Development in the Territory Sample Clauses

Development in the Territory. The parties agree that, at least [***] days prior to the proposed initiation by TAIHO or any of its Sublicensees of (a) any GLP-compliant in vivo pre-clinical study, the results of which would be required to be reported to any Regulatory Authority in the Territory to which TAIHO has submitted or proposes to submit an IND or NDA for a Licensed Product, or (b) any Clinical Trial of Licensed Product in the Territory, TAIHO shall deliver to Arcus the draft protocol for such study or trial for review. Arcus shall review such draft protocol and notify TAIHO within [***] days of Arcus’s receipt thereof if Arcus in good faith believes that the conduct or design of the proposed study or trial poses an unreasonable risk to the successful Development, registration or Commercialization of Licensed Products in the Field outside the Territory. If Arcus so notifies TAIHO, the parties’ Executives shall meet and attempt to resolve any dispute regarding whether such risk exists and how to address such risk. If the Executives are unable to reach a mutually agreeable resolution within [***], TAIHO shall have the final decision making rights with respect to the conduct or design of the proposed study or trial, provided, however that TAIHO shall consider Arcus’s concerns in good faith.
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Development in the Territory. Subject to the terms and conditions of this Agreement, Lian will lead Development activities for the Licensed Product in the Territory as required to obtain, support and maintain the Regulatory Approval of the Licensed Product for CRS in the Territory. Lian will have the right to determine after considering in good faith Lyra’s suggestions from which Regions all patients in any Clinical Trial for the Licensed Product conducted in the Territory are enrolled, provided that such sites selected by Lian for the Regions do not [***] under the Global Development Plan, and otherwise, the Parties will agree upon (i) [***]; provided however, if the NMPA requires or recommends additional study endpoints, a different study design, or other study protocol changes for the Phase III Trial that are not consistent with the study endpoints, study design, or study protocol contemplated by the IND in the U.S., and Lyra reasonably determines that accommodating such modifications in the Global Phase III Trial would materially delay Regulatory Approval of the Licensed Product in the U.S., then Lyra shall have the right to [***], and (ii) [***]. Notwithstanding anything to the contrary herein, if Lian does not provide its Clinical Trial data from the Global Phase III Trial in the PRC to Lyra prior to the date set forth in the Global Development Date for the U.S. data read-out for the Global Phase III Trial (which such date will be discussed and approved by the JSC), then Lyra shall have the right, [***].
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Development in the Territory. P&U shall have the right to manage and control the development of Candidate Drugs selected in accordance with Section 2.6 in the Territory at its own expense. Promptly after selection of each Candidate Drug, P&U shall prepare a written Development Plan for the further preclinical and clinical development of such Candidate Drug, which Plan shall be amended periodically as necessary. P&U shall provide a copy of such Development Plan, and any amendments thereto, to Geron for review and comment. P&U shall provide Geron with notice of all meetings of the P&U project committee responsible for the development of the Candidate Drug, as well as written materials sufficient to inform Geron of the progress of the clinical development, and Geron shall be permitted to attend all such meetings. P&U shall use reasonable diligent efforts, consistent with good pharmaceutical industry practices, to develop Candidate Drugs selected by P&U for sale as Products in the Territory in accordance with the Development Plan. Commencing upon the [*] covering a Candidate Drug, P&U shall prepare and maintain complete and accurate information regarding the world-wide clinical development of Products and shall make such information available to Geron in the form of written detailed reports to Geron at least twice per year. Such reports shall summarize the status and results of all such development efforts. P&U also will respond to reasonable requests by Geron for additional information regarding the development of Candidate Drug. Notwithstanding Geron's right to review such information and * Certain portions of this Exhibit have been omitted for which confidential treatment has been requested and filed separately with the Securities and Exchange Commission. provide such comments, P&U retains the right, subject to diligence requirements contained in this Agreement, to develop Candidate Drugs in its sole discretion.
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Development in the Territory. Tanabe shall have sole responsibility to conduct the Development, itself or through its Affiliates on its behalf, of one or more Licensed Compounds within the Territory in order to obtain and maintain Regulatory Approval of Products. Tanabe and its Affiliates shall be solely responsible for all costs and expenses of Tanabe and its Affiliates relating to such Development efforts and to obtaining such Regulatory Approval of Products.
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Development in the Territory. In accordance with Section 2.1(b), ASTELLAS shall assume responsibility for and bear all related Other Development Costs in relation to the Development of the Product solely for the Territory other than those specified in the Clinical Development Plan which are dealt with in Section 3.1. All decisions in relation to Development pursuant to this Section 3.2 shall be made by ASTELLAS.
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Development in the Territory. Xxxxxxx Pharma shall have the responsibility to conduct the Development, itself or through its Affiliates or Sublicensees, as applicable, on its behalf, of the Licensed Compound within the Territory in order to obtain and maintain Regulatory Approval of Products as promptly as practicable. As provided below, the Parties agree to work closely together in conducting such Development and to cooperate in attempting to proceed with Development efforts as quickly as practicable. Xxxxxxx Pharma will consult regularly with the Development Committee concerning the Development efforts undertaken by Xxxxxxx Pharma, its Affiliates and Sublicensees in the Territory. In addition to Lynx's other duties under the Agreement, Lynx agrees to provide Xxxxxxx Pharma reasonable assistance, at Xxxxxxx Pharma's cost and expense (other than expenses related to the Drug Master File), in conducting such Development. Except as provided in the following, Xxxxxxx Pharma, its Affiliates and Sublicensees shall be solely responsible for all costs and expenses of Xxxxxxx Pharma, its Affiliates and Sublicensees relating to such Development efforts and to obtaining such Regulatory Approval of Products. Lynx agrees to pay for and conduct the ITALICS Trial, according to the protocol as existing on the Effective Date or as subsequently modified by Lynx at its discretion, subject to the approval of Xxxxxxx Pharma not to be unreasonably withheld or delayed. Xxxxxxx Pharma may request changes to such ITALICS Trial protocol, and is responsible for all additional costs and expenses caused predominantly by such changes. Lynx also agrees, at Xxxxxxx Pharma's expense, to prepare and provide to Xxxxxxx Pharma for filing the IND for the U.S. Multi-Dose Efficacy Trial, which filing shall occur no later than [REDACTED] days after Lynx provides the complete IND.
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Development in the Territory 
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Related to Development in the Territory

  • Territory 33.1 This Agreement applies to the territory in which CenturyLink operates as an ILEC in the State. CenturyLink shall be obligated to provide services under this Agreement only within this territory. 33.2 Notwithstanding any other provision of this Agreement, CenturyLink may terminate this Agreement as to a specific operating territory or portion thereof pursuant to Section 6.7 of this Agreement.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Marketing Activities The Borrower will not, and will not permit any of its Subsidiaries to, engage in marketing activities for any Hydrocarbons or enter into any contracts related thereto other than (i) contracts for the sale of Hydrocarbons scheduled or reasonably estimated to be produced from their proved Oil and Gas Properties during the period of such contract, (ii) contracts for the sale of Hydrocarbons scheduled or reasonably estimated to be produced from proved Oil and Gas Properties of third parties during the period of such contract associated with the Oil and Gas Properties of the Borrower and its Subsidiaries that the Borrower or one of its Subsidiaries has the right to market pursuant to joint operating agreements, unitization agreements or other similar contracts that are usual and customary in the oil and gas business and (iii) other contracts for the purchase and/or sale of Hydrocarbons of third parties (A) which have generally offsetting provisions (i.e. corresponding pricing mechanics, delivery dates and points and volumes) such that no “position” is taken and (B) for which appropriate credit support has been taken to alleviate the material credit risks of the counterparty thereto.

  • Field The term “

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

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