Common use of SPECIFIC INVESTMENTS Clause in Contracts

SPECIFIC INVESTMENTS. (1) Sandoz shall use commercially reasonable efforts to implement the modifications to its manufacturing facility required for the Manufacture of Product as identified in Schedule 6, collectively the “Facility Modifications”. (2) The assets acquired for the Facility Modifications will be purchased by Sandoz on its own behalf, and Sandoz shall become the sole owner of such assets. Amylin shall reimburse Sandoz for all costs and expenses, including without limitation capital expenditures, reasonably incurred by Sandoz for the Facility Modifications and for any assets acquired as part of the Facility Modifications as follows: Sandoz shall be entitled to invoice for such costs as a surcharge on each individual Batch of the process Validation Campaign. Sandoz shall bear the costs of maintaining such assets to keep them in acceptable working condition. (3) If (i) the specific attributes of the Product, (ii) Amylin and/or (iii) a Regulatory Authority (because of an inspection of Sandoz’ facilities or otherwise) require a change in the Process of Manufacture or to the Product Specifications that affects the cost of Manufacturing the Product, then upon written notification by either party to the other, Sandoz and Amylin will meet to negotiate in good faith (a) any change to the fees, (b) the date upon which such fee change will take effect, and (c) any other consequences arising from such change (including but not limited to investments). In the event no agreement can be reached, Sandoz shall be under no obligation to Manufacture Product. (4) Any acquisition of fixed or moveable assets or any other investments that may be required for Sandoz to perform the activities under this Agreement shall require prior written agreement between the parties, and Sandoz shall have no obligations whatsoever to make such investments and/or to bear any costs, expenses or capital expenditures with respect to such investments.

Appears in 2 contracts

Sources: Contract Manufacturing Agreement (Amryt Pharma PLC), Contract Manufacturing Agreement (Amryt Pharma PLC)