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.
11.2. GW undertakes to inform Bayer or its Affiliates of any amendments or additions to the Marketing Authorisations which are relevant to the performance by Bayer of its obligations under this Agreement at which time the Agreement shall be amended in accordance with the amendments or additions implemented by GW in the Manufacture of the Products to the extent required.
MARKETING AUTHORISATIONS. 4.1. La Jolla and the Licensors shall initiate the transfer of all Marketing Authorisations for the Licensed Products in the Territory with the Regulatory Authority [***] in order for Paion (or its Licensed Subsidiaries) to be appointed as holders of all Marketing Authorisations for the Licensed Products in the Territory.
4.2. La Jolla and the Licensors shall reasonably assist Paion and Licensed Subsidiaries, upon reasonable request, in connection with any queries made by Regulatory Authority during the transfer of the Marketing Authorisations or following the transfer the Marketing Authorisations. La Jolla and the Licensors shall give reasonable support to the application, transfer and maintenance of the Marketing Authorisations in the Territory, including but not limited to providing additional documents requested by Regulatory Authority. La Jolla and the Licensors shall reasonably assist Paion in answering any deficiency letters from the Regulatory Authority in the Territory regarding the Licensed Products, as reasonably requested by Paion or Licensed Subsidiaries. Where the Regulatory Authority may require a letter of authorisation or other similar document that La Jolla and/or Licensors are required to provide, La Jolla and the Licensors shall provide these promptly after being requested to do so.
4.3. La Jolla and the Licensors shall reasonably assist Paion and Licensed Subsidiaries, upon reasonable request, in connection with any queries made by Regulatory Authority during the application for any new Marketing Authorisations in the Territory. La Jolla and the Licensors shall give reasonable support to the application and maintenance of the new Marketing Authorisations in the Territory. La Jolla and the Licensors shall reasonably assist Paion in answering any deficiency letters from the Regulatory Authority in the Territory regarding the Licensed Products, as reasonably requested by Paion or Licensed Subsidiaries. Where the Regulatory Authority may require a letter of authorisation or other similar document that La Jolla and/or Licensors are required to provide, La Jolla and the Licensors shall provide these promptly after being requested to do so.
4.4. All reasonable costs and fees associated with La Jolla and Licensors complying with their obligations under Clauses 4.1, 4.2 and 4.3 shall be shared by the Parties, with the Parties consulting on how such reasonable costs and fees will be incurred and shared.
MARKETING AUTHORISATIONS. Description of Supplies and Services
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 .
11.2. Notwithstanding the provisions of clause 11.1, in the event of the existing MARKETING AUTHORISATIONS requiring further work to be undertaken thereon in order to procure their transfer to ASPEN, its AFFILIATES and/or the THIRD PARTY SUB-LICENSEE/S, the PARTIES shall take all necessary steps to cause the necessary further work to be undertaken and shall cooperate in the utmost good faith to that end. IROKO will use its best commercial endeavours to procure the consent of MERCK for any technical work requiring MERCK’s consent.
11.3. All or any reasonable fees, costs and expenses incurred by ASPEN and/or IROKO and mutually agreed to by the PARTIES in procuring (i) the transfer of the MARKETING AUTHORISATIONS to ASPEN, its AFFILIATES and/or the THIRD PARTY SUB-LICENSEE/S and/or associated with any further work which requires to be undertaken in order to procure such transfer; (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, shall be deemed to be REGULATORY COSTS. The provisions of this clause 11.3 shall, where applicable, apply mutatis mutandis to the SUPPOSITORIES, ALDOMET® (METHYLDOPA) TABLETS 125MG and/or SRC PRODUCT.
11.4. After the transfer of the MARKETING AUTHORISATIONS to ASPEN, its AFFILIATES and/or the THIRD PARTY SUB-LICENSEES, ASPEN will be solely responsible for maintaining all MARKETING AUTHORISATIONS in the TERRITORY. All or any fees, costs or expenses incurred and paid by ASPEN in so maintaining the MARKETING AUTHORISATIONS shall be deemed to be a REGULATORY COST.
11.5. Should additional data be required for the purposes of obtaining and/or maintaining the MARKETING AUTHORISATIONS, then the PARTIES shall meet and undertake negotiations in good faith to determine an ...
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”).
24.2 A list of all applications to obtain Marketing Authorisations applied for by the Group or in respect of a pipeline product of the Group are set out at Part B of Schedule 8 and the information in Part B 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 MA Applications”, together with the Group Marketing Authorisations, the “Group MAs”).
24.3 The Group Marketing Authorisations comprise all the Marketing Authorisations required by the Group to operate the business of the Group as it is currently conducted.
24.4 So far as the Vendors are aware, all of the Products are and have been developed, manufactured, tested, packaged, labelled, held, stored, distributed, marketed, imported, exported, and sold, in all material respects in accordance with (i) the requirements, specifications and standards contained in the relevant Marketing Authorisation and (ii) all applicable Laws.
24.5 All licence and registration fees, and any registration deadlines in respect of filing documents and other Authority requests, in respect of the Group MAs that are required to be paid or met in order to retain and maintain (and in the case of the Group MA Applications, obtain) such Group MAs pursuant to and in accordance with applicable Law, have been paid or met.
24.6 The Group Companies are in compliance in all material respects with the terms of all Group Marketing Authorisations, and so far as the Vendors are aware, no event has occurred that would result in a material penalty under, or the revocation, cancellation, challenge, non-renewal or modification which would be adverse to the Group of, any Group Marketing Authorisation. No proceeding or action is pending or, so far as the Vendors are aware, threatened, regarding, and no material correspondence has been entered into with any Authority which is likely to result in, the revocation, cancellation, non-renewal or modification, or the imposition of a material penalty, which would be adverse to the Group of any Group Marketing Authorisat...
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. 3.3.1 ACAM 2000 (Acambis)
3.3.1.1 Acambis shall initially have the right to file for any Marketing Authorization(s) with respect to ACAM 2000 (Acambis). Should Acambis decide, in its sole discretion, to apply for and obtain a Marketing Authorization in a country or region, then Acambis will be responsible for filing and maintaining the Marketing Authorization(s) for ACAM 2000 (Acambis) and shall bear all related costs. If (1) Acambis decides to not apply for or obtain a Marketing Authorization in a specific country or region or (2) Baxter or any Baxter affiliate is required by law or government request to apply for a Marketing Authorization in any country, then Acambis and BHSA shall consult to jointly decide if a Marketing Authorization in this particular country is commercially justified from a business perspective. Acambis shall not unreasonably refuse to file and maintain the Marketing Authorization(s) for ACAM 2000 (Acambis) nor shall it unreasonably refuse to allow Baxter or any Baxter affiliate to file for a Marketing Authorization under the circumstances of (2) above.
3.3.1.2 If obtaining a Marketing Authorization for a certain country or region is not commercially justified from a business perspective and Acambis elects not to file for such Authorization, Baxter may apply for and obtain such Marketing Authorization(s) and shall bear all related costs.
3.3.1.3 Baxter shall provide all documents to Acambis (either in English or German) required for Acambis to apply for and obtain such Marketing Authorization(s). Baxter shall not be required to provide any document or information that is not in its possession or that Baxter is not entitled to disclose to Acambis.
3.3.2 ACAM 2000 (******)
3.3.2.1 If (1) Baxter or any Baxter affiliate is required by law or government request to apply for and obtain a Marketing Authorization for ACAM 2000 (******) or (2) Baxter determines that it wants to apply for and obtain a Marketing Authorization for ACAM 2000 (******), Baxter may do so. Should Baxter decide to apply for and obtain a Marketing Authorization for ACAM 2000 (******), Baxter shall bear all related costs.
3.3.2.2 If, in the first instance discussed in Provision 3.3.2.1 above, Baxter decides not to apply for and obtain a Marketing Authorization, then Acambis and BHSA shall consult to jointly decide if a Marketing Authorization in this particular country is commercially justified from a business perspective.
3.3.2.3 Acambis shall provide all documents to ...
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.
14.2 All Regulatory Permits held by the Group Companies, are valid and have been issued pursuant to applications or filings made materially in accordance with all applicable laws and regulations, and there are no circumstances or actions likely to lead to any of them being suspended, terminated, materially modified, cancelled or revoked. All application and renewal fees due and payable regarding any Regulatory Permits have been paid. All applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Regulatory Permit, when submitted to the Governmental Entity, were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to the Governmental Entity. The claims allowed by the Governmental Entities for the Group Companies’ products are valid and supported by proper research, design, testing, analysis and disclosure.
14.3 In the last three (3) years: (i) no Regulatory Permits have been materially breached; (ii) no material deficiencies have been asserted by any applicable Governmental Entity with respect to any Regulatory Permits nor are there any facts or circumstances that would be likely to lead to such assertions being made; and (iii) all conditions imposed by relevant Governmental Entities in connection with the Regulatory Permits have been materially complied with.
14.4 There is no investigation, proceeding or enquiry by, or order, decree, decision or judgment of, any court, tribunal, arbitrator, governmental, administrative or regulatory authority pending, outstanding or, so far as the Management Warrantors are aware, anticipated against any Group Company nor, so far as the Management Warrantors are aware, any of its directors, officers or employees, any of its Associated Persons, nor any other person acting on the Group Company’s behalf by any Governmental Entit...
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. 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.
