Territory Development Activities definition

Territory Development Activities means those Development Activities consistent with the applicable Development Plan that are (i) necessary solely for obtaining or maintaining Regulatory Approval for the Product in the Field in the Territory and (ii) post-Regulatory Approval-filing date Development Activities for the Product in the Field in the Territory. Notwithstanding the foregoing, in the event that Asahi requests that Auxilium perform certain Development Activities, within the Territory, which are not necessary solely for obtaining Regulatory Approval in the Territory, and Auxilium agrees at its sole discretion to perform such activities within the Territory, then such activities as are conducted in the Territory shall be deemed Territory Development Activities. For clarity, (i) those Development Activities which Auxilium proposes (absent Asahi’s request) to conduct in the Territory shall not be included in the definition of Territory Development Activities, and shall therefore be deemed General Development Activities, and (ii) Territory Development Activities shall not include activities associated with Territory-Specific Analytical Release Testing and Characterization.
Territory Development Activities means those Development Activities consistent with the Development Plan that are (i) necessary solely for obtaining or maintaining Regulatory Approval for the Product in the Field in the Territory and (ii) post-Regulatory Approval-filing date Development Activities for the Product in the Field in the Territory. Notwithstanding the foregoing, in the event that Licensee requests that Amarin perform certain Development Activities, within the Territory, which are not necessary solely for obtaining Regulatory Approval in the Territory, and Amarin agrees at its sole discretion to perform such activities within the Territory, then such activities as are conducted in the Territory shall be deemed Territory Development Activities.
Territory Development Activities means those Development Activities that are (i) necessary solely for obtaining or maintaining Regulatory Approval for Product in the Field in the Territory and (ii) post-Regulatory Approval filing date Development Activities for Product in the Field in the Territory. [ ** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

Examples of Territory Development Activities in a sentence

  • Any amendment to the Development Plan for the Compound and Products under this Agreement, including the Ovid Ongoing Trials, Licensee Territory Development Activities for registrational purposes, all Joint Development Activities, and all Independent Development Activities shall be conducted pursuant to a comprehensive written updated (from time to time) Development Plan (the “Amended Development Plan”), which shall be incorporated by reference into this Agreement.

  • Ovid shall have the right to use Data resulting from the Licensee Territory Development Activities as necessary for Ovid or its Affiliates or licensees (other than Licensee) to comply with its regulatory reporting and compliance obligations, including safety reporting obligations, and to support its own Development, Regulatory Approval, or Commercialization of the Product in the Ovid Territory.

  • With respect to all Joint Development Activities, Licensee Territory Development Activities, and Independent Development Activities (but subject to Section 4.7(c)), each Party shall promptly provide the other Party with [***].

  • Licensee shall be solely responsible for all Development Costs incurred in connection with Licensee Territory Development Activities, except as provided in Section 4.2(c)(ii) with respect to the Additional Pivotal Study.

  • In connection with the Development of Product for use in the Field in the Territory, Ono shall conduct Territory Development Activities pursuant to a comprehensive development plan (the “Development Plan”).

  • Licensee shall provide the JDC with reports detailing its respective Territory Development Activities and the results thereof at least [***] prior to any JDC meeting, but in any event, on at least a Calendar Quarter basis.

  • Prior to commencing any Licensee Territory Development Activities, Licensee shall provide the CGB with a draft workplan therefor, and following review and approval of such Licensee Territory Development activities by the CGB, such Licensee Territory Development Activities shall be included in and conducted in accordance with the Development Plan, subject to the oversight of the CGB and JPT as set forth in Article 3.

  • Ono shall conduct, in accordance with the Development Plan, the Territory Development Activities, including bridging studies, clinical studies, Phase IV Clinical Studies (and other post-Regulatory Approval studies).

  • In addition, Licensee shall use Commercially Reasonable Efforts to perform any Independent Development Activities of Licensee, and Licensee Territory Development Activities and file XXXx and seek and maintain Regulatory Approval (including Pricing and Reimbursement Approval, as applicable) for the Products throughout the Licensee Territory.

  • Amarin shall be given an adequate opportunity, in any event not less than [***], to comment on and approve the drafts of reports resulting from Territory Development Activities conducted under the Development Plan.


More Definitions of Territory Development Activities

Territory Development Activities means those Development Activities (other than Development Activities that have already been or are being conducted by Amarin as of the Effective Date) that are (a) necessary solely for obtaining or maintaining Regulatory Approval for the Product in the Territory for the Field and (b) post-Regulatory Approval-filing date Development Activities for the Product in the Territory for the Field. Such activities shall include, without limitation, designing, managing and conducting registration stability studies for the Product in the Territory for the Field, amending the shelf-life specifications to be in compliance with local Applicable Laws in the Territory, and assigning shelf-life/expiry dating of the Product. [***]
Territory Development Activities means those Development Activities consistent with the Development Plan that are (i) necessary for obtaining or maintaining Regulatory Approval for the Product in the Field solely with respect to the Territory and (ii) post-Regulatory Approval-filing date Development Activities for the Product in the Field solely with respect to the Territory. Notwithstanding the foregoing, in the event that Licensee requests that VBL perform certain Development Activities within the Territory and the Parties agree that VBL shall perform such activities within the Territory in accordance with Section 4.2.1(c), then such activities as are conducted in the Territory shall be deemed Territory Development Activities.
Territory Development Activities has the meaning given to it in Section 8.1.

Related to Territory Development 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;

  • 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 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.

  • licensed activities means things authorised to be done by the licence

  • 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.

  • 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.

  • 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.

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

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

  • Licensed Territory means worldwide.

  • 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;

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • 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.

  • Territory means worldwide.

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

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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.

  • 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.

  • Project Activities means the activities to be undertaken or Works to be delivered or Property to be contributed or provided by you, your approved Sub-Grantees or your approved sub- contractors as summarised in the Particulars and more particularly described in the Agreed Proposal for which Xxxxx is payable under this Agreement;

  • Commercialise means to promote, market, distribute, sell and/or otherwise commercialise a product, and Commercialising and Commercialisation shall be construed accordingly;

  • 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)).

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Union territory means the territory of—

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • 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.