Exhibit 10.1
SECOND AMENDMENT TO CO-DEVELOPMENT AGREEMENT
This Second
Amendment to Co-Development Agreement (this “Second
Amendment”) is made as of May 24, 2007, by and between
Southern Research Institute (“SRI”) and Bioenvision,
Inc. (as successor-in-interest to Eurobiotech Group, Inc.)
(“Bioenvision”).
RECITALS:
A.
SRI and Eurobiotech Group, Inc. entered into that certain
Co-Development Agreement, dated as of August 31, 1998, and
that certain Amendment to the Co-Development Agreement (the
“First Amendment”), dated as of March 12, 2001
(collectively, the “Co-Development
Agreement”).
B.
The parties desire to further amend the Co-Development Agreement as
provided herein to (i) provide that SRI will be entitled to a 7%
royalty on all product sales, whether such sales are made directly
by Bioenvision or by a sublicensee, sales partner or distributor,
(ii) to delete the profit-sharing agreement set forth in Section 6
of the current Co-Development Agreement in exchange for an
agreement by Bioenvision to pay to SRI certain milestone payments
provided for in this Second Amendment, and (iii) to make certain
other changes to the Co-Development Agreement in order to clarify
the respective rights and obligations of the parties.
C.
The parties specifically acknowledge that certain co-development
agreement, dated March 12, 2001, between Bioenvision, Inc. and ILEX
Oncology, Inc., predecessor-in-interest to Genzyme Corporation
(“Genzyme”, and such agreement, as amended, is the
“ILEX Co-Development Agreement”), and agree that this
Second Amendment does not purport to amend the Ilex Co-Development
Agreement.
D.
The parties specifically acknowledge that certain License
Agreement, dated and effective September 12, 2006, between
Bioenvision and SRI (the “Japan License”), pursuant to
which SRI granted to Bioenvision an exclusive license to
manufacture, sell, market and distribute Product in Japan and
“Southeast Asia” (as defined in the ILEX Co-Development
Agreement”), and agree that this Second Amendment does not
purport to amend the Japan License.
E.
Capitalized terms used but not otherwise defined herein shall have
the meaning(s) ascribed to such terms in the Co-Development
Agreement.
AGREEMENT
In consideration
of the foregoing and the mutual covenants and agreements set forth
in this Second Amendment and for other consideration, the receipt
and sufficiency of which is hereby acknowledged, the parties hereto
agree as follows:
1.
Article 1 “DEFINITIONS” is hereby amended by deleting
the text in Sections 1.C., 1.F., 1.G., 1.H. and 1.L. (definition of
“Net Income” included in the First Amendment) in their
entirety and replacing each with the following text:
“RESERVED.” Article 1 is further amended by
adding the following text immediately following Section 1.P.
thereof:
a.
Direct Sales” shall mean all sales of the Product made by
Bioenvision in the Territory, but not including sales by
Bioenvision to a Sales Partner.
b.
“Indirect Sales” shall mean sales of the Product by
any Sales Partner in the Territory.
c.
“Net Sales Revenue” shall mean the gross revenue
recognized by Bioenvision or its Sales Partner, as applicable, from
the sale of the Product through normal distribution channels to a
third party (other than an Affiliate of Bioenvision or a Sales
Partner) in the Territory, less Allowable Costs.
d.
“Sales Partner” shall mean any third party to which
Bioenvision grants a Sublicense of some or all of the rights
licensed to Bioenvision by SRI under Article 2 or Article 3
hereof.
e.
“Sublicense” shall mean an agreement pursuant to which
Bioenvision grants a sublicense of or otherwise transfers some or
all of the rights licensed to Bioenvision by SRI under Article 2 or
Article 3 hereof. If Bioenvision enters into an agreement
with such a third party pursuant to which such third party shall
have the right to control the marketing and sale of the Product
within a defined territory (for example, a marketing and/or
distribution arrangement under which a third party will have the
right to market, sell and/or resell the Product), then such an
agreement shall be deemed to be a “Sublicense.”
For avoidance of doubt, in certain limited circumstances in which
if Bioenvision enters into an agreement with a third party under
which such third party will exercise certain of the rights licensed
to Bioenvision under Article 2 hereof (other than the marketing or
sale of the Product) for the benefit of Bioenvision (for example,
if Bioenvision enters into a contract with a contract research
organization or a contract sales organization, and Bioenvision
retains the right to oversee and
2
control such third
party’s performance), then such arrangements shall not be
“Sublicenses” and such third parties shall not be
“Sales Partners.”
f.
“Sublicense Revenue” shall means all consideration
received by Bioenvision from a third party for the grant, or in
connection with the exercise of rights under, a Sublicense, but
excluding royalty payments based on Indirect Sales.
Sublicense Revenue shall include all upfront license fees,
milestone payments and the fair market value of any rights granted
to Bioenvision to use, market, sell, distribute, develop, import or
export products or technologies of a third party, in either case,
received by Bioenvision from any Sales Partner pursuant to a
Sublicense. Bioenvision shall not be entitled to deduct from
Sublicense Revenues any start-up costs, research and development
costs, general administrative expenses or other costs. For
clarity, (i) revenues derived from Indirect Sales shall be deemed
not to be Sublicense Revenue, and (ii) Bioenvision shall not be
obligated to pay SRI with respect to any such monies paid to
Bioenvision by a Sales Partner: (A) in exchange for shares of
Bioenvision stock or other equity securities, up to the fair market
value thereof; (B) to fund salaries, materials and related capital
in support of specific research activities pursuant to the
applicable Sublicense; or (C) for Product or other property or
assets up to an amount equal to the lesser of the fair market value
of such Product (meaning, the amount Bioenvision charges to third
parties for similar quantities of Product sold on similar delivery,
payment and other terms), property or assets, or
Bioenvision’s actual cost to acquire or manufacture such
Product, property or assets.
g.
“Allowable Costs” shall mean the following actual,
documented costs incurred by the seller (either Bioenvision or
Sales Partner) that relate specifically to the sale of the Product
for which Net Sales Revenue is being calculated: (i) value
added, sales, or use taxes, duties or other governmental tariffs;
(ii) trade, quantity and cash discounts, credits, rebates, or
allowances; (iii) Product returns and bad debts; (iv) freight,
shipping, transportation, and insurance charges; (v) discounts
mandated by, or granted to meet the requirements of, applicable
territorial laws or regulations; (vi) market based commissions paid
to unaffiliated contract sales organizations under non-exclusive
sales arrangements, not to exceed 8.0% unless agreed to in advance
in writing by SRI; and (vii) any other customary and reasonable
deductions that may be made from the sales price of the Product in
the Territories. Allowable Costs shall not include any (i)
start-up costs, (ii)
3
research and
development costs, or (iii) corporate overhead and general
administrative expenses.
All references to
“sublicenses” in the Agreement shall be deemed to be
deleted and replaced with the term
“Sublicenses.”
All references to
“sublicensees,” “distributors” and
“joint ventures” shall be deemed to be deleted and
replaced with the term “Sales Partner.”
2.
Article 5 of the Co-Development Agreement is hereby deleted in its
entirety and replaced with the following:
5.
ACQUISITION
A.
Genzyme Royalties . For purposes of the ILEX
Co-Development Agreement and only for such purpose, it is agreed
that the royalties received by Bioenvision from ILEX, its
Affiliates or sublicensees for the sales of Clofarabine or any
Product in the Field and in the Territory (as such terms are
defined in the ILEX Co-Development Agreement) shall be divided
between SRI and Bioenvision according to the percentage set forth
in the following table:
|
Annual Net Sales
Revenue ($Million)
|
|
Total Royalty
(% Net Sales Revenue)
|
|
% Total Royalty to SRI
|
|
0 – 30
|
|
8.75
|
|
71.429
|
|
30 –
100
|
|
11.25
|
|
55.556
|
|
100-200
|
|
12.50
|
|
56.000
|
|
200 –
500
|
|
15.00
|
|
50.000
|
|
500+
|
|
18.75
|
|
53.333
|
Bioenvision will pay
SRI its percentage of the royalties as