Drug Listing. 3.1 It shall be the responsibility of Reliant Regulatory to submit FDA Form #2657 every June and December updating the Drug Product Listing. When no changes have occurred since the previously submitted list, no report is required.
Drug Listing. The PRODUCTS are intended to be registered as a component of a medical device. In the event that the PRODUCTS are registered as a drug, TransMedics is responsible for drug listing domestic products as the REGULATORY APPROVAL holder, and distributor of the PRODUCTS. Fresenius will provide TransMedics with all reasonably required information related to Fresenius’s facility and operations needed to register the PRODUCTS. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Drug Listing. 14 APPENDIX I - The PRODUCTS........................... 15 APPENDIX II - List of Quality Contracts.............. 16 APPENDIX III - Release Documentation.................. 17 -34-
Drug Listing. 12.2.1 C*P is responsible for drug listing as the manufacturer of the PRODUCTS, while ORPHAN is responsible for drug listing as the distributor of the PRODUCTS. ORPHAN will provide C*P with all required information needed by them for their listing. ORPHAN will notify C*P of the scheduled PRODUCTS launch date. APPENDIX I The PRODUCTS APPENDIX II List of Quality Contacts (name, phone, fax, e-mail) ISSUE ORPHAN C*P Product Release Xxxxx Xxxxxx, Ph.D Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxxx@xxxxxx.xxx Xxxxx Xxxxxxxx Ph: (000) 000-0000 Fax: (000) 000-0000 xxxxxxxxx@xxxxxxxxxx-xxxxx.xxx QC Testing Xxxxx Xxxxxx, Ph.D Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxxx@xxxxxx.xxx Xxxxx Xxxx Ph: (000) 000-0000 Fax: (000) 000-0000 xxxxx@xxxxxxxxxx-xxxxx.xxx Investigations Xxxxx Xxxxxx, Ph.D Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxxx@xxxxxx.xxx Xxxxxxxx Xxxxx Ph: (000) 000-0000 Fax: (000) 000-0000 xxxxxx@xxxxxxxxxx-xxxxx.xxx Regulatory Affairs Xxxxx Xxxxxxxx Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxxxxx@xxxxxx.xxx Xxxxxxx Xxxxx Ph: (000) 000-0000 Fax: (252) 2326 blewis@ xxxxxxxxxx-xxxxx.xxx Validation Xxxxx Xxxxxx, Ph.D Ph: (000) 000-0000 Fax: (000) 000-0000 xxxxxxx@xxxxxx.xxx Xxxxx Xxxxxx Ph: (000) 000-0000 Fax: (000) 000-0000 xxxxxxx@xxxxxxxxxx-xxxxx.xxx Compliance Audits Xxxxxxx Xxxxxxx Ph: (000) 000-0000 Fax: (000) 000-0000 xxxxxxxx@xxxxxx.xxx Xxxxxxxx Xxxxx Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxx@xxxxxxxxxx-xxxxx.xxx Product Complaints Xxxxx Xxxxxx, Ph.D Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxxx@xxxxxx.xxx Xxxxxxxx Xxxxx Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxx@xxxxxxxxxx-xxxxx.xxx Change Management Xxxxx Xxxxxx, Ph.D Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxxx@xxxxxx.xxx Xxxxxxxx Xxxxx Ph: (000) 000-0000 Fax:(000)000-0000 xxxxxx@xxxxxxxxxx-xxxxx.xxx Documentation The Batch/Lot Release Document Package will include a Certificate of Analysis and Certificate of Compliance. Certificate of Analysis (COA) This document will include the name of the PRODUCT, the batch number and the date of manufacture. The COA will list the In-Process QC tests performed by C*P and actual test results. The COA will also list the product release QC tests performed by C*P and actual test results. Certificate of Compliance (COC)
Drug Listing. 12.2.1 C*P is responsible for drug listing as the manufacturer of the PRODUCTS, while ORPHAN is responsible for drug listing as the distributor of the PRODUCTS. ORPHAN will provide C*P with all required information needed by them for their listing. ORPHAN will notify C*P of the scheduled PRODUCTS launch date. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. APPENDIX I The PRODUCTS [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. APPENDIX II List of Quality Contacts (name, phone, fax, e-mail) ISSUE ORPHAN C*P Product Release [ * ] [ * ] QC Testing [ * ] [ * ] Investigations [ * ] [ * ] Regulatory Affairs [ * ] [ * ] Validation [ * ] [ * ] Compliance Audits [ * ] [ * ] Product Complaints [ * ] [ * ] Change Management [ * ] [ * ] [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. Release Documentation The Batch/Lot Release Document Package will include a Certificate of Analysis and Certificate of Compliance. Certificate of Analysis (COA) This document will include the name of the PRODUCT, the batch number and the date of manufacture. The COA will list the In-Process QC tests performed by C*P and actual test results. The COA will also list the product release QC tests performed by C*P and actual test results. Certificate of Compliance (COC) This document will attest to the fact that the batch of PRODUCTS was made in accordance with all applicable regulations, product licenses, and company policies. This document will include the batch quantity approved, the batch yield, and the expiration date. It will also include a listing of all manufacturing variances and/or incidents for the batch.
Drug Listing. DSM is responsible for drug listing as the manufacturer of the Products for Barrier, while Barrier is responsible for drug listing as the distributor of the Products. Barrier will provide DSM with all required information needed to register the Products. Barrier will notify DSM of the scheduled Product launch, where applicable. [Appendices are attached] APPENDIX I: SPECIFICATIONS FOR THE PRODUCTS QUALITY AGREEMENT • Zimycan ointment 0xx, 00xx, & 60gm APPENDIX II: LIST OF QUALITY CONTACTS QUALITY AGREEMENT ISSUE BARRIER DSM Product Release *** *** QC Testing *** *** Investigations *** *** Regulatory Affairs *** *** Validation *** *** Compliance Audits *** *** Product Complaints *** *** Change Management *** *** APPENDIX III: RELEASE DOCUMENTATION The lot release document package will include a Certificate of Analysis (“COA”) and a Certificate of Compliance (“COC”). Certificate of Analysis: A COA which is generated by DSM Quality Assurance/Regulatory Affairs will be provided and will include the name of the Products, lot number, date of manufacture, and analytical specifications. The COA will list the release tests performed by DSM laboratories (and/or qualified third-party laboratories) and actual test results.
Drug Listing. 12.2.1 C*P is responsible for drug listing as the manufacturer of the PRODUCTS, while POZEN is responsible for drug listing as the distributor of the PRODUCTS. POZEN will provide C*P with all required information needed by them for their listing. POZEN will notify C*P of the scheduled PRODUCTS launch date.
Drug Listing. 12.3.1 C*P is responsible for drug listing as the manufacturer of the PRODUCTS, while CLIENT is responsible for drug listing as the distributor of the PRODUCTS. CLIENT will provide C*P with all required information needed by them for their listing. CLIENT will notify C*P of the scheduled product launch. APPENDIX I The PRODUCTS Provigil 100 mg, bulk tablets Provigil 100 mg, 30 count blister Provigil 100 mg, 100 count bottle Provigil 200 mg, bulk tablets Provigil 200 mg, 6 count bottle Carton x 2 bottles Provigil 200 mg x 100 count
Drug Listing. SkyePharma is responsible for drug listing domestic products as the manufacturer of the PRODUCTS, while Enzon is responsible for drug listing as the distributor of the PRODUCTS. Enzon and SkyePharma will provide each other with all required information needed to register the PRODUCTS.
Drug Listing. DSM is responsible for drug listing as the manufacturer of the Products for Barrier, while Barrier is responsible for drug listing as the distributor of the Products. Barrier will provide DSM with all required information needed to register the Products. Barrier will notify DSM of the scheduled Product launch, where applicable. [Appendices are attached] APPENDIX I: SPECIFICATIONS FOR THE PRODUCTS QUALITY AGREEMENT • Zimycan ointment 0xx, 00xx, & 60gm APPENDIX II: LIST OF QUALITY CONTACTS QUALITY AGREEMENT ISSUE BARRIER DSM Product Release *** *** QC Testing *** *** Investigations *** *** Regulatory Affairs *** *** Validation *** *** Compliance Audits *** *** Product Complaints *** *** Change Management *** ***
