Development and Commercialization Outside the Territory Clause Samples

Development and Commercialization Outside the Territory. LGLS shall have the sole responsibility for development and commercialization of the Product outside of the Territory. LGLS shall regularly disclose to GS its plans for such development and afford GS a reasonable opportunity to comment thereon. During the term of this Agreement, LGLS shall * Confidential Treatment has been requested for the marked portions. assure that its development of Product outside of the Territory (whether directly or through one or more sub-licenses) is conducted in a manner which minimizes the risk of disruption of or other adverse effects on the development and commercialization of the Product in the Territory by GS as contemplated herein. Without limiting the foregoing: *****. At LGLS’s request, the Parties shall in good faith discuss the matters for which GS approval or consultation is required pursuant subsections (ii) and (iii), above, at each meeting of the Steering Committee.
View SourceView Similar (2)
Development and Commercialization Outside the Territory. LGLS shall have the sole responsibility for development and commercialization of the Product outside of the Territory. LGLS shall regularly disclose to GS its plans for such development and afford GS a reasonable opportunity to comment thereon. During the term of this Agreement, LGLS shall assure that its development of Product outside of the Territory (whether directly or through one or more sub-licenses) is conducted in a manner which minimizes the risk of disruption of or other adverse effects on the development and commercialization of the Product in the Territory by GS as contemplated herein. Without limiting the foregoing: (i) following good faith consultation with GS, LGLS and its other licensees shall be free to conduct clinical, regulatory, sales and marketing activities anywhere outside the Territory so long as they are for indications and/or formulations of Product consistent with label(s) for Product approved by Regulatory Authorities in the United States or European Union, (ii) LGLS and its other licensees shall not conduct any pre-clinical activities with respect to the Product for any indication or formulation without the prior approval of GS, and (iii) LGLS and its other licensees shall not conduct clinical, regulatory, sales or marketing activities with respect to any Additional Indication or a materially increased dosage or new means of administration of the Product without the prior approval of GS. At LGLS’s request, the Parties shall in good faith discuss the matters for which GS approval or consultation is required pursuant subsections (ii) and (iii), above, at each meeting of the Steering Committee.
View Source

Related to Development and Commercialization Outside 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).

  • 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 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 ▇▇▇▇▇; 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.

  • 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 Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time