Baxter and Nexell shall cooperate in any action taken by a third party solely involving a nullity action, opposition, reexamination or any other action taken by such third party alleging the invalidity or unenforceability of any Licensed Intellectual Property. Both parties agree to share equally in the cost of the defense of such Licensed Intellectual Property.
Subdistributors Subject to the provisions of this Section 2.2, Nipro --------------- may appoint one or more third parties, with a reputation for competence and ethical behavior, within any portion of the Territory to distribute the FreeStyle Products in the Field of Use. Within twenty (20) days after the appointment of such Subdistributor, Nipro shall notify TheraSense of the identity of such Subdistributor. Nipro shall not sell or otherwise transfer the FreeStyle Products to any Subdistributor until such Subdistributor enters into a form of written agreement ("Subdistributor Agreement") with Nipro, binding the Subdistributor to terms and conditions substantially similar to those terms and conditions agreed upon by Nipro in this Agreement. Further, Nipro shall only grant Subdistributors the right to make sales of the FreeStyle Products in the Territory in the Field of Use. Nipro agrees to terminate a Subdistributor's right to distribute the FreeStyle Products promptly upon becoming aware that such Subdistributor, or its authorized distributor(s) or reseller(s), is selling or otherwise distributing the FreeStyle Products in violation of its Subdistributor Agreement. Each Subdistributor Agreement shall contain provisions making TheraSense a direct and intended third party beneficiary of such Subdistributor Agreement.
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.
Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.
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.
Licensee Licensee represents and warrants that:
Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.
Licensed Technology The term "Licensed Technology" shall mean the ------------------- Licensed Patents, plus all improvements thereto developed by Licensor, and all related data, know-how and technology.
Sublicensees Licensee shall have the full right (but not the obligation) to sublicense those rights granted to it under Section 2.1 to a Third Party (a “Sublicensee”); provided, however, that, prior to the payment of the first milestone pursuant to Section 7.2, Licensee may not grant any such sublicense to any contract research organization conducting Clinical Trials of Products or any Third Parties conducting contract Manufacturing activities without Licensee’s prior written notice (at least twenty (20) Business Days in advance) to Lilly, which shall include a description of the rights to be granted and the purpose therefor, the identity of the Third Party and the countries involved, and Lilly’s prior written consent, but such consent shall only be required (i) until such time as Licensee is the holder of record for the Regulatory Materials related to Taladegib and (ii) to the extent such organization is not performing services for Licensee as of the Effective Date; and provided further, that Licensee shall remain responsible for the performance by any of its Sublicensees. With respect to any Sublicensee granted a sublicense to any Commercialization rights hereunder, Licensee shall ensure that each of its Sublicensees accepts in writing all applicable terms and conditions of this Agreement, including the non-compete, reporting, audit, inspection and confidentiality provisions hereunder. Each Sublicensee shall also be prohibited from further sublicensing. For the avoidance of doubt, (a) Licensee will remain directly responsible for all amounts owed to Lilly under this Agreement, and (b) each Sublicensee is subject to the negative and restrictive covenants set forth in Sections 2.3.1 and 2.5, respectively. Licensee hereby expressly waives any requirement that Lilly exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee.
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.
