Common use of Marketing Authorizations Clause in Contracts

Marketing Authorizations. 8.1.1 ARIAD SWISSCO shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, Regulatory Authorities with respect to Products in the Field in the Territory. ARIAD US shall provide ARIAD SWISSCO with reasonable assistance, information, and access to ARIAD US’s personnel, to support ARIAD SWISSCO’s or the relevant ARIAD SWISSCO Sublicensees’ applications for Marketing Authorizations and other interactions with Regulatory Authorities in the Territory relating to Product and ARIAD SWISSCO shall reimburse ARIAD US for [**] in connection therewith. Each Party shall use appropriately qualified personnel for such activities, including personnel with local regulatory expertise. In accordance with its responsibilities as the MAH in the Territory, ARIAD SWISSCO or the relevant ARIAD SWISSCO Sublicensee shall act as the authorized contact for the Regulatory Authorities in the Territory in connection with obtaining and maintaining Marketing Authorizations (subject to ARIAD US’s involvement as provided in Section 8.3), as well as in connection with the Development, Manufacturing (if applicable) or Commercialization of the Product. [**]. 8.1.2 ARIAD US shall be responsible for maintaining the Company Core Data Sheet (“CCDS”) / Company Core Safety Information (“CCSI”) / core Risk Management Plan (“RMP”) for the Product. In the event that a change to the CCDS/CCSI/RMP necessitates a change to the local labeling in a country within the Territory, ARIAD SWISSCO shall be responsible for developing a proposed revised draft product label or package insert for each country in the Territory. ARIAD US shall provide ARIAD SWISSCO with information and reasonable access to ARIAD US’s personnel, to support ARIAD SWISSCO’s changes to the Marketing Authorizations to modify the revised draft labeling provided that ARIAD SWISSCO shall reimburse ARIAD US for [**]. ARIAD SWISSCO or the relevant ARIAD SWISSCO Sublicensee shall promptly submit a change to applicable Marketing Authorizations in the Territory to modify the labeling.

Marketing Authorizations. 8.1.1 ARIAD SWISSCO shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, Regulatory Authorities with respect (a) The Borrower hereby agrees to Products in the Field in the Territory. ARIAD US shall provide ARIAD SWISSCO with reasonable assistance, information, and access file (or cause Merus Luxco II to ARIAD US’s personnel, to support ARIAD SWISSCO’s or the relevant ARIAD SWISSCO Sublicensees’ file) applications for Marketing Authorizations and other interactions with Regulatory Authorities in the Territory relating to Product and ARIAD SWISSCO shall reimburse ARIAD US for [**] in connection therewith. Each Party shall use appropriately qualified personnel for such activities, including personnel with local regulatory expertise. In accordance with its responsibilities as the MAH in the Territory, ARIAD SWISSCO or the relevant ARIAD SWISSCO Sublicensee shall act as the authorized contact for the Regulatory Authorities in the Territory in connection with obtaining and maintaining Marketing Authorizations (subject to ARIAD US’s involvement as provided in Section 8.3), as well as in connection with the Development, Manufacturing (if applicable) or Commercialization transfer of the Product. [**]. 8.1.2 ARIAD US shall be responsible for maintaining the Company Core Data Sheet (“CCDS”) / Company Core Safety Information (“CCSI”) / core Risk Management Plan (“RMP”) for the Product. In the event that a change to the CCDS/CCSI/RMP necessitates a change to the local labeling in a country within the Territory, ARIAD SWISSCO shall be responsible for developing a proposed revised draft product label or package insert for each country in the Territory. ARIAD US shall provide ARIAD SWISSCO with information and reasonable access to ARIAD US’s personnel, to support ARIAD SWISSCO’s changes to the Marketing Authorizations in respect of Sintrom to modify Merus Luxco II by no later than eighteen (18) months after the revised draft labeling provided date of completion of the Sintrom Purchase Transaction (the “Sintrom Acquisition Date”). The Borrower confirms that ARIAD SWISSCO shall reimburse ARIAD US for [**]in accordance with and subject to the terms and conditions of the Novartis Sintrom Agreements, until the earlier of (i) the completion of such transfers; or (ii) two years from after the Sintrom Acquisition Date, Novartis is obliged to sell Sintrom in each applicable country and remit the profits thereof (less certain fees and charges) to Merus Luxco II, all as more particularly set out therein. ARIAD SWISSCO or The Borrower hereby represents and warrants to the relevant ARIAD SWISSCO Sublicensee shall promptly submit a change to applicable Agent and the Lenders that based on its previous experience in obtaining transfers of Marketing Authorizations in Europe in respect of Emselex, the Territory Borrower reasonably believes that each said Marketing Authorization in respect of Sintrom will be transferred to modify Merus Luxco II within four (4) months of filing the labelingrelevant transfer application. (b) The Borrower hereby agrees to file (or cause Merus Luxco II to file) applications for transfer of the Marketing Authorizations in respect of UCB to Merus Luxco II by no later than eighteen (18) months after the date of completion of the UCB Purchase Transaction (the “UCB Acquisition Date”) The Borrower confirms that in accordance with and subject to the terms and conditions of the UCB Purchase Agreement, UCB has agreed to continue to operate the Business (as defined in the USB Purchase Agreement) in the Ordinary Course of Business (as defined in the USB Purchase Agreement) and provide certain agreed upon transitional services on a country by country and product by product basis for the time periods specified therein, in each case as more particularly outlined in the Transitional Services Agreement (as defined in the USB Purchase Agreement) and remit the profits thereof (less certain fees and charges) to Merus Luxco II, all as more particularly set out therein. The Borrower hereby represents and warrants to the Agent and the Lenders that based on its previous experience in obtaining transfers of Marketing Authorizations in Europe, the Borrower reasonably believes that each said Marketing Authorization in respect of UCB will be transferred to Merus Luxco II within four (4) months of filing the relevant transfer application. (c) [REDACTED: REFERENCE TO FILING OF MARKETING AUTHORIZATIONS IN CONNECTION WITH POSSIBLE FUTURE PRODUCT ACQUISITION TRANSACTION].

Marketing Authorizations. 8.1.1 ARIAD SWISSCO shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, Regulatory Authorities with respect to Products in the Field in the Territory. ARIAD US shall provide ARIAD SWISSCO with reasonable assistance, information, and access to ARIAD US’s personnel, to support ARIAD SWISSCO’s or the relevant ARIAD SWISSCO Sublicensees’ applications for Marketing Authorizations and other interactions with Regulatory Authorities in the Territory relating to Product and ARIAD SWISSCO shall reimburse ARIAD US for [***] in connection therewith. Each Party shall use appropriately qualified personnel for such activities, including personnel with local regulatory expertise. In accordance with its responsibilities as the MAH in the Territory, ARIAD SWISSCO or the relevant ARIAD SWISSCO Sublicensee shall act as the authorized contact for the Regulatory Authorities in the Territory in connection with obtaining and maintaining Marketing Authorizations (subject to ARIAD US’s involvement as provided in Section 8.3), as well as in connection with the Development, Manufacturing (if applicable) or Commercialization of the Product. [***]. 8.1.2 ARIAD US shall be responsible for maintaining the Company Core Data Sheet (“CCDS”) / Company Core Safety Information (“CCSI”) / core Risk Management Plan (“RMP”) for the Product. In the event that a change to the CCDS/CCSI/RMP necessitates a change to the local labeling in a country within the Territory, ARIAD SWISSCO shall be responsible for developing a proposed revised draft product label or package insert for each country in the Territory. ARIAD US shall provide ARIAD SWISSCO with information and reasonable access to ARIAD US’s personnel, to support ARIAD SWISSCO’s changes to the Marketing Authorizations to modify the revised draft labeling provided that ARIAD SWISSCO shall reimburse ARIAD US for [***]. ARIAD SWISSCO or the relevant ARIAD SWISSCO Sublicensee shall promptly submit a change to applicable Marketing Authorizations in the Territory to modify the labeling.