Marketing Authorizations. Upon termination of this Agreement, Distributor shall promptly assign or otherwise transfer to Micrus or its designees all of Distributor’s rights, title and interest in and to the Marketing Authorizations and/or pending applications for the Product; provided, however, if such termination does not result from a breach of this Agreement by Distributor, Micrus shall reimburse Distributor for its costs incurred in obtaining such Marketing Authorizations.
Marketing Authorizations. Celltech shall prepare and submit to Orphan Medical, (i) within sixty (60) days of the Effective Date, a written plan for obtaining approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication and (ii) within one hundred twenty (120) days of the Effective Date, a written plan for obtaining approval to commercially promote and distribute the Product for the cataplexy Licensed Indication from the Regulatory Authority of each country in the Territory not covered by an EMEA Registration. On the basis of Orphan Medical's NDA and the Know How and related Proprietary Information delivered pursuant to Section 3.2, Celltech shall collect, assemble, organize and format all necessary components required to apply for such approvals, and shall submit such materials to the appropriate Regulatory Authorities in accordance with Section 3.2. Celltech shall maintain, at its own expense, the Registrations and other authorizations necessary to import, label, promote, market, sell and distribute the Product in the Territory. Orphan Medical shall provide, at its own cost and expense (but subject to the limitations set forth in Section 3.2), reasonable assistance to Celltech in the acquisition of such Registrations, including without limitation, the services set forth on Appendix H hereto. All applications for Marketing Authorizations for the Product shall be submitted in the name of Celltech and all Marketing Authorizations for the Product shall be assigned to Orphan Medical upon termination of this Agreement for any reason. Celltech shall ensure that all pages of documents submitted to Regulatory Authorities for the purpose of obtaining Registrations and Marketing Authorizations shall be coded as confidential.
Marketing Authorizations. 4.3.1 Corvus shall have the 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 Authorizations and other approvals, consents or licenses to Exploit Licensed Products, including any filings and applications to any Regulatory Authority for any pricing or reimbursement approval required or commercially desirable, and for avoidance of doubt, Corvus 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 licenses issued by, any Regulatory Authority and they shall be responsible for all costs and expenses in connection with clinical trials and securing regulatory approvals.
4.3.2 To the extent that Corvus requires regulatory support from Vernalis to obtain or maintain any approvals, consents or licenses referred to in Clause 4.3.1 due to the Regulatory Authority requiring knowledge of work [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. conducted by Vernalis prior to the date of this Agreement, Vernalis shall provide commercially reasonable assistance provided it is given reasonable notice by Corvus. [***].
Marketing Authorizations. 8.1.1 ARIAD SWISSCO shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, Regulatory Authorities with respect to Products in the Field in the Territory. ARIAD US shall provide ARIAD SWISSCO with reasonable assistance, information, and access to ARIAD US’s personnel, to support ARIAD SWISSCO’s or the relevant ARIAD SWISSCO Sublicensees’ applications for Marketing Authorizations and other interactions with Regulatory Authorities in the Territory relating to Product and ARIAD SWISSCO shall reimburse ARIAD US for [**] in connection therewith. Each Party shall use appropriately qualified personnel for such activities, including personnel with local regulatory expertise. In accordance with its responsibilities as the MAH in the Territory, ARIAD SWISSCO or the relevant ARIAD SWISSCO Sublicensee shall act as the authorized contact for the Regulatory Authorities in the Territory in connection with obtaining and maintaining Marketing Authorizations (subject to ARIAD US’s involvement as provided in Section 8.3), as well as in connection with the Development, Manufacturing (if applicable) or Commercialization of the Product. [**].
8.1.2 ARIAD US shall be responsible for maintaining the Company Core Data Sheet (“CCDS”) / Company Core Safety Information (“CCSI”) / core Risk Management Plan (“RMP”) for the Product. In the event that a change to the CCDS/CCSI/RMP necessitates a change to the local labeling in a country within the Territory, ARIAD SWISSCO shall be responsible for developing a proposed revised draft product label or package insert for each country in the Territory. ARIAD US shall provide ARIAD SWISSCO with information and reasonable access to ARIAD US’s personnel, to support ARIAD SWISSCO’s changes to the Marketing Authorizations to modify the revised draft labeling provided that ARIAD SWISSCO shall reimburse ARIAD US for [**]. ARIAD SWISSCO or the relevant ARIAD SWISSCO Sublicensee shall promptly submit a change to applicable Marketing Authorizations in the Territory to modify the labeling.
Marketing Authorizations. Company shall maintain the Marketing Authorizations in full force and effect at all times. Upon request by Company, AAIPharma shall use commercially reasonable efforts to assist Company in connection therewith; provided that, in exchange, Company will pay AAIPharma its standard fees and expenses therefor.
Marketing Authorizations. 1. When developing or implementing a regulation for the marketing authorization of a pharmaceutical product, each Party shall consider relevant scientific or technical guidance documents developed through international collaborative efforts. Each Party is further encouraged to consider regionally-developed scientific or technical guidance documents that are aligned with international collaborative efforts.
2. Each Party shall make a determination whether to grant marketing authorization for a specific pharmaceutical product on the basis of information that is necessary to evaluate the safety, effectiveness, and quality of the pharmaceutical product. This information may include:
(a) clinical data and information on safety and effectiveness of the product;
(b) information on the quality of the product, including manufacturing controls for the ingredients of the product; and
(c) labeling information related to the safety, effectiveness, quality, and use of the product.
3. No Party shall require sales data, or other financial data concerning the marketing of the product in making the determination referred to in paragraph 2. Further, each Party shall endeavor not to require pricing data in making the determination.
4. Each Party shall administer its marketing authorizations:
(a) reasonably, including by:
(i) avoiding duplicative requests or requests for unnecessary information from the applicant,
(ii) promptly communicating any deficiencies, and the reasons for the deficiencies, to the applicant, if the deficiency would prevent or delay consideration of the application, and
(iii) providing an applicant that requests marketing authorization for a pharmaceutical product with a determination within a reasonable period of time;14
(b) objectively, through application of published criteria;
(c) impartially, including by adopting or maintaining procedures to manage any conflicts of interest; and
(d) transparently, including by publishing a checklist or other guidance concerning the information that must be provided in any application.
Marketing Authorizations. Nycomed agrees, at its sole cost and expense, to apply for and maintain the Marketing Authorizations throughout the Term of this Agreement, including obtaining any variations or renewals thereof. Nycomed agrees that it will file the first MAA as promptly as practicable, but in any event within [CONFIDENTIAL TREATMENT REQUESTED] /*/ after delivery by Acusphere of all required Data as provided in Section 9.02 above; provided that if the Intellectual Property Strategy has not resulted in outcomes reasonably satisfactory to Nycomed at such time, Nycomed may delay its filing for up to an additional [CONFIDENTIAL TREATMENT REQUESTED] /*/ after such delivery; and further provided that if an additional clinical trial or additional stability testing is required to file an MAA for the Product in the Territory, Nycomed may delay its filing for as long as is necessary to conduct and complete such trial or testing, so long as Nycomed uses diligent efforts to pursue such trial or test. Notwithstanding any other provision of this Agreement describing specific costs or expenses to be borne by Nycomed, the Parties agree that Nycomed shall be responsible for the payment of all costs and expenses that are necessary to maintain the Marketing Authorizations in the Territory.
Marketing Authorizations. Client shall use commercially reasonable efforts to maintain the Marketing Authorizations in full force and effect at all times. Upon request by Client, Company shall use commercially reasonable efforts to assist Client in connection therewith as may be outlined in a separate statement of work or other related agreement, the terms of which shall be governed by this Agreement.
Marketing Authorizations all authorizations, registrations, filings, permits, licenses, franchises, orders, approvals, concessions, consents and other regulatory approvals issued by any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other Governmental Authority, including, without limitation, the U.S. Food and Drug Administration, to Seller or otherwise controlled by Seller (or any Affiliates) as required for (a) the importation, marketing, promotion, pricing and sale of products relating to the Business or (b) a purchaser of such products relating to the Business to seek reimbursement from private or public health insurance organizations, as well as all related regulatory filings (including all related correspondence)(collectively, the “Marketing Authorizations”);
Marketing Authorizations. EKR shall, as determined in its sole discretion to be commercially reasonable, prepare studies of the markets and sales potential of the Products for countries in the Territory other than the United States and present such studies to the Committee. EKR shall at its own cost and expense use commercially reasonable efforts to take those steps reasonably necessary in order to obtain and thereafter maintain Marketing Authorizations (including pricing and reimbursement approvals) for the Product in those countries of the Territory other than the United States which the Committee determines to present commercially viable opportunities for the Product. EKR shall provide PPI with a copy of any original certificates of approval/registration in each country in the Territory other than the United States. EKR shall provide PPI with a copy of any other registration matters received from the appropriate Regulatory Authorities concerning maintenance, renewal or variations to the original certificates of approval/registration in each country in the Territory. Except as provided in Section 3.17, EKR shall be solely responsible for, and shall bear all costs associated with, all regulatory activities related to the development and approval of the Product in the countries of the Territory (including, after the Agreement Date, the United States) and shall own the Marketing Authorizations for the Product in each other country of the Territory. EKR will comply with all conditions and requirements attaching to such Marketing Authorizations.
