Commercial or Marketing Use Prohibition Contractor agrees that it will not sell PII or use or disclose PII for a Commercial or Marketing Purpose.
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.
Territorial application This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States.
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.
Regulatory Prohibition Notwithstanding any other provision of this Agreement to the contrary, any payments made to the Executive pursuant to this Agreement, or otherwise, are subject to and conditioned upon their compliance with Section 18(k) of the FDIA (12 U.S.C. §1828(k)) and 12 C.F.R. Part 359.
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).
No Unlawful or Prohibited Use Intellectual Property
Third Party Patents If, after June 17, 2014, it was or is Necessary or Useful for Allogene (or Pfizer, to the extent identified by Pfizer prior to the Assignment) to license one or more Patent Rights from one or more Third Parties in order to Develop, Manufacture, Commercialize or use any Allogene Licensed Product, whether directly or through any Allogene Affiliate or Sublicensee, then Allogene may, in its sole discretion, negotiate and obtain a license under such Patent Right(s) (each such Third Party license, or any such Third Party license entered into as of the Effective Date by Allogene or by Pfizer and assigned to Allogene, referred to herein as an “Additional Third Party License”). Any royalty otherwise payable to Cellectis under this Agreement with respect to Net Sales of any Allogene Licensed Product by Allogene, its Affiliates or Sublicensees will be reduced by [***] of the amounts payable to Third Parties pursuant to any Additional Third Party Licenses, such reduction to continue until all such amounts have been expended, provided that in no event will the total royalty payable to Cellectis for any Allogene Licensed Product be less than [***] of the royalty amounts otherwise payable for such Allogene Licensed Product and in no event will the royalty payable to Cellectis for any Allogene Licensed Product be reduced below [***] (in each case, other than in the case of Cellectis’ breach of any representation, warranty or covenant hereunder). For purposes of this Section 5.2.2(b), (i) “Necessary” means that, without a license to use the Third Party’s Patent Right, the Development, Manufacture, Commercialization or use of any Allogene Licensed Product in the form such Allogene Licensed Product exists at the time that the Additional Third Party License is executed would, in Allogene’s opinion, infringe such Third Party’s Patent Right and (ii) “Useful” means that Allogene has determined in its discretion that use of such Third Party’s Patent Right would enhance the commercial potential of such Allogene Licensed Product. For the avoidance of doubt, the Parties agree and acknowledge that this Section 5.2.2(b) will not apply with respect to royalties payable by Allogene to any Third Party under any agreement in existence as of June 17, 2014. Neither Party will intentionally negotiate with a Third Party an exclusive license that excludes sublicense rights to the other Party, in the event such Third Party rights are necessary, as determined by the negotiating Party, to Develop and Commercialize Allogene Licensed Products and Cellectis Products in connection with this Agreement in the Field.
Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.
Infringement of Third Party Rights Each Party shall promptly notify the other in writing of any allegation by a Third Party that the activity of either of the Parties hereunder infringes or may infringe the intellectual property rights of such Third Party. Genentech shall have the first right but not the obligation to control any defense of any such claim involving alleged infringement of Third Party rights by Genentech’s activities under this Agreement at its own expense and by counsel of its own choice, and Curis shall have the right but not the obligation, at its own expense, to be represented in any such action by counsel of its own choice. If Genentech fails to proceed in a timely fashion with regard to such defense, Curis shall have the right but not the obligation to control any such defense of such claim at its own expense and by counsel of its own choice, and Genentech shall have the right but not the obligation, at its own expense, to be represented in any such action by counsel of its own choice. Curis shall have the first right but not the obligation to control any defense of any such claim involving alleged infringement of Third Party rights by Curis’ activities under this Agreement at its own expense and by counsel of its own choice, and Genentech shall have the right but not the obligation, at its own expense, to be represented in any such action by counsel of its own choice. If Curis fails to proceed in a timely fashion with regard to such defense, Genentech shall have the right but not the obligation to control any such defense of such claim at its own expense and by counsel of its own choice, and Curis shall have the right but not the obligation, at its own expense, to be represented in any such action by counsel of its own choice. Neither Party shall have the right to settle any infringement action under this Section 10.5 in a manner that diminishes the rights or interests of the other Party hereunder without the consent of such Party.
