Confidential Treatment
Requested
DEVELOPMENT AND REGULATORY SERVICES
AGREEMENT
AMENDMENT
This Amendment,
dated as of the 22nd day of June, 2009, (the
“Amendment”) to the Development and Regulatory Services
Agreement, is between Kensey Nash Corporation , a Delaware
corporation, having its principal place of business at 735
Pennsylvania Dr., Exton, PA 19341 (hereinafter referred to as
“KNC”) and The Spectranetics Corporation , a
Delaware corporation, having its principal place of business at
9965 Federal Drive, Colorado Springs CO 80921 (hereinafter referred
to as “Spectranetics”).
WHEREAS, KNC and Spectranetics are parties to a
certain Development and Regulatory Services Agreement, dated
May 30, 2008 (the “Agreement”);
WHEREAS, KNC and Spectranetics desire to modify
various aspects of the Agreement related to, among other things,
regulatory services, milestone payments and the Development
Plan;
NOW, THEREFORE, in consideration of the
foregoing premises and the mutual covenants and agreements provided
herein, and other good and valuable consideration, KNC and
Spectranetics agree as follows.
1. Section 6.1, Milestone
Payments is amended by substitution of the following
subsections for the subsection of the equivalent letter in the
Agreement:
“(a) one million five hundred thousand
dollars ($1,500,000) within ten (10) business days following
the receipt of CE Mark Approval from Spectranetics’ European
notified body for the ***** described in the Development
Plan;
(b) five hundred thousand dollars
($500,000) within ten (10) business days following the receipt
of an Approval from the FDA of an Investigational Device Exemption
(IDE) for ***** for the ***** described in the Development
Plan;
(d) one million dollars ($1,000,000) within
ten (10) business days following the mutually agreed upon
successful completion of the Design Verification Design Review for
the ***** described in the Development Plan; and
(e) one million dollars ($1,000,000) within
ten (10) business days following the receipt of CE Mark
Approval from Spectranetics’ European notified body for the
***** described in the Development Plan.”
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Confidential portions of the material have been
omitted and filed separately with the Securities and Exchange
Commission.
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Confidential Treatment
Requested
2. The Parties hereto agree that the
requirements of Section 6.1 (c) have been met and such
milestone payment has been satisfied.
3. Section 6.1, Milestone
Payments is further amended by addition of the following
subsections:
“(f) two million dollars ($2,000,000)
within ten (10) business days following the receipt of a
510(k) Clearance or Pre-Market Approval (PMA) from the FDA for
a ***** for the ***** described in the Development Plan;
and
(g) one million dollars ($1,000,000) within
ten (10) business days following the receipt of a 510(k)
Clearance or Pre-Market Approval (PMA) from the FDA for a
***** for the ***** described in the Development
Plan.”
4. Schedule B, Development Plan, is
amended as set forth in the Revised Schedule B, which is dated
June 22, 2009, and attached hereto.
5. Sections 3.1, 4.5, 4.6, and 6.3 are
hereby amended in their entirety, as set forth below, to indicate
modified sharing of certain Clinical Trial Costs and Regulatory
Costs with regard to the activities in the Development Plan
directed toward the milestones set forth as 6.1(f) and
6.1(g).
“3.1 Development Roles . Subject to
the terms of this Agreement, KNC agrees to, in consultation with
Spectranetics, work in good faith to develop the Products in
accordance with the Development Plan (the “Development
Program”). KNC and Spectranetics will jointly define the
Products’ specifications to meet market requirements;
provided that Spectranetics shall have final approval of all design
inputs, including without limitation, Product needs and
Specifications. The parties have agreed upon a general allocation
of responsibilities for such purposes as set forth in this
Section 3, and a specific allocation of responsibilities for
the activities under this Agreement as set forth in the Development
Plan. KNC may conduct independent development work at its own
expense regarding Products other than in accordance with the
Development Plan, provided that (a) KNC shall regularly update
Spectranetics regarding such efforts, (b) KNC shall not
incorporate any modifications or additions into the Products as a
result of such efforts without the prior written consent of
Spectranetics on a case-by-case basis; and (c) any
modific
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