Exhibit 10.1
[*****] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
FRESENIUS BIOTECH GmbH
AND
NABI BIOPHARMACEUTICALS
AGREEMENT TO
DEVELOP, SUPPLY AND MARKET ATG - FRESENIUS NORTH AMERICA
March 30, 2006
1.
DEFINITIONS/INTERPRETATION
2
1.1.
DEFINITIONS
2
1.2.
INTERPRETATION
5 2.
GRANT OF RIGHTS
5
2.1.
BY FRESENIUS
5
2.2.
BY NABI
6 3.
SPECIFIC OBLIGATIONS
6
3.1.
MARKETING
6
3.2.
SOLE SUPPLY
6
3.3.
EXPORT
6
3.4.
COMPETITION
6
3.5.
TRANSITION
8 4.
DEVELOPMENT
8
4.1.
DEVELOPMENT PLAN
8
4.2.
CLINICAL DEVELOPMENT
10
4.3.
NON-CLINICAL, INCLUDING
TOXICOLOGY, CMC AND PROCESS DEVELOPMENT
11
4.4.
REGULATORY APPROVAL OF
LICENSED PRODUCT AND COMPLIANCE
11
4.5.
DEVELOPMENT COSTS
12
4.6.
STEERING COMMITTEE AND WORKING GROUP
12 5.
MANUFACTURE AND SUPPLY
13
5.1.
CLINICAL DEVELOPMENT SUPPLIES
13
5.2.
COMMERCIAL SUPPLIES
13
5.3.
MANUFACTURE
13
5.4.
FORECASTS
14
5.5.
INFORMATION REQUIRED ON PURCHASE ORDERS
14
5.6.
PRODUCT LABELING
14
5.7.
BATCH DOCUMENTATION; CERTIFICATE OF ANALYSIS
15
5.8.
FRESENIUS TESTING
15
5.9.
NABI TESTING
15
5.10.
REJECTION OF
PRODUCT BY NABI
15 6.
AUDIT
16
6.1.
MANUFACTURING AND LABORATORY
16
- i -
6.2.
CLINICAL
16
6.3.
FINANCIAL
16 7.
FINANCIAL TERMS
16
7.1.
CURRENCY OF PAYMENTS
16
7.2.
INVOICES
17
7.3.
TRANSFER PRICE FOR COMMERCIAL SUPPLIES
17
7.4.
MINIMUM MONTHLY PAYMENT
18
7.5.
RECALCULATION DUE TO CURRENCY RATE CHANGES
19
7.6.
SHIPMENT OF FRESENIUS PRODUCT
20
7.7.
TAXES
20
7.8.
MILESTONE
PAYMENTS
20 8.
TRADEMARK LICENSE
21
8.1.
FRESENIUS' ATG
TRADEMARKS
21
8.2.
NABI TRADEMARKS
21
8.3.
Trademark OWNERSHIP
21
8.4.
TRADEMARK INFRINGEMENT AND TRADEMARK ENFORCEMENT
22 9.
CONFIDENTIALITY AND PUBLIC ANNOUNCEMENTS
22
9.1.
CONFIDENTIALITY
22
9.2.
CONFIDENTIAL TREATMENT
22
9.3.
EXCLUSIONS
23
9.4.
PUBLIC ANNOUNCEMENTS
23 10.
INDEMNIFICATION AND INSURANCE
24
10.1.
INDEMNIFICATION BY FRESENIUS
24
10.2.
INDEMNIFICATION BY NABI
24
10.3.
THIRD PARTY CLAIMS
25
10.4.
PROCEDURE FOR OTHER CLAIMS
26
10.5.
PRODUCT LIABILITY INSURANCE
26 11.
TERM AND TERMINATION
26
11.1.
TERM
26
11.2.
TERMINATION RIGHTS/BREACH
27
11.3.
CONSEQUENCE OF TERMINATION
27
11.4.
LATE
PAYMENTS/ADJUSTMENTS/MATERIAL DEFAULT
30 12.
REPURCHASE OF INVENTORY
30
- ii -
13.
REPRESENTATIONS AND WARRANTIES
30
13.1.
FRESENIUS'
REPRESENTATIONS AND WARRANTIES
30
13.2.
NABI'S REPRESENTATIONS AND
WARRANTIES
31
13.3.
GENERAL REPRESENTATIONS AND WARRANTIES
31
13.4.
NO OTHER WARRANTIES
31 14.
MISCELLANEOUS
32
14.1.
JURISDICTION AND DISPUTE RESOLUTION
32
14.2.
FORCE MAJEURE
33
14.3.
RELATIONSHIP OF THE PARTIES
33
14.4.
ASSIGNMENT AND CHANGE OF
CONTROL:
34
14.5.
BINDING EFFECT
37
14.6.
ENTIRE AGREEMENT
37
14.7.
COMPLIANCE WITH LAWS
37
14.8.
NOTICES
37
14.9.
SEVERABILITY
38
14.10.
WAIVER OF MODIFICATION OF AGREEMENT
38
14.11.
SURVIVAL
38
14.12.
HEADINGS
39
14.13.
COUNTERPARTS
39 Schedules
A.
Initial Specifications
B.
Transfer Price
Illustrations
- iii -
FRESENIUS BIOTECH GmbH
AND
NABI BIOPHARMACEUTICALS
AGREEMENT TO
DEVELOP, SUPPLY AND MARKET ATG - FRESENIUS NORTH AMERICA
This AGREEMENT TO DEVELOP, SUPPLY AND MARKET ATG - FRESENIUS NORTH AMERICA is
made as of the 30th day of March 2006, by and between FRESENIUS BIOTECH GmbH, a
company organized under the laws of the