AMENDMENT TO LICENSE AGREEMENT
Exhibit 10.14.1
AMENDMENT
TO
This Amendment (the “Amendment”) is entered into as of April 5, 2005 (the “Effective Date”) to
modify the terms of the License Agreement (the “License Agreement”) dated as of March 15, 2004 by
and between DAIICHI SUNTORY PHARMA CO., LTD., a corporation organized and existing under the laws
of Japan and having its registered office at 0-0, Xxxxxxxxx 0-xxxxx, Xxxxxxx-xx, Xxxxx 000-0000,
Xxxxx (hereinafter referred to as “DSP”) and REPLIDYNE, INC., a corporation organized and existing
under the laws of the State of Delaware, having its principal business office at 0000 Xxxxxxxx
Xxxxx, Xxxxxxxxxx, Xxxxxxxx 00000, X.X.X. (hereinafter referred to as “REPLIDYNE”). DSP and
REPLIDYNE are sometimes referred to collectively herein as the “Parties” or individually as a
“Party.”
WITNESSETH:
WHEREAS, DSP and REPLIDYNE have signed a License Agreement regarding the development and
commercialization of Faropenem Daloxate for the United States and Canadian markets; and
WHEREAS, DSP and REPLIDYNE have entered into the License Agreement regarding the development and
commercialization of Faropenem Daloxate for the United States and Canadian markets; and
WHEREAS, since the License Agreement was signed, plans for the development and commercialization of
Faropenem Daloxate have changed; and
WHEREAS, in light of those developments, the parties agree to revise certain economic terms of the
License Agreement as indicated below.
NOW, THEREFORE, for and in consideration of the premises and covenants contained herein, DSP and
REPLIDYNE agree to amend the License Agreement as written below.
1. Section 6.1 “License Fees” shall be replaced in its entirety. The new Section 6.1 shall be
written as:
“6.1 License Fees. In consideration of the rights and benefits
granted hereunder, REPLIDYNE shall pay to DSP the following license fees
in Japanese Yen (hereinafter referred to as “JPY”):
| (a) | Four hundred million Japanese Yen (JPY 400,000,000) within thirty (30) days after execution of this Agreement; |
[ *** ] = Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
406 of the Securities Exchange Act Of 1933, as amended.
| (b) | Two hundred fifty million Japanese Yen (JPY 250,000,000) within ninety (90) days after the NDA filing in the Territory [ *** ]; | ||
| (c) | [ *** ] Japanese Yen (JPY [ *** ]) within ninety (90) days after the NDA approval in the Territory of [ *** ]; | ||
| (d) | [ *** ] Japanese Yen (JPY [ *** ]) within ninety (90) days after the NDA filing in the Territory of [ *** ]. | ||
| (e) | [ *** ]; | ||
| (f) | Five hundred million Japanese Yen (JPY 500,000,000) within ninety (90) days after the Launch, provided, however, [ *** ]; | ||
| (g) | [ *** ]. |
It is expressly understood that the amount paid by REPLIDYNE under the LOI,
i.e., One hundred million Japanese Yen (JPY 100,000,000) as the Up-Front
Payment and the payment for [ *** ] (as defined in the LOI), shall be
creditable to the payment due under subsection (a) of this Section
6.1.”
2. Furthermore, DSP and REPLIDYNE agree that a new Section 7.2(a) shall be replaced in its
entirety. The new Section 7.2(a) shall be written as:
“(a) If this Agreement is terminated by REPLIDYNE before [ *** ] the Drug Product for any
reason whatsoever, but excluding termination by REPLIDYNE due to DSP’s material breach
pursuant to Section 16.2, DSP’s bankruptcy, insolvency or the like pursuant to
Section 16.5, or DSP’s failure to obtain agreement from an Acquiring Party pursuant to
Section 16.6, then, provided that [ *** ], REPLIDYNE shall [ *** ] as a result of such
termination by REPLIDYNE such amount not to exceed [ *** ] Japanese Yen (JPY [ *** ]).
REPLIDYNE shall establish a commercially reasonable mechanism for securing REPLIDYNE’s
financial ability to make such payment or obtain an insurance, upon the signing of this
Agreement, which enables REPLIDYNE to finance the aforementioned payment.
If this Agreement is terminated by REPLIDYNE after [ *** ] the Drug Product for any reason
whatsoever, but excluding termination by REPLIDYNE due to DSP’s material breach pursuant to
Section 16.2, DSP’s bankruptcy, insolvency or the like pursuant to Section
16.5, or DSP’s failure to obtain agreement from an Acquiring Party pursuant to Section
16.6, then, provided that [ *** ], REPLIDYNE shall [ *** ] as a result of such termination
by REPLIDYNE such amount not to exceed an amount (the “Fee Cap”) determined from time to time
by the following formula:
JPY
[ *** ] – S MP = Fee Cap
| S MP = | the cumulative sum of the Milestone Payments due under Sections 6.1(b) through (f) for milestones actually achieved and paid as of any given date during the term of this Agreement. |
[ *** ] = Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
406 of the Securities Exchange Act of 1933, as amended.
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When S MP becomes greater than or equal to JPY [ *** ] no further [ *** ] will be required
under this Section 7.2(a).
For example: if the first [ *** ] of the Drug Product is for [ *** ] described under Section
6.1(b), then the Fee Cap will be reduced as follows:
JPY [ *** ] – JPY [ *** ] = JPY [ *** ]
To continue this example: If the second milestone achieved is [ *** ] described in Section
6.1(c), then the Fee Cap will be further reduced as follows:
JPY [ *** ] – (JPY [ *** ] + JPY [ *** ]) = [ *** ]”
3. Furthermore, DSP and REPLIDYNE agree that Section 18.3(b) shall be revised to read in its
entirety as follows:
(b) with respect to REPLIDYNE: (i) general liability insurance, including blanket
contractual liability coverage with bodily injury, death and property damage limits of
$10,000,000 per occurrence and $10,000,000 in the aggregate; and (ii) clinical studies and
product liability insurance with bodily injury, death and property damage limits of not less
than $5,000,000 per occurrence and $5,000,000 in the aggregate; provided, however, that
REPLIDYNE’s obligation to have such insurance shall not be required until commencement of
Development.
4. No other changes. Except as otherwise expressly provided in this Amendment, all of the terms
and conditions of the License Agreement shall remain in full force and effect.
5. Term of this Amendment. This Amendment shall become effective as of the Effective Date and
shall remain in full force and effect during the term of the License Agreement.
IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed by their duly
authorized officers upon the date first above written in duplicate original, one (1) original to be
retained by each of DSP and REPLIDYNE.
| DAIICHI SUNTORY PHARMA CO., LTD. | REPLIDYNE, INC. | |||||||||
Signature:
|
/s/ Xxxxxx Xxxxxxxx | Signature: | /s/ Xxxxxxx Xxxxxxx | |||||||
Name: Xxxxxx Xxxxxxxx
|
Name: Xxxxxxx Xxxxxxx | |||||||||
Title: President
|
Title: President and Chief Executive Officer | |||||||||
Date: May 9, 2005
|
Date: 4-5-05 | |||||||||
[ *** ] = Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
406 of the Securities Exchange Act of 1933, as amended.
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