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.
AutoNDA by SimpleDocs
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.

Related to TERRITORY B and TERRITORY C

  • Country and Territory Names The country and territory names (including their IDN variants, where applicable) contained in the following internationally recognized lists shall be withheld from registration or allocated to Registry Operator at All Levels:

  • Territory 43.1 This Agreement applies to the territory in which Verizon operates as an Incumbent Local Exchange Carrier in the Commonwealth of Pennsylvania. Verizon shall be obligated to provide Services under this Agreement only within this territory.

  • 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.

  • 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 During the term of this Agreement and any extension hereof, the Seller shall sell and supply the products as set out in Schedule 1 hereto (“Products”) to SiPM and SiPM shall buy from the Seller such Products on a non-exclusive basis. The specifications of the Products are set out in Schedule 2 hereto. SUPPLY AGREEMENT - SiPM A Supply Agreement is a document between two parties, a Supplier and a Purchaser. The Supplier can be an individual or business and is the party that " supplies," or sells, the goods to the Purchaser. The Purchaser can also be an individual or a business and is the party that purchases for its use the goods that the Supplier provides.

  • 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.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

Time is Money Join Law Insider Premium to draft better contracts faster.