Preclinical Development Costs definition

Preclinical Development Costs means actual external costs incurred by ACADIA before the Effective Date, or at Sepracor’s written request after the Effective Date, for conduct of any of the following types of studies using a compound that is at any time designated as a Licensed Compound specifically intended to support the filing of an IND: in vivo and in vitro genotoxicity; safety pharmacology; drug metabolism; pharmacokinetics; general toxicology studies; GLP and GMP drug supply manufacturing; or stability.
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Preclinical Development Costs means the (i) external out-of-pockets costs and expenses, and (ii) internal costs and expenses calculated on an FTE basis as the FTE Rate, in each case incurred after the Effective Date by CPC in accordance with the Preclinical Development Plan and Budget that are reasonably attributable and fairly allocable to Preclinical Development activities performed pertaining to any Other Protein Variants or Other Compounds, including the costs of (a) processes and activities, whether in vitro or in vivo, conducted to discover, screen, optimize, clone, express, purify, formulate, characterize or enhance any Other Compound, including synthesis or Shuffling of any Other Compound, conjugation thereof, or similar activities; (b) the conduct of IND Enabling Studies with respect to an Other Compound; (c) processes and activities conducted to discover, develop, optimize, characterize or enhance technologies and tools including assays, screens, biological models, software and databases reasonably necessary for the support of any of the activities described in clauses (a) and (b) above, or development or manufacture of Other Compounds, and (d) manufacture of Other Compounds or Other Products for such activities; and (iii) any other costs or expenses that are expressly included in the Preclinical Plan and Budget as approved by the JSC.
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Preclinical Development Costs means the Costs incurred by a Party after the Effective Date that are attributable to Preclinical Development activities performed in accordance with the Preclinical Development Plan and Budget pertaining to any Compounds, including the Costs of (a) processes and activities, whether in vitro or in vivo, conducted to discover, screen, optimize, clone, express, purify, formulate, characterize or enhance any Compound, including synthesis or Shuffling of any Compound, conjugation thereof, or similar activities; (b) the conduct of IND Enabling Studies with respect to a Compound; (c) processes and activities conducted to discover, develop, optimize, characterize or enhance technologies and tools including assays, screens, biological models, software and databases reasonably necessary for the support of any of the activities described in clauses (a) and (b) above, or Development or Manufacture of Compounds, and (d) Manufacture of Compounds or Products for such activities.
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Examples of Preclinical Development Costs in a sentence

  • Except to the extent included in a Preclinical Development Plan funded pursuant to Section 8.1.3 (Preclinical Development Costs), Kite shall be solely responsible for, and shall bear all costs associated with, the manufacture of Kite Products.

  • Following the Effective Date and at all times during the Term (except as expressly stated otherwise herein), except as set forth in Section 8.1.3 (Preclinical Development Costs), Amgen shall be responsible for, and shall bear all costs associated with, the clinical development and commercialization of Amgen Products, including development, distribution, marketing and sales activities.

  • For clarity, other than with respect to Amgen obligations under this Section 8.1.3 (Preclinical Development Costs), each Party shall be responsible for, and shall bear all costs associated with, the clinical development and commercialization of its Products, including development, distribution, marketing and sales activities.

  • Upon any Change of Control of Kite, Amgen would no longer be responsible for the reimbursement of Kite’s costs and expenses related to Preclinical Development activities for Kite Targets pursuant to Section 8.1.3 (Preclinical Development Costs).

  • Notwithstanding the provisions of Section 8.1.3 (Preclinical Development Costs), […***…].

  • Following the Effective Date and at all times during the Term (except as expressly stated otherwise herein), except as set forth in Section 8.1.3 (Preclinical Development Costs), Kite shall be responsible for, and shall bear all costs associated with, the clinical development and commercialization of Kite Products, including development, distribution, marketing and sales activities.

  • Prior to the beginning of each calendar quarter during the Preclinical Funding Period, Astellas shall pay CPC for CPC’s expected Preclinical Development Costs for such calendar quarter as provided in the Preclinical Development Plan and Budget for such calendar quarter.

  • If Licensed Compound is an Option Compound for which ACADIA has unreimbursed Preclinical Development Costs, then Sepracor shall reimburse ACADIA for [...***...] such Preclinical Development Costs.

  • It seeks to tackle a wide range of issues and largely achieves this in a manner which meets the Basic Conditions.

  • ACADIA shall deliver a reasonably detailed written invoice of such Preclinical Development Costs to Sepracor within [...***...] of ACADIA’s receipt of Sepracor’s Exercise Notice, and Sepracor shall pay such invoice in full within [...***...] of receipt.


More Definitions of Preclinical Development Costs

Preclinical Development Costs means actual external costs incurred by ACADIA before the Effective Date, or at Sepracor’s written request after the Effective Date, for conduct of any of the following types of studies using a compound that is at any time designated as a Licensed Compound
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Related to Preclinical Development Costs

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

  • Development Plan has the meaning set forth in Section 3.2.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;