DEVELOPMENT AND REGULATORY SERVICES AGREEMENT AMENDMENT
Exhibit 10.2
Confidential Treatment Requested
This Amendment, dated as of the 22nd day of June, 2009, (the “Amendment”) to the Development and
Regulatory Services Agreement, is between Xxxxxx Xxxx Corporation, a Delaware corporation, having
its principal place of business at 000 Xxxxxxxxxxxx Xx., Xxxxx, XX 00000 (hereinafter referred to
as “KNC”) and The Spectranetics Corporation, a Delaware corporation, having its principal place of
business at 0000 Xxxxxxx Xxxxx, Xxxxxxxx Xxxxxxx XX 00000 (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 Xxxx 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 Xxxx Approval from Spectranetics’ European notified body for the *****
described in the Development Plan.”
| ***** | Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission. |
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 modifications or
Inventions resulting from such independent work shall be subject to the provisions of
Section 7.2 below. Spectranetics will review and advise on product development progress,
including without limitation, medical input to provide assistance in the definition of the
end-user product requirements and marketing specifications and phase review approval in the
KNC design control process. If Spectranetics requests a material deviation from the
Development Plan for a particular Product, then KNC will provide Spectranetics an estimate
of the additional development and regulatory costs that would not have otherwise been
incurred by KNC in the
absence of such material deviation and Spectranetics will elect to either (i) bear
such additional development and regulatory costs, in which case, the parties would still
share Clinical Trial Costs equally, or (ii) not to proceed with the proposed change to the
Development Plan. Notwithstanding the foregoing, or as otherwise set forth in this
Amendment, the parties hereto agree that the filing of a second PMA, or a PMA Supplement,
hereunder shall constitute a material deviation as set forth above.
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4.5 Product Approvals. KNC shall have the responsibility for seeking the FDA
Approvals (but not for CE Marking or for Approvals outside of the United States) on
Spectranetics’ behalf and in Spectranetics’ name for the Products. Upon obtaining any FDA
Approval, KNC will transfer to Spectranetics copies of related regulatory filings and
correspondence, and to the extent not already granted, title to such filings, and
correspondence, including without limitation complete submission files relating to such
Approvals in agreed upon formats.
4.6 Expanded Indication Approvals. KNC shall have the responsibility for the
efforts to obtain Approval from the FDA for:
| (a) | the ***** described in the Development Plan; |
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| (b) | the ***** described in the Development Plan; |
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| (c) | the ***** described in the Development Plan; |
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| (d) | ***** described in the Development Plan for the *****; and |
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| (e) | the ***** described in the Development Plan for either a *****. |
KNC shall pay the Development and Regulatory Costs incurred in connection with the
efforts to obtain such Approvals from the FDA; however, the parties agree to share equally
any applicable Clinical Trial Costs to obtain such Approvals from the FDA.
Notwithstanding the foregoing, the parties agree to share equally the associated
Clinical Trial Costs pursuant to the Expanded Indication Approvals set forth at Subsections
4.6 (d) and 4.6 (e), herein this Section, however, Clinical Trial Costs shall be limited to
a shared maximum amount of $5.5 million (the “Maximum Combined Trial Cost”), further, the
maximum amounts of shared contributions pursuant to the efforts under Subsections 4.6 (d)
and 4.6 (e), shall be $2.5 Million and $4.5 million, respectively (each a “Maximum Product
Trial Cost”).If the design of the Trial(s) indicates that such Maximum Combined Trial Cost
or any Maximum Product Trial Cost will likely be exceeded, or if such Trial is proposed to
be modified in such a way as to likely exceed such Maximum Combined Trial Cost or any
Maximum Product Trial Cost, the parties shall meet
and agree upon an appropriate way to proceed, but in no case shall KNC be liable for
any Clinical Trial Costs in excess of one-half the Maximum Combined Trial Cost, or one-half
of each Maximum Product Trial Cost. Spectranetics shall have no obligation to fund
Clinical Trial Costs in excess of one-half the Maximum Combined Trial Costs, or one-half of
each Maximum Product Trial Cost.
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6.3 Clinical Trial Cost Reimbursement. Before commencing clinical trials with
respect to any particular Product, Spectranetics and KNC shall negotiate with each other in
good faith to agree on the scope, budget, allocation of expenses and methods of
reimbursement in connection with such clinical trials, subject in each case to KNC’s
agreement as set forth in Section 3.1 and the limitations set forth at Section 4.6
regarding the Clinical Trial Costs. Each party agrees that actual Clinical Trial Costs may
not equal the preliminary estimates and that, except for additional Clinical Trial Costs
that may be incurred following a termination event pursuant to Section 11.1(b), where the
KNC portion of any additional, post-termination Clinical Trial Costs would be credited
against the Revenue Share as set forth in Section 11.1(b), each party’s share of incurred
Clinical Trial Costs is non-refundable regardless of clinical trial or approval outcome.”
6. This Amendment is meant to amend, modify or supercede only those specific Sections, rights,
responsibilities, liabilities and/or covenants expressly referred to in this Amendment, and only to
the extent so referred to; and accordingly all other Sections and covenants of the Agreement shall
remain unaffected and shall continue to have full force and effect.
7. This Amendment may be executed in one or more counterparts, all of which taken together
will constitute one and the same instrument.
8. This Amendment, to the extent signed and delivered by means of a facsimile machine or pdf
or other electronic transmission, shall be treated in all manner and respects and for all purposes
as an original agreement and shall be considered to have the same binding legal effect as if it
were the original signed version hereof delivered in person.
IN WITNESS WHEREOF, the parties have executed this Amendment through their duly authorized
representatives as of the date first written above.
| SPECTRANETICS CORPORATION | XXXXXX XXXX CORPORATION | |||||||||
| By: | /s/ Guy A. Childs | By: | /s/ Xxxxxx X. Xxxxxxxx | |||||||
| Name: | Guy A. Childs | Xxxxxx X. Xxxxxxxx | ||||||||
| Title: | Chief Financial Officer | Chief Executive Officer | ||||||||
| ***** | Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission. |
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AMENDED SCHEDULE B
DEVELOPMENT PLAN
DATED JUNE 22, 2009
DEVELOPMENT PLAN
DATED JUNE 22, 2009
*****
| ***** | Confidential portions of the material have been omitted and filed separately with the Securities and Exchange Commission. |
