License, Development and Supply Agreement (2004)Full Document 

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LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT


BETWEEN

McNEIL PDI Inc.
(acting through its McNEIL Consumer Healthcare Division)

a corporation existing under the laws of Canada

AND

McNEIL Consumer & Specialty Pharmaceuticals Division of McNEIL-PPC, Inc.


a corporation existing under the laws of New Jersey, U.S.A.
 
AND
 
IMI INTERNATIONAL MEDICAL INNOVATIONS INC.
 
a corporation existing under the laws of Canada
 
AND
 
IMI INTERNATIONAL MEDICAL INNOVATIONS INC.
 
a corporation existing under the laws of Switzerland
 
 
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TABLE OF CONTENTS

 
 
Page
1.
Definitions
4
2.
Development of the Product
13
3.
License Grants, Exclusivity, and Future Rights
17
4.
Payments and Reports
18
5.
Government Authorizations
25
6.
Supply Requirements
29
7.
Manufacture
33
8.
Purchase Price
35
9.
Packaging And Labeling
38
10.
Inspection
38
11.
Warranties and Indemnities
40
12.
Insurance
42
13.
Product Recalls
43
14.
Patents and Trademarks
43
15.
Confidentiality
46
16.
Contractual Relationship
48
17.
Term And Termination
49
18.
Steering Committee
54
19.
Miscellaneous Provisions
55

Appendix A
Summary of Cholesterol 1,2,3™
Appendix AA
Correlation Study Success Factors
Appendix C
J&J Universal Calendar
Appendix D
Framingham Risk Factor & Scores
Appendix E
***** – IMI Clinical Trial Agreement
Appendix F
IMI Licensed Know How
Appendix G
IMI Improvement Intellectual Property
Appendix H
IMI Patents and Patent Applications
Appendix I
Palm Test Summary and Prototype Drawing
Appendix J
Cholesterol 1,2,3™ Product Specifications
Appendix K
Tape Test Summary & Prototype Drawing
Appendix L
Licensed Product Royalty Report
Appendix M
Rolling Demand Forecast
Appendix N
Quality Control
Appendix O
Quality Agreement

 
 
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LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT

THIS AGREEMENT dated as of May 28th, 2004 (the “Agreement”) by and between IMI International Medical Innovations Inc., a corporation incorporated under the laws of Canada, and having its principal place of business at Suite 615, 4211 Yonge Street, Toronto, Ontario, M2P 2A9, Canada (“IMI-Canada”), IMI International Medical Innovations Inc., a corporation incorporated under the laws of Switzerland, and having its office c/o Schmid Attorneys at Law, Stockerstrasse 38 Schwanengasse 1, CH-3011 Berne, Switzerland (“IMI-Switzerland”) (IMI-Canada together with IMI-Switzerland being herein referred to collectively as “IMI” or “Party) and McNEIL Consumer & Specialty Pharmaceuticals Co, incorporated under the laws of the State of New Jersey, the United States of America, and having its principal place of business at 7050 Camp Hill Road, Pennsylvania, PA 19034 (“McNEIL-US”), and McNEIL PDI Inc., a corporation incorporated under the laws of Canada, with and having its principal place of business at 768 Hebert Street, Desbiens, Quebec, Canada (acting through its McNEIL Consumer Healthcare division) (“McNEIL-Canada” )( MCNEIL-US together with MCNEIL-Canada being herein referred to collectively as “MCNEIL” or “Party). McNEIL and IMI may also be referred to as “Parties.”

Whereas:
 
A.   IMI desires that McNEIL expand its role in the joint development and commercialization of IMI’s skin Sterol measurement technology.
 
B.   McNEIL desires to jointly develop with IMI and market certain cardiac risk predictors, for both professional and consumer markets.
 
C.   IMI desires to have manufactured and supply to McNEIL such cardiac risk predictors, at least for an initial period, and McNEIL desires to have IMI have manufactured and supply to McNEIL such cardiac risk predictors, at least for an initial period.

ARTICLE I
DEFINITIONS

As used in this Agreement, the following terms shall have the following respective meanings:
 
1.1 All currency used in this Agreement shall be denominated in Canadian Dollars, unless specifically identified otherwise.
 
 
 
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1.2
Affiliate(s)” shall mean any company(ies) or other legal entity(ies) directly or indirectly controlling, controlled by, or under common control with a respective Party. For purposes of this definition, “control” shall mean possession of the power to direct or cause the direction of the management and policies of the company or other legal entity, whether pursuant to the ownership of at least 50% of its voting securities, by contract, or otherwise.
   
1.3
Applicable Laws” shall mean all applicable laws, statutes, rules, regulations and guidelines that may apply to the sale of a Product in a particular jurisdiction within the Territory or the promotion, marketing, manufacturing, packaging, labeling, importation, exportation, warehousing or distribution of a Product that is to be sold in such jurisdiction within the Territory or the performance of either Party’s obligations under this Agreement, and including all GLP, GMP, and GCP, and all applicable standards or guidelines promulgated by applicable Regulators.
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