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EXHIBIT 10.57
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
LICENSE AGREEMENT
This License Agreement (the "Agreement") is effective as of
December
31, 2001 (the "Effective Date") between ISIS PHARMACEUTICALS, INC.,
a Delaware
corporation having an address at 2292 Faraday Avenue, Carlsbad, CA
("Isis") and
EYETECH PHARMACEUTICALS, INC., a corporation having an address at
666 Fifth
Avenue, 35th Floor, New York, NY 10103 ("EyeTech"). Isis and
Eyetech may be
referred to herein as the "Parties," or each individually as a
"party."
ARTICLE 1
DEFINITIONS
Capitalized terms used herein have the meaning set forth in Exhibit
A.
ARTICLE 2
SCOPE OF LICENSE
2.1
Grant. Subject
to the terms of this Agreement and during the Term, Isis
grants to EyeTech a non-exclusive license under the Licensed Patent
Rights to
make, have made, use and sell EYE001 worldwide. The license is
sublicensable.
ARTICLE 3
LICENSE FEES AND ROYALTIES
3.1 Fees and
Royalties. EyeTech will pay to Isis the fees,
milestones and royalties set forth in this Article 3.
3.1.1
License Fees. EyeTech will pay an initial,
irrevocable and non-refundable license fee of $2,000,000 (the
"License Fee") to
Isis, $1,000,000 of which will be paid upon execution of this
Agreement and
$1,000,000 of which will be paid upon the earlier of (i) the date
of the AMD
Completed Patient Enrollment, or (ii) July 31, 2002.
3.1.2
Milestones. EyeTech will pay the following milestones
to Isis:
a. For
the initial indication of age-related
macular degeneration for EYE001:
[**]
b. For
each additional therapeutic indication
for EYE001:
[**]
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3.1.3
Royalties on EYE001. EyeTech will pay Isis a royalty
of [**] on Net Sales of EYE001 when the manufacture, use or sale of
EYE001 would
infringe the Licensed Patent Rights.
ARTICLE 4
PAYMENTS AND REPORTS
4.1 Payment.
Royalty payments will be due every three (3) months
beginning with the first commercial sale of EYE001 (each such
3-month period a
"Reporting Period") and will be paid within sixty (60) days of the
close of each
Reporting Period. Each royalty payment will be accompanied by a
statement of the
amount of Net Sales and all adjustments thereto during such
Reporting Period.
4.2 Mode of
Payment. EyeTech will make all payments required under
this Agreement in U.S. Dollars. The payments due on the sale of
EYE001 received
outside the United States will be translated using exchange rates
published in
the Wall Street Journal on the last day of the Reporting Period in
question.
4.3 Records
Retention. EyeTech and its sublicensees will keep
complete and accurate records pertaining to the sale of EYE001 and
covering all
transactions from which the Net Sales are derived for a period of
thirty-six
(36) months after the year in which such Net Sales were received,
and in
sufficient detail to permit Isis to confirm the accuracy of royalty
calculations
hereunder.
4.4 Audit
Request. No more than once each calendar year and at the
request of Isis, EyeTech will permit an independent, certified
public accountant
appointed by Isis and acceptable to EyeTech, at reasonable times
and upon
reasonable notice, to examine those records and all other material
documents
relating to or relevant to Net Sales in the possession or control
of EyeTech,
for a period of two (2) years after such royalties have accrued, as
may be
necessary to: (a) determine the correctness of any report or
payment made under
this Agreement; or (b) obtain information as to the royalties
payable for any
Reporting Period in the case of EyeTech's failure to report or pay
pursuant to
this Agreement. Said accountant will not disclose to Isis any
information other
than information relating to said reports, royalties, and payments
and will
disclose such information in a format agreed upon by the parties
that will
ensure that no confidential information of EyeTech is disclosed.
Results of any
such examination will be made available to both parties. The fees
charged by the
public accountant conducting the audit will be paid for by Isis,
provided that,
if the audit determines that the additional royalties payable by
EyeTech for an
audited period exceed [**] of the royalties actually paid for such
period, then
EyeTech will pay the fees and expenses charged by such accounting
firm.
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ARTICLE 5
PATENTS, INFRINGEMENT AND ENFORCEMENT
5.1 Patent
Prosecution and Maintenance. Isis will have the right
and responsibility to prosecute and/or maintain the Licensed Patent
Rights in
any country at its own expense. If ISIS decides to discontinue the
prosecution
or maintenance of any Licensed Patent Right entirely or in a
particular
country, it will inform EyeTech thereof with sufficient time for
EyeTech to
assume the prosecution or maintenance of such Licensed Patent
Right, and EyeTech
may assume such prosecution or maintenance if such Licensed Patent
Right
provides a substantial competitive advantage to EyeTech with
respect to EYE001
in the applicable country. If Isis has granted similar rights to
third parties,
EyeTech's rights under this section 5.1 will be shared equally with
such third
parties.
ARTICLE 6
REPRESENTATIONS AND WARRANTIES
6.1 Isis
Representation and Warranty. Isis warrants that it has
the lawful right to grant the license made the subject of this
Agreement. Except
as expressly stated in this section, Isis makes no other
representations of any
kind or nature whatsoever. ISIS MAKES NO WARRANTIES OR
REPRESENTATIONS, EXPRESS
OR IMPLIED, INCLUDING BUT NOT LIMITED TO, WARRANTIES OF FITNESS FOR
A PARTICULAR
PURPOSE OR MERCHANTABILITY OR NONINFRINGEMENT REGARDING OR WITH
RESPECT TO THE
LICENSED PATENTS. Without limiting the generality of the foregoing,
nothing in
this Agreement will be construed as (a) a warranty or
representation by Isis as
to validity or scope of the Licensed Patent Rights or (b) a
warranty or
representation that anything made, used, sold or otherwise disposed
of under the
license is or will be free from infringement of third party
rights.
6.2 EyeTech
Representations and Warranties. EyeTech represents and
warrants to Isis that EyeTech has the power and authority to
execute, deliver
and perform this Agreement, and this Agreement is a valid and
binding obligation
of EyeTech, enforceable in accordance with its terms.
ARTICLE 7
INDEMNITY
7.1 EyeTech
agrees to indemnify, hold harmless and defend Isis,
its officers, directors, employees and agents, from and against any
and all
claims, suits, losses, damages, costs, fees and expenses
(collectively,
"Claims") resulting from or arising out of (a) the development,
manufacture,
storage, sale or other distribution or any other use of EYE001 by
EyeTech, its
affiliates, sublicensees, agents and representatives or use by end
users and
other third parties of EYE001; and (b) EyeTech's breach of any
representation or
warranty herein.
7.2 In all
cases where Isis seeks indemnification from EyeTech
under this Article 7, Isis will promptly notify EyeTech of receipt
of any claim
or lawsuit covered by
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such indemnification obligation and will coopera