SECOND MANUFACTURING SOURCE. Atrix, at its own cost and expense, shall validate, qualify and obtain all Governmental Approvals for a Third Party as a second source (the "Second Source") to Manufacture the Product. Atrix will file a supplement to the NDA for each Product with the FDA no later than six (6) months after the NDA for each Product is approved to seek FDA approval for such Second Source to Manufacture each such Product. After such filing, Atrix shall use reasonable efforts to obtain final FDA approval for such Second Source to Manufacture each such Product including modifying the NDA supplement if required by the FDA. Upon prior written notice to Atrix, Sanofi-Synthelabo shall have the right to inspect and audit the Second Source's facilities used to Manufacture the Product to confirm that such facilities are in compliance with Applicable Laws and the Governmental Approvals. Atrix, at its sole cost and expense, may have a representative(s) accompany Sanofi-Synthelabo's representative(s) on any such inspection or audit.
SECOND MANUFACTURING SOURCE. At any time during the Term, X4 may submit a written notice to the Company that it wishes to designate a Third Party identified by X4 as a second manufacturing source for any Compound, which notice shall include the Third Party it wishes to so designate (the “Third Party Manufacturer”). Promptly following the Company’s receipt of any such request, the Parties shall agree in good faith upon the terms of any technology transfer from the Company to the Third Party Manufacturer that may be reasonably necessary in order for the Third Party Manufacturer to undertake such manufacture, including the transfer by the Company to the Third Party Manufacturer of all necessary tangible materials and any other Technology and documentation Controlled by the Company that is reasonably necessary to manufacture such Compound (each, a “Technology Transfer”). X4 shall reimburse the Company for (i) the Company’s reasonable internal (FTE-based) costs and out of pocket expenses incurred in undertaking any such Technology Transfer and (ii) any facility scale-up, validation and regulatory authorization costs and expenses incurred to establish the Third Party Manufacturer as such second Manufacturing source.
