US Commercialization Plans definition

US Commercialization Plans shall have the meaning assigned in Section 7.4.
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Examples of US Commercialization Plans in a sentence

  • Each Party shall keep the JCC fully informed regarding the progress and results of Commercialization activities for Products in the U.S. and RoW, including an annual review of results versus plans (as set forth in the U.S. Commercialization Plan(s)).

  • Subject to the terms and conditions of this Agreement, AstraZeneca hereby grants FibroGen a non-exclusive, worldwide, sublicensable, royalty-free, fully-paid license, under the AstraZeneca Technology during the Term, to conduct any and all activities assigned to FibroGen under the Development Plans and U.S. Commercialization Plans, and to Develop and Commercialize Products outside the Territory.

  • The Lead Party will be responsible, [***], the Global Commercialization Plan and the Country/Region Commercialization Plans (as applicable), including the U.S. Commercialization Plans (as applicable), for the creation, preparation, production and reproduction of all Promotional Materials and for filing, as appropriate, all Promotional Materials with all Regulatory Authorities in the world.

  • The U.S. Commercialization Plans shall specify the allocation and assignment of U.S. Commercialization Activities between the Parties with the goal that each Party's participation shall be substantially equal on an ongoing basis, taking into account the levels of participation in prior years and the participation specified in the Commercialization Plans for the following year.

  • On a Calendar Quarterly basis, Infinity shall determine all amounts payable by AbbVie to Infinity to reimburse the applicable portion of costs incurred by Infinity in such Calendar Quarter under Sections 3.5.1(d) and 3.5.2 (Infinity Third Party Agreement Payments) in connection with the Development, Manufacture or Commercialization of Products in the Ex-US Territory in accordance with the GDP or the Ex- US Commercialization Plans and the terms of this Agreement (such amounts, the “Reimbursable Amounts”).

  • The Lead Party shall use Commercially Reasonable Efforts to Commercialize Co-Funding Products in accordance with this Agreement and the applicable Plans, and each Party shall use Commercially Reasonable Efforts to carry out the Commercialization activities assigned to it in Global Commercialization Plans and Country/Region Commercialization Plans, including the U.S. Commercialization Plans, in a timely manner, and in each case shall conduct all such activities in compliance with Applicable Laws.

  • On an annual basis (no later than October 31st of the preceding Calendar Year), or more often as the Parties deem appropriate, the JCC shall prepare amendments to the then-current U.S. Commercialization Plan(s) and the corresponding U.S. Commercialization Budgets.

Related to US Commercialization Plans

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

  • 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;

  • 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.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

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

  • 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;

  • Development Program means the implementation of the development plan.

  • 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.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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.

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

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

  • 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 Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

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

  • Research Program has the meaning set forth in Section 3.1.

  • 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.

  • Marketing Plan has the meaning set forth in Section 4.3(a).

  • 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 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.