TERRITORY B and TERRITORY C Sample Clauses

TERRITORY B and TERRITORY C. Any manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY for DEVELOPMENT and MANUFACTURE DEVELOPMENT purposes or commercial sale in TERRITORY B or TERRITORY C shall be performed in full compliance with GCP, GLP and GMP and all applicable United States laws and regulations. SB will notify Coulxxx xx any regulatory requirements for manufacture of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY for sale in TERRITORY B or TERRITORY C with which it wishes THIRD PARTY manufacturers of UNCONJUGATED ANTIBODY and/or RADIOLABELED ANTIBODY to comply. To the extent Coulxxx xxx cause such manufacturers to comply with such regulatory requirements under the PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and any NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS, Coulxxx xxxl do so. If Coulxxx xx unable to do so pursuant to such agreements, the MANUFACTURE AND SUPPLY CHAIN SUBTEAM will meet to discuss how best to address such regulatory requirements, including seeking to amend the applicable PRE-EXISTING THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS and/or NEW THIRD PARTY MANUFACTURE AND SUPPLY CHAIN AGREEMENTS to cause such THIRD PARTY manufacturer to be in compliance with the applicable regulatory requirements. The Parties will seek to enter into three-way technical agreements with such manufacturers for the purpose of defining the respective responsibilities of the Parties and such manufacturers for quality control and regulatory compliance. SB shall be entitled to collaborate with Coulxxx xx audit GCP, GLP, and GMP and any other agreed-to compliance for the manufacture of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY. To the extent permitted by applicable laws, SB or its designee shall serve as the point of contact with the foreign equivalents of the FDA and any other applicable governmental entity in TERRITORY B and TERRITORY C concerning the manufacture and supply of UNCONJUGATED ANTIBODY and RADIOLABELED ANTIBODY, but may, as appropriate, request the assistance of Coulxxx xx the JDC with communications with such governmental entities. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1
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TERRITORY B and TERRITORY C. In TERRITORY B and TERRITORY C, PRODUCT will be packaged in standard SB packaging, subject to Section 7.1.8. If SB's rights to PRODUCT are terminated in accordance with this Agreement in a particular country, Coulxxx xxxll not be permitted to use SB packaging with respect to PRODUCT in such country, and shall not permit its subsequent licensees to use SB packaging with respect to PRODUCT in such country.
Sample 1

Related to TERRITORY B and TERRITORY C

  • 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.

  • 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.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • 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.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed 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).

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Supply of Products TheraSense shall be responsible for the ------------------ manufacture of FreeStyle Products for sale to Nipro.

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