses and applications therefor, government certifications and findings, and related materials, information and rights (including without limitation information regarding bioavailability and bioequivalence, and any adverse drug reactions), developed, commissioned or otherwise obtained by Penwest or any of its Affiliates during the term of this Agreement relating to TIMERx, Penwest Patents, and/or TIMERx Production Technology and that are developed for or are otherwise related to or useful with the Product, including, without limitation, all patents, trade secrets, copyrights, periods of market exclusivity and other related rights and interests therein.

Examples of PENWEST TEST AND REGULATORY DATA in a sentence

  • These residents must be given a choice as to whether or not they wish to receive care on an extra service basis.


More Definitions of PENWEST TEST AND REGULATORY DATA

PENWEST TEST AND REGULATORY DATA means any and all test data, test designs and protocols, clinical studies and results thereof, government licenses and applications therefor, government certifications and findings, and related materials, information and rights (including without limitation information regarding bioavailability and bioequivalence, and any adverse drug reactions), developed, commissioned or otherwise obtained by Penwest or any of its Affiliates during the term of this Agreement relating to TIMERx, Penwest Patents, and/or TIMERx Production Technology and that are developed for or are otherwise related to or useful with the Product, including, without limitation, all patents, trade secrets, copyrights, periods of market exclusivity and other related rights and interests therein. 1.35 "PENWEST TRADEMARK(S)" shall mean those names, symbols and or characters described in Exhibit 1.17 hereto, as the same may be amended from time to time during the term of this Agreement by Penwest on at least six (6) months' prior written notice to Endo (or such shorter notice as reasonably agreed to by the parties), that are owned by Penwest and that have been designated by it for use in conjunction with Endo's packaging and promotion of the Product hereunder, pursuant to Section 8 hereof.

Related to PENWEST 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).

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • API means American Petroleum Institute.

  • Hemp products means all products made from industrial hemp,

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

  • Regulatory Materials means materials developed or compiled in preparation for Regulatory Authority meetings, regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable for the Development, manufacture, market, sale, or Commercialization of a Licensed Product in a particular regulatory jurisdiction.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • 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.

  • 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.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Product Know-How means Know-How

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.

  • Third Party Data has the meaning set forth in Section 9.3(a).

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • 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);