Change of Manufacturer. Provided it has no negative impact on the Regulatory Approval in the Territory, Vyrix has the right to subcontract manufacturing by providing Endo with no less than six (6) months advance notice of any change in manufacturer not listed in the regulatory dossier for the Product as of the Effective Date.
Change of Manufacturer. If at any time during the term of this Agreement, XXX decides to outsource the Manufacture of the Product, XXX will notify Pharmion promptly and in any event at least twelve (12) months before such transfer of Manufacture is expected to be completed, and the Parties will negotiate in good faith any necessary changes to Sections 9 and 12 of this Agreement, and any procedures developed thereunder. XXX shall only select a Manufacturer that holds cGMP certification from the FDA. XXX will use Commercially Reasonable Efforts to ensure that the change of Manufacturer will not affect the safety or efficacy of the Product. The necessary steps for the change of the Manufacturer will be handled within the scope of an NDA supplement submitted to the FDA. XXX will cooperate with Pharmion by providing the available Manufacturing and other data required to support any required supplement to the NDA. Any such change of Manufacturer may also require changes to the forecasting and ordering procedures set forth in this Agreement, and the Parties agree to make any reasonable changes to such procedures resulting from any such change of Manufacturer. Costs associated with any such change of Manufacturer will be borne by XXX except where such costs are associated with changes requested by Pharmion or where additional work is required only in order to comply with new regulatory or other requirements in the Territory, in which case such costs will be reimbursed by Pharmion.
Change of Manufacturer. Pharmion is aware that Schering intends, on or before July 27, 2009 to transfer Manufacture of the Product from Aventis to another Manufacturer. Schering shall only select a Manufacturer that holds current Manufacturing authorisation with, or holds an internationally recognized equivalent certificate to, the standards detailed in European Community Directive 91/356/EEC. Schering will notify Pharmion promptly and in any event at least twelve (12) months before such transfer of Manufacture is expected to be completed and the Parties will negotiate in good faith any necessary changes to Sections 9 and 12 of this Agreement, and any procedures developed thereunder. Pharmion acknowledges that the transfer of Manufacture from Aventis to another Manufacturer is likely to result in changes to the Manufacturing process and specifications of the Product, some of which may require variations to the Marketing Authorizations. Such variations to the Marketing Authorizations will be made by Pharmion at its own expense. However, Schering will use Commercially Reasonable Efforts to ensure that the change of Manufacturer will not affect the safety or efficacy of the Product. The necessary steps for the improvement of the Manufacturing process and the change of the Manufacturer will be handled within the scope of variation reports submitted to the EMEA. Schering will cooperate with Pharmion by providing the available Manufacturing and other data required to support any required application for variation of Marketing Authorizations. Pharmion is obliged to submit the variations related to changes of the Manufacturing process/Manufacturer without delay to the Agencies in the countries within the Territory in which it holds a Marketing Authorization and in which it is marketing and selling the Product. Such change of Manufacturer may also require changes to the forecasting and ordering procedures listed in this Agreement, and the Parties agree to make any reasonable changes to such procedures resulting from such change of Manufacturer. Costs associated with such change of Manufacturer will be borne by Schering except where such costs are associated with changes requested by Pharmion or where additional work is required only in order to comply with new regulatory or other requirements in the Territory, in which case such costs will be reimbursed by Pharmion.
