This excerpt taken from the ISPH 10-Q filed Nov 9, 2007.


All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. No change in the Specifications shall be implemented by Catalent, whether requested by Inspire or Catalent or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change and the implementation date of such change. Catalent shall respond promptly to any request made by


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Inspire or any Regulatory Authority for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Inspire of the costs associated with such change and shall provide such supporting documentation as Inspire may reasonably require. Inspire shall be responsible for all costs associated with any such agreed upon changes, excepting only (i) changes that are generally applicable to the manufacture of pharmaceutical products or applicable dosage forms and required by any Regulatory Authority in order to maintain compliance with Applicable Laws, and (ii) corrective actions taken by Catalent in response to a deficiency noted by any Regulatory Authority, the costs of each of which will be borne by Catalent.

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