Common use of Ownership of Regulatory Approvals Clause in Contracts

Ownership of Regulatory Approvals. Nisso and Replidyne shall cooperate as necessary to obtain and maintain Regulatory Approvals. Replidyne shall own and control all Regulatory Approvals and applications, amendments or supplements underlying any such Regulatory Approvals; provided that it is expressly understood and agreed that the Drug Master File for the Drug Substance shall be registered and controlled by Nisso. Nisso shall, without additional compensation, (i) collaborate with Replidyne to prepare and file the Drug Master File in “Common Technical Document” format, which shall be in form and substance satisfactory to both Nisso and Replidyne prior to filing by Nisso with the FDA, (ii) maintain such Drug Master File in good standing with all applicable Regulatory Authorities, including the payment of all required fees and the filing of all required reports (including without limitation an annual report filed with the FDA within thirty (30) days of the anniversary date of original Drug Master File submission date of each year), supplements and amendments, (iii) give a reference letter to the Regulatory Authorities in connection with Replidyne’s efforts in seeking Regulatory Approvals and submitting any such applications, amendments, or supplements for Drug Products, and (iv) only make or permit filings, submissions, changes, reports, supplements, modifications, deviations or exceptions to such Drug Master File in accordance with Section 6.1 (Drug Substance Specifications; DMF) hereof. Replidyne acknowledges and agrees that Nisso may maintain as confidential and not disclose to Replidyne the manufacturing information specified in Attachment 7.9 hereto that will be included in the Drug Master File (the “Sensitive Manufacturing Information”), provided that Replidyne shall have the right to engage a mutually agreeable third party to verify the suitability of such information for filing with the FDA in “Common Technical Document” format. Nisso shall cooperate with Replidyne in the coordination of supplements and annual reports for the Drug Master File and Regulatory Approvals, including without limitation classification of changes as “minor”, “moderate” and “major” for reporting purposes. Replidyne shall have the right, but not the obligation, to list all patents of the Supplier which are relevant to the Drug Substance in the FDA’s “Orange Book” and similar documents for other Regulatory Authorities with respect to each Drug Product. Upon the occurrence of any of the circumstances specified in Section 8.1 (Termination of Exclusive Purchase) hereof, Nisso shall promptly provide Replidyne with a complete copy of all Drug Master File documents, and Replidyne shall have the right to prepare and file a new drug master file and use all information in or related to the Drug Master File.

Ownership of Regulatory Approvals. Nisso Subject to the license grants in Article 3, each Regulatory Approval and Replidyne any Regulatory Documentation with respect to a Collaboration Product shall be owned by Medarex, unless otherwise agreed by the Steering Committee. Notwithstanding the Party that owns a Regulatory Approval with respect to a Collaboration Product, the Parties shall cooperate in obtaining, maintaining and satisfying their obligations under such Regulatory Approval, including by promptly exchanging information, such as necessary adverse event data, so as to obtain enable the owner to make reports to, and maintain respond to requests of, the Regulatory ApprovalsAuthorities and perform its other obligations under such Regulatory Approval. Replidyne In the event that a Party Opts-Out with respect to a Collaboration Product and the non-Opting Out Party elects to proceed unilaterally with the research, development and commercialization of such Collaboration Product, the Opting-Out Party shall own assign all of its right, title and control interest in and to all Regulatory Approvals and applicationsfor such Collaboration Product, amendments including any applications therefor, to the Pursuing Party (or supplements underlying its designee). Notwithstanding the ownership of any such Regulatory Approvals; provided that it is expressly understood and agreed that the Drug Master File for the Drug Substance shall be registered and controlled by Nisso. Nisso Approval, neither a Party nor any of its Affiliates, licensees or sublicensees shall, directly or indirectly, use or reference any Regulatory Approval with respect to a Collaboration Product without additional compensation, (i) collaborate with Replidyne to prepare and file the Drug Master File in “Common Technical Document” format, which shall be in form and substance satisfactory to both Nisso and Replidyne prior to filing by Nisso with the FDA, (ii) maintain such Drug Master File in good standing with all applicable Regulatory Authorities, including the payment of all required fees and the filing of all required reports (including without limitation an annual report filed with the FDA within thirty (30) days consent of the anniversary date of original Drug Master File submission date of other Party, not to be unreasonably withheld or delayed; provided, however, that each year), supplements and amendments, (iii) give a reference letter to the Regulatory Authorities in connection with Replidyne’s efforts in seeking Regulatory Approvals and submitting any such applications, amendments, or supplements for Drug Products, and (iv) only make or permit filings, submissions, changes, reports, supplements, modifications, deviations or exceptions to such Drug Master File in accordance with Section 6.1 (Drug Substance Specifications; DMF) hereof. Replidyne acknowledges and agrees that Nisso may maintain as confidential and not disclose to Replidyne the manufacturing information specified in Attachment 7.9 hereto that will be included in the Drug Master File (the “Sensitive Manufacturing Information”), provided that Replidyne Party shall have the right to engage a mutually agreeable third party to verify the suitability of such information for filing with the FDA in “Common Technical Document” format. Nisso shall cooperate with Replidyne in the coordination of supplements use and annual reports for the Drug Master File and reference any Regulatory Approvals, including without limitation classification of changes as “minor”, “moderate” and “major” for reporting purposes. Replidyne shall have the right, but not the obligation, to list all patents of the Supplier which are relevant to the Drug Substance in the FDA’s “Orange Book” and similar documents for other Regulatory Authorities Approval with respect to each Drug Producta Collaboration Product or a Unilateral Product in connection with the Exploitation of Collaboration Products as provided in this Agreement or Unilateral Products or other Antibody-Based Products as provided in any Unilateral Development and Commercialization Agreement. Upon Notwithstanding the occurrence foregoing, any Regulatory Approval containing Production Process Know-How of any a Party or, with respect to Medarex, the Mice-Related Know-How shall be and remain the sole and exclusive property of the circumstances specified in Section 8.1 (Termination of Exclusive Purchase) hereof, Nisso shall promptly provide Replidyne with a complete copy of all Drug Master File documents, such Party and Replidyne such Party shall have the right to prepare and file submit any such Production Process Know-How or, with respect to Medarex, the Mice-Related Know-How, directly to the Regulatory Authorities using a new drug master file file, or any foreign equivalent that is designed to protect such Party's Confidential Information, which filing shall be and use all information in or related to remain the Drug Master Filesole and exclusive property of such Party.

Ownership of Regulatory Approvals. Nisso (a) Progenics shall remain the owner of all right, title and Replidyne shall cooperate as necessary to obtain interest in all FDA Registrational Filings and maintain Regulatory Approvals. Replidyne shall own and control all FDA Regulatory Approvals and applications, amendments or supplements underlying any such Regulatory Approvals; provided that it is expressly understood and agreed that the Drug Master File for the Drug Substance shall be registered SC Product and controlled by Nisso. Nisso shall, without additional compensation, (i) collaborate with Replidyne to prepare and file the Drug Master File in “Common Technical Document” format, which shall be in form and substance satisfactory to both Nisso and Replidyne prior to filing by Nisso with the FDA, (ii) maintain such Drug Master File in good standing with all applicable Regulatory Authorities, including the payment of all required fees and the filing of all required reports (including without limitation an annual report filed with the FDA within thirty (30) days of the anniversary date of original Drug Master File submission date of each year), supplements and amendments, (iii) give a reference letter to the Regulatory Authorities in connection with Replidyne’s efforts in seeking Regulatory Approvals and submitting any such applications, amendments, or supplements for Drug Products, and (iv) only make or permit filings, submissions, changes, reports, supplements, modifications, deviations or exceptions to such Drug Master File in accordance with Section 6.1 (Drug Substance Specifications; DMF) hereof. Replidyne acknowledges and agrees that Nisso may maintain as confidential and not disclose to Replidyne the manufacturing information specified in Attachment 7.9 hereto that will be included IV Product in the Drug Master File U.S. (the “Sensitive Manufacturing InformationProgenics Regulatory Filings/Approvals”), provided that Replidyne . Progenics and Wyeth shall have each use Commercially Reasonable Efforts to take such actions as are necessary to enable Wyeth efficiently to take on the right role described in Section 12.1.2 (FDA Interactions Related to engage a mutually agreeable third party to verify the suitability of such information for filing with the FDA in “Common Technical Document” format. Nisso shall cooperate with Replidyne in the coordination of supplements SC Product and annual reports for the Drug Master File and Regulatory ApprovalsIV Product), including without limitation classification of changes as “minor”, “moderate” and “major” for reporting purposes. Replidyne shall have submitting with the right, but not the obligation, to list FDA all patents of the Supplier which are relevant documents, letters, and information reasonably necessary or advisable to the Drug Substance enable Wyeth to efficiently perform its responsibilities. (b) Except as otherwise provided in the FDA’s “Orange Book” and similar documents for other Regulatory Authorities Section 12.1.4(a) with respect to each Drug the Progenics Regulatory Filings/Approvals, which shall remain the property of Progenics, Wyeth shall own all right, title and interest in all Registrational Filings and Regulatory Approvals for any Product and any applications therefore throughout the Territory. Promptly after the Effective Date, Progenics shall (i) transfer to Wyeth all Registrational Filings and Regulatory Approvals (if any) for any Product throughout the Territory and any applications therefore, other than the Progenics Regulatory Filings/Approvals (the “Transferred Regulatory Filings/Approvals”), and (ii) take such actions as are necessary to enable Wyeth to take on the role described in Sections 12.1.2 (FDA Interaction Related to SC Product and IV Product) and 12.1.3 (Other Regulatory Interactions). Upon Wyeth shall reimburse Progenics for its non-de minimis out-of-pocket costs incurred in [*] CONFIDENTIAL TREATMENT REQUESTED CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION Table of Contents complying with the occurrence of foregoing sentence. Wyeth and Progenics shall, at Wyeth’s expense, take any and all actions required by the relevant Regulatory Authorities to effect the transfer of the circumstances specified in Section 8.1 (Termination Transferred Regulatory Filings/Approvals from Progenics to Wyeth as soon as reasonably practicable after the Effective Date, including without limitation filing with appropriate Regulatory Authorities all of Exclusive Purchase) hereof, Nisso shall promptly provide Replidyne with a complete copy of all Drug Master File documents, letters and Replidyne shall have information required by the right Regulatory Authorities to prepare effect such transfer. Progenics may retain archival copies of the Transferred Regulatory Filings/Approvals, including supplements and file a new drug master file and use all information in or related to the Drug Master Filerecords relating thereto.