Marketing Authorisations. 11.1. GW undertakes to observe and comply with all requirements of the valid Marketing Authorisations and any amendments or additions thereto in so far as they apply to the Manufacture of the Products hereunder and have been disclosed by GW to Bayer or its Affiliates in writing.
Marketing Authorisations. 4. Description of Supplies and Services
Marketing Authorisations. Partner, when marketing, agrees (i) to market Xxxxxxxx’s Products using only pre-approved and/or jointly developed materials; and (ii) not to negotiate any business terms nor make any representations, warranties or statements regarding Fonality Products other than through the use of pre-approved materials/media. Fonality acknowledges that Partner may offer ancillary services that Partner may propose in conjunction with Fonality Products.
Marketing Authorisations. Anebulo or its Sublicensees shall have the sole right and responsibility for conducting communications with Regulatory Authorities with respect to Licensed Product in the Territory, and for preparing, submitting, prosecuting and maintaining all filings and applications required to be made to any Regulatory Authority to obtain any necessary or commercially desirable Marketing Authorisations and other approvals, consents or licences to Exploit Licensed Products, including any filings and applications to any Regulatory Authority for any pricing or reimbursement approval required or commercially desirable. Anebulo or its Sublicensees shall, respectively, own all right, title and interest in all the filings and applications made to, and all the approvals, consents or licences issued by, any Regulatory Authority and they shall be responsible for all costs and expenses in connection with clinical trials and securing regulatory approvals.
Marketing Authorisations. 11.1. As soon as is practically possible after the EFFECTIVE DATE, ASPEN and IROKO shall do all things reasonably necessary, with the utmost dispatch and good faith, to procure (i) the transfer of the MARKETING AUTHORISATIONS in the TERRITORY from MERCK to ASPEN, its AFFILIATES and/or the THIRD PARTY SUB-LICENSEES; (ii) the approval in accordance with the APPLICABLE LAWS pertaining to ASPEN as the manufacturer and packer of the PRODUCTS; and (iii) the approval in accordance with the APPLICABLE LAWS of new PACKAGING for the PRODUCTS, all in accordance with the procedures and time lines set out in Appendix C .
Marketing Authorisations. 5.1 KSB shall collate all Product Data deemed by the Development Committee to be required by the EMEA for the compilation of a Dossier capable of obtaining a Marketing Authorisation for the Product in the EU in respect of the relevant Indication. Upon completion of the Phase III Study and delivery of a copy of the Product Data in respect thereof, the Parties shall meet and review the adequacy quality and content of the Product Data and consider in good faith whether it is sufficient and appropriate to enable the compilation and submission of a Dossier reasonably anticipated to be capable of obtaining a Marketing Authorisation for the Product in respect of the relevant Indication in the EU. In the event that the Parties consider that the Product Data is appropriate for such Dossier, such date of determination shall be deemed the Dossier Delivery Date. KSB shall as soon as reasonably practicable after the Dossier Delivery Date procure the compilation by a third party of the Dossier in accordance with the terms of Clause 4.2 and promptly upon completion of the Dossier and verification of the Dossier by Nycomed, Nycomed shall submit the Dossier in respect of the relevant Product to the EMEA under the Centralized Procedure and shall subsequently use all reasonable endeavours to conduct the approval process in order to obtain a Marketing Authorisation for the relevant Product in the EU.
Marketing Authorisations. CollaGenex shall deliver to Alliance documentation in appropriate form sufficient to enable Alliance to initiate the transfers of all the Existing Marketing Authorisations.
Marketing Authorisations. 24.1 A list of all Marketing Authorisations used and/or owned by the Group is set out at Part A of Schedule 8 and the information in Part A of Schedule 8 (which shall include registered holder, grant date, granting body, date of expiry and product and jurisdiction covered) is true and accurate in all material respects (the “Group Marketing Authorisations”).
Marketing Authorisations. 5.1 SOSEI shall, subject to the provision by KSB to SOSEI of all relevant and necessary technical information promptly after the Effective Date, complete within 60 (sixty) days following the Effective Date preparation of all necessary documentations for submitting to the Regulatory Authority in the Territory an application for obtaining the Orphan Medicine Status of the Product and start promptly thereafter negotiations with the Regulatory Authority in the Territory for obtaining the Orphan Medicine Status of the Product. SOSEI shall as soon as reasonably practicable file the Dossier in respect of the Product with the Regulatory Authority in the Territory and shall use all best endeavours to obtain a Marketing Authorisation of the Product in the Territory
Marketing Authorisations. 14.1 Group Companies are the exclusive registered holders or licensees, applicants of, or hold the right to use all Regulatory Permits as such products have been researched, tested, developed, manufactured, marketed, sold, labelled, packaged, advertised and distributed by the Group, on the date of this Deed and in the twelve (12) months before the date of this Deed.
