Common use of SPECIFIC INVESTMENTS Clause in Contracts

SPECIFIC INVESTMENTS. (1) If after the Demonstration Lot Campaign i) the specific attributes of API, ii) Unigene and/or iii) a Regulatory Authority (because of an inspection of Sandoz’s facilities or otherwise) require a change in the Process or Manufacture or to the API Specifications that affects the cost of Manufacturing the API, then upon written notification by either party to the other, Sandoz and, Unigene will meet to discuss (a) any change to the Fees, (b) the date upon which such Fee increase will take effect, and (c) any other consequences arising from such change. (2) In the event such change in the Process or Manufacture after the Demonstration Lot Campaign or to the API Specifications, result in start up costs (including but not limited to investments) then Unigene shall indemnify Sandoz for such costs in the year of completion of such activities in quarterly installments according to progress of work. Investments which may exceed EUR **. during the term of this Agreement in total are subject to separate agreement. (3) In the event such change in the Process or Manufacture after the Demonstration Lot Campaign or to the API Specifications is a consequence of requirements of Novartis and Unigene or Novartis Drug Product and Unigene Drug Product and result in start up costs (including but not limited to investments) then Sandoz shall charge Unigene and Novartis equally for such costs in the year of completion of such activities in quarterly installments according to progress of work. Investments which may exceed EUR **. during the term of this Agreement in total are subject to separate agreement.