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.
Marketing Authorizations. 2.1 Subject to the terms of this Agreement, ELITE shall exclusively manufacture, supply, package and label the Products for LANNETT, and LANNETT shall have the right to promote, market, store, distribute and sell the Products in the Territory. ELITE hereby grants to LANNETT and its Affiliates an exclusive right to fully commercialize the Products in the Territory. LANNETT agrees to exclusively purchase Products it requires from ELITE.
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.
Marketing Authorizations. Partner, when marketing, agrees (i) to market Fonality’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 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. 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. [**].
Marketing Authorizations. (a) The transfer to Sanofi of marketing authorizations (which shall be held by a Sanofi legal entity) for the Products currently held by BMS or its Affiliates that are set forth on Schedule 5.1(a) shall be undertaken in accordance with the timelines and processes to effect the transfer of such marketing authorizations to be agreed to in good faith by the Parties prior to the Initial Closing Date. All external costs for such transfer of such marketing authorizations shall be shared equally between BMS and Sanofi.
Marketing Authorizations. Licensee shall, at its sole cost, use Diligent Efforts, itself or through its Affiliates and the Sublicensees, to prepare, file, prosecute and maintain all applications for Marketing Authorization for the marketing, use, promotion, import, sale, distribution or commercialization of the IPI-145 Product in the Field in the Territory.
