Sharing of Regulatory Filings. Without limiting Section 4.8, each Party shall permit the other Party to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of such Party’s, its Affiliates’ and, to the extent it has the right to do so, its Marketing Partners’ Regulatory Materials (including Data), with respect to the Products in the Field in the Territory.
Sharing of Regulatory Filings. GSK shall permit Adolor access to and ----------------------------- xxxxx Xxxxxx the right to reference and use, in association with the Collaboration Products and the Combination Products, all data, regulatory filings and regulatory communications associated with any submissions for Investigational Authorization or Marketing Authorization or other issues associated with any Collaboration Product or GSK Other GI Product that is or would be relevant to Adolor's Development or Commercialization of a Collaboration Product or Combination Product. Adolor shall permit GSK access to and grant GSK the right to reference and use, in association with the Collaboration Products, all data, regulatory filings and regulatory communications associated with any submissions for Investigational Authorization or Marketing Authorization or other issues associated with any Collaboration Product or, subject to any Third Party Rights, Combination Products, that is or would be relevant to GSK's Development or Commercialization of a Collaboration Product. To the extent that any such data, regulatory filings or regulatory communications are held by a Third Party, then Adolor or GSK, as the case may be, shall endeavor to arrange direct access to the portions of such data, regulatory filings or regulatory communications that are relevant to the activities of the other Party that are contemplated by this Agreement.
Sharing of Regulatory Filings. Without limiting Section 4.5 above, each Party shall permit the other Party to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations with respect to the Compound and/or XenoPort Products under this Agreement (including the right of XenoPort to commercialize, alone or through its Affiliates and/or licensees, the Compound and XenoPort Products outside the Territory) all of such Party's and its Affiliates' Data, regulatory filings and regulatory communications associated with the submissions of INDs, XXXx or other approvals for the Compound and/or XenoPort Products in the Territory. XenoPort shall permit Xanodyne to access, and shall provide Xanodyne with sufficient rights to reference and use in association with Xanodyne's exercise of its rights and performance of its obligations with respect to the Compound and/or XenoPort Products in the Territory, Data, regulatory filings and regulatory communications, associated with the submissions of INDs, XXXx or approvals for the Compound and/or XenoPort Products outside the Territory to the extent XenoPort has the right to do so. Each Party shall pay the costs and expenses associated with its exercise of the rights granted in this Section 4.6.
Sharing of Regulatory Filings. Without limiting Section 4.7 above, each Party shall permit the other to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement (including the right of Inovio to commercialize the Product outside of the Territory), all of such Party’s, its Affiliates’ and, to the extent it has the right to do so, its Sublicensees’ Data, regulatory filings and regulatory communications associated with any submissions of XXXx or other approvals for the Product and the Delivery Device respectively in the Territory. Without limiting the foregoing, Inovio shall permit Apollo to access and shall provide Apollo with sufficient rights to reference and use in support of Apollo’s XXXx and Marketing Approvals in the Territory, Inovio’s IND for VGX-3100 and any Regulatory Filings for the Delivery Device outside of the Territory.
Sharing of Regulatory Filings. Without limiting Section 4.8 above, each Party shall permit the other to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement [… * …], all of such Party’s, and its Affiliates’ (and, to the extent it has the right to do so, its Sublicensees’), Data, Regulatory Filings and regulatory communications associated with any submissions of XXXx or other approvals for the Product in the Territory. Without limiting the foregoing, each Party shall permit the other to access and shall provide such other Party with sufficient rights to reference and use, in support of XXXx filed and Marketing Approvals received by or on behalf of the other Party, any Regulatory Filings relating to the Compound or a Product in the Territory and/or, upon the other Party’s request, shall obtain from a Regulatory Authority any certificate or other documentation (including, a Certificate of Pharmaceutical Product) that may be requested or required by a Regulatory Authority for such purposes. Notwithstanding the foregoing, and excluding any Regulatory Filings made available to XenoPort pursuant to Section 2.1(b) and Exhibit 2.1, GSK shall be obligated to [… * …]
Sharing of Regulatory Filings. Each Party shall disclose to the other Party a draft copy of any Regulatory Filing for a Licensed Product in an Indication no less than [*] days prior to filing it with a Governmental Authority. Each Party shall consider in good faith any comments made by the other Party with respect to such filings. Where documents are not in English, each Party shall also provide an English translation. Amgen shall maintain a centralized database which contains all clinical trial data accumulated from all clinical trials of a Licensed Product conducted by, on behalf of, or with the support of each Party under the Collaboration (in a computer readable format as reasonably specified by Amgen), and each Party shall have full access to the database. Upon the request of either Party, the other Party shall provide a right of reference to any requested Regulatory Filings or Regulatory Approvals for a Licensed Product in such Party’s respective territory under the Collaboration, in each case as reasonably necessary for the requesting Party’s development or commercialization of such Licensed Product as permitted hereunder (and/or, with respect to Amgen, as reasonably necessary for the manufacture of such Licensed Product). Notwithstanding the foregoing, (i) Amgen shall not be required to provide to Licensee nor to allow Licensee to access (but shall provide a right of reference as set forth in Section 4.13 (Amgen Cooperation – Manufacturing Information) to the extent necessary) to Amgen’s manufacturing information with respect to a Licensed Product or any sections of any Regulatory Filing related thereto, and (ii) neither Party shall have an obligation to provide information relating to any product other than a Licensed Product.
Sharing of Regulatory Filings. Without limiting Section 5.1.6 or Section 5.2.3 above, each Party shall permit the other Party access to and a right to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of such Party’s, and its Affiliates’ and, to the extent it has the right to do so, its licensees’ and Sublicensees’ data, regulatory filings and regulatory communications associated with any submissions of XXXx or other approvals for Products (a) in the case of either Party, in each Major ****** - Material has been omitted and filed separately with the Commission. Market or Expanded Major Market, as applicable, in such Party’s respective territory or (b) in the case of GSK, upon Amicus’ request, in a country outside the Expanded Major Market in the GSK Territory.
Sharing of Regulatory Filings. Without limiting Section 4.6 or 4.7 above, Galderma shall permit ZARS to access, and shall provide ZARS with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of Galderma’s, its Affiliates’ and Sublicensees’ Data, regulatory filings and regulatory communications associated with any submissions of MXXx or other approvals for a Product in the Galderma Territory.
Sharing of Regulatory Filings. Without limiting Section 5.11 above, and without prejudice to the terms of the Supply Agreement, GSK and Sepracor shall permit the other to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of such Party’s, its Affiliates’ and Sublicensees’ Data, regulatory filings and material regulatory communications associated with any submissions of INDs, XXXx, Marketing Approvals or other approvals for the Product in the GSK Territory and in the Sepracor Territory, respectively. It is understood that such rights and access shall be limited respectively to Sepracor’s, its Affiliate’s and sublicensees’ commercialization of the Product in the Sepracor Territory and to GSK’s, its Affiliate’s and Sublicensee’s commercialization of the Product in the GSK Territory.
Sharing of Regulatory Filings. Without limiting Section 4.5 above, each Party shall permit the other to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement (including the right of XenoPort to commercialize the Product in the ROW Territory), all of such Party’s, and, in the case of DRL, its Affiliates’ and, to the extent a Party has the right to do so and subject to Section 10.5 if applicable, its licensees’ Data, regulatory filings and regulatory communications associated with any submissions of NDAs or other regulatory approvals for the Compound or a Product in such Party’s respective territory (i.e., in the Territory, in the case of DRL and in the ROW Territory, in the case of XenoPort).
