Joint Development Territory definition

Joint Development Territory means […***…].
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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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Joint Development Territory means the USA and the European Union.
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Examples of Joint Development Territory in a sentence

  • 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.

  • 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.

  • 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.

  • 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 […***…].

  • Astellas shall have sole responsibility for planning, coordinating, monitoring, and regulating all aspects of the research and development of Licensed Compounds and Products for the benefit of countries other than those in the Joint Development Territory; provided that the JSC shall review such development activities and coordinate to the extent practicable the Development Plan activities applicable to such Product.

  • 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.

  • The Party with primary responsibility for preparing submissions of Regulatory Materials shall keep the other Party reasonably informed of submissions of Regulatory Materials, including applications for Regulatory Approval in the Joint Development Territory and the status and progress of such submissions or applications.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • 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.

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

  • Research Program Term means the duration of the Research Program as it may be extended or terminated as described more fully in Section 2.10 and Article 8.

  • 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 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.

  • 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.

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

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products, to the extent that the same are Controlled by or in Adapt’s or its Affiliates’ or Adapt’s Commercial Sublicensees’ possession, and may be disclosed to Lightlake without violating any obligation under Applicable Law.

  • 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.