Development and Manufacture of Product Sample Clauses

Development and Manufacture of Product. 5.1 Resources; Applicable Law. Manufacturer will comply with all Applicable Law in performing Services.
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Development and Manufacture of Product. 5.1 Piramal will perform all Services at the Facility, and will hold at the Facility all Equipment, Bolt Materials and other items used in the Services. Piramal may change the location of the Facility or use any additional facility for the performance of Services by providing Bolt at least [***] prior written notice, and receiving Bolt’s prior written consent, [***]. The Parties agree that [***]. Piramal will maintain the Facility and all Equipment required for the Manufacture of Product in a state of repair and operating ·efficiency consistent with the requirements of cGMP, the applicable Statement of Work and Applicable Law.
Development and Manufacture of Product. 5.1 Piramal will perform all Services at the Facility, and will hold at the Facility all Equipment, PLUS THERAPEUTICS Materials and other items used in the Services. Piramal may change the location of the Facility or use any additional facility for the performance of Services providing PLUS THERAPEUTICS is given at least [***] prior written notice, and receiving PLUS THERAPEUTICS’s prior written consent, which consent will not be unreasonably withheld or delayed. The Parties agree that it will be reasonable for PLUS THERAPEUTICS to withhold such consent pending satisfactory completion of a quality assurance audit and/or regulatory impact assessment of the new location or additional facility, as the case may be. Piramal will maintain the Facility and all Equipment required for the Manufacture of Product in a state of repair and operating efficiency consistent with the requirements of cGMP and Applicable Law.
Development and Manufacture of Product 

Related to Development and Manufacture of Product

  • 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).

  • 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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