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LICENSE AND DISTRIBUTION AGREEMENT

Distribution Agreement

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Cambridge Laboratories Ltd. | Immuno-Designed Molecules S.A

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Title: LICENSE AND DISTRIBUTION AGREEMENT
Date: 3/31/2006
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AND DISTRIBUTION AGREEMENT, Parties: cambridge laboratories ltd. , immuno-designed molecules s.a
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EXHIBIT 10.60

***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and
240.24b-2(b)(1)

LICENSE AND DISTRIBUTION AGREEMENT

by and between

Immuno-Designed Molecules S.A.

and

Cambridge Laboratories Ltd.

 

 

 

 

IDM Initial

 

CL Initial

 


 

 

 

 

May 10, 2005

 

2 / 36

TABLE OF CONTENTS

 

 

 

 

 

1 DEFINITIONS

 

 

5

 

2 APPOINTMENT

 

 

8

 

2.1 APPOINTMENT AND GRANT

 

 

8

 

2.2 SUB-DISTRIBUTION AND SUB-LICENSES

 

 

8

 

3 SCOPE OF APPOINTMENT

 

 

8

 

3.1 TERRITORY

 

 

8

 

3.2 COMPETITIVE PRODUCTS AND CLINICAL TRIALS

 

 

9

 

3.3 NEW INDICATIONS / ADDITIONAL TERRITORY

 

 

10

 

3.4 IMPROVEMENTS

 

 

10

 

3.4.1 Distributor’s Improvements

 

 

10

 

3.4.2 Development of Distributor’s Improvements

 

 

11

 

3.4.3 Supply of data by the Distributor

 

 

11

 

3.4.4 IDM Improvements

 

 

11

 

3.4.5 Rejection of IDM Improvements

 

 

11

 

4 UP-FRONT FEE / MILESTONES

 

 

11

 

4.1 UP-FRONT FEE

 

 

11

 

4.2 UP-FRONT FEE PARTIAL REIMBURSEMENT

 

 

11

 

4.3 REGISTRATION MILESTONE

 

 

11

 

4.4 NET SALES-RELATED PERFORMANCE ROYALTY

 

 

12

 

 

 

 

 

 

5 RELATIONSHIP BETWEEN THE PARTIES

 

 

12

 

5.1 INDEPENDENT CONTRACTORS

 

 

12

 

5.2 WHOLESALERS

 

 

12

 

5.3 IDM RESPONSIBILITIES AND OBLIGATIONS

 

 

12

 

6 REGULATORY

 

 

12

 

7 DISTIBUTOR’S DUTIES

 

 

13

 

7.1 GENERAL

 

 

13

 

7.2 PROMOTION, MARKETING AND SALES

 

 

14

 

7.3 COMMENCEMENT OF MARKETING

 

 

15

 

7.4 PROMOTIONAL MATERIALS

 

 

15

 

7.5 PROVISION OF Know-How

 

 

16

 

7.6 MINIMUM ANNUAL QUOTAS

 

 

16

 

 

 

 

 

 

8 IDM’S DUTIES

 

 

16

 

8.1 CONFORMITY OF PRODUCT

 

 

16

 

8.1.1 Compliance with Product Specifications

 

 

16

 

8.1.2 Claims of non-conformity

 

 

16

 

8.1.3 Non-conforming Product

 

 

16

 

8.1.4 Laboratory costs

 

 

17

 

8.1.5 Disclaimer

 

 

17

 

8.1.6 Warranty exclusions

 

 

17

 

8.1.7 Additional specifications

 

 

17

 

8.2 LICENSES TO PERFORM

 

 

18

 

8.3 MARKETING ASSISTANCE, PROVISION OF KNOW-HOW

 

 

18

 

 

 

 

 

 

9 COOPERATION BETWEEN PARTIES

 

 

18

 

9.1 MARKETING PLANNING

 

 

18

 

9.2 INTELLECTUAL PROPERTY RIGHTS

 

 

18

 

9.3 IDM’s PATENT OBLIGATIONS

 

 

18

 

9.4 IDM S ORPHAN DRUG DESIGNATION OBLIGATIONS

 

 

19

 

10 FORECASTS AND ORDERS

 

 

19

 

10.1 FORECASTS

 

 

19

 

10.2 ORDERS

 

 

20

 

11 PRICE OF PRODUCT

 

 

20

 

11.1 CONDITION PRECEDENT

 

 

20

 

11.1.1 Public Price

 

 

20

 

11.1.2 No material adverse change

 

 

20

 

11.2 TRANSFER PRICE OF PRODUCT

 

 

20

 

11.3 ROYALTIES

 

 

21

 

11.4 ROYALTY PAYMENT AND RECONCILIATION

 

 

21

 

11.5 CURRENCY AND EXCHANGE RATES

 

 

21

 

 

 

 

 

IDM Initial

 

CL Initial

 


 

 

 

 

May 10, 2005

 

3 / 36

 

 

 

 

 

 

11.6 PRICE REVISION

 

 

21

 

11.6.1 Following Cost of Goods changes

 

 

21

 

11.6.2 Following commercial amendments

 

 

21

 

12 DELIVERY OF PRODUCT

 

 

21

 

13 RECORDS

 

 

22

 

13.1 RECORDS

 

 

22

 

13.2 LATE PAYMENTS

 

 

22

 

13.3 GUARANTEE

 

 

22

 

14 STORAGE — INVENTORY — RETURNS

 

 

22

 

14.1 STORAGE

 

 

22

 

14.2 RETURN OF PRODUCT

 

 

22

 

15 QUALITY

 

 

22

 

15.1 QUALITY CONTROL

 

 

22

 

15.2 SUSPENSION OF DISTRIBUTION

 

 

23

 

15.3 PRODUCT RECALL

 

 

23

 

16 TRADEMARKS

 

 

23

 

16.1 USE OF TRADEMARKS

 

 

23

 

16.2 PRODUCT MARK INFRINGEMENT

 

 

24

 

16.3 MAINTENANCE OF THE TRADEMARKS

 

 

25

 

16.4 INACTIVE OR ABANDONED TRADEMARKS

 

 

25

 

 

 

 

 

 

17 TERM AND TERMINATION OF THE AGREEMENT

 

 

25

 

17.1 TERM OF THE AGREEMENT

 

 

25

 

17.2 TERMINATION

 

 

25

 

17.3 CHANGE OF CONTROL / ASSIGNMENT

 

 

26

 

17.4 CONSEQUENCES OF TERMINATION

 

 

26

 

18 CONSEQUENTIAL LOSS — INSURANCE

 

 

27

 

18.1 CONSEQUENTIAL LOSS

 

 

27

 

18.2 INSURANCE

 

 

27

 

19 INDEMNIFICATION

 

 

28

 

19.1 INDEMNIFICATION BY THE DISTRIBUTOR

 

 

28

 

19.2 INDEMNIFICATION BY IDM

 

 

28

 

19.3 INDEMNITY PROCEDURE

 

 

29

 

19.4 DEFENCE OF CLAIM

 

 

29

 

20 ACTIONS OF COMPETITORS, LITIGATION

 

 

29

 

21 CONFIDENTIALITY

 

 

29

 

21.1 CONFIDENTIAL INFORMATION

 

 

29

 

21.2 PRIOR CONFIDENTIALITY AGREEMENT

 

 

30

 

22 GOVERNING LAW — DISPUTES

 

 

30

 

22.1 GOVERNING LAW

 

 

30

 

22.2 DISPUTES

 

 

30

 

22.2.1 Mediation

 

 

30

 

22.2.2 Arbitration

 

 

30

 

23 FORCE MAJEURE

 

 

30

 

24 REPRESENTATIONS AND WARRANTIES

 

 

31

 

24.1 REPRESENTATIONS AND WARRANTIES OF IDM

 

 

31

 

24.1.1 Organization and authority

 

 

31

 

24.1.2 No conflict

 

 

31

 

24.1.3 Ownership

 

 

31

 

24.1.4 Enforceability

 

 

31

 

24.1.5 Actions

 

 

31

 

24.1.6 No infringement

 

 

31

 

24.1.7 Warranty

 

 

32

 

24.2 REPRESENTATIONS AND WARRANTIES OF CL

 

 

32

 

24.2.1 Organization and authority

 

 

32

 

24.2.2 No conflict

 

 

32

 

25 MISCELLANEOUS

 

 

32

 

25.1 ENTIRE AGREEMENT

 

 

32

 

25.2 No WAIVER

 

 

33

 

25.3 PUBLIC ANNOUNCEMENTS

 

 

33

 

25.4 NOTICES

 

 

33

 

 

 

 

 

IDM Initial

 

CL Initial

 


 

 

 

 

May 10, 2005

 

4 / 36

 

 

 

 

 

 

25.5 SEVERABILITY

 

 

34

 

25.6 LANGUAGE

 

 

34

 

25.7 EXPENSES

 

 

34

 

26 SCHEDULES

 

 

35

 

26.1 SCHEDULE A

 

 

35

 

26.2 SCHEDULE B

 

 

35

 

26.3 SCHEDULE B-1

 

 

35

 

26.4 SCHEDULE C

 

 

35

 

26.5 SCHEDULE D

 

 

35

 

27 SCHEDULE E — PATENT LIST

 

 

36

 

 

 

 

 

IDM Initial

 

CL Initial

 


 

 

 

 

May 10, 2005

 

5 / 36

LICENSE AND DISTRIBUTION AGREEMENT

This License and Distribution Agreement (the “Agreement”) is made as of the Date of Signature between:

IDM IMMUNO-DESIGNED MOLECULES S.A., a limited company organised and existing under the laws of France, registered at Paris RCS under 382 632 263, whose office is at 172 rue de Charonne 75011 Paris FRANCE.

Hereinafter referred to as “IDM”

and

CAMBRIDGE LABORATORIES LTD. trading as CAMBRIDGE LABORATORIES IRELAND whose principal place of business is Alexandra House, The Sweepstakes, Ballsbridge, Dublin 4, IRELAND.

Hereinafter referred to as “CL” or “Distributor”.

RECITALS

1. CL is engaged in the business of promoting, marketing, selling and distributing certain pharmaceutical products.

2. IDM desires to appoint the Distributor as its exclusive distributor of the Product in the Territory and the Distributor desires to accept such appointment subject to the terms of this Agreement.

AGREED TERMS

1 DEFINITIONS

When used in this Agreement, including the Recitals and the Schedules (which are an integral part of this Agreement) and unless otherwise expressly indicated, the following terms shall have the following meanings:

Adverse Events means any undesirable event (from any source, including consumers or competitors) including serious adverse events reported to the Distributor or of which the Distributor becomes aware, and, in particular, those events relating to the Product in respect of which the Parties’ respective obligations are set out in Schedule B.

Affiliates means with respect to any Party, any person that directly, or indirectly through one or more intermediaries, controls or is controlled by or is under common Control with such Party. The term control , for the purpose of this definition, with respect to the relationship between or among two persons, means the possession, directly or indirectly or as trustee or executor of the power to direct or cause the direction of the affairs or management of a person, whether through ownership of voting securities or executor, by contract or otherwise, including, without limitation, the ownership, directly or indirectly, of securities having the power to elect a majority of the board of directors or similar body governing the affairs of such person.

Agreement means this agreement between the Parties.

Authorities means the competent authorities in the Territory in charge of determining and/or approving the marketing, the pricing and/or the reimbursement (as applicable) of pharmaceutical products.

Business Year means a calendar year or, in the case of the first Business Year, the remainder of the calendar year current at the Effective Date.

 

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