Exhibit 10.27
Amendment to the Co-Development Agreement
between Bioenvision, Inc. and Southern Research Institute
WHEREAS Southern Research Institute ("SRI") and Eurobiotech Group, Inc. (now
Bioenvision, Inc., through a 100% equity purchase) (hereinafter "Bioenvision"),
had executed a Co-Development Agreement on August 31, 1998 for the commercial
development of Clofarabine, and
WHEREAS the parties to that Agreement now wish to amend the Agreement.
IT IS HEREBY AGREED THAT the following amendments shall apply:
1. In Article 1. DEFINITIONS, Clause H replaces the term Gross Sales
Revenue and shall now read:
H. Net Sales Revenue means the gross amount recognized by a party or
its Affiliates or sublicensees for the sale of Clofarabine or
other Product(s) through normal distribution channels (as
determined by generally accepted accounting principles and
industry practices), less any deductions for value added taxes
incurred, and not recovered by such party or the equivalent, or
trade discounts, or returns, or such deductions that may be made
from the sale price in the Territory.
In Article 1. DEFINITIONS, Clause F and G, substitute the term
"Gross Sales Revenue" with the term "Net Sales Revenue."
In Article 1. DEFINITIONS, Clause L shall now read:
L. Net Income means the difference between Net Sales Revenue
and the sum of Cost of Goods sold and Operating Expenses
(Appendix IV) with all royalties, local taxes, corporate
income taxes, foreign taxes, and accrued start-up and
development costs treated as excluded costs.
In Article 1. DEFINITIONS, Clause F delete the term "SRI" and replace with the
term "all."
2. In Article 10. DILIGENCE, Clause B shall now read:
B. Retention of rights by Bioenvision is contingent upon submission
of a NDA to the FDA within six years of the effective date of
this Agreement, provided that such date is consistent with the
regulatory strategy agreed upon by Bioenvision and SRI with the
FDA. The parties acknowledge and agree that SRI may agree to
extend the deadline for submission of a NDA to the FDA upon
request by Bioenvision, which agreement shall not be unreasonably
withheld, so long as Bioenvision continues to use all reasonable
efforts to complete the filing in due form as promptly and as
reasonably practicable during such extended period.
3. The following shall be an addendum to Article 5A:
For the purposes of the Co-Development Agreement between Bioenvision, Inc. and
Ilex Oncology, Inc. (hereinafter "ILEX") executed on March 8, 2001 (hereinafter
"Bioenvision-ILEX Agreement") in which ILEX shall be considered a sublicensee of
Bioenvision, and only for such purposes, 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 shall be divided
between SRI and Bioenvision according to the following table:
Annual Net Sales Total Royalty % Total Royalty
Revenue ($ Million) (% Net Sales Revenue) to SRI
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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 per above within
five (5) business days of receipt by Bioenvision from ILEX of the royalty
payments due Bioenvision in accordance with Article 8.2 of the Bioenvision-ILEX
Agreement by electronic wire transfer of funds in US dollars as per above to the
following account:
AmSouth Bank
Account No. 00000000
Routing No. 000000000
For Intellectual Property
The milestone payments paid by ILEX to Bioenvision in Article 3 of the
Bioenvision-ILEX Agreement shall be split 50/50 between Bioenvision and SRI.
Additionally, SRI shall receive 50% of the US$1.35 million closing payment to
Bioenvision from ILEX, referred to in Article 3.3 of the Bioenvision-ILEX
Agreement. All payments due SRI under Article 3 of the Bioenvision-ILEX
Agreement shall be made within five (5) business days of receipt by Bioenvision
from ILEX by electronic wire transfer of funds in US$ to the account designated
above.
4. In Article 4. LICENSE FEE AND RESEARCH AND DEVELOPMENT FUNDING, Clause D
shall now read:
Upon successful completion of Phase II clinical trials SRI and
Bioenvision may jointly pay the costs of Phase III clinical
trials and further Product development. If SRI shall not jointly
fund the cost of such trials Bioenvision may pay the costs in
full after paying a non-refundable option fee of $750,000 within
60 days of completion and evaluation of Phase II trials or 60
days from the commencement of Phase III trials, whichever is
earlier. Completion and evaluation, for this purpose, shall mean
the date on which all patients will have finished treatment as
defined in the protocol for the pivotal Phase II clinical trial.
If Bioenvision and SRI jointly develop the Product in Phase III
trials no option fee shall be payable by Bioenvision.
In Article 4, Clause E shall now read:
E. Bioenvision has issued to SRI one or more share certificates
evidencing, in the aggregate, 100,000 shares of Bioenvision
common stock. The share certificate(s) were issued in a
transaction not involving a public offering and, consequently,
bear a restrictive legend in accordance with requirements and
practice under The Securities Act of 1933, as amended. SRI
desires to have the restrictive legend on the share
certificate(s) removed. Bioenvision covenants and agrees to take
all necessary steps to cause new share certificates evidencing
those shares, without the restrictive legend, to be issued in
exchange for the share certificates containing the restrictive
legend, promptly and, in any event, within 15 business days after
SRI surrenders the existing share certificates, along with
customary stockholder representation letters and opinions of
counsel (relating to the satisfaction of the applicable holding
period and other requirements under Rule 144, etc.) for the
removal of the restrictive legend in compliance with applicable
securities laws.
5. In Article 12, PATENT PROSECUTION, Clause B shall now read
B. Bioenvision shall bear all patenting expenses related to the
filing, prosecution or maintenance of all Patent and Improvement
licensed hereunder in whole or in part.
Payments owed to SRI shall be payable within five (5) days after
the end of the month in which the invoice(s) for payment is
received by Bioenvision.
6. In Article 8. PAYMENTS AND REPORTS, Clause C shall now read:
C. All payments from Bioenvision to SRI shall be made by electronic
wire transfer of funds in US dollars to the account referred to
in Article 5A.
In Article 8, Clause H shall now read:
H. Bioenvision shall deliver to SRI within forty-five (45) days
after the end of each calendar quarter a report, certified by the
chief financial officer (or equivalent) of Bioenvision, setting
forth in reasonable detail the calculation of SRI payments made
during the quarter and for each calendar quarter, including gross
sales, net sales, value added taxes, number of units sold, unit
price, royalties by net sales range and the like on a
country-by-country basis, and include a sufficient basis for
understanding the methodology and rationale for calculating
profit sharing as per Appendix IV, by Bioenvision, sublicencees,
joint ventures and their affiliates.
In Article 8, add Clause X
X. Within fifteen (15) days of execution of the Bioenvision-ILEX
Agreement, Bioenvision shall pay to SRI all past due patent
prosecution costs in the sum of $US36,682.75 pursuant to Article
12.
7. Appendix I, attached hereto, is amended to update the list of patents
and/or patent applications referred to in Article 1, Clause M.
8. Appendix IV shall now read:
H Excludes all royalties.
I Excludes all royalties, local taxes, corporate income taxes, foreign taxes,
and accrued start-up and development costs.
In Appendix IV, substitute the term "Net Sales Revenue" for the term "Gross
Sales Revenue."
9. The following shall be added as Article 34.
34. SURVIVAL OF OBLIGATIONS
In the event of any termination of this Agreement, all obligations of
Bioenvision and SRI existing prior to termination and all obligations, whether
known or unknown at the time of termination, stemming from the act or omissions
of a given Party while this Agreement was in force and effect, shall remain an
obligation of the given Party until discharged. Article(s) 5, 6, 7, 9, 15, 18,
19, 21, 22 and 36 as well as any other provisions to the extent required for the
full observation and performance of the foregoing Articles or which by their
nature are intended to survive such termination, shall survive the termination
of this Agreement and continue to be enforceable.
10. Article 34. NOTICE is renumbered Article 35.
11. In Article 6, COMMERCIALIZATION STAGE, Clause A, substitute the term
"Net Sales Revenue" for the term "Gross Sales Revenue.
12. In Article 35, EXECUTION is renumbered as Article 36.
TN WITNESS WHEREOF, the parties have caused this amendment to be executed by
their duly authorized officers on the respective dates hereinafter set forth,
said amendment to be effective as of March 12th, 2001.
Bioenvision, Inc. Southern Research Institute
Signature /s/ X.X. Xxxx Signature /s/ Xxxxxxx X. Xxxxxx
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Print Name X.X. Xxxx Print Name Xxxxxxx X. Xxxxxx
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Date March 12, 2001 Date March 12, 2001
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