Transition Supply. If Prothena was supplying (or having supplied) any Licensed Antibody and/or Licensed Product for any Clinical Trial(s) or other Development activities conducted with respect to the Licensed Program under the Master Collaboration Agreement, then, at Celgene’s written request, Prothena will be responsible for supplying, and shall supply, to Celgene (or its designee) Licensed Antibody(ies) and/or Licensed Product(s), for use in Development by or on behalf of Celgene hereunder for a period not to exceed [***] ([***]) [***] (or such longer period of time as agreed to by the Parties), as and to the extent requested by Celgene; provided that Celgene shall pay to Prothena a reasonable, fair value cost for such supply, which cost shall be negotiated in good faith and agreed to by the Parties prior to such supply. In such case, at the request of Celgene, the Parties shall negotiate in good faith and enter into an appropriate supply agreement (including a quality agreement) for Prothena to supply (or have supplied) Licensed Antibody and/or Licensed Product, as applicable, to Celgene (or its designee). Notwithstanding the foregoing, if Prothena has engaged a Third Party contract manufacturer for the supply of Licensed Antibodies and/or Licensed Products, and the agreement with such Third Party prohibits the supply to Celgene in accordance with the foregoing (provided that Prothena used good faith efforts not to include such prohibition during negotiations), then in lieu of the foregoing supply obligation, Prothena shall take such actions as reasonably requested by Celgene to facilitate the negotiations between Celgene and Prothena’s Third Party contract manufacturer of an appropriate supply agreement (including a quality agreement) for the supply of Licensed Antibody and/or Licensed Product, as applicable, to Celgene (or its designee).
Transition Supply. Beginning on the Second Restated Effective Date and for a period of the shorter of (i) twelve (12) months thereafter, or (ii) the date upon which Amicus has obtained its own supply commitment from JCR for the supply of JR051, GSK will supply to Amicus, either itself or from a Third Party, JR051 (the “Co-Formulation Transition Supply Period”). During the Co-Formulation Transition Supply Period, GSK shall supply JR051 to Amicus, at a price of ¥ 90M per 2000L batch plus an allocation of the costs of GSK FTEs of USD$312,000 per 2000L batch), such quantity of JR051 to be agreed in writing in advance, such amounts to be consistent with the current amounts and timelines set forth in the research plan for the Co-Formulation Development Plan during such period of time. At Amicus’ request, GSK will fill and finish (including testing for stability) such quantity of JR051 into Co-Formulation Product in ****** - Material has been omitted and filed separately with the Commission. finished form as further set forth in the Transition Plan; provided that Amicus will reimburse GSK for GSK’s costs and expenses to provide such fill and finish services, which will not include a xxxx-up. Immediately after the Second Restated Effective Date and during the Co-Formulation Transition Supply Period, GSK will use reasonable efforts to either (A) transition to Amicus its arrangement with any Third Party contractor (including JCR) for the supply of JR051 for use in a Co-Formulation Product or (B) facilitate discussions between JCR or any such other Third Party contractor and Amicus to allow Amicus to obtain from JCR or other Third Party contractor a supply agreement for the supply of JR051 for use in a Co-Formulation Product. Without limiting the foregoing, within a reasonable period of time following the Second Restated Effective Date of this Agreement, the Parties will negotiate and enter into an appropriate supply agreement(s) on customary and reasonable terms, including representations and warranties and indemnification, for the transition supply of JR051, and at Amicus’ request, the fill and finish of the transition supply of JR051 into Co-Formulation Product, set forth in this Section 6.3. In addition, GSK shall supply to Amicus the Co-Formulation Product to be re-worked in the JCR Murotani plant in finished form in accordance with the Transition Plan set forth in Exhibit A, attached hereto.
Transition Supply
