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.
(b) If the Licensed Product and/or Additional Licensed Product fails on efficacy, safety or toxicological grounds or if Nuvectis fails to obtain Regulatory Approval for the Licensed Product and/or Additional Licensed Product in a country in the Territory, Nuvectis shall promptly give to University written notice and a summary of relevant information. Nuvectis shall, if requested, give further evidence reasonably required by University, at University’s cost.
Marketing Authorisation.
2.1 The award of this Contract shall be conditional upon the Supplier being in possession of a valid marketing authorisation(s) from the Licensing Authority required for supply of the Goods (such validity to be determined by the Licensing Authority) on or prior to the Commencement Date or on such other date as is agreed between the Parties (such date always being prior to the delivery of any Goods under this Contract). The Authority may request that the Supplier delivers to the Authority evidence of the grant of such valid marketing authorisation(s). For the avoidance of doubt a marketing authorisation which has been expired or has been suspended or withdrawn by the Licensing Authority does not constitute a valid marketing authorisation for the purposes of this Clause 2.1.
2.2 If the Supplier fails to be in possession of the documentation required by Xxxxxx
2.1 of this Schedule 1 of these Call-off Terms and Conditions by the agreed date then the Authority shall be entitled to terminate this Contract with immediate effect on giving written notice to the Supplier.
2.3 The Authority may in its sole discretion at any time agree to waive compliance with the requirement in Clause 2.1 of this Schedule 1 of these Call-off Terms and Conditions by giving the Supplier notice in writing.
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:
(a) Marketing authorisation shall be provided within ninety (90) days without any inspections by each Party for Pharmaceutical Products of the other Party which have been approved by the relevant Regulatory Authorities of Australia, Canada, European Union, Japan, the United States of America, or United Kingdom.
(b) For all other Pharmaceutical Products where inspections are required, each Party shall, to the extent possible, and only as practicably feasible, grant marketing authorisation within two hundred and seventy (270) days of application for such marketing authorisation.
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. 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. 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”).
3.2 Galena will use Reasonably Diligent Efforts to cooperate and assist Teva with all requests it may have with respect to the Registration Dossier. Teva shall place at Galena’s disposal a list of missing documents (if any) which Galena has to provide Teva with, if already in its possession.
3.3 The Audit of the Registration Dossier shall be reasonably satisfactory to Teva. Teva shall confirm to Galena in writing following the last document transfer whether Teva accepts the Registration Dossier, which acceptance will not unreasonably be withheld. Following the aforesaid, Teva shall submit Marketing Authorization application as soon as reasonably possible, and at its own expense in the Territory (including all fees to the Regulatory Authorities) and in its own name, and use Reasonably Diligent Efforts to obtain such Marketing Authorization. For the sake of clarification, if any clinical trials are required in order to obtain an authorization from the Regulatory Authorities to commercialize the Product, the costs of such trials shall be borne by Galena, and run soley at the option of Galena.
3.4 Galena will use Reasonably Diligent Efforts to cooperate with Teva in its efforts to obtain the Marketing Authorization in the Territory and if required shall supply Teva with the appropriate samples in necessary amount including without limitation samples of the Medicinal Product, samples of the Active Substance, Reference Substance and Impurities together with Certificate of Analysis. Galena shall cooperate with Teva in answering any deficiency letters or any other question of the respective Health Authority within reasonable time according to circumstances.
3.5 Teva will notify Galena as of the date when Teva submits the Marketing Authorization application and will keep Galena informed on a current basis as to progress thereof. Where possible, Teva shall provide Galena with full copy of each respective Marketing Authorization application filed in the Territory. In the event that any letter of deficiency is issued or any other questions are rai...
Marketing Authorisation. The award of this Contract shall be conditional upon the Supplier being in possession of a valid marketing authorisation(s) from the Licensing Authority required for supply of the Goods (such validity to be determined by the Licensing Authority) on or prior to the Commencement Date or on such other date as is agreed between the Parties (such date always being prior to the delivery of any Goods under this Contract). The Authority may request that the Supplier delivers to the Authority evidence of the grant of such valid marketing authorisation(s). For the avoidance of doubt a marketing authorisation which has been expired or has been suspended or withdrawn by the Licensing Authority does not constitute a valid marketing authorisation for the purposes of this Clause 2.1.
Marketing Authorisation. 4.1 ADAMIS will be responsible for the regulatory dossier development, USFDA interactions including filings. Beximco will be responsible for site inspections required by the FDA or other governing body. Adamis will require support and data from Beximco to complete the dossier. Adequate support will be provided by Beximco at agreed upon rates.
4.2 ADAMIS will be responsible for the payment of annual fees and charges payable in respect of receiving and maintaining the Marketing Authorisations for the Products and other costs related to any variation of a Marketing Authorisation for the Products.
4.3 BEXIMCO warrants that all information supplied to ADAMIS in relation to the Products is true to the best of BEXIMCO’s knowledge after all due enquiries and that it is legally entitled to supply this information to ADAMIS.
4.4 BEXIMCO warrants that BEXIMCO will maintain any GMP licence granted to it under any scheme in the United States of America or Australia or any scheme recognised by the USFDA and will use reasonable endeavours to promptly provide ADAMIS with evidence of this when requested by ADAMIS to do so.
