Gentium SpA Piazza XX Settembre, 2 - 22079 Villa Guardia (CO) Italy
Exhibit
99.4
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Gentium
SpA
Xxxxxx
XX Xxxxxxxxx, 0 - 00000 Xxxxx Xxxxxxx (XX)
Xxxxx
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October
12, 2007
Sigma-Tau
Pharmaceuticals Inc.
000
Xxxxx
Xxxxxxxxx Xxxxxx
Xxxxxxxxxxxx,
XX 00000
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Re:
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Defibrotide
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Ladies
and Gentlemen:
Reference
is made to the License and Supply Agreement dated as of December 7, 2001, as
amended (the “Agreement”),
between Sigma-Tau Pharmaceuticals, Inc. (“Sigma-Tau”)
and
Gentium S.p.A. (“Gentium”),
and
to Gentium’s proposal that Sigma-Tau share in certain costs relating to the
Development of the Product (all capitalized terms used and not defined herein
having the meanings set forth in the Agreement).
1. Section
3.3 (Variations) of the Agreement provides that “Either Party shall promptly
inform the other Party as soon as it becomes aware of any event which is likely
to cause a variation or materially impair the continuation of the Development
of
the Product. If such event (including but not limited to unforeseen requests
by
FDA or any other Governmental Authority), notwithstanding the exercise of due
care, is likely to cause a material increase of the budget allocated for the
Development of the Product and/or the schedule thereof, the Parties shall
discuss in good faith a revision of the Development plan and the terms and
conditions of this Agreement (including but not limited to the Consideration
provided for in Section V). In the event that the Parties do not agree upon
the
continuation of the Development of the Product within thirty (30) Business
Days
of the starting of the negotiation, each Party shall have the right to terminate
this Agreement by thirty (30) days written notice to the other
Party.”
2. Gentium
hereby invokes Section 3.3 of the Agreement and informs Sigma-Tau that events
which Gentium could not reasonably anticipate upon the date of the of the
Agreement have occurred that will cause a material increase of the budget and
schedule for Development of the Product. Therefore Gentium has requested that
Sigma-Tau pay for fifty percent (50%) of the following documented costs
(excluding any of Gentium’s internal costs), as well as associated legal fees,
for the Development of the Product:
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(i)
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costs
incurred by Gentium with the provider(s) of contract research organization
services relating to the Development of the Product, currently MDS
Pharma
Services (US) Inc.,
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(ii)
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reasonable
costs incurred by Gentium in connection with any additional clinical
trials, companion trials, or similar expansion of the Development
of the
Product required or recommended by the Food and Drug Administration
and
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(iii)
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other
reasonable costs that speed up or improve the Development of the
Product
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(collectively,
the “Costs”).
3. For
Sigma-Tau’s budgeting purposes, the currently known Costs and, where applicable,
estimates of their amounts, are attached hereto as Appendix
A;
Gentium
will promptly inform Sigma-Tau in advance of any additional Costs of which
it
becomes aware or changes to the estimates of the Costs and will then send
Sigma-Tau a revised budget of the Costs. The costs payable to MDS Pharma
Services (US) Inc. are hereby referred to as the “MDS
Pharma Costs.”
Exhibit
4
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Gentium
SpA
Xxxxxx
XX Xxxxxxxxx, 0 - 00000 Xxxxx Xxxxxxx (XX)
Xxxxx
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4. Without
prejudice to Sigma-Tau’s rights under the Agreement, including without
limitation those under Section III, Sigma-Tau agrees to pay fifty percent (50%)
of the Costs. To such effect, Sigma-Tau will reimburse Gentium fifty percent
(50%) of each documented invoice for the Costs, within thirty (30) days from
receipt of a copy of such invoice. Sigma-Tau agrees that two initial invoices
for a portion of the MDS Pharma Costs are attached hereto as Appendix
B
and to
pay fifty percent (50%) of such invoices within thirty (30) days of the date
of
this Agreement. This agreement of Sigma-Tau to share in the Costs is made with
the purpose to speed up the Development of the Product relating to Approval
of
the Product and to proceed in the shortest possible time with the registration
and commercialization activities under the Agreement.
5. For
the
avoidance of doubt, should Sigma-Tau elect at any time not to reimburse Gentium
fifty percent (50%) of any of the Costs (other than MDS Pharma Costs, of which
Sigma-Tau hereby agrees to pay fifty percent (50%)), the Parties shall discuss
in good faith a revision of the Development plan and the terms and conditions
of
the Agreement (including but not limited to the Consideration provided for
in
Section V) pursuant to Section 3.3 of the Agreement and the provisions of the
Agreement relevant to any termination shall apply. In particular, for the
interpretation of Section 3.4 (Discontinuation) of the Agreement, the portion
of
the Costs paid by Sigma-Tau hereunder is deemed to be included in Schedule
2 of
the Agreement.
This
letter is made in two originals. If you are in agreement with its contents,
please sign both of them for acceptance and return one original to
us.
Yours
sincerely,
By:
/s/
Xxxx
X. Xxxxxxxxx
Name: Xxxx
X.
Xxxxxxxxx
Title: Chief
Financial Officer
and
Executive Vice President
Accepted
and agreed
SIGMA-TAU
PHARMACEUTICALS INC.
By:
/s/
Xxxxx
Xxxxxxx
Name: Xxxxx
Xxxxxxxx
Title: Chief
Operating Officer
Appendix
A
Current
Costs Estimate
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MDS
Pharma Historical Arm Costs:
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$5,170,574
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MDS
Pharma Prospective Arm Costs:
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$2,935,994
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To
be determined
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Expanded
Access Trial Costs:
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To
be determined
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Appendix
B
Invoices
for MDS Pharma Costs
[Intentionally
omitted]
