Marketing Authorisation. Such authorisation(s) granted by the relevant regulatory authorities which are necessary to market the Medicinal Product in the Territory.
Marketing Authorisation. (a) Nuvectis shall give University thirty (30) days’ written notice before submission of any Marketing Authorisation Application.
Marketing Authorisation. Each Party shall administer any marketing authorisation process it maintains for Pharmaceutical Products in a timely, reasonable, objective, transparent and impartial manner. In particular, the Parties shall adhere to the following timelines:
Marketing Authorisation. Holders shall purchase from Teva Manufacturing Site not less than the annual minimum quantities of each Product based on batch size set out in Appendix D. If Marketing Authorisation Holders fail to meet these minimum quantities in any year, Teva shall have the right to terminate this Agreement on a Product-by-Product basis. MARKETING AUTHORISATION HOLDERS shall maintain at least three (3) month inventory of each Product for Commercialisation in the Territory.
Marketing Authorisation. HOLDERS shall have a maximum of forty-five (45) days from the date of its receipt of any delivery of Products by TEVA Manufacturing Site to inspect the quantity and quality delivered and to accept or reject such delivery, in whole or in part. The methods of analysis agreed upon by the Parties shall be used to determine whether or not the Products meet the relevant specifications. In the event MARKETING AUTHORISATION HOLDERS do not notify TEVA Manufacturing Site in writing of either acceptance, defect or a shortage within such forty-five (45) day period, all of such delivery shall be deemed to be accepted. Notwithstanding the foregoing, in the event of a latent defect to any batch of the Products, which could not have been discovered by MARKETING AUTHORISATION HOLDERS with reasonable diligence within such forty-five (45) day period, MARKETING AUTHORISATION HOLDERS shall have fifteen (15) days from the date that such latent defect was in fact discovered or should have been discovered to notify TEVA Manufacturing Site in writing, failing which such batch shall be deemed accepted. TEVA Manufacturing Site shall upon verification of such defect or shortage, as the case may be, dispatch non-defective quantities of the relevant Product in a quantity sufficient to cure the shortage or defect free of charge.
Marketing Authorisation. 6. Inform the SFDA of any adverse events that have occurred outside the KSA but have consequences for medical devices that have been authorized to be placed on the market of the KSA. The authorized representative shall explain the circumstances and provide information on the corrective action the manufacturer has taken or intends to take.
Marketing Authorisation. 5.1 Obtaining and maintaining Marketing Authorisations HPPI must:
Marketing Authorisation. 3.1 Galena will provide Teva with the Registration Dossier in a European CTD format in the English language including without limitation the CPP form (Certificate of Pharmaceutical Product) for the Product, the details of which shall be listed in Appendix C, in order to allow Teva to audit the Registration Dossier before applying for a Marketing Authorization in the respective Territory (“Audit of the Registration Dossier”).
Marketing Authorisation. 3.1 A Marketing Authorisation for the Territory already exists and is owned by [...***...]. If The Regulatory Authority requires the Marketing Authorisation to be in the name of Prestwick Cambridge shall procure that [...***...] assigns the Marketing Authorisation to Prestwick. If Prestwick presents evidence that it would be more advantageous to both parties if the Marketing Authorisation were held by Prestwick, Cambridge shall present such evidence to [...***...] and use all reasonable endeavours to procure that [...***...] assigns the Marketing Authorisation to Prestwick. Until the date of transfer of the Marketing Authorisation from [...***...] Limited to Prestwick Cambridge shall procure that the Marketing Authorisation is renewed and maintained [...***...] save that Cambridge shall procure that any changes to the Marketing Authorisation required by the Regulatory Authority during this time to permit Prestwick to sell the Product in the Territory are [...***...]. *CONFIDENTIAL TREATMENT REQUESTED 5.
Marketing Authorisation. 3.1 KSB is engaged in the preparation of the dossier and shall deliver such parts of the dossier and updates of the same to RANBAXY within 21 days from the date of submission to the US FDA and/or EMEA.
