Territory Development Plan definition

Territory Development Plan means the clinical development plan designed for the purpose of obtaining Registration of the Product in the Field in each country in the Territory, as amended from time to time, the current draft of which is attached hereto as Exhibit D.
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Territory Development Plan means the three-year rolling plan approved by the JSC for Developing the Licensed Products in the Field for a specific country (or countries) in the Territory, including the related Territory Development Budget, as the same may be amended from time-to-time in accordance with the terms of this Agreement. For the avoidance of doubt, the Territory Development Plan will not include (a) any Development activities that are conducted as part of the Global Development Plan or (b) Non-Approval Trials, but will include any other clinical trials of the Licensed Products in the Field in the Territory, including any studies or other activities conducted for Pricing Approval.
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Territory Development Plan has the meaning set forth in Section 5.2.1 (Territory Clinical Development).
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Examples of Territory Development Plan in a sentence

  • During the term of the Territory Development Plan and the [*] period thereafter, the Territory Development Committee shall meet at least [*] during every calendar year, and more frequently as the Parties deem appropriate, on such dates, and at such times and places, as the Parties shall agree; provided, however, that at least one meeting during each calendar year shall be held in each of the United States and Russia, unless the Parties otherwise agree.

  • The Territory Development Committee shall exist until the termination or expiration of the Territory Development Plan plus the [*] period thereafter and for such longer period as necessary to perform the responsibilities assigned to it under this Agreement.

  • Scynexis hereby grants to R-Pharm, during the term of the Territory Development Plan, such exclusive rights under the Patents, Scynexis’ interest in Joint Patent Rights, both valid as of the Effective date of this Agreement and as are created within the Term of this Agreement, in the Field, in the Territory, to conduct the Territory Development Plan and to meet its obligations under the Global Development Plan.

  • R-Pharm shall be responsible for, and hereby assumes, any and all risks of personal injury or property damage incurred due to R-Pharm’s fault in connection with the Territory Development Plan and R-Pharm’s work under the Global Development Plan in the Territory.

  • The foregoing licenses shall include the right to grant sublicenses to the extent necessary to allow R-Pharm to meet R-Pharm’s obligations under the Territory Development Plan or the Global Development Plan.

  • Scynexis hereby grants to R-Pharm a non-exclusive, royalty-bearing license under the Scynexis Know-How and Scynexis’s interest in the Joint Know-How, both valid as of the Effective date of this Agreement and as are created within the Term of this Agreement, to conduct the Territory Development Plan and to meet its obligations under the Global Development Plan.


More Definitions of Territory Development Plan

Territory Development Plan means a written plan, for the conduct of the Territory-Specific development activities with respect to the Product in the Field in the Territory to support MAA filing and Regulatory Approval for the Product in each indication within the Field in the Territory, and, if agreed, any activities to be conducted by Licensee to support the global development of Products pursuant to the Global Development Plan. The high level outline of the initial version of the Territory Development Plan is attached hereto as Exhibit C, and the parties will use diligent efforts to agree on the initial version of the Territory Development Plan as soon as reasonably possible following the Effective Date.
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Territory Development Plan means the written plan approved by the JSC for Development of the Approved Product for Approved Indications that is specific to the Territory (and not, for clarity, any Global Trials), as the same may be amended from time to time in accordance with the terms of this Agreement. For the avoidance of doubt, the “Territory Development Plan” will not include any Manufacturing activities.
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Territory Development Plan means the China Development Plan or the U.S. Development Plan, as applicable.
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Territory Development Plan has the meaning set forth in Section 4.2 (Territory Development Plans). 1.192 “Territory Medical Affairs Plan” has the meaning set forth in Section 7.1 (Territory Medical Affairs Plans). 1.193 “Total Annual Net Sales” means, with respect to a Licensed Product, the total Net Sales of such Licensed Product in a particular Calendar Year. 1.194 “Third Party” means any Person other than a Party or an Affiliate of a Party. 1.195 “Third Party Claims” means collectively, any and all Third Party demands, claims, actions, suits, and proceedings (whether criminal or civil or in contract, tort, or otherwise). 1.196 “United States” or “U.S.” means the United States of America and its territories and possessions. 1.
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Territory Development Plan means the plan for the Development of the Albireo Compound and Products for Regulatory Approval in the Field in the Territory approved by the JDC and as amended or updated from time to time, but in no event less frequently than once a year, in accordance with this Agreement. The initial Territory Development Plan as of the date hereof is attached hereto as Exhibit 1.115.
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Territory Development Plan means the development plan for the Territory attached hereto as Schedule 1.67, as it may be amended from time to time.
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Related to Territory Development Plan

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

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

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

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

  • 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.

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

  • 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;

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • 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.

  • developing country means a country which is for the time being regarded as such in conformity with the practice of the General Assembly of the United Nations;

  • WTO GPA country end product means an article that—

  • 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 Program means the implementation of the development plan.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • 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;

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Licensed Territory means worldwide.

  • Territory means worldwide.

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

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

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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.

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

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and