Small Molecule Development Plan definition

Small Molecule Development Plan means a plan that, depending upon the stage of Development, details the Research and/or Development activities to be conducted pursuant to this Agreement with respect to Small Molecule Collaboration Compounds during the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Term, and may include without limitation the following anticipated Development activities or events: [***]. The Small Molecule Development Plan will include, without limitation, [***].
Small Molecule Development Plan means a plan that, depending upon the stage of Development, details the Research and/or Development activities to be conducted pursuant to this Agreement with respect to Small Molecule Collaboration Compounds during the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Examples of Small Molecule Development Plan in a sentence

  • Each Party will test the Collaboration Compounds for which it is responsible for performing Research and Early Development pursuant to Section 2.2 using the Assay Technology as set forth in the Biologic Development Plan or the Small Molecule Development Plan, and using other appropriate analytical and evaluative tools and methods, to generate the data required to evaluate such a Collaboration Compound against the Candidate Selection Criteria.

  • Such Development Plans are appended to this Agreement as Exhibit 2.5. The JSC may approve modifications of such Development Plans from time to time, provided, however, that no Small Molecule Development Plan may [***] taking into account [***].

  • From time to time during the Small Molecule Research Term, OncoMed shall transfer to BSP OncoMed Know-How necessary to enable BSP to practice the Assay Technology identified by the JSC as necessary for BSP to perform in vitro assays, or other activities that the JSC agrees are necessary for BSP to perform, in Developing Small Molecule Collaboration Compounds pursuant to the Small Molecule Development Plan.

  • Machine Documentation allows all Customers to manage documents of any kind such as the maintenance manual of a Machine Asset from the Manufacturer or specific adjustments that were made to a Machine Asset by the Operator.

  • OncoMed shall transfer the quantities of Materials for the [***] to be performed pursuant to the initial Small Molecule Development Plan as described in Section 2.1.3 and other Materials as set forth in the Small Molecule Development Plan.

  • Thereafter, during the Biologic Research and Early Development Term, the JSC shall approve a Biologic Development Plan proposed by OncoMed for each new Biologic Collaboration Compound that OncoMed elects to Develop after the Effective Date, and during the Small Molecule Research Term the JSC shall approve a Small Molecule Development Plan proposed by BSP for each new Small Molecule Collaboration Compound that BSP elects to Develop after the Effective Date.

  • Generally, except as otherwise expressly provided in this Agreement or in a Small Molecule Development Plan, BSP (with the assistance of OncoMed as set forth in the Small Molecule Development Plan) shall be primarily responsible for, and shall [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

  • The Small Molecule Development Plan will include, without limitation, [***].

  • OncoMed, at its expense, will perform certain assays, in vitro and/or in vivo screening, or other Development activities, and provide the quantities of Materials required for the [***] described in the initial Small Molecule Development Plan, and additional reasonable quantities of other Materials required by BSP in connection with the Development of Small Molecule Collaboration Compounds conducted under a Development Plan, as described in Section 2.3.3. 2.2 Efforts.

  • The Parties have agreed on a Biologic Development Plan proposed by OncoMed for the Research activities to be initiated with regard to the identification of new Biologic Collaborations Compounds and Early Development activities for each Biologic Collaboration Compound to be Developed as of the Effective Date, and a Small Molecule Development Plan proposed by BSP for Research activities to be initiated with regard to the identification of Small Molecule Collaboration Compounds as of the Effective Date.

Related to Small Molecule Development Plan

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

  • Development Program means the implementation of the development plan.

  • 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)).

  • 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;

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

  • 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.

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

  • 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;

  • Collaboration Technology means the Collaboration Know-How and the Collaboration Patents.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

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

  • 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.

  • 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.

  • Development Phase means the period before a vehicle type is type approved.

  • 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).

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

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

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Research Program has the meaning set forth in Section 2.1.

  • 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.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • 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;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.