Common use of Final Summary Report Clause in Contracts

Final Summary Report. The Final Summary Report to be sent to Novartis by Supplier shall include the following information: *** *** Technical QA-Agreement between Novartis and Unigene for Supply of API batches Page 1 of 13 This Quality Assurance (QA) Agreement is between Novartis Pharma AG and Unigene Laboratories, Inc.. Address: Unigene ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ Boonton, New Jersey 07005 hereinafter called “Unigene” as contract acceptor and Novartis Pharma AG Technical Research and Development ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇, ▇▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ hereinafter called “Novartis” as contract giver This quality agreement (“The Quality Agreement”) relates to the supply of *** (”the API”) from Unigene to Novartis. This Quality Agreement forms an annex to the supply agreement entered into between the parties relating to the supply of API by Unigene to Novartis (“the Supply Agreement”) It is intended that this QA agreement be consistent with the supply agreement. The Supply agreement shall be executed at the same time as this Agreement. For the avoidance of doubt regarding the requirement for confidentiality prior to the execution of a license agreement between the parties, Unigene and Novartis agree to use a level of confidentiality appropriate to the supply agreement. Novartis’s Quality department will be allowed to audit and to review batch records but it is expected that access to confidential information will be on a need-to-know basis only. For the avoidance of doubt, Unigene will be responsible for the “Release for Shipment” of its batches, providing assurance that the batch was manufactured in accordance with GMPs and tested and released according to the agreed specifications. Novartis will perform final Release and will be responsible for final GMP assessments and clinical use of the batch.

Final Summary Report. The Final Summary Report to be sent to Novartis by Supplier shall include the following information: *** *** Technical QA-Agreement between Novartis and Unigene for Supply of API batches Page 1 49 of 13 16 This Quality Assurance (QA) Agreement is between Novartis Pharma AG and Unigene Laboratories, Inc.. Address: Unigene ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ Boonton, New Jersey 07005 hereinafter called “Unigene” as contract acceptor and Novartis Pharma AG Technical Research and Development ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇, ▇▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ hereinafter called “Novartis” as contract giver This quality agreement (“The Quality Agreement”) relates to the supply of *** (”the API”) from Unigene to Novartis. This Quality Agreement forms an annex to the supply agreement entered into between the parties relating to the supply of API by Unigene to Novartis (“the Supply Agreement”) It is intended that this QA agreement be consistent with the supply agreement. The Supply agreement shall be executed at the same time as this Agreement. For the avoidance of doubt regarding the requirement for confidentiality prior to the execution of a license agreement between the parties, Unigene and Novartis agree to use a level of confidentiality appropriate to the supply agreement. Novartis’s Quality department will be allowed to audit and to review batch records but it is expected that access to confidential information will be on a need-to-know basis only. For the avoidance of doubt, Unigene will be responsible for the “Release for Shipment” of its batches, providing assurance that the batch was manufactured in accordance with GMPs and tested and released according to the agreed specifications. Novartis will perform final Release and will be responsible for final GMP assessments and clinical use of the batch.