Marketing Authorization Holder. Unless otherwise required by Applicable Laws and subject to the provisions of this Agreement, Nycomed or Affiliates of Nycomed shall be the holders of all Marketing Authorizations for each Jurisdiction in the Territory during the term of this Agreement. Each Party agrees that neither it nor its Affiliates or Partners will do anything to adversely affect a Marketing Authorization.
Marketing Authorization Holder. Unless otherwise required by Applicable Laws, Atrix shall be the holder of all Marketing Authorizations for each country in the Territory; provided, however, that Sanofi-Synthelabo shall hold the Canadian Marketing Authorization. Atrix will own and maintain the Marketing Authorizations (other than the Canadian Marketing Authorization which shall be the responsibility of Sanofi-Synthelabo) during the term of this Agreement. Each Party agrees that neither it nor its Affiliates will do anything to adversely affect a Marketing Authorization.
Marketing Authorization Holder. Subject to Collegium’s obligations upon termination pursuant to Section 13.06, Collegium shall, upon assignment of the Current Product NDA to Collegium following Supplement Approval, be the holder and owner of all Marketing Authorizations and Governmental Approvals in the Territory concerning Licensed Products and responsible for all associated legal obligations with respect thereto, including but not limited to the performance of all obligations with respect to Licensed Products under the Transmucosal Immediate Release Fentanyl (“TIRF”) Risk Evaluation and Mitigation Strategy (“REMS”) program established by FDA. Collegium acknowledges and agrees that such responsibilities under such TIRF REMS program shall include appointing a Collegium representative on the relevant TIRF REMS working group established by the FDA or otherwise associated with such program and paying its portion of all fees, costs, and expenses imposed on, or incurred as, members of such group or otherwise imposed by FDA with respect to such program or group (“TIRF Fees”), and Collegium further agrees that it shall promptly reimburse BDSI for the portion of any TIRF Fees paid by BDSI after the Effective Date which correspond to any period of time during which Collegium is the holder of the Current Product NDA.
Marketing Authorization Holder. Subject to Purdue’s obligations upon expiration or termination of this Agreement pursuant to Section 13.06, Purdue shall, upon Marketing Authorization Transfer, be the holder and owner of all Marketing Authorizations and Governmental Approvals in the Territory concerning Licensed Products and responsible for all associated legal obligations with respect thereto.
Marketing Authorization Holder. Unless otherwise required by Applicable Laws, Pharmacyclics shall be the holder of the UK Marketing Authorization and all other Marketing Authorizations and E-Z-EM shall be named as Pharmacyclics' distributor in the Territory with respect to the Marketing Authorizations. In the event that the parties determine that it is desirable, for legal or administrative reasons, for E-Z-EM to hold the Marketing Authorizations, E-Z-EM understands and agrees that E-Z-EM will hold the Marketing Authorizations in trust for the benefit of Pharmacyclics and that, therefore, E-Z-EM will not transfer, assign, mortgage, charge or sub-contract any of the Marketing Authorizations other than to Pharmacyclics or to a third-party distributor appointed by E-Z-EM to distribute the Licensed Product, and that E-Z-EM will not do anything intentionally to adversely affect a Marketing Authorization. E-Z-EM agrees that Pharmacyclics shall be free from time to time to inform the Competent Authorities that the Marketing Authorizations are held in trust for Pharmacyclics. Any transfer of the Marketing Authorization by E-Z-EM to a third party distributor shall be contingent upon the execution by the third party distributor of a written agreement pursuant to which the third party distributor agrees to hold the Marketing Authorization on the same terms and conditions as set forth in this Section 7.6. E-Z-EM agrees to provide Pharmacyclics with copies of any agreements with third parties entered into by E-Z-EM and such third party in order to comply with this Section 7.6 within 30 days of the effective date of any transfer of any Marketing Authorization, along with appropriate evidence from the Competent Authorities documenting the transfer of the Marketing Authorization. Any transfers of any Marketing Authorizations made in violation of this Section 7.6 shall be null, void and unenforceable. For the avoidance of doubt, the term "transfer" shall include, but not be limited to, transfers from E-Z-EM to a third party distributor of an existing Marketing Authorization as well as cases in which the third party distributor rather than E-Z-EM makes an application for a Marketing Authorization.
Marketing Authorization Holder. Unless otherwise required by Applicable Laws and subject to the provisions of Section 14.05, Arius shall be the holder of all Marketing Authorizations and Governmental Approvals in the Territory. Each Party agrees that neither it, its Affiliates nor any sublicensee will do anything to intentionally adversely affect a Marketing Authorization.
Marketing Authorization Holder. Subject to Meda’s obligations upon termination pursuant to Section 13.05, Meda shall, following final approval of a particular Governmental Approval or Marketing Authorization by a given Competent Authority, be the holder and owner of such Marketing Authorization and Governmental Approval in the Territory. Meda agrees that neither it nor its Affiliates will do anything to recklessly, negligently, or intentionally adversely affect any Marketing Authorization or Governmental Approval.
Marketing Authorization Holder. Without limiting its obligations under Section 3.2, Licensee or its Affiliates or nominees shall be the Marketing Authorization Holder (“MAH”) for the Licensed Products in the Territory and shall be responsible for preparing, seeking, submitting and maintaining all regulatory filings and Regulatory Approvals for all Licensed Products in the Territory.
Marketing Authorization Holder. Unless otherwise required by Applicable Laws, Chugai or its Affiliates shall be the holder of all Marketing Authorization in the Territory. Chugai, its Affiliates or sublicensees will not transfer, assign, mortgage, charge or sub-contract any of the Marketing Authorizations other than to MBI or to a Third Party sublicensee or distributor approved in writing by MBI and sublicensed or appointed by Chugai to distribute the Licensed Product, and Chugai will not do anything that might adversely affect any of the Marketing Authorizations. Any transfer of the Marketing Authorization by Chugai or its Affiliates to a Third Party sublicensee or distributor shall be subject to MBI's prior written approval (which shall not be unreasonably withheld). Chugai agrees to provide MBI with appropriate evidence from the Competent Authorities documenting the transfer of any Marketing Authorization within thirty (30) days of the effective date of any transfer of the Marketing Authorization. Any transfers of a Marketing Authorization made in violation of this Section 8.3 shall be null, void and unenforceable. The term "transfer" shall include, but not be limited to, transfers from Chugai or its Affiliates to a Third Party sublicensee or distributor of an existing Marketing Authorization as well as cases in which the Third Party sublicensee or distributor rather than Chugai or one of its Affiliates makes an application for a Marketing Authorization.
Marketing Authorization Holder. Company shall be the Marketing Authorization holder; provided, that it acknowledges that Misonix shall be the beneficial owner of such Marketing Authorizations. Company shall not be entitled to transfer, assign, encumber or otherwise convey the Marketing Authorizations to any Third Party without the written consent of Misonix. Within ten (10) days of a written request by Misonix, Company shall relinquish its Marketing Authorization for the Product.
