Development Material definition

Development Material means the Licensed Compound in bulk form that is intended to be used solely for Development purposes.
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Development Material means materials supplied by MTEM hereunder for use in the Early Stage Program or other clinical or nonclinical development.
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Development Material means development tools and libraries and other software, documentation and information to be provided by a Party as necessary to permit each Party to perform its obligations and responsibilities set forth in a Statement of Work.
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Examples of Development Material in a sentence

  • Ironwood will be responsible for shipping the bulk Development Material and other Licensed Compound to the locations designated by Astellas.

  • Ironwood will supply Development Material and Licensed Compound for Commercial supply to Astellas in bulk form ready for formulation, packaging and labeling.

  • In furtherance of the foregoing, the Parties will execute a manufacturing and supply agreement promptly following the Effective Date, (a) under which Astellas will pay Ironwood [**] for supplying Development Material and Commercial supply of the Licensed Compound for the Product to Astellas, [**], and (b) which will contain, at a minimum, such terms and conditions as are described in Schedule 3.4 hereto and the last sentence of Section 4.10 (“Manufacturing and Supply Agreement”).

  • Development Material and Licensed Compound for Commercial supply will be shipped to Astellas F.O.B. [**], and title to such Development Material and other Licensed Compound will pass to Astellas upon placement by Ironwood with a carrier for delivery to Astellas.

  • Ironwood will supply Development Material in finished, packaged form ready for labeling.

  • In furtherance of the foregoing, the Parties will execute a manufacturing and supply agreement promptly following the Effective Date, under which Partner will pay Ironwood [**] for supplying Development Material and Commercial supply of the Licensed Compound for the Product to Partner, [**].

  • With respect to Takeda Development Material, MTEM will provide Takeda with reasonable access to its CMOs, including permitting and enabling Takeda to accompany MTEM in audits and inspections and using reasonable efforts to cause its CMOs to permit Takeda to conduct audits and inspections, as well as for regulatory purposes and technical transfer.

  • Within [***] after the [***] (if any), the Parties will agree on a development material service agreement between the Parties pursuant to which MTEM would supply Development Material, for preclinical development supporting IND filing and Phase I Clinical Trial supply and thereafter until the completion of the Technology Transfer, provided however that MTEM will not be required to supply Development Material after the Phase 1 Clinical Trials.

  • Except as would not have an RLJ Development Material Adverse Effect, no deficiencies for any Taxes have been proposed, asserted or assessed against RLJ Development, and no requests for waivers of the time to assess any such Taxes are pending.

  • Each RLJ Development Subsidiary, to the extent required under applicable Laws, is qualified to do business and is in good standing in each jurisdiction in which the nature of its business or the character of its property make such qualification necessary, other than such failures to be so qualified as would not, individually or in the aggregate, reasonably be expected to have a RLJ Development Material Adverse Effect.

Related to Development Material

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • Development Activities means those Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • 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.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.