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. 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. 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. 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. 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. 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 
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Related to Development in the Territory

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Territory The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

  • 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 Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • 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 of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • 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.

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