ANNUAL REPORT TO FDA. BTG will prepare a summary of all changes to the product, production process, quality controls, equipment or facilities that have a potential to affect the identity, strength, quality, purity or potency of the Product. Such data will be prepared and sent to SAVIENT within thirty days of the end of the review period. BTG will also ensure that the results of all stability testing performed within the review period are sent to Savient within thirty days of the end of the review period. Approvals Print Name Signature Date SAVIENT QA Xxxxxx X. Xxxx /s/ Xxxxxx X. Xxxx 20-Mar-07 BTG QA Xxxxx Xxxxxx /s/ Xxxxx Xxxxxx 00 Xxxxx 0000 APPENDIX I
Appears in 4 contracts
Samples: Commercial Supply Agreement (Horizon Therapeutics Public LTD Co), Commercial Supply Agreement (Horizon Pharma PLC), Commercial Supply Agreement (Horizon Pharma PLC)
ANNUAL REPORT TO FDA. BTG will prepare a summary of all changes to the product, production process, quality controls, equipment or facilities that have a potential to affect the identity, strength, quality, purity or potency of the Product. Such data will be prepared and sent to SAVIENT within thirty days of the end of the review period. BTG will also ensure that the results of all stability testing performed within the review period are sent to Savient within thirty days of the end of the review period. Approvals Print Name Signature Date SAVIENT QA Xxxxxx X. Xxxx /s/ Xxxxxx X. Xxxxxxxxx /s/Xxxx 20Xxxxxxxxx 19-Mar-07 FEB-2009 BTG QA Xxxxx Xxxxxx /s/ Xxxxx Xxxxxx 00 Xxxxx 0000 /s/Xxxxxx Xxxxxx 19/02/09 APPENDIX I
Appears in 3 contracts
Samples: Commercial Supply Agreement (Horizon Therapeutics Public LTD Co), Commercial Supply Agreement (Horizon Pharma PLC), Commercial Supply Agreement (Horizon Pharma PLC)
ANNUAL REPORT TO FDA. BTG will prepare a summary of all changes to the product, production process, quality controls, equipment or facilities that have a potential to affect the identity, strength, quality, purity or potency of the Product. Such data will be prepared and sent to SAVIENT within thirty days of the end of the review period. BTG will also ensure that the results of all stability testing performed within the review period are sent to Savient within thirty days of the end of the review period. Approvals Print Name Signature Date SAVIENT QA Xxxxxx X. Xxxx /s/ Xxxxxx X. Xxxx 20-Mar-07 BTG QA Xxxxx Xxxxxx /s/ /x/ Xxxxx Xxxxxx 00 Xxxxx 0000 20 March 2007 APPENDIX I
Appears in 1 contract
