Common use of Rights of Reference Clause in Contracts

Rights of Reference. CKD shall provide Cara in writing letters of reference, granting Cara (and its Affiliates and sublicensees) the right of reference for all purposes relating to development or commercialization of products containing CR-845 outside the Territory except upon termination of this Agreement pursuant to Section 11.2(c), with respect to all filings with Regulatory Authorities made by or on behalf of CKD or its Affiliate in the Territory relating to Licensed Product, and to all Regulatory Approvals. Such letters of reference shall expressly permit Cara to transfer such rights to its Affiliates and licensees and allow such entities the right of reference to all such filings and Regulatory Approvals for anywhere outside the Territory except upon termination of this Agreement pursuant to Section 11.2(c), and such rights of reference shall expressly be binding on any assignee or transferee of CKD’s rights to such filings and Regulatory Approvals under this Agreement. If the FDA, or any other Regulatory Authority outside the Territory, requires access to certain portions of any such filings, registrations and approvals related to CR-845 and/or Licensed Product for legal or regulatory purposes in connection with Cara’s or its Affiliate’s or licensee’s development and/or commercialization efforts, including without limitation for making patent-related submissions, then CKD shall cooperate with such Regulatory Authority and make such portions available to the Regulatory Authority and, if legally required for Cara to submit or pursue an application for Regulatory Approval, to Cara (or its Affiliate or sublicensee) solely for such purpose. For all purposes involving the development or commercialization of Licensed Products in the Territory pursuant to the license granted in Section 2.1, CKD shall have the right of reference during the Term equivalent to Cara’s right ascribed in this section 3.6.

Rights of Reference. CKD Maruishi shall provide Cara in writing letters of reference, granting Cara (and its Affiliates and sublicensees) the right of reference for all purposes relating to development or commercialization of products containing CR-845 outside the Territory except upon termination of this Agreement pursuant to Section 11.2(c)Territory, with respect to all filings with Regulatory Authorities made by or on behalf of CKD Maruishi or its Affiliate in the Territory relating to Licensed Product, and to all Regulatory Approvals. Such letters of reference shall expressly permit Cara to transfer such rights to its Affiliates and licensees and allow such entities the right of reference to all such filings and Regulatory Approvals for anywhere outside the Territory except upon termination of this Agreement pursuant to Section 11.2(c)Territory, and such rights of reference shall expressly be binding on any assignee or transferee of CKDMaruishi’s rights to such filings and Regulatory Approvals under this Agreement. If the FDA, or any other Regulatory Authority outside the Territory, requires access to certain portions of any such filings, registrations and approvals related to CR-845 and/or Licensed Product for legal or regulatory purposes in connection with Cara’s or its Affiliate’s or licensee’s development and/or commercialization efforts, including without limitation limitation, for making filing patent-related submissions, then CKD Maruishi shall cooperate with such Regulatory Authority and make such portions available to the Regulatory Authority and, if legally required for Cara to submit or pursue an application for Regulatory Approval, to Cara (or its Affiliate or sublicensee) solely for such purpose. For all purposes involving the development or commercialization of Licensed Products in the Territory pursuant to the license granted in Section 2.12.1 and 2.2 during the Term, CKD Maruishi shall have the right of reference during the Term equivalent to Cara’s right ascribed in this section 3.63.8.

Rights of Reference. CKD On or promptly after the NDA Transfer Date, the parties shall provide Cara cooperate in writing letters good faith, take such actions, and execute and deliver, and file with the FDA, such documents as, in each case, are necessary to ensure that the Existing Rights of referenceReference remain in full force and effect following transfer and assignment of the Product NDA and are exercisable by the grantee(s) thereof. In addition, granting Cara (and in the event Depomed grants any Additional Rights of Reference during the Term, or in the event any grantee of Existing Rights of Reference or Additional Rights of Reference changes its Affiliates and sublicensees) the right of reference for all purposes corporate name, or sells or transfers its business relating to development the applicable ROR Product to another Person, Santarus shall, promptly, and in any event within five (5) business days after, Depomed’s written request, file the requisite authorization letter with the FDA in order for such Additional Rights of Reference to become effective, or commercialization for such Existing Rights of products containing CR-845 outside Reference or Additional Rights of Reference to be updated to reflect such grantee’s new corporate name or the Territory except upon termination name of this Agreement pursuant the acquirer of its business relating to Section 11.2(c)such ROR Product, with respect to all filings with Regulatory Authorities made by or as applicable. Santarus hereby covenants that neither it nor any of its Affiliates, nor any Third Party acting on behalf of CKD Santarus or any of its Affiliate in Affiliates, will withdraw, revoke or terminate any Existing Rights of Reference or any Additional Rights of Reference without Depomed’s express prior written authorization to do so. From and after the Territory relating NDA Transfer Date, Santarus shall provide to Licensed Product, and to Depomed copies of all Regulatory Approvals. Such letters of reference shall expressly permit Cara to transfer such rights to its Affiliates and licensees and allow such entities Approvals arising after the right of reference to all such filings and Regulatory Approvals for anywhere outside the Territory except upon termination of this Agreement pursuant to Section 11.2(c), and such rights of reference shall expressly be binding on any assignee NDA Transfer Date as promptly as practicable after approval or transferee of CKD’s rights to such filings and Regulatory Approvals under this Agreement. If the FDA, or any other Regulatory Authority outside the Territory, requires access to certain portions of any such filings, registrations and approvals related to CR-845 and/or Licensed Product for legal or regulatory purposes in connection with Cara’s or its Affiliate’s or licensee’s development and/or commercialization efforts, including without limitation for making patent-related submissions, then CKD shall cooperate with such Regulatory Authority and make such portions available to the Regulatory Authority and, if legally required for Cara to submit or pursue an application for Regulatory Approval, to Cara receipt (or its Affiliate or sublicenseeas applicable) solely for such purpose. For all purposes involving the development or commercialization of Licensed Products in the Territory pursuant to the license granted in Section 2.1, CKD shall have the right of reference during the Term equivalent to Cara’s right ascribed in this section 3.6thereof.

Rights of Reference. CKD shall provide Cara in writing letters of reference, granting Cara (and its Affiliates and sublicensees) MEI hereby grants KHK the right of to use and reference all Regulatory Materials (including data contained therein) and Regulatory Approvals for all purposes relating to development or commercialization of products containing CR-845 the Compound and Products outside the Territory except upon termination of this Agreement pursuant to Section 11.2(c), with respect to all filings with Regulatory Authorities made submitted by or on behalf of CKD MEI, its Affiliates or licensees (to the extent that MEI has the right to grant such cross reference rights on behalf of its Affiliate licensee(s)), which right may be used by KHK only in the Field in the Territory relating [*CONFIDENTIAL*] to Licensed ProductKHK. MEI shall use Commercially Reasonable Efforts to cause all relevant licensees of MEI to grant such cross reference rights, with right to sublicense to KHK, provided that if MEI, its Affiliates or its licensees does not grant such cross reference rights to KHK to either or both of the Clinical Trials described in subclauses (ii) and/or (iii) of Section 4.3(b) (Development Diligence), then KHK [*CONFIDENTIAL*] that is the subject of such Clinical Trial(s) for which such cross reference rights are not granted (and, accordingly, [*CONFIDENTIAL*] which relate to such Clinical Trial(s)). KHK hereby grants MEI the right to use and to reference all Regulatory Approvals. Such letters of reference shall expressly permit Cara to transfer such rights to its Affiliates and licensees and allow such entities the right of reference to all such filings Materials (including data contained therein) and Regulatory Approvals for anywhere outside the Territory except upon termination of this Agreement pursuant to Section 11.2(c), Compound and such rights of reference shall expressly be binding on any assignee or transferee of CKD’s rights to such filings and Regulatory Approvals under this Agreement. If the FDA, or any other Regulatory Authority outside the Territory, requires access to certain portions of any such filings, registrations and approvals related to CR-845 and/or Licensed Product for legal or regulatory purposes in connection with Cara’s or its Affiliate’s or licensee’s development and/or commercialization efforts, including without limitation for making patent-related submissions, then CKD shall cooperate with such Regulatory Authority and make such portions available to the Regulatory Authority and, if legally required for Cara to submit or pursue an application for Regulatory Approval, to Cara (or its Affiliate or sublicensee) solely for such purpose. For all purposes involving the development or commercialization of Licensed Products in the Territory pursuant submitted by or on behalf of KHK, its Affiliates or Sublicensees, which right may be used by MEI only outside the Territory [*CONFIDENTIAL*] to MEI. KHK shall cause all relevant Sublicensees of KHK to grant such cross reference rights, with right to sublicense to MEI. Each Party shall execute any documentation that is reasonably requested by the license granted in Section 2.1other Party to facilitate the exercise of such rights of reference. MEI shall not provide any cross-reference rights of KHK, CKD shall have the right its Affiliates, or Sublicensees to any of reference during the Term equivalent MEI’s licensees who do not agree to Cara’s right ascribed in this section 3.6permit its Regulatory Materials to be cross-referenced by KHK, its Affiliates, and its Sublicensees.