MANUFACTURING AGREEMENT FOR CLINICAL TRIAL AND COMMERCIAL SUPPLYClinical Trial Agreement |
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CORAUTUS GENETICS INC | BOEHRINGER INGELHEIM AUSTRIA GmbH. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here. |
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Exhibit 10.1
ABCD
Boehringer Ingelheim
Austria GmbH
MANUFACTURING AGREEMENT
FOR
CLINICAL TRIAL AND COMMERCIAL SUPPLY
B E T W E E N:
CORAUTUS GENETICS INC.
a corporation incorporated under the laws of Delaware,
having its corporate head office and principal place of business at
75 Fifth Street, NW, Suite 313,
Atlanta, GA 30308, USA
(hereinafter referred to as “Corautus”)
- and -
BOEHRINGER INGELHEIM AUSTRIA GmbH
a corporation incorporated under the laws of the Federal Republic of Austria,
having its registered seat at
Dr. Boehringer-Gasse 5 – 11
A-1121 Vienna, Austria
(hereinafter referred to as “BI Austria”)
Page 1 of 138 / Confidential
ABCD
Boehringer Ingelheim
Austria GmbH
TABLE OF CONTENTS
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1. |
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DEFINITIONS |
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8 |
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2. |
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PURPOSE AND SCOPE |
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12 |
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3. |
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DELIVERABLES OF CORAUTUS |
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14 |
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3.1 |
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Documentation Transfer |
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14 |
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3.2 |
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Material Transfer |
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14 |
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3.3 |
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Assistance and Support by Corautus |
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14 |
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4. |
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EQUIPMENT |
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15 |
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4.1 |
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Required Equipment |
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15 |
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4.2 |
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Ownership and Rights to Possession |
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15 |
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4.3 |
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Validation and Maintenance |
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16 |
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5. |
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MATERIALS |
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16 |
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5.1 |
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CORAUTUS WCB |
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16 |
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5.2 |
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Resins, Raw Materials and Storage Containers |
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17 |
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6. |
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BI AUSTRIA SERVICES |
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18 |
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6.1. |
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BI Austria Facilities |
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18 |
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6.2 |
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BI Austria Documentation and Set-Up |
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18 |
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6.3 |
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FEASIBILITY STUDY |
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19 |
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6.4 |
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Method Transfer Services |
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19 |
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6.5 |
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Establishment of Production Process for DRUG PRODUCT |
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19 |
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6.6 |
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Implementation Batches |
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20 |
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6.7 |
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Batches for Reference Standard and Clinical Trials |
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21 |
Page 2 of 138 / Confidential
ABCD
Boehringer Ingelheim
Austria GmbH
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6.8 |
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Conformance Batches |
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21 |
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6.9 |
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Labeling and Packaging |
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21 |
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6.10 |
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Stability Studies |
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22 |
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7. |
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TIMETABLE AND INCENTIVES |
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22 |
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8. |
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DELAYED APPROVAL OF CLINICAL TRIALS |
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22 |
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9. |
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STERILITY DRUG SUBSTANCE |
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23 |
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10. |
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CLINICAL AND COMMERCIAL MANUFACTURE DURING PERIOD THREE |
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23 |
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10.1. |
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Product Supply |
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23 |
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10.2. |
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Preliminary Market Launch Date and Product Estimate |
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23 |
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10.3. |
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Minimum and Maximum Volume |
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24 |
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10.4. |
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Rolling Forecast |
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25 |
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10.5. |
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Packaging/Labeling by BI Austria |
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25 |
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10.6. |
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Warehousing at BI Austria Facilities |
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25 |
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10.7. |
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Release |
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26 |
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11. |
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SHIPMENT OF DRUG PRODUCT |
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26 |
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11.3 |
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Drug Product Delivery and Delivery Documents |
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26 |
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11.4 |
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Ownership and Insurance Liabilities |
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27 |
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12. |
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DOCUMENTATION |
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27 |
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13. |
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QUALITY CONTROL AND QUALITY MANAGEMENT |
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28 |
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13.1 |
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Validation Services |
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28 |
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13.2 |
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Quality Control |
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29 |
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13.3 |
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Quality Management |
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29 |
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13.4 |
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Change Control |
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30 |
Page 3 of 138 / Confidential
ABCD
Boehringer Ingelheim
Austria GmbH
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14. |
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REGULATORY |
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30 |
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14.1 |
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Regulatory Compliance |
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30 |
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14.2 |
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Manufacturing Audits and Regulatory Inspections |
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30 |
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14.3 |
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Regulatory Filings |
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31 |
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15. |
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CORAUTUS’ ACCESS TO BI AUSTRIA FACILITIES |
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31 |
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16. |
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DISPUTE RESOLUTION FOR NON-CONFORMING DRUG PRODUCT |
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32 |
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16.1 |
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Rejection Procedure / Confirmatory Third PARTY Testing |
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32 |
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16.2 |
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Replacement |
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33 |
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16.3 |
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Stock Build-up |
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33 |
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16.4 |
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Unforeseeable Quality Problems |
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33 |
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17. |
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PRICES AND PAYMENTS |
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34 |
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17.1 |
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Prices for the SERVICES |
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34 |
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17.2 |
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Prices for DRUG PRODUCT during PERIOD THREE |
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34 |
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17.3 |
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Taxes |
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35 |
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17.4 |
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Currency |
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35 |
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17.5 |
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Terms of Payment |
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35 |
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17.6 |
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Accrual Accounting |
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36 |
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18. |
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PROJECT MANAGEMENT, MEETINGS AND PLANNING |
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36 |
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19. |
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CONFIDENTIAL INFORMATION |
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37 |
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20. |
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INTELLECTUAL PROPERTY |
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39 |
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20.1. |
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Ownership of INTELLECTUAL PROPERTY |
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39 |
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20.2. |
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