Common use of Change of Specification Clause in Contracts

Change of Specification. No alterations of the Specifications for the Products or other changes requiring prior approval by the FDA, or material changes to the manufacturing process or validated processes, can be made without the prior written approval of LANNETT. ELITE shall notify LANNETT in writing of any proposed alterations for the Specifications for the Products or any Major Changes to the manufacturing process or validated processes. LANNETT shall notify ELITE of LANNETT’s decision within thirty (30) days of receipt of such proposal from ELITE. If ELITE does not receive LANNETT’s decision in writing within thirty (30) days, the alteration of the Specifications or other Major Changes to the manufacturing process or validated process proposed by ELITE shall be deemed rejected by LANNETT. In the event that the FDA or any other governmental authority shall suggest or mandate any change or revision to the Product, such that the Specifications would no longer comply with such suggestion or mandate, the Parties shall work together in good faith to develop revised Specifications that meet all changes or revisions suggested or mandated by the FDA or other governmental authority and Schedule B shall be amended in writing to set forth the new agreed upon Specifications.

Change of Specification. No alterations of the Specifications for the Products or other changes requiring prior approval by the FDA, or material changes to the manufacturing process or validated processes, can be made without the prior written approval of LANNETT. ELITE shall notify LANNETT in writing of any proposed alterations for the Specifications for the Products or any Major Changes to the manufacturing process or validated processes. LANNETT shall notify ELITE of LANNETT’s decision within thirty (30) days of receipt of such proposal from ELITE. If ELITE does not receive LANNETT’s decision in writing within thirty (30) days, the alteration of the Specifications or other Major Changes to the manufacturing process or validated process proposed by ELITE shall be deemed rejected by LANNETT. In the event that the FDA or any other governmental authority shall suggest or mandate any change or revision to the Product, such that the Specifications would no longer comply with such suggestion or mandate, the Parties shall work together in good faith to develop revised Specifications that meet all changes or revisions suggested or mandated by the FDA or other governmental authority and Schedule B shall be amended in writing to set forth the new agreed upon Specifications.. EXPLANATORY NOTE: [**] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND

Change of Specification. No alterations of the Specifications for the Products or other changes requiring prior approval by the FDA, or material changes to the manufacturing process or validated processes, can be made without the prior written approval of LANNETT. ELITE shall notify LANNETT LXXXXXX in writing of any proposed alterations for the Specifications for the Products or any Major Changes to the manufacturing process or validated processes. LANNETT LXXXXXX shall notify ELITE of LANNETTLXXXXXX’s decision within thirty (30) days of receipt of such proposal from ELITE. If ELITE does not receive LANNETTLXXXXXX’s decision in writing within thirty (30) days, the alteration of the Specifications or other Major Changes to the manufacturing process or validated process proposed by ELITE shall be deemed rejected by LANNETTLXXXXXX. In the event that the FDA or any other governmental authority shall suggest or mandate any change or revision to the Product, such that the Specifications would no longer comply with such suggestion or mandate, the Parties shall work together in good faith to develop revised Specifications that meet all changes or revisions suggested or mandated by the FDA or other governmental authority and Schedule B shall be amended in writing to set forth the new agreed upon Specifications.

Change of Specification. No alterations of the Specifications for the Products or other changes requiring prior approval by the FDA, or material changes Major Changes to the manufacturing process or validated processes, can be made without the prior written approval of LANNETTGLENMARK. ELITE shall notify LANNETT GLENMARK in writing of any proposed alterations for the Specifications for the Products or any Major Changes to the manufacturing process or validated processes. LANNETT GLENMARK shall notify ELITE of LANNETTGLENMARK’s decision within thirty sixty (3060) days of receipt of such proposal from ELITE. If ELITE does not receive LANNETTGLENMARK’s decision in writing within thirty sixty (3060) days, the alteration of the Specifications or other Major Changes to the manufacturing process or validated process proposed by ELITE shall be deemed rejected by LANNETTGLENMARK. In the event that the FDA or any other governmental authority shall suggest or mandate any change or revision to the Product, such that the Specifications would no longer comply with such suggestion or mandate, the Parties shall work together in good faith to develop revised Specifications that meet all changes or revisions suggested or mandated by the FDA or other governmental authority and Schedule B shall be amended in writing to set forth the new agreed upon Specifications.