Regulatory Files. STA, Agritope and Sunseeds shall each have full access to all materials filed and correspondence with the U.S.D.A., FDA and other regulatory agencies in connection with the Cooperative Development Work and each Product, and shall be entitled to use and rely on such materials with respect to any regulatory approvals for a product sought by either, whether or not such product relates to this Agreement.
Regulatory Files. Within a reasonable time after the Effective Date, and no later than *** days thereafter, Sublicensor and Sublicensee shall, at Sublicensor’s sole cost and expense, take all actions necessary to provide Sublicensee or its designee with a right of access, reference and use of the Regulatory Files with respect to a Program. Sublicensor shall, at the reasonable request of Sublicensee and at Sublicensee’s expense, perform any acts that Sublicensee may reasonably deem necessary or desirable to evidence or confirm Sublicensee’s right to access, reference and use such Regulatory Files. Without limiting the sublicense rights granted under ARTICLE 2, the Parties understand and agree that any assignment of such Regulatory Files does not include an assignment of any Sublicensed IP.
Regulatory Files. Baxter and Xxxxxtech shall each have full access to all materials filed and correspondence with the FDA and other regulatory agencies in connection with the Cooperative Development Work and the System, and shall be entitled to use and rely on such materials with respect to any regulatory approvals for a product sought by either, whether or not such product relates to this Agreement.
Regulatory Files. Genentech or VaxGen or its licensee will be the holder of the AIDSVAX product License in the United States and other countries. The submission and amendment of the License Application(s) in each jurisdiction is the sole responsibility of the holder. Celltrion shall be responsible for providing to VaxGen all relevant documentation and information pertaining to the Product produced at the Facility and to the Facility, processes and equipment used, so as to enable VaxGen to submit License Applications or amendments thereto. In addition, Celltrion shall be responsible for providing ongoing support by providing any additional information and documentation related to the Product or Facility requested by the FDA or other regulatory authorities, all at VaxGen's expense.
Regulatory Files. Baxtxx xxx Cerus shall each have full access to all materials filed and correspondence with the FDA and other regulatory agencies in connection with the Cooperative Development Work and each System, and shall be entitled to use and rely on such materials with respect to any regulatory approvals for a product sought by either, whether or not such product relates to this Agreement, provided that Baxtxx xxxll be entitled to use or rely on any such materials relating to regulatory approvals sought for the S59 System only for the purpose of developing and marketing Systems pursuant to this Agreement and the Platelet
Regulatory Files. Effective upon expiration or termination of the Purchase Option, Licensor hereby assigns to SNDC all right, title, and interest in and to the Regulatory Files filed in the Territory to the extent related to the Field. Licensor shall, at the reasonable request of SNDC and at SNDC’s expense, perform any acts that SNDC may reasonably deem necessary or desirable to evidence or confirm SNDC’s ownership interest in such Regulatory Files, including, but not limited to, making further written assignments in a form determined by SNDC. Without limiting the license rights granted under this Article 2, the parties understand and agree that the assignment of such Regulatory Files (i) is subject to Licensor’s reservation of rights in the Licensed Intellectual Property and the terms and conditions of the JHU Agreement, (ii) does not include an assignment of any Licensed Intellectual Property, and (iii) and does not include the assignment of any portion of the Regulatory Files outside of the Field or outside of the Territory.
Regulatory Files. Cornerstone shall own all regulatory files with respect to the Product including without limitation regulatory data and documentation prepared by Neos under Section 2.2 respecting the manufacture of the Product, including without limitation the CMC section of any NDA filing with the FDA related to the Product.
Regulatory Files. Pall and Vitex shall each have full ---------------- access to all materials filed and correspondence with the FDA and other regulatory agencies in connection with the Cooperative Development Work and the Systems, and shall be entitled to use and rely on such materials with respect to any Regulatory Approval for a product covered by this Agreement which is sought by either Pall or Vitex.
Regulatory Files. Xxxxxx and Cerus shall each have full access to all materials filed and correspondence with the FDA and other regulatory agencies in connection with the Cooperative Development Work and each System, and shall be entitled to use and rely on such materials with respect to any regulatory approvals for a product sought by either, whether or not such product relates to this Agreement, PROVIDED THAT Xxxxxx shall be entitled to use or rely on [ *** ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. any such materials relating to regulatory approvals sought for the S59 System only for the purpose of developing and marketing Systems pursuant to this Agreement and the Platelet Agreement. In the event that product registration is in the name of Xxxxxx in any country and Cerus obtains marketing rights for such product in such country, then Xxxxxx will, at Cerus' expense, cause the product to be co-registered in Cerus' name or take other steps so that Cerus may market and sell the product under such registration. Promptly following the First Amendment Effective Date, Xxxxxx will take all actions, including execution and filing of all documents, necessary or appropriate to transfer to Cerus all applications and filings relating to regulatory approvals sought for the S59 FFP System.
Regulatory Files. (a) Within a reasonable time after the expiration or termination of the Purchase Option without exercise by Licensor and as of a date to be agreed upon by Licensor and Symphony Evolution, Licensor and Symphony Evolution shall, at Symphony Evolution’s expense, take all actions necessary to effect the assignment to Symphony Evolution or its designee of the sponsorship to the Regulatory Files with respect to the Programs for which Licensor has not exercised its Program Option or Discontinuation Option. After such Regulatory Files are assigned to Symphony Evolution, Licensor shall have no further rights therein or obligations thereunder. Licensor shall, at the reasonable request of Symphony Evolution and at Symphony Evolution’s expense, perform any acts that Symphony Evolution may reasonably deem necessary or desirable to evidence or confirm Symphony Evolution’s ownership interest in such Regulatory Files, including, but not limited to, making further written assignments in a form determined by Symphony Evolution. Without limiting the license rights granted under this ARTICLE 2, the Parties understand and agree that the assignment of such Regulatory Files does not include an assignment of any Licensed Intellectual Property.
(b) In the event of the expiration of a Discontinuation Option without exercise by Licensor, the provisions of Section 2.7(a) shall apply solely with respect to the Regulatory Files for the Program to which the Discontinuation Option pertained.
