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 28^th, 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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