Cardiome’s Responsibilities Sample Clauses

Cardiome’s Responsibilities. (i) The Product is approved in certain EU countries under a decentralized procedure and Basilea holds National Marketing Authorisations in the Territory in Austria, Belgium, France, Germany, Italy, Luxembourg, Spain, and the UK as of the Effective Date. Promptly after the Effective Date, Basilea shall transfer all National Marketing Authorisations in these countries to Cardiome. (ii) Basilea has completed the Repeat-Use Procedure for Ireland, Poland, and Portugal but has not yet received National Marketing Authorisations in these countries. Once Basilea receives the National Marketing Authorisations in these countries, Basilea shall transfer them to Cardiome (iii) Basilea holds a Marketing Authorization in Switzerland. Promptly after the Effective Date, Basilea shall transfer the Marketing Authorisation for Switzerland to Cardiome. (iv) For any countries in the Core European Territory in which the Product is not yet registered, Cardiome shall notify Basilea of its intent to register the Product in such countries in line with the Commercial Launch Plan. Basilea shall thereafter initiate a Repeat-Use Procedure in such country within six (6) months of receipt of Cardiome’s notice of its intent to register in such country (such six (6) month period being elongated if there is an ongoing or urgent planned regulatory process not allowing the filing of the Repeat-Use Procedure within such timeframe). Once Basilea receives the National Marketing Authorisations in such countries, Basilea shall transfer them to Cardiome or, upon Cardiome’s request, to Cardiome’s approved Third Party Sublicensees (pursuant to Section 2.1). Confidential/Basilea Pharmaceutica International Ltd. & Correvio International Sàrl page 18 of 80 (v) After transfer of the National Marketing Authorisations from Basilea pursuant to Sections 4.1(a)(i), (ii) or (iv), or transfer of the Marketing Authorisation for Switzerland pursuant to Section 4.1(a)(iii), Cardiome shall be the National Marketing Authorisation holder of all National Marketing Authorisations in the Core European Territory. Cardiome shall undertake all national regulatory activities and procedures including preparing and filing Submission of national variations and Submission of the national phase after the end of any harmonized EU procedure in the required format, e.g. eCTD, ▇▇▇▇, etc. (vi) For the avoidance of doubt, Cardiome shall conduct all regulatory activities under its responsibility as specified in Sections 4.1(a)(i)-(v) at...