Joint Commercialization Budget definition

Joint Commercialization Budget has the meaning set forth in Section 5.2.1 (General).
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Joint Commercialization Budget has the meaning set forth in Section 8.3(a)(i).
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Joint Commercialization Budget has the meaning set forth in Section 6.2 (Joint Commercialization Plans).
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Examples of Joint Commercialization Budget in a sentence

  • If Astellas believes any individual Commercialization Cost that it expects or plans to incur with respect to the Licensed Territory will also reasonably benefit the Shared Territory, Astellas may propose that a portion of such Commercialization Cost be allocated in the applicable Joint Commercialization Budget to the Shared Territory, and Medivation shall consider that request reasonably and in good faith.

  • The amount budgeted for each Party’s Co-Promotion activities in each Joint Commercialization Budget will be consistent with the Co-Promotion activities assigned to such Party pursuant to the Joint Commercialization Plan.

  • On a Calendar Year basis, or more often as the Parties deem appropriate, the JCC shall prepare and approve amendments to the then-current Joint Commercialization Plan, including the corresponding Joint Commercialization Budget.

  • The amount budgeted for Medivation’s co-promotion activities in each Joint Commercialization Budget will be consistent with the Co-Promotion Activities assigned to Medivation pursuant to the Joint Commercialization Plan (it being understood that Medivation shall be allocated the Medivation Promotional Share of the budgeted aggregate Detail Costs).

  • At any time during the term of the CDCP Agreement, if Precision believes that it may not have access to cash sufficient to cover its share of Development or Commercialization costs (in accordance with the Annual Joint Development Budget or Annual Joint Commercialization Budget, as applicable) for the then-following [***], Precision shall promptly notify Baxalta, and the Parties shall promptly meet and discuss in good faith to resolve the issue.

  • Any JSC-approved amended Joint Commercialization Plan (including its corresponding Joint Commercialization Budget and Long Term Joint Commercialization Budget) will supersede the previous Joint Commercialization Plan (including its corresponding Joint Commercialization Budget and Long Term Joint Commercialization Budget) for the applicable period.

  • Once approved by the JSC, an amended annual Joint Commercialization Plan (including its corresponding Joint Commercialization Budget and Long Term Joint Commercialization Budget) will become effective for the applicable period on the date approved by the JSC (or such other date as the JSC will specify).

  • Each such amended Joint Commercialization Plan will specify the items described in Section 5.2.1.1 (General) for each Product Class for the next Calendar Year (and additional periods as reasonably determined by the Parties) and the Joint Commercialization Budget included therein will appropriately itemize FTE Costs and Out-of-Pocket Costs for the activities undertaken pursuant to such Joint Commercialization Plan.

  • The Joint Commercialization Plan, including the corresponding Joint Commercialization Budget, with respect to the applicable Licensed Product in the Shared Territory and subsequent revisions thereto shall contain such information as the JCC and JSC believes necessary for the successful Commercialization of such Licensed Product in the Shared Territory, both pre- and post-launch.

  • Notwithstanding the foregoing, the initial Joint Commercialization Plan (including the initial high-level Joint Commercialization Budget [***]), which includes a forecasted profit and loss plan [***] based on initial product plan activities for the Lead Product during such period, is attached hereto as Exhibit H.

Related to Joint Commercialization Budget

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

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

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

  • Research Budget has the meaning set forth in Section 2.2.

  • 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.

  • 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;

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

  • Development Budget has the meaning set forth in Section 3.1.

  • Development Program means the implementation of the development plan.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

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

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

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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 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.

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

  • 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).

  • 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.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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.

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.

  • 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.