Co-Formulation Development Plan definition

Co-Formulation Development Plan means the development plan and associated budget for the Development of Co-Formulation Products for intravenous and subcutaneous deliveries in the Field in the Territory, as attached to the First Restated Agreement as Schedule 5.1B, as such development plan and associated budget have been amended in accordance with the First Restated Agreement and in the form in which such development plan and associated budget exist as of the Second Restated Effective Date.
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Co-Formulation Development Plan has the meaning ascribed to that term in Section 5.1.1(b).
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Examples of Co-Formulation Development Plan in a sentence

  • The Co-Formulation Development Plan shall be deemed to be a Development Plan under this Agreement for all purposes, and may be amended by the Joint Development Subcommittee and the JSC in accordance with Section 5.1.1(c) below.

  • A preliminary Co-Formulation Development Plan and associated preliminary budget for the Development of Co-Formulation Products for intravenous and subcutaneous deliveries in the Field in the Territory is attached to this Agreement as Schedule 5.1B and sets out separately the Development activities for a Co-Formulation Product to be conducted by each Party following the Restatement Effective Date and a budget for such activities (the “Co-Formulation Development Plan”).

  • In addition, unless expressly agreed in writing by the Joint Development Subcommittee, the Co-Formulation Development Plan shall include the use of JR051 as the Co-Formulation Product ERT Enzyme.

  • Without limiting this Section 5.1.1(b), it is understood that the Co-Formulation Development Plan will at all times provide for Amicus and for GSK to have an active role in the Development activities for the Development of Co- Formulation Products in the Field.

  • With respect to any such dispute related to amendments to be made to the Co-Formulation Development Plan in accordance with Section 5.1.1(c) below that could result in the amount of Development Costs that Amicus is required to fund pursuant to ****** - Material has been omitted and filed separately with the Commission.

  • During the Co-Formulation Transition Supply Period, GSK shall supply JR051 to Amicus, at a price of ¥ 90M per 2000L batch plus an allocation of the costs of GSK FTEs of USD$312,000 per 2000L batch), such quantity of JR051 to be agreed in writing in advance, such amounts to be consistent with the current amounts and timelines set forth in the research plan for the Co-Formulation Development Plan during such period of time.

  • Included are themes such as the presumption of innocence, fundamental rights as the right to life, the right to integrity, prohibition of inhuman or degrading treatment or punishment, respect for private and family life and protection of personal data.

  • In addition, with respect to Joint Development Subcommittee meetings regarding the Development of the Co- Formulation Product and/or activities pursuant to the Co-Formulation Development Plan, GSK may elect for designated individuals from JCR to attend and participate in such Joint Development Subcommittee meetings, solely in the capacity of designated GSK agents.

  • Without limiting this Section 5.1.1(b), it is understood that the Co-Formulation Development Plan will at all times provide for Amicus and for GSK to have an active role in the Development activities for the Development of Co-Formulation Products in the Field.

Related to Co-Formulation Development Plan

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

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • 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;

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Development Program means the implementation of the development plan.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.