ROW Commercialization Sample Clauses

ROW Commercialization. For the avoidance of doubt, and notwithstanding anything to the contrary in this Celgene Lead Co-Co Agreement, the Parties acknowledge and agree that Celgene has the sole right and responsibility for the Commercialization of the Co-Co Candidate and Co-Co Products for ROW Administration and, except as expressly set forth in this Celgene Lead Co-Co Agreement, and subject to the terms and conditions of this Celgene Lead Co-Co Agreement and the Master Collaboration Agreement, nothing will restrict Celgene from taking any action regarding the Commercialization of the Co-Co Candidate or Co-Co Products for ROW Administration. At least [***] during the Co-Co Term, Celgene shall provide to Jounce, through the JSC, a written progress report on the status of its material Commercialization activities with respect to Co-Co Products and related Co-Co Diagnostic Products (a “Commercialization Report”) during the applicable year, and Celgene’s plans with respect to Commercialization of Co-Co Product during the following [***] period.
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ROW Commercialization. (a) MYLAN shall have the sole right and responsibility for, and shall use Diligent Efforts to, Commercialize Licensed Product in the Field in the ROW Countries in compliance with applicable Laws and within the parameters of the then-current Commercialization Plan. (b) MYLAN shall bear all costs and expenses associated with the Commercialization of Licensed Product in the Field in the ROW Countries. (c) MYLAN shall have the sole right and responsibility to distribute, sell, record sales and collect payments for Licensed Product in the Field in the ROW Countries. (d) MYLAN shall have the sole right and responsibility for establishing and modifying the terms and conditions with respect to Commercialization of Licensed Products in the Field in the ROW Countries, including the price or prices at which Licensed Products will be sold, any discount applicable to payments or receivables, all managed care contracting issues and any other similar matters. (e) MYLAN will be responsible for storage, order receipt, order fulfilment, shipping and invoicing of Licensed Products in the Field in the ROW Countries. (f) If MYLAN does not use Diligent Efforts to Commercialize a Licensed Product in the Field in accordance with the Commercialization Plan for any particular ROW Country approved by the JSC, then THERAVANCE may provide MYLAN with written notice of such failure, including a description of such failure, and THERAVANCE's desire to the have the rights to Commercialize Licensed Product in the Field in such ROW Country revert to THERAVANCE. Such notice shall reference this Section 5.04(f) and Section 13.02 and shall be a notice of material breach solely with respect to such Country, triggering THERAVANCE's right to terminate this Agreement solely with respect to such ROW Country, subject to the provisions (including the cure and dispute provisions) of Section 13.02. This Section 5.04(f) sets forth ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ​ THERAVANCE's sole remedy in the event that MYLAN fails to use Diligent Efforts to Commercialize a Licensed Product in the Field in accordance with the Commercialization Plan for any particular ROW Country; and THERAVANCE shall not have the right to terminate this Agreement in its entirety pursuant to Section 13.02 based on such failure. Any such ROW Country with respect to which this Agreement is terminated pursuant ...
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ROW Commercialization. Pfizer shall have the sole right and responsibility for Commercialization of Licensed Products outside of the U.S., and all Commercialization activities relating to the ROW shall be outside of the scope of the USCC; provided, however, that once each Calendar Year, or more frequently as the Parties may mutually agree, Pfizer shall provide Adolor with an update of ROW Commercialization plans and activities, including Commercialization plans for China and India, at a regularly-scheduled meeting of the USCC.
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ROW Commercialization. 41 ARTICLE 7 CO-PROMOTION......................................................................... 43
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ROW Commercialization. In addition to Axxxxxx’s worldwide efforts to prepare for the commercialization of CellCept in autoimmune indications, Roche has undertaken certain activities to prepare for the commercialization of CellCept in autoimmune indications in territories outside the US, Canada and the major five EU countries. Activities performed by Roche included non-promotional pre-market preparation, educational programs, medical product related training, and market assessment. Such activities are described in more detail in Exhibit A.
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ROW Commercialization. Subject to the terms and conditions of this Agreement, KKC shall be responsible for all aspects of the Commercialization of the Products in the Field in the RoW, including, solely with respect to the Products in the Field in the RoW: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating with applicable Government Authorities in the RoW regarding the price and reimbursement status of the Products and obtaining and maintaining the Pricing Approvals; (c) marketing, medical affairs, and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures to Applicable Law relating to the marketing, detailing and promotion of Products in the Field in the RoW. As between the Parties, KKC shall be solely responsible for the costs and expenses of Commercialization of the Products in the Field in the RoW. (a) RoW - Commercialization Plan. KKC shall conduct all Commercialization of Products in the Field in the RoW in accordance with a comprehensive commercialization plan that is consistent with this Agreement (as amended in accordance with this Agreement, the “RoW Commercialization Plan”), the initial version of which KKC will prepare and provide to the JCC for review and discussion, and subsequent presentation to the JSC for review, no later than [*CONFIDENTIAL*] after initial submission of the Marketing Authorization Application of Product in the Field in a first country in RoW, and such plan will include a pricing strategy for the Product; provided, however, that KKC shall have ultimate decision-making authority and control over the content of the RoW Commercialization Plan, subject to KKC under no circumstances conducting any Commercialization activities that would reasonably be expected to have a material adverse effect on the Commercialization of the Product in the U.S. From time to time, but at least once every [*CONFIDENTIAL*], KKC will update the RoW Commercialization Plan and submit such updated plan to the JCC for review and discussion, and subsequent presentation to the JSC for review and discussion; provided, that, (i)
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Related to ROW Commercialization

  • 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.

  • 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).

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular: (a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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. (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any; (f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product; (g) discuss Product list price and status of reimbursement in the Collaborator Territory; and (h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • 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 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.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

  • Research Collaboration 3.7.1 Aarvik shall carry out the activities of each Work Item and deliver the required Data Package and/or deliverables in accordance with the applicable SOW. Without limiting the generality of the foregoing, Aarvik shall, in accordance with the applicable SOWs and the timeline approved by JRC, apply the Aarvik IP to (i) design and synthesize Collaboration Compounds, and (ii) by itself or through subcontractor(s), [***]. During the Research Term, if any Party identifies any Third Party Patent or Know-How that is necessary or reasonably useful for any activity under the SOWs but has not been included in the Aarvik IP, then such Party shall immediately inform the other Party and the Parties shall discuss in good faith the need of obtaining a license from such Third Party. 3.7.2 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver the Data Packages and all other deliverables required under the [***], as well as the results of the Patentability and FTO Analysis as described in Section 3.2.3, to ArriVent. ArriVent shall have the sole discretion to decide whether or not to advance any Collaboration Compound and which Collaboration Compound(s) will be advanced for further studies beyond the [***]. ArriVent shall inform Axxxxx of its decision in writing. If AxxxXxxx decides to advance the Collaboration Program to [***], ArriVent shall make the payment for the [***] pursuant to Section 6.2.1. 3.7.3 If, upon completion of the [***] for the Collaboration Program, AxxxXxxx decides not to advance the Collaboration Program to [***], ArriVent may terminate the Collaboration Program. If AxxxXxxx decides to advance the Collaboration Program to [***], ArriVent shall make the payment for the [***] pursuant to Section 6.2.1. 3.7.4 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver all Data Packages and deliverables required under the [***] to ArriVent. ArriVent shall have the sole discretion to decide whether or not to advance any Collaboration Compound and which Collaboration Compound(s) will be advanced for further studies beyond the [***]. ArriVent shall inform Axxxxx of its decision in writing. 3.7.5 No later than [***] ([***]) days after completion of the [***], Aarvik shall, to the extent not already provided to ArriVent, deliver all Data Packages and deliverables required under the [***] to ArriVent. 3.7.6 Within [***] ([***]) days after completion of the [***], Aarvik shall deliver to ArriVent a full report on all key results and findings of the Collaboration Program, and such other data, results and information as ArriVent may deem necessary for it to determine whether or not to exercise the Option (the “Full Report”).

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

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