Common use of Marketing Authorizations Clause in Contracts

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. 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 '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.