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Exhibit 10.39
AMENDED AND RESTATED LICENSE AGREEMENT
by and between
ORTHOVITA, INC.
and
ANGIOTECH PHARMACEUTICALS (US), INC.
CONFIDENTIAL TREATMENT REQUESTED BY ORTHOVITA, INC.
TABLE OF
CONTENTS
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Page
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DEFINITIONS
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2
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LICENSES; RESPONSIBILITIES
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9
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License Grants
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9
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Sublicense Agreements
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10
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Improvements and New Accessories
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11
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Independent Contractor
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13
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Misappropriation of Licensed Patents and Licensed
Know-How
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13
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Retained Rights of Angiotech
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13
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Costs Borne by each Party
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14
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CERTAIN PERFORMANCE REQUIREMENTS
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14
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Orthovita’s Commercialization of
Products
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14
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***
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14
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Collection of Taxes
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14
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Product Packaging and Labeling
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15
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Promotion and Marketing
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15
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JOINT COMMITTEE
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15
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Joint Committee
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15
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Committee Responsibilities
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16
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Committee Meetings
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16
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Committee Decisions; Dispute
Resolution
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16
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ANGIOTECH-BRANDED COSTASIS PRODUCTS
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17
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Notice of Intent to Commercialize an
Angiotech-Branded CoStasis Product(s)
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17
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Joint Committee Oversight
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17
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Promotion and Marketing
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17
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Booking of Product Sales
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18
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Promotional Materials
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18
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Branding of CoStasis Products by
Angiotech
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18
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***
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CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN
OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST
UNDER 17 C.F.R. SECTIONS 200.80(B)(4) AND 230.406.
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-i-
TABLE OF
CONTENTS
(continued)
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Page
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MANUFACTURE OF PRODUCTS BY ORTHOVITA
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18
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Responsibility for Product
Manufacturing
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18
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Orthovita’s Supply of Products and
Accessories to Angiotech
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18
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PAYMENTS AND REPORTS BY ORTHOVITA
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21
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Payments on Sales of Products by Orthovita and
its Agents
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21
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Non-Arm’s Length Sales; Non-Cash
Sales
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21
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Reports
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22
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Audit Rights
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23
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Intentionally omitted
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23
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Intentionally omitted
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23
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Payments
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23
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Interest Due
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24
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REGULATORY MATTERS
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24
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No Misstatements, Adulteration or
Misbranding
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24
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Responsibility for Regulatory Approvals and
Regulatory Filings
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24
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Clinical Data
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25
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Adverse Events
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25
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Product Recalls
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25
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Right of Reference
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26
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REPRESENTATIONS, WARRANTIES AND
INDEMNIFICATION
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26
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Each Party
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26
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Additional Representations, Warranties and
Covenants By Orthovita
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27
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Books and Records of Orthovita
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27
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Representations to Third Parties
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27
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Sole Remedy for Non-Conformance
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27
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Additional Representations and Warranties of
Angiotech
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28
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Limitations
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29
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Indemnification by Orthovita
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29
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Indemnification by Angiotech
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29
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-ii-
TABLE OF
CONTENTS
(continued)
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Page
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Indemnification Procedure
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30
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Product Liability Claims
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30
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Insurance
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31
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Employee Safety
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31
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INTELLECTUAL PROPERTY
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31
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Patent Applications and Foreign Filing
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31
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Notification of Infringement
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32
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Defense and Enforcement of Patents
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32
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TERM AND TERMINATION
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34
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Term
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34
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Angiotech’s Rights with Respect to
Orthovita’s Breach
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34
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Orthovita’s Remedy for Angiotech’s
Breach
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35
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Orthovita’s Right to Terminate for
Angiotech Insolvency
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35
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Intentionally omitted
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35
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Intentionally omitted
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35
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Effects of Expiration or Termination
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35
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Manufacturing Technology Transfer
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36
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Post-Termination Sale of Inventory
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37
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Survival
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37
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TRADEMARKS
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37
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Ownership; Permitted and Required Uses
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37
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Right to Review and Approve Trademark
Usage
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38
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Use of Other Party’s Trademarks
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38
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Infringement
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38
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Remedies
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38
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CONFIDENTIAL INFORMATION
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38
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General
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38
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Terms of this Agreement
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39
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-iii-
TABLE OF
CONTENTS
(continued)
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Page
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FORCE MAJEURE
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39
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Event of Force Majeure
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39
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Monetary Payments Not Excused
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40
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AMENDMENT
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40
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Executed in Writing
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40
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ENTIRE AGREEMENT
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40
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Entire Agreement
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40
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Invalid or Unenforceable Provision
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40
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ASSIGNMENT
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40
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Rights and Limitations
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40
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GOVERNING LAW
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41
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New York Law
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41
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NOTICES
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41
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Notice Requirements
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41
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WAIVER
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42
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No Waiver
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42
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ARBITRATION
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42
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Arbitration Procedure
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42
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Arbitrator
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42
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Decision
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43
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INTERPRETATION
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43
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Headings
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43
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Singular Includes Plural
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43
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References to Law
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43
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EXHIBITS
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43
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Integral Part
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43
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BINDING EFFECT
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43
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Successors
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43
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COUNTERPARTS; FACSIMILE
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44
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Execution of Agreement
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44
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-iv-
AMENDED AND RESTATED LICENSE
AGREEMENT
THIS AMENDED AND RESTATED LICENSE AGREEMENT ( "Agreement"
) is made and entered into as of this 29 th day of December 2006, by and
between Orthovita, Inc., a Pennsylvania corporation with principal
offices at 77 Great Valley Parkway, Malvern, Pennsylvania 19355 (
"Orthovita" ), and Angiotech Pharmaceuticals (US), Inc., a
Washington corporation with principal offices at 101 W. North Bend
Way, Suite 201, PO Box 2840, North Bend, WA 98045 (
"Angiotech" ), and amends and restates in its entirety that
certain License Agreement executed as of March 20, 2006 and
effective January 1, 2006 (the "Original Agreement" )
by and between Orthovita and Angiotech.
W I T N E S S E T H :
WHEREAS, Angiotech is engaged in the business of developing,
manufacturing, selling and distributing certain biopharmaceutical
and biosurgical products;
WHEREAS, Angiotech (through its former subsidiary, Angiotech
BioMaterials Corp., under its former name, Cohesion Technologies,
Inc.) and Orthovita previously executed an Exclusive Sales
Distribution Agreement dated July 1, 2004, as amended by
Amendment No.1 dated September 30, 2005 (the "Distribution
Agreement" ), to establish Orthovita as distributor of CoStasis
® products in
the United States (with options for the European Union and the rest
of the world);
WHEREAS, pursuant to the terms of the Original Agreement,
Orthovita became Angiotech’s licensee for Products in the
Territory (as each term is defined in Article 1 hereof), and
assumed responsibilities for manufacturing Products for sale within
the Territory;
WHEREAS, pursuant to the terms of the Original Agreement,
Angiotech granted such license to Orthovita, and transferred
CoStasis Product manufacturing responsibilities to Orthovita;
WHEREAS, Orthovita desires to purchase from Angiotech, and
Angiotech desires to sell to Orthovita, all royalties payable to
Angiotech under the Original Agreement, and the parties hereto are,
as of this date, entering into a Royalty Sale Agreement ("
Royalty Sale Agreement ") to effect such transaction;
and
WHEREAS, to facilitate the purchase of the royalties, the
Parties wish, as contemplated by the Royalty Sale Agreement, to
enter into this Agreement, which constitutes an amendment and
restatement of the Original Agreement, in order to, among other
things, eliminate the royalties payable by Orthovita to Angiotech
upon sale of the Products; eliminate certain minimum sales
requirements for Orthovita; eliminate certain termination rights
for Angiotech; extend the term of the Agreement; and effect other
amendments as provided herein.
1
NOW, THEREFORE, the Parties hereto, in
consideration of the premises and mutual covenants and undertakings
herein contained, intending to be legally bound, agree as
follows:
Article 1.
Definitions
As used in this Agreement, the following terms shall have the
meanings specified in this Article 1:
1.1 "AAA" is defined in Section 21.1.
1.2 "Accessory(ies)" means both the Existing Accessories
and the New Accessories, collectively.
1.3 Intentionally omitted .
1.4 "Act" means the United States Food, Drug and Cosmetic
Act of 1938, as it has been amended prior to the Effective Date and
may be amended thereafter during the Term.
1.5 "Action" is defined in Section 10.3(c)(i).
1.6 "Adverse Event" means any untoward medical occurrence
in a patient or clinical investigation subject administered a
Product and which may or may not have a causal relationship with
such treatment. An Adverse Event includes any unfavorable and
unintended sign (including an abnormal laboratory finding), symptom
or disease temporally associated with the use of a Product, whether
or not related to the Product.
1.7 "Affiliate" of a Party means any entity
(a) which directly or indirectly through one or more
intermediaries controls, is controlled by, or is under common
control with, that Party, but only for so long as the relationship
exists; or (b) wherein more than fifty percent (50%) of
the voting capital stock (or such lesser maximum percentage
permitted by applicable law) is beneficially owned or held by that
Party or any of such Party’s subsidiaries or parents.
1.8 "Agent(s)" means an Affiliate(s), a permitted
sublicensee(s) or a distributor(s) of Orthovita or Angiotech (as
applicable).
1.9 "Agreement" is defined in the introductory
paragraph.
1.10 "Angiotech" is defined in the introductory
paragraph.
1.11 "Angiotech-Branded CoStasis Product(s)" means a
CoStasis Product(s) for use and exploitation in the Non-Orthopedic
Hemostat Field that is distributed, promoted, marketed and/or sold
by or on behalf of Angiotech and/or its Affiliates under one or
more Angiotech Trademarks selected by Angiotech.
1.12 "Angiotech Improvement" is defined in
Section 2.3(b)(i).
1.13 "Angiotech Improvement Patents" is defined in
Section 10.1.
2
1.14 "Angiotech Trademark(s)" means a
Trademark(s) owned or Controlled by Angiotech. Angiotech shall
select one or more Angiotech Trademarks for use in conjunction with
an Angiotech-Branded CoStasis Product(s), and these Angiotech
Trademark(s) shall be different from Orthovita Trademark(s) used in
conjunction with CoStasis Product(s). Angiotech Trademark(s) shall
expressly include ANGIOTECHKNOWLEDGY ® and CELLPAKER
® .
1.15 Intentionally omitted.
1.16 "Calendar Quarter" means each three (3) month
period during the Term commencing on
January 1, April 1, July 1 or
October 1; provided, however, that the calendar quarter in
which this Agreement is terminated or expires shall extend from the
first day of such calendar quarter until the effective date of the
termination or expiration of this Agreement.
1.17 "Calendar Year" means each twelve (12) month
period during the Term starting on January 1 of a year and
ending on December 31 of the same year; provided, however,
that the calendar year in which this Agreement is terminated or
expires shall extend from January 1 of such calendar year
until the effective date of the termination or expiration of this
Agreement.
1.18 "CellPaker Field" means human medical uses of the
CellPaker Products and/or Accessories in connection with CoStasis
Products.
1.19 "CellPaker Product(s)" means a CellPaker
® Plasma
Collection System product(s) for use with CoStasis Products, as
further described in Exhibit A hereto.
1.20 "CFO" means Chief Financial Officer.
1.21 "Clinical Data" means the study protocols, results
and analysis of data arising from the testing of a biomaterial,
device or a combination thereof in vitro, in vivo in non-human
subjects and in vivo in human subjects, including safety and
toxicity testing (or other pre-clinical testing), patient
screening, patient enrollment, patient status, any clinical or
patient data included in any communications (including Regulatory
Filings) with Regulatory Authorities, actions taken or modification
in study design/conduct and summary of data collected on CRFs (Case
Report Forms), either paper or electronic, and interactions with a
DSMB (data safety monitoring board), if applicable.
1.22 "Co-Chair" is defined in Section 4.1.
1.23 "Competitive Product" means a product, other than a
CoStasis Product or a CellPaker Product, which has obtained
Regulatory Approval for use as a Hemostat for any indication.
1.24 "Confidential Information" is defined in
Section 13.1.
1.25 "Control" or "Controlled" means the legal
authority or right of a Party to grant a license or sublicense of
intellectual property rights to the other Party, without breaching
the terms of any agreement with a Third Party, or misappropriating
or unlawfully disclosing the confidential, proprietary or trade
secret information of a Third Party.
-
"Cost of Goods" means the fully allocated cost of
manufacturing a Product, which may include the following items:
(a) the costs of labor, including salaries, wages,
benefits,
3
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payroll taxes and current period employee
benefits, (b) material costs, including raw materials,
supplies, services and fees, as well as any freight and duty (where
applicable), (c) direct and factory overhead determined in
accordance with Orthovita’s standard internal practices and
consistently applied, including Product-related expenses associated
with quality assurance testing, batch review, equipment maintenance
costs, manufacturing energy and utilities, waste removal, storage,
transportation, insurance, management and administrative costs for
personnel integral to manufacturing, general facilities costs,
environmental engineering, interest expense and property taxes, and
(d) depreciation costs, including the depreciation costs of
the manufacturing facility, machinery or equipment dedicated either
solely or partly (on a pro rata basis) to the manufacturing cost of
such Products, as applicable, all the foregoing items as determined
in accordance with generally accepted accounting principles,
consistently applied, and in a manner consistent with the exemplary
cost determinations set forth in Exhibit C , and with the
methods used by Orthovita to calculate cost of goods for its other
products. ***
1.26 "CoStasis Ingredient Improvement" is defined in
Section 2.3(a)(iii).
1.27 "CoStasis Ingredient Improvement Patents" is defined
in Section 10.1.
1.28 "CoStasis Ingredients" means collagen and
thrombin.
1.29 "CoStasis Product(s)" means a product(s) containing
the Formulated CoStasis Ingredients in a syringe that is
manufactured by or for Orthovita or by or for Angiotech (and/or
Angiotech’s Affiliates) for use and exploitation in the
Licensed Field in accordance with this Agreement. The current
formulation of the CoStasis Product is described in Exhibit
A hereto. The term "CoStasis Products" includes
Angiotech-Branded CoStasis Products. The term "CoStasis Products"
shall expressly exclude Drug-Loaded Products. However, Orthovita
may add one or more additional ingredients to the CoStasis
Ingredients to make a CoStasis Product; provided that no such
additional ingredient is an active pharmaceutical ingredient or a
drug.
1.30 "Declined Action" is defined in
Section 10.3(c)(ii).
1.31 "Distribution Agreement" is defined in the
recitals.
1.32 "Dollars" means the lawful currency of the United
States of America.
1.33 "Drug-Loaded Product" means a mixture, formulation
or product that includes at least one active pharmaceutical
ingredient or drug in addition to the CoStasis Ingredients, whether
or not such mixture, formulation or product is used as a
Hemostat.
1.34 "Effective Date" means January 1, 2006.
|
***
|
CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN
OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST
UNDER 17 C.F.R. SECTIONS 200.80(B)(4) AND 230.406.
|
4
1.35 "Existing Accessory(ies)" means the
malleable extended applicator (MEA) and/or the laparoscopic
extended applicator (LEA) accessory items, collectively or
individually, as the context requires, for use with the CoStasis
Products, as such accessories exist as of the Effective
Date.
1.36 "Force Majeure" is defined in Section 14.1.
1.37 "Formulated CoStasis Ingredients" means the
pharmaceutically formulated sterile suspension of the CoStasis
Ingredients in calcium chloride. Notwithstanding the foregoing
sentence, the term "Formulated CoStasis Ingredients" shall
expressly exclude Drug-Loaded Products. However, Orthovita may add
one or more additional ingredients to the Formulated CoStasis
Ingredients to make a CoStasis Product; provided that no such
additional ingredient is an active pharmaceutical ingredient or a
drug.
1.38 "Future Indication" means an indication for a
Product in the Licensed Field which has not obtained Regulatory
Approval in a given country in the Territory as of the Effective
Date. For the sake of clarity, and by way of example only, if a
Product has obtained Regulatory Approval for a certain indication
in Canada, but not in the United States, as of the Effective Date,
then such indication is a Future Indication with respect to the
United States.
1.39 "Hemostat" means a product, the primary purpose of
which is to stop bleeding through an activation of the coagulation
cascade.
1.40 "Improvement(s)" means any enhancement, upgrade,
addition or modification to the CoStasis Ingredients, Formulated
CoStasis Ingredients, Products and/or Accessories (and/or the
manufacture or use thereof) that is or may be useful in the
Licensed Field, and that is conceived, reduced to practice,
discovered, derived or developed by or on behalf of a Party or its
Affiliates prior to or during the Term. The term "Improvements"
includes Angiotech Improvements and Orthovita Improvements.
1.41 "Indemnified Party" means the Party entitled to be
indemnified by the other Party pursuant to Article 9.
1.42 "Indemnifying Party" means the Party obligated to
indemnify the Indemnified Party.
1.43 "Joint Committee" is defined in
Section 4.1.
1.44 "Licensed Field" means, collectively or
individually, as the context requires, (a) the Orthopedic
Hemostat Field; (b) the Non-Orthopedic Hemostat Field; and
(c) the CellPaker Field. The terms "Licensed Field,"
"Orthopedic Hemostat Field" and "Non-Orthopedic Hemostat Field" are
expressly inapplicable to Drug-Loaded Products, even if a
Drug-Loaded Product is approved for human use in the Licensed
Field.
1.45 "Licensed Know-How" means information, materials,
formulations, manufacturing technology, trade secrets and data that
are owned or Controlled by Angiotech and have been or are
transferred by Angiotech or its Affiliates to Orthovita prior to or
during the Term, and that are necessary for the manufacture, use,
sale, offer for sale or importation of CoStasis Ingredients,
Formulated CoStasis Ingredients, CoStasis Product(s), CellPaker
Product(s) or Existing Accessories.
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1.46 "Licensed Patents" means all
(a) patents and patent applications listed on Exhibit B
, and (b) corresponding foreign patents and patent
applications, including any patents issuing from any of the
foregoing patent applications and any reissues, re-examinations,
confirmations, extensions, renewals, substitutions, continuations,
divisions, patent term extensions, and continuation-in-part
applications (only to the extent, however, that the
continuation-in-part applications are entirely supported in the
specification and entitled to the priority date of a parent patent
application) of the foregoing. The term "Licensed Patents"
expressly excludes Angiotech Improvement Patents and CoStasis
Ingredient Improvement Patents.
1.47 "Licensed Technology" means, collectively, Licensed
Patents and Licensed Know-How.
1.48 "Loss" is defined in Section 9.8.
1.49 Intentionally omitted .
1.50 Intentionally omitted .
1.51 "Net Sales" means the gross amount invoiced for the
sale of the CoStasis Products (other than Angiotech-Branded
CoStasis Products) and CellPaker Products anywhere in the Territory
during the period commencing October 1, 2006 and ending on the
date of this Agreement that are attributable to sales of such
Products by Orthovita or its Affiliates to a Third Party, less the
sum of the following items (as applicable, and to the extent not
included in Cost of Goods) as determined in accordance with
generally accepted accounting principles:
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(a) discounts (including cash discounts and quantity discounts),
cash and non-cash coupons, refunds, rebates, credits, chargebacks,
returns and allowances, vouchers, retroactive price adjustments and
any other allowances, including amounts written off by reason of
uncollectible debt, actually granted or given with respect to the
Products that effectively reduce the net selling price, in each
case, as may be extended in the ordinary course of business
consistent with past practice or as customary in the industry,
including those granted or given to managed health care
organizations, wholesalers and other distributors, buying groups,
health care insurance carriers, and/or to federal, state and local
governments, their agencies;
(b) any tax imposed on the sale, delivery or use of the Products
(other than Angiotech-Branded CoStasis Products), including,
without limitation, sales, use, excise or value added taxes,
provided in each such case that such tax is included in the gross
amount invoiced for such Products; and
(c) allowances for reasonable and customary Product shipping
expenses, provided that such allowance is included in the gross
amount invoiced for such Product(s).
For purposes of this Agreement, the sale or transfer of Products
in the Territory between Orthovita (or an Affiliate of Orthovita)
and an Affiliate of Orthovita for resale by the receiving entity
shall not be deemed a sale for the purpose of this provision, but
the resale by such receiving entity to any other Third Party shall
be a sale for such purposes.
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1.52 "New Accessory(ies)" means any
accessory item (other than a CellPaker Product or an Existing
Accessory) for use with CoStasis Ingredients, Formulated CoStasis
Ingredients, CoStasis Products or CellPaker Product(s) that is
conceived, reduced to practice, discovered, derived or developed by
or on behalf of Orthovita or its Affiliates, and wherein Orthovita
and/or its Affiliates own or Control intellectual property
pertaining to such New Accessory(ies) that would preclude a Third
Party from making, using, selling, offering for sale, importing or
otherwise exploiting such New Accessory(ies) without a license from
Orthovita and/or its Affiliates.
1.53 "Non-Orthopedic Hemostat Field" means, with respect
to a CoStasis Product, human medical uses of the CoStasis Product
as a Hemostat for all indications, other than indications within
the Orthopedic Hemostat Field.
1.54 "Orthopedic Hemostat Field" means, with respect to a
CoStasis Product, human medical uses of the CoStasis Product as a
Hemostat for all indications treated by an orthopedic surgeon or
other surgeon relating to the surgical repair of diseases or
injuries of the spine, bone or related soft tissue, such as
ligaments or cartilage.
1.55 "Orthovita" is defined in the introductory
paragraph.
1.56 "Orthovita Improvement" is defined in
Section 2.3(a)(i).
1.57 "Orthovita Trademark(s)" means a Trademark(s) owned
or Controlled by Orthovita. Orthovita shall select one or more
Orthovita Trademarks for use in conjunction with CoStasis
Product(s) (other than Angiotech-Branded CoStasis Product(s)), and
these Orthovita Trademark(s) shall be different from Angiotech
Trademark(s) used in conjunction with Angiotech-Branded CoStasis
Product(s).
1.58 "Parties" means both Angiotech and Orthovita, and
"Party" means either of them, as the context requires.
1.59 "Post-Licensure Marketing Study" means human
clinical trials of a Product in the Licensed Field conducted or
continued after Regulatory Approval has been achieved (for example,
such trials may be designed to provide information that will
optimize or expand use of the Product, and/or to provide additional
safety and effectiveness data for a specific procedure for which
the Product is currently indicated for use).
1.60 "Product Liability Claim" means a Loss (other than a
Loss described in Section 9.8 and/or Section 9.9)
resulting from, arising out of, or relating to claims, actions or
suits (including a governmental investigation) by Third Parties
arising from the attributes of a Product manufactured by or on
behalf of Orthovita, including, but not limited to, the
immunogenicity, toxicity, teratogenicity, carcinogenicity, or
inherent risk of the use or administration of such Product.
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1.61 "Products" means CoStasis Products
and CellPaker Products, collectively or individually, as the
context requires.
1.62 "Program Director" is defined in
Section 4.1.
1.63 "Proposal" is defined in Section 8.2(b).
1.64 "R&D Products" is defined in
Section 6.2(b).
1.65 "Regulatory Approval" means all authorizations by
the appropriate governmental entity or entities necessary for
commercial sale of a Product in a country in the Territory,
including, without limitation and where applicable, approval of
labeling, price, reimbursement and/or manufacturing.
1.66 "Regulatory Authority" means, with respect to any
particular country, territory or union, the governmental authority,
body, commission, agency or other instrumentality of such country,
territory or union with the primary responsibility for the
evaluation and/or approval of Products and Accessories before such
Products and Accessories can be tested, marketed, promoted,
distributed or sold in such country, territory or union, including,
without limitation, such governmental bodies that have jurisdiction
over the pricing of such Product. The term "Regulatory Authority"
includes, but is not limited to, the United States Food and Drug
Administration, the European Agency for the Evaluation of Medicinal
Products, European Member State Competent Authorities and the
Ministry of Health, Labour and Welfare.
1.67 "Regulatory Filing" means all activities, filings
and documents relating to the filing for and procurement of
Regulatory Approval for the marketing and sale of a Product or
Accessory from the relevant Regulatory Authorities.
1.68 "Sales & Marketing Commission" means the
average actual commission paid by Orthovita to its sales
representatives, independent sales agencies, and authorized and
trained representatives with experience in the Licensed Field for
sale of a Product.
1.69 "Section 7.1 Payment" is defined in
Section 7.1.
1.70 Intentionally omitted .
1.71 Intentionally omitted .
1.72 "Supplied Products" is defined in
Section 6.2(a).
1.73 "Term" is defined in Section 11.1.
1.74 "Territory" means the entire world.
1.75 "Third Party(ies)" means any person or entity other
than Angiotech or Orthovita and their respective Affiliates.
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1.76 "Trademarks" means all trademarks,
trade names, service marks, logos and derivatives thereof relating
to Products and Accessories as of the Effective Date and during the
Term that are used, or are intended to be used, in conjunction with
distribution, promotion, marketing, sales, offers to sell, import,
export or other exploitation of Products or Accessories, but
excluding any trademarks, trade names, service marks, logos and
derivatives thereof (a) containing the word "Orthovita" or
"Angiotech," or (b) which are not used solely on Products or
Accessories. The term "Trademarks" includes Angiotech Trademarks
and Orthovita Trademarks.
1.77 "Original Agreement" is defined in the introductory
paragraph.
1.78 "Royalty Sale Agreement" is defined in the
recitals.
Article 2.
Licenses; Responsibilities
2.1 License Grants. Subject to the terms and conditions
of this Agreement, during the Term Angiotech hereby grants to
Orthovita, and Orthovita hereby accepts:
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(a) an exclusive license under the Licensed Technology, CoStasis
Ingredient Improvements and CoStasis Ingredient Improvement Patents
to make, have made, sell, have sold, offer for sale, export, have
exported, import and have imported CoStasis Products in the
Orthopedic Hemostat Field in the Territory;
(b) until such time as Angiotech elects to distribute, promote,
market and/or sell one or more Angiotech-Branded CoStasis Products
pursuant to Article 5, an exclusive license under the Licensed
Technology, CoStasis Ingredient Improvements and CoStasis
Ingredient Improvement Patents to make, have made, sell, have sold,
offer for sale, export, have exported, import and have imported
CoStasis Products in the Non-Orthopedic Hemostat Field in the
Territory;
(c) from and after such time as Angiotech elects to distribute,
promote, market and/or sell one or more Angiotech-Branded CoStasis
Products pursuant to Article 5, a co-exclusive (meaning that only
Orthovita and Angiotech can act in each country of the Territory)
license under the Licensed Technology, CoStasis Ingredient
Improvements and CoStasis Ingredient Improvement Patents to make,
have made, sell, have sold, offer for sale, export, have exported,
import and have imported CoStasis Products in the Non-Orthopedic
Hemostat Field in the Territory;
(d) a non-exclusive license under the Licensed Technology to
make, have made, use, sell, have sold, offer for sale, export, have
exported, import and have imported CellPaker Products and
Accessories in the CellPaker Field in the Territory; and
(e) a non-exclusive license under the Licensed Technology and
CoStasis Ingredient Improvements and CoStasis Ingredient
Improvement Patents to use (including, without limitation, to
research, have researched, develop and have developed) CoStasis
Ingredients and Formulated CoStasis Ingredients (but only for uses
directly related to Orthovita’s Product licenses and rights
hereunder), Products (other than Angiotech-Branded CoStasis
Products) and Accessories in the Licensed Field in the
Territory.
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2.2 Sublicense Agreements.
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(a) Except as otherwise expressly set forth herein, Orthovita
shall have no right to grant a sublicense under the license rights
granted to Orthovita in Section 2.1 without Angiotech’s
prior written consent. If applicable laws and/or regulations
require Orthovita to grant a sublicense to its Agent in a
country(ies) in the Territory to enable such Agent to distribute,
promote, market, sell, offer for sale and/or import Products and/or
Existing Accessories in the Licensed Field in accordance with this
Agreement, then Orthovita shall notify the Joint Committee of such
requirement. The Joint Committee shall determine in good faith
whether Orthovita is required by applicable law and/or regulation
to grant such sublicense for this limited purpose to such Agent,
and if the Joint Committee determines that such limited sublicense
is required, such limited sublicense agreement shall be subject to
the following: (i) Orthovita shall promptly provide to
Angiotech a copy of the applicable executed limited sublicense
agreement, subject to applicable confidentiality restrictions;
(ii) Orthovita’s execution and delivery of each such
limited sublicense agreement does not in any way diminish, reduce
or eliminate any of Orthovita’s obligations under this
Agreement, and Orthovita remains liable for all such obligations;
and (iii) Orthovita shall not receive cash or non-cash
consideration for such limited sublicense. In addition, Orthovita
shall obtain contractual undertakings from every such permitted
sublicensee that provide that the rights of such permitted
sublicensee shall terminate upon expiration or termination of this
Agreement. For the avoidance of doubt, the foregoing shall not
preclude Orthovita from appointing an Agent who does not need a
sublicense to distribute, promote, market, sell, offer for sale
and/or import Products and/or Existing Accessories in the Licensed
Field.
(b) Except as otherwise expressly set forth herein, Angiotech
shall have no right to grant a license under the Licensed
Technology with respect to Angiotech-Branded CoStasis Products in
the Non-Orthopedic Hemostat Field without Orthovita’s prior
written consent. If applicable laws and/or regulations require
Angiotech to grant a license to its Agent in a country(ies) in the
Territory to enable such Agent to distribute, promote, market
and/or sell Angiotech-Branded CoStasis Products in the Licensed
Field in accordance with this Agreement, then Angiotech shall
notify the Joint Committee of such requirement. The Joint Committee
shall determine in good faith whether Angiotech is required by
applicable law and/or regulation to grant such license for this
limited purpose to such Agent and if the Joint Committee determines
that such limited license is required, such limited license
agreement shall be subject to the following: (i) Angiotech
shall promptly provide to Orthovita a copy of the applicable
executed limited license agreement, subject to applicable
confidentiality restrictions; and (ii) Angiotech’s
execution and delivery of each such limited license agreement does
not in any way diminish, reduce or eliminate any of
Angiotech’s obligations under this Agreement, and Angiotech
remains liable for all such obligations. For the avoidance of
doubt, the foregoing shall not preclude Angiotech from appointing
an Agent who does not need a sublicense to distribute, promote,
market, sell, offer for sale and/or import Products and/or Existing
Accessories in the Non-Orthopedic Hemostat Field.
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(c) For the avoidance of doubt, Angiotech shall
have no right to grant a license (except for the licenses granted
to Orthovita under this Agreement) under the Licensed Technology
(i) with respect to CoStasis Products in the Orthopedic
Hemostat Field or (ii) except as set forth in
Section 2.2(b), with respect to CoStasis Products in the
Non-Orthopedic Hemostat Field.
2.3 Improvements and New Accessories .
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(a) By Orthovita and its Affiliates . Orthovita and its
Affiliates have a right to make Improvements prior to or during the
Term. Orthovita shall notify the Joint Committee in writing of any
CoStasis Ingredient Improvements as soon as reasonably possible,
and shall provide the Joint Committee with a written description of
all such CoStasis Ingredient Improvements. Within sixty
(60) days after the end of each Calendar Year during the Term,
Orthovita shall deliver to the Joint Committee a summary report of
all other Improvements that have been conceived, reduced to
practice, discovered, derived or developed by Orthovita and its
Affiliates during that Calendar Year which are relevant to
Angiotech’s rights, licenses and retained rights in
connection with this Agreement.
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(i) Orthovita Improvements . Orthovita and/or its
Affiliates (as applicable) shall own all right, title and interest
in and to Improvements to the CoStasis Products (other than the
CoStasis Ingredient Improvements), CellPaker Products and
Accessories that are conceived, reduced to practice, discovered,
derived or developed by or on behalf of Orthovita and/or its
Affiliates (as applicable); provided that no employee or agent of
Angiotech or its Affiliates is properly named as an inventor of
such Improvement (each, an "Orthovita Improvement" ).
(ii) Angiotech Licenses to Orthovita Improvements .
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(A) During the period when Angiotech is distributing, promoting,
marketing and/or selling Angiotech-Branded CoStasis Products in the
Non-Orthopedic Hemostat Field in the Territory, Orthovita hereby
grants to Angiotech an exclusive option to obtain on commercially
reasonable terms a license to any Orthovita Improvements to make,
have made, use, sell, have sold, offer for sale and import
Angiotech-Branded CoStasis Products, CellPaker Products and/or
Accessories (as applicable) to which such Orthovita Improvements
relate within the Non-Orthopedic Hemostat Field and/or CellPaker
Field, as applicable, in the Territory.
(B) Upon the request of Angiotech or the election of Orthovita,
Orthovita (in its sole discretion) may provide notice to Angiotech,
through the Joint Committee, that Orthovita desires to offer to
Angiotech on commercially reasonable terms a license under one or
more Orthovita Improvements to research, have researched, develop,
have developed, make, have made, use, sell, have sold, offer for
sale and import one or more (1) CellPaker Products and/or
Accessories (as applicable) to which such Orthovita Improvements
relate outside the Non-Orthopedic Hemostat Field in the Territory;
and/or (2) products other than CellPaker Products and/or
Accessories (and related processes) to which such Orthovita
Improvements relate within or outside of the Licensed Field in the
Territory.
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(iii) CoStasis Ingredient Improvements . With respect to
an Improvement to the CoStasis Ingredients and/or the Formulated
CoStasis Ingredients (including, without limitation, any
Improvement constituting a composition, method of making and/or
method of using any of the foregoing) that is conceived, reduced to
practice, discovered, derived or developed by or on behalf of
Orthovita or its Affiliates (each, a "CoStasis Ingredient
Improvement" ), Orthovita and its Affiliates agree to assign,
and hereby do assign, their right, title and interest in and to
each such CoStasis Ingredient Improvement to Angiotech.
(b) By Angiotech and its Affiliates . Angiotech and its
Affiliates have a right to make Improvements. Within sixty
(60) days after the end of each Calendar Year during the Term,
Angiotech shall deliver to the Joint Committee a summary report of
all Angiotech Improvements that have been conceived, reduced to
practice, discovered, derived or developed during that Calendar
Year which are relevant to Orthovita’s rights and licenses in
the Licensed Field.
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(i) Angiotech Improvements . Angiotech and/or its
Affiliates (as applicable) shall own all right, title and interest
in and to Improvement(s) to the CoStasis Ingredients, Formulated
CoStasis Ingredients, CoStasis Products, CellPaker Products and/or
Accessories (including, without limitation, any Improvement
constituting a composition, method of making and/or method of using
any of the foregoing) that are conceived, reduced to practice,
discovered, derived or developed by or on behalf of Angiotech
and/or its Affiliates (as applicable); provided that no employee or
agent of Orthovita or its Affiliates is properly named as an
inventor of such Improvement (each an "Angiotech
Improvement" ).
(ii) Orthovita Licenses to Angiotech Improvements .
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(A) Upon the request of Orthovita or the election of Angiotech,
Angiotech (in its sole discretion) may provide notice to Orthovita,
through the Joint Committee, that Angiotech desires to offer to
Orthovita on commercially reasonable terms a license (without the
right to sublicense) under one or more Angiotech Improvements to
research, have researched, develop, have developed, make, have
made, use, sell, have sold, offer for sale and import one or more
products (including, without limitation, Products and/or
Accessories) and related processes to which such Angiotech
Improvements relate within the Licensed Field in the Territory.
(B) For the avoidance of doubt, Orthovita shall have no right to
any Angiotech Improvement outside of the Licensed Field or in
connection with any Drug-Loaded Product, or for any purposes other
than those expressly set forth herein or otherwise mutually agreed
by the Parties in writing.
(iii) Orthovita’s First Right to Negotiate . With
respect to any CoStasis Ingredient Improvement(s), if Angiotech
elects (in its sole discretion) to use a Third Party (other than
distributors or contract sales organizations that Angiotech and/or
its Affiliates then use (or in the future elect to use) for
distribution, promotion, marketing and/or sale of other
Angiotech
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products and/or products of Angiotech’s
Affiliates) to distribute any product that incorporates such
CoStasis Ingredient Improvement, Orthovita shall have a first right
to negotiate in good faith with Angiotech for a commercially
reasonable period of time a mutually acceptable agreement whereby
Orthovita would obtain a right to distribute such product on
commercially reasonable terms.
(c) New Accessories . Orthovita shall own all right,
title and interest in and to New Accessories that are conceived,
reduced to practice, discovered, derived or developed by or on
behalf of Orthovita. Upon the request of Angiotech or the election
of Orthovita, Orthovita (in its sole discretion) may provide notice
to Angiotech, through the Joint Committee, that Orthovita desires
to offer to Angiotech on commercially reasonable terms a license to
research, have researched, develop, have developed, make, have
made, use, sell, have sold, offer for sale and import New
Accessories for use with the Products and/or other products and
processes within or outside of the Licensed Field.
2.4 Independent Contractor. Orthovita shall be considered
an independent contractor and shall not be considered a partner,
employee, agent or servant of Angiotech or its Affiliates. As such,
Orthovita and its Agents have no authority of any nature whatsoever
to bind Angiotech or its Affiliates, or to incur any liability for
or on behalf of Angiotech or its Affiliates, and Orthovita shall
not represent itself as anything other than a licensee of Angiotech
in the Licensed Field with respect to Products and Accessories in
the Territory; and Angiotech and its Agents have no authority of
any nature whatsoever to bind Orthovita or its Affiliates, or to
incur any liability for or on behalf of Orthovita or its
Affiliates, and Angiotech shall not represent itself as anything
other than a licensor of Orthovita in the Licensed Field with
respect to Products and Accessories in the Territory. For the
avoidance of doubt, Orthovita agrees to make clear in all dealings
with Third Parties that it is acting as a licensee of the Products
and Accessories in the Licensed Field in the Territory, and not as
an agent of Angiotech or any of its Affiliates.
2.5 Misappropriation of Licensed Patents and Licensed
Know-How. Orthovita shall, and shall ensure that its Agents
shall, promptly inform Angiotech of any misappropriation of the
Licensed Patents and Licensed Know-How which comes to
Orthovita’s or its Agents’ attention. After discussing
any such misappropriation situation with Orthovita, Angiotech shall
have the sole right, in its discretion, to take such action as it
deems appropriate, and Orthovita, at Angiotech’s written
request and expense, shall cooperate with and assist Angiotech in
taking legal action, if deemed appropriate by Angiotech, to stop
any such misappropriation of Licensed Know-How; provided that if
Orthovita has reasonably requested that Angiotech take legal action
to stop such misappropriation of Licensed Know-How, and if
Angiotech determines that such legal action is not appropriate,
then Orthovita may present this issue to the Joint Committee.
Promptly thereafter, and taking into account each Party’s
circumstances and concerns, the Joint Committee shall analyze and
resolve such issue regarding misappropriation of Licensed Know-How
in a commercially reasonable manner that is acceptable to both
Parties.
2.6 Retained Rights of Angiotech. Except as expressly set
forth herein or as otherwise mutually agreed by the Parties in
writing, no rights or licenses are granted to Orthovita under this
Agreement. Angiotech retains all rights to all Licensed Technology,
Angiotech Improvement Patents, CoStasis Ingredient Improvement
Patents, Angiotech Improvements and CoStasis Ingredient
Improvements, to the extent such rights are not expressly granted
to
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Orthovita under this Agreement. The Parties
acknowledge and agree that Angiotech retains the right under the
Licensed Technology, Angiotech Improvement Patents, CoStasis
Ingredient Improvement Patents, Angiotech Improvements and CoStasis
Ingredient Improvements to research, develop, make, have made, use,
sell, have sold, offer for sale, import and otherwise exploit the
CoStasis Ingredients, Formulated CoStasis Ingredients, Product(s)
and Existing Accessories for all purposes other than those
expressly granted to Orthovita hereunder. For the avoidance of
doubt, Angiotech has and retains (a) the sole and exclusive
right (even as to Orthovita and its Affiliates) to research,
develop, make, have made, use, sell, have sold, offer for sale and
import (i) CoStasis Ingredients, Formulated CoStasis
Ingredients and Products and Existing Accessories outside the
Licensed Field in the Territory, and (ii) Drug-Loaded Products
in and outside of the Licensed Field in the Territory, and
(b) the sole and exclusive right (even as to Orthovita and its
Affiliates) to distribute, promote, market and sell
Angiotech-Branded CoStasis Products outside of the Orthopedic
Hemostat Field in the Territory.
2.7 Costs Borne by each Party. Except as expressly set
forth herein, all costs and expenses connected with a Party’s
activities or performance under this Agreement shall be borne
solely by that Party.
Article 3.
Certain Performance Requirements
3.1 Orthovita’s Commercialization of Products.
Orthovita shall use commercially reasonable efforts to promote,
market, sell and distribute the Products (other than
Angiotech-Branded CoStasis Products) in the Licensed Field in the
Territory. Orthovita shall not knowingly, under any circumstances,
either directly or indirectly through Third Parties, promote,
market, sell, or distribute CoStasis Products (a) for any use
outside the Licensed Field, or (b) in any circumstance wherein
the purchaser incorporates, or intends to incorporate, such
CoStasis Product into a Drug-Loaded Product.
3.2 *** For purposes of estimating the transfer price of any
Angiotech-Branded CoStasis Products, Supplied Products and R&D
Products provided to Angiotech and/or its Affiliates by Orthovita
hereunder, within sixty (60) days prior to the end of each
Calendar Year, Orthovita shall provide Angiotech with a good faith,
reasonable estimate of *** for the following Calendar Year;
provided that the forecast for Calendar Year 2006 shall be provided
within sixty (60) days after the Effective Date. Orthovita
shall promptly notify Angiotech if it reasonably believes that ***
at any time in such Calendar Year will vary from the applicable
estimated ***, by more than ***.
3.3 Collection of Taxes. Orthovita shall be responsible
for and shall collect all governmental and regulatory sales and
other taxes, charges, duties and fees that are due and owing upon
sales of
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