Preview | Distributorship Agreement |

TABLE OF CONTENTS


	Page
ARTICLE 1
DEFINITIONS		1
1.1 ReGen Territory		1
1.2 Allo Pro Territory		1
1.3 CMI Product		1
1.4 Net Sales Price		1
ARTICLE 2
APPOINTMENT OF EXCLUSIVE DISTRIBUTORSHIP		2
2.1 Distributorship		2
2.2 Sub-Distributors		2
2.3 Right of First Negotiation for the ReGen Territory		2
2.4 Non-Compete		2
2.5 Non-Compete of Affiliated Companies		2
ARTICLE 3
FINAL DEVELOPMENT AND COMMERCIALIZATION OF THE CMI PRODUCT		3
3.1 Development Responsibilities		3
3.2 Annual Plan and Budget; Reports		3
3.3 Funding of Costs		3
3.4 Clinical Trials Supply		3
3.5 Applicability of this Article		3
3.6 Publications		3
3.7 Government Approvals; Registrations		4
ARTICLE 4
SECOND GENERATION CMI PRODUCT		4
ARTICLE 5
COMMERCIAL SUPPLY OF CMI PRODUCT; PRICES; TERMS OF PAYMENT		4
5.1 Commercial Supply		4
5.4 Sales Milestones Payments		5
5.5 Initial Suggested Price of CMI Product		5
5.6 Suggested Price of CMI Product		5
5.7 Reports on CMI Product Sales		6
5.8 Purchase Orders; Payments		6
5.9 Point of Delivery		6
5.10 Passing of Title and Risk of Loss		6
5.11 Warranty		6

TABLE OF CONTENTS
(continued)


	Page
ARTICLE 6
DISTRIBUTION AND MARKETING OF CMI PRODUCT		7
6.1 Marketing Diligence		7
6.2 Other Promotion and Marketing Obligations		7
6.3 Reimbursement for Expenses		8
ARTICLE 7
PROCEDURE FOR PAYMENTS; RECORDS; AUDIT		8
7.1 Manner and Place of Payment		8
7.2 Records and Audit of Sales and Expenses		8
ARTICLE 8
REGULATORY MATTERS		9
8.1 Regulatory Compliance; Adverse Reactions		9
8.2 Post-Launch Testing and Reporting		9
8.3 Product Recall		9
8.4 Reports		9
ARTICLE 9
CONFIDENTIALITY		10
9.1 Nondisclosure and Non-Use Obligations		10
9.2 Exceptions		10
9.3 Authorized Disclosure		11
9.4 Confidentiality of Agreement		11
ARTICLE 10
INTELLECTUAL PROPERTY		11
10.1 Filing, Prosecution and Maintenance of Patents		11
10.2 Infringement of ReGen Patents		12
10.3 Infringement of Third Party Patents		12
ARTICLE 11
TERM AND TERMINATION; BANKRUPTCY; CHANGE OF CONTROL		12
11.1 Term		12
11.2 Termination by Allo Pro		13
11.3 Termination for Material Breach		13
11.4 Default of Allo Pro		13
11.5 Supply Default of ReGen		13
11.6 Bankruptcy Events		14
11.7 Change of Control		14
11.8 Escrow		14
11.9 Remedies for Allo Pro; License to Manufacture		14
11.10 Surviving Terms of Distributorship Agreement		14
11.11 License Terms		15
11.12 Termination of Agreement in Case of Patent and Trademark Lawsuits		15

TABLE OF CONTENTS
(continued)


	Page
ARTICLE 12
THIRD PARTY CLAIMS; INDEMNIFICATION		16
12.1 Handling of Third Party Claims		16
12.2 Indemnification		16
12.4 Exclusive Remedy		17
12.5 Limitation of Liability		17
ARTICLE 13
REPRESENTATION AND WARRANTIES		17
13.1 Representation and Warranties of ReGen		17
13.2 Representations and Warranties of Allo Pro		18
ARTICLE 14
MISCELLANEOUS		18
14.1 Export Law Compliance		18
14.2 Foreign Corrupt Practices Act		18
14.3 Benefits and Binding Nature of Agreement		18
14.4 Entire Agreement; Amendments		19
14.5 No Other Terms and Conditions		19
14.6 Force Majeure		19
14.7 Notice		19
14.8 English Language; Governing Law		20
14.9 Waiver		20
14.10 Severability		20
14.11 Independent Contractors		20
14.12 Counterparts		20
14.13 Assignment		20
Schedule I Suggested Price and Discount Schedule of CMI Product
Schedule II Major Countries
Schedule III Form of Escrow Agreement

iii

DISTRIBUTORSHIP AGREEMENT

This Distributorship Agreement effective February 16, 1996 (Effective Date), by and between ReGen Biologics, Inc., a Delaware corporation having its offices at 2730 Sand Hill Road, Menlo Park, California 94025 (hereinafter ReGen), and Allo Pro AG, a Swiss corporation having its offices at Baar, Switzerland (hereinafter Allo Pro).

RECITALS

WHEREAS, ReGen is engaged in the development of a collagen meniscus implant (CMI) for the treatment of knee injuries involving the meniscus; and

WHEREAS, Allo Pro has substantial experience in the distribution, marketing and sale of orthopedic health care products;

NOW THEREFORE, in consideration of the above premises and the covenants set forth below, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

1.1 ReGen Territory shall mean the United States of America, its territories and possessions.

1.2 Allo Pro Territory shall mean all countries and territories of the world other than the United States of America, its territories and possessions.

1.3 CMI Product shall mean that collagen meniscus implant product which is under development by ReGen as of the Effective Date of this Agreement and which is manufactured according to the proprietary manufacturing technology of ReGen. The term CMI Product shall include the product and instrumentation as (i) they will exist on the date of the first commercial sale as well as (ii) they may be improved during the term of this Agreement in a manner for which regulatory approval can reasonably be sought from the U.S. Food and Drug Administration by way of a supplement to the PMA application anticipated to be filed by ReGen based on the IDE on file as of the Effective Date.

1.4 Net Sales Price shall mean the price charged for commercial sales of CMI Product to the customer in the Allo Pro Territory, exclusive of any Value Added Tax or similar sales taxes as well as shipping and handling of CMI product to the customer.

ARTICLE 2

APPOINTMENT OF EXCLUSIVE DISTRIBUTORSHIP

2.1 Distributorship. Subject to the terms and conditions of this Agreement, ReGen hereby appoints and Allo Pro hereby accepts appointment as the exclusive distributor of ReGens CMI Product within the Allo Pro Territory. Allo Pro shall not sell any of ReGens other products without ReGens prior written consent.

2.2 Sub-Distributors. Allo Pro shall have the right to appoint sub-distributors within the Allo Pro Territory. However, in the countries listed on the attached Schedule II, Allo Pro shall not change distributorship from a company affiliated with Allo Pro to a non-affiliated third party without prior written approval of ReGen.

2.3 Right of First Negotiation for the ReGen Territory. So long as ReGen distributes, markets and sells the CMI Product in the ReGen Territory by itself or through a company or companies controlled by ReGen, ReGen shall have exclusive rights to distribute, market and sell the CMI Product in the ReGen Territory. Allo Pro shall have a right of first negotiation if ReGen elects to distribute, market and sell the CMI Product in the ReGen Territory through or in cooperation with any partner other than those described above or through or in cooperation with a company that would gain control of or be under common control with ReGen by virtue of such cooperation or in connection therewith. ReGen shall notify Allo Pro of its intent in writing, and the Parties shall negotiate in good faith to reach an agreement regarding the commercialization of the CMI Product in the ReGen Territory. If Allo Pro elects not to deliver a written notice of interest within thirty (30) days, or the Parties are unable to reach a definitive agreement within ninety (90) days, ReGen shall have the unfettered right to enter into one or more transactions with third parties without any further obligation to Allo Pro; provided that such transaction is substantially more favorable to ReGens stockholders than that last offered by Allo Pro in writing during the ninety (90) day negotiation period, as determined in the reasonable judgement of ReGens Board of Directors after full deliberation of all relevant factors.

2.4 Non-Compete. Each party hereby covenants not to conduct, fund, license or participate in, directly or indirectly through one or more third parties, the research, development, distribution or commercialization in any country in the Allo Pro Territory of any collagen-based meniscus implant competing with the CMI Product, except pursuant to an agreement for the development of a second generation meniscus implant pursuant to Article 4 herein below.

End of Preview

Home Intelligence Services Subscriptions News About Us