Joint Development Territory definition

Joint Development Territory means […***…].
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Joint Development Territory means the USA and the European Union.
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Joint Development Territory means the Joint Commercialization Territory and each of the then-current countries in Europe, including in each case their territories, protectorates and possessions.
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Examples of Joint Development Territory in a sentence

  • If this Agreement is terminated with respect to any or all Products with respect to one or more Terminated Country(ies) in the Joint Development Territory, but not in its entirety, such Terminated Country(ies) shall be deemed to be excluded from the Joint Development Territory with respect to the applicable Product(s) from and after the effective date of such termination event.

  • The Development Programs shall cover the research and clinical development activities intended to generate the data to be used in seeking, obtaining, maintaining and expanding Regulatory Approvals for Products in the Joint Development Territory or for supporting the marketing and selling of Products in the Joint Development Territory, and such activities shall be determined and overseen by the JSC, under the decision-making provisions of Section 2.1.4 below.

  • Starting from the date of the First Commercial Sale in any country in the Joint Development Territory of a Product to which Declined Development Activities relate, […***…], Astellas shall reduce the total amount due to Ambit hereunder with respect to sales of such Product during the applicable Calendar Year (whether in the form of Ambit’s portion of the U.S. Profit/Loss or royalty payments), by […***…].

  • All other sublicenses to be granted by Astellas or any Astellas Affiliate in the Joint Development Territory prior to […***…] will require prior written approval from Ambit, which shall not be unreasonably withheld or delayed, provided that in the event such sublicense is to all of Astellas’s rights in the U.S. or the Joint Development Territory to a Person who is not an Astellas Affiliate such approval shall be at Ambit’s sole discretion.

  • Each Party shall promptly provide the other Party with copies of all material written or electronic communications received by it or its Affiliates from, or forwarded or submitted by it or its Affiliates to, the Regulatory Authorities, in the case of Astellas, solely within the Joint Development Territory, with respect to any Product.

  • Astellas shall use Commercially Reasonable Efforts to develop each Product that is the subject of a Development Program in the Joint Development Territory through Regulatory Approvals in the countries outside the Joint Development Territory.

  • In the event that Astellas retains responsibility for preparing any Regulatory Materials, Astellas shall (a) provide Ambit with an opportunity to review and comment upon any Material Regulatory Submissions in the Joint Development Territory, in each case a reasonable period prior to the anticipated date of such submissions and (b) reasonably consider Ambit’s comments with respect to such submissions or applications in good faith.

  • All other research, clinical development and regulatory activities for Products that are intended to generate data for use in seeking, obtaining, maintaining and expanding Regulatory Approvals outside the Joint Development Territory shall be discussed and reviewed at a strategic level by the JSC, but Astellas shall have the final decision-making authority at the JSC level over all aspects of such activities as provided in Section 2.1.4 below.

  • Astellas shall keep Ambit reasonably informed about the status of the activities performed with respect to Astellas’s development and commercialization of Products as provided in Section 2.8.1 and 2.8.2 above, including of the status of Regulatory Approvals for Products outside the Joint Development Territory.

  • At any time prior to the First Commercial Sale in the Joint Development Territory of the Product to which Declined Activities relate, Ambit may at its sole discretion reverse its decision not to fund its share of the Development Costs with respect to a Declined Activity and shall promptly notify Astellas in writing of such decision.

Related to Joint Development Territory

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • 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.

  • Licensed Territory means worldwide.

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

  • Collaboration has the meaning set forth in Section 2.1.

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

  • 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.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • Development Program means the implementation of the development plan.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Development Works means the external development works and internal development works on immovable property;

  • Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.

  • Research Program Term has the meaning set forth in Section 2.2.

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • 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)).

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

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

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

  • 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.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

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

  • Development Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or Product.

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

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