Clinical Development and Collaboration Agreement definition

Clinical Development and Collaboration Agreement means that certain written agreement to be executed between the Company and NovaMedica for cooperation in clinical trials and other Development activities related to the Covered Products, as set forth in Section 3.1 and Article 5, below.
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Clinical Development and Collaboration Agreement shall have the meaning set forth in Section 5.1, below.
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Examples of Clinical Development and Collaboration Agreement in a sentence

  • If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then such matter shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement.

  • The Clinical Development and Collaboration Agreement shall, among other things, require that Company and the Transferee establish a Joint Steering Committee (“Joint Steering Committee” or “JSC”) to oversee Development of Covered Products until the First Commercial Sale of a Covered Product in the Territory, unless otherwise agreed in writing by Company and the Transferee.

  • The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (or a Permitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work shall be conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures.

  • The Clinical Development and Collaboration Agreement shall, among other things, provide that all Clinical Trials necessary to register a Covered Product for any Indication in the Field in any country or jurisdiction within the Territory shall be the sole obligation and responsibility of the Transferee.

  • Unless otherwise agreed in writing by the Transferee and Company, until the First Commercial Sale of a Covered Product in the Territory, the JDC will meet on a regular basis, at such times and in such manner as provided in Clinical Development and Collaboration Agreement.

  • If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance with the terms and conditions of this Agreement, the Clinical Development and Collaboration Agreement and Law.

  • The Clinical Development and Collaboration Agreement shall, among other things, also require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company.

  • Company and Transferee shall enter into the Sublicense Agreement, Clinical Development and Collaboration Agreement, Supply Agreements for clinical and commercial supplies of Covered Products, and Pharmacovigilance Agreement, as provided herein.

  • The provisions of this Article 12 concern resolution of disputes between the Parties with respect to the subject matter of this Agreement, exclusive of disputes between the Parties with respect to the subject matter of the Clinical Development and Collaboration Agreement and other Ancillary Agreements (“Development Disputes”), which Development Disputes shall be resolved in accordance with dispute resolution procedures in the Clinical Development and Collaboration Agreement and other Ancillary Agreements.

  • The Company shall fulfill all of its obligations under the TTA, the Assignment and Assumption Agreement and the Clinical Development and Collaboration Agreement, which shall be entered into within ninety (90) days after the effective date of the TTA (collectively, the “IP Transfer Agreements”).

Related to Clinical Development and Collaboration Agreement

  • Collaboration Agreement has the meaning set forth in the Recitals.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • Joint Development Agreement has the meaning provided in Section 5.3.

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

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

  • Development Agreement has the meaning set forth in the Recitals.

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

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

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

  • Collaborative agreement means a voluntary, written, or electronic arrangement between one

  • Development Program means the implementation of the development plan.

  • Development Agreements means all development, utility or similar agreements included in the Permitted Encumbrances.

  • 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.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • 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;

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • 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.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • 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)).

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Collaborative practice agreement means a written agreement