Transfer of Data, Technology and Regulatory Filings Sample Clauses

Transfer of Data, Technology and Regulatory Filings. Promptly following the Amgen Option Effective Date, such that such transfer is completed within [***] ([***]) [***] of the Amgen Option Effective Date, CK shall deliver to Amgen (or provide copies where CK is required by Law to maintain original records), [***] data, [***] data, [***] data, [***] data and [***] data (including [***] (both [***] and [***]), [***], [***], [***]) reasonably necessary for Amgen to exercise its rights and perform its obligations under this Agreement with respect to Compounds, and other information pertaining to the Compounds reasonably requested by Amgen, in each case Controlled by CK or its Affiliates, and Amgen shall reimburse CK [***] costs incurred in connection therewith. Each Party shall provide the other with such assistance as the other Party reasonably requests from time to time, to enable such other Party to fully understand and implement the foregoing and the requesting Party shall reimburse the other [***] costs incurred in connection therewith. Without limiting the foregoing, with respect to Confidential Information of a Party, which Confidential Information the other Party desires to include in any regulatory filing, the Party whose Confidential Information it is shall either: (i) make such information available to the other Party or (ii) make such information available directly to the applicable Regulatory Authority (whether by reference or otherwise). In addition, CK (itself or through a designee) shall have the right to reference regulatory filings and data [***] with respect to [***] Compounds for CK’s use [***] for the purposes of development and commercialization of [***] Compounds [***], subject to [***] of Section [***]. The Parties shall [***], including [***] and [***] with respect thereto. The Parties will [***]. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
Sample 1
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Transfer of Data, Technology and Regulatory Filings. From time to time, or upon reasonable request, each Party shall promptly provide hard and electronic copies or (with respect to large Regulatory Filings) access and electronic copies to the other Party all previously undisclosed Data and Regulatory Filings relating to the Products that are in its possession or control. Without limiting the foregoing, each Party shall have the right to access, use and reference the other Party’s Data and reference the other Party’s Regulatory Filings relating to the Products, and access and use other non-confidential portions thereof, for purposes of Development and Commercialization of Products and Manufacture Bulk Drug Substance and Finished Drug Product, in each case in accordance with this Agreement, including the right to file such items with Regulatory Authorities. Each Party shall provide the other Party with such assistance as the other Party reasonably requests from time to time, to enable such other Party to fully understand and implement the Data, Regulatory Filings, Alliance Technology and Licensed Technology transferred under this Section 6.3. Notwithstanding anything herein to the contrary, in all agreements with Third Parties or Affiliates involving Data, Maxygen and Astellas, respectively, shall require that such Third Parties and Affiliates provide the other Party access to all such Data, to the extent reasonably necessary to fulfill its obligations or exercise the rights granted to it hereunder. Without limiting the foregoing, with respect to proprietary information that is not Alliance Technology or such Party’s Licensed Technology, which proprietary information a Party includes in any Regulatory Filing, such Party shall to the extent useful in connection with the filing for, prosecution or maintenance of Regulatory Filings by the other Party make such information available to the other Party.
Sample 1

Related to Transfer of Data, Technology and Regulatory Filings

  • Books, Records and Regulatory Filings (a) The Sub-Adviser agrees to maintain and to preserve for the applicable periods any such records as are required to be maintained by the Sub-Adviser with respect to the Fund by the 1940 Act and rules adopted thereunder, and by any other applicable laws, rules and regulations. The Sub-Adviser further agrees that all records that it maintains for the Fund are the property of the Fund and it will promptly surrender any of such records upon request; provided, however, that the Sub-Adviser may retain copies of such records for the applicable periods they are required by law to be retained, and thereafter shall destroy such records.

  • Regulatory Filings Except as disclosed in the Registration Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authorities (including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

  • Transfer of Technology Upon AVENTIS' request, GENTA shall promptly disclose to AVENTIS such of the GENTA TECHNOLOGY as AVENTIS determines is reasonably necessary for AVENTIS to perform its obligations or exercise its rights under this AGREEMENT. The manner of such disclosure shall be as mutually determined by the Parties in good faith and shall be at no additional cost to AVENTIS.

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

  • Transfer of Intellectual Property Rights Except in connection with the sale of all or substantially all of the assets of the Company or licensing arrangements in the ordinary course of the Company's business, the Company shall not transfer, sell or otherwise dispose of any Intellectual Property Rights, or allow any of the Intellectual Property Rights to become subject to any Liens, or fail to renew such Intellectual Property Rights (if renewable and it would otherwise lapse if not renewed), without the prior written consent of the Purchasers.

  • 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.

  • 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.

  • Technical Information Methods, processes, formulae, compositions, systems, techniques, inventions, machines, computer programs and research projects, unpatented inventions, designs, know-how, trade secrets, technical information and data, specifications, blueprints, transparencies, test data, and additions, modifications, and improvements thereon which are revealed to Employee.

  • 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.

  • Intellectual Property Filings Such patent, trademark and copyright notices, filings and recordations necessary or appropriate to perfect the security interests in intellectual property and intellectual property rights, as determined by the Collateral Agent.

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