EXHIBIT 10.8
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 0000 Xxxxxxx Xxxxxx, Xxxxxxxx, XX ("Isis") and
EYETECH PHARMACEUTICALS, INC., a corporation having an address at 000 Xxxxx
Xxxxxx, 00xx Xxxxx, Xxx Xxxx, XX 00000 ("EyeTech").
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 cooperate fully with EyeTech in
connection with the investigation and defense of such claim or lawsuit. EyeTech
will have the right to control the defense, with counsel of its choice, provided
that Isis will have the right to be represented by advisory counsel at its own
expense. Neither party will settle or dispose of the matter in any matter that
could negatively and materially affect the rights or liability of the other
party without the prior written consent of such party, which will not be
unreasonably withheld or delayed.
ARTICLE 8
TERM AND TERMINATION
8.1 Term. This Agreement will commence as of the Effective Date
and continue until the last Licensed Patent Rights expire (the "Term").
8.2 Termination for Breach. Notwithstanding anything to the
contrary herein, a party may terminate this Agreement in the event that the
other party (the "Defaulting Party") materially breaches its obligations
hereunder and fails to cure such breach within [**] days of receipt of written
notice thereof (which notice will specify the breach in reasonable detail and
demand it be cured) (or, if such breach cannot be cured in such [**] day period,
if the Defaulting Party does not commence and diligently continue (until
completed) actions to cure such default). Such termination will be without
prejudice to the non-Defaulting Party's other rights under this Agreement, or
any of its other rights or remedies available to it by law or in equity.
8.3 Termination by EyeTech. Notwithstanding anything contained
herein to the contrary, EyeTech has the right to terminate this Agreement at any
time in its sole discretion by giving [**] days advance written notice to ISIS;
provided, that at the time of such termination EyeTech is not conducting (and
does not intend to conduct) itself in a manner that would, but for the license
granted in Article 2 of this Agreement, infringe the Licensed Patent Rights. In
the event of such termination by EyeTech, EyeTech will still be obligated to pay
any amounts due to Isis hereunder which, but for the lapse of time, will be owed
to Isis, including the unpaid portion of the License Fee. Notwithstanding
Section 3.1.1 above, any unpaid portion of the License Fee will be immediately
due and payable upon such termination.
8.3 Effect of Termination. Upon the termination of this Agreement
for any reason, all rights licensed to EyeTech will revert to Isis.
8.4 Accrued Rights, Surviving Rights and Obligations. Termination
or expiration of this Agreement for any reason will be without prejudice to any
rights that will have accrued to the benefit of either party prior to such
termination or expiration. Such termination or expiration will not relieve
either party from obligations that are expressly indicated to survive
termination or expiration of this Agreement including, without limitation,
EyeTech's obligation to pay all royalties that will have accrued hereunder.
Without limiting the foregoing, the parties' rights and obligations under
Articles 4, 6 and 7, and section 8.3 will likewise survive termination or
expiration of this Agreement.
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ARTICLE 9
MISCELLANEOUS
9.1 Relationship of the Parties. Nothing in this Agreement is
intended to create, or creates, a partnership or joint venture relationship
between the parties. The relationship between the parties hereunder is that of
independent contractors.
9.2 Successors and Assigns. Except as otherwise provided herein,
this Agreement may not be assigned by a party without the prior written consent
of the other, provided, however, that either party may assign this Agreement to
any successor by merger or to the purchaser of all or substantially all of its
assets provided that the party will remain liable and responsible for the
performance and observance of all of its duties and obligations hereunder.
Nothing in this Agreement, express or implied, is intended to confer upon any
party other than the parties hereto or their respective permitted successors and
assigns any rights, remedies, obligations or liabilities under this Agreement.
9.3 Governing Law. This Agreement will be governed by and
construed under the laws of the State of Delaware without giving effect to its
conflict of laws rules.
9.4 Counterparts. This Agreement may be executed in two or more
counterparts, each of which will be decreed an original, but all of which
together will constitute one and the same instrument.
9.5 Compliance With Laws. Both parties will comply with all
applicable laws, rules and regulations pertaining to the development, testing,
manufacture, marketing and import or export of EYE001 and will, as appropriate,
include similar provisions in any sublicense agreements requiring sublicensees
to do the same.
9.6 Notices. Unless otherwise provided, any notice required or
permitted under this Agreement will be given in writing and will be deemed
effectively given upon personal delivery to the party to be notified or five (5)
days after upon deposit with the United States Post Office by registered or
certified mail, postage prepaid or through a major courier (such as Federal
Express, DHL or UPS), or sent by facsimile, and addressed to the party to be
notified at the address set forth below.
To Isis: Isis Pharmaceuticals, Inc.
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
Attn: Executive Vice President
Fax: 000-000-0000
Phone: 000-000-0000
with copies to: General Counsel
Fax: 000-000-0000
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To EyeTech: Eyetech Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx
00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Chief Executive Officer
with copies to: General Counsel
9.7 Amendments and Waivers. Any term of this Agreement may be
amended and the observance of any term of this Agreement may be waived (either
generally or in a particular instance and either retroactively or
prospectively), only with the written consent of Isis and EyeTech. The waiver by
either of the parties of any breach of any provision hereof by the other party
shall not be construed to be a waiver of any succeeding breach of such provision
or a waiver of the provision itself.
9.8 Severability. If one or more provisions of this Agreement are
held to be unenforceable under applicable law, such provision will be excluded
from this Agreement and the balance of the Agreement will be interpreted as if
such provision were so excluded and will be enforceable in accordance with its
terms.
9.9 Force Majeure. No party will be deemed to be in default of
this Agreement to the extent the performance of its obligations or attempts to
cure any breach are delayed or prevented by reason of any act of God, war, fire,
natural disaster, accident, act of government, or any other cause beyond the
reasonable control of such party, if the party affected will give prompt notice
of any such event to the other party. In the event of such a force majeure
event, the time for performance or cure will be extended for the period equal to
the duration of such force majeure event but not in excess of six (6) months.
9.10 Entire Agreement. This Agreement is the entire agreement of
the parties with respect to the subject matter hereof, and any previous
agreements, discussions or understandings, whether written or oral, are hereby
merged herein.
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the
Effective Date.
ISIS PHARMACEUTICALS, INC. EYETECH PHARMACEUTICALS, INC.
By: /s/ B. Xxxxx Xxxxxxxx By: /s/Xxxxx Xxxxx
--------------------------------- -------------------------------
Name: B. Xxxxx Xxxxxxxx Name: Xxxxx Xxxxx
Title: Executive Vice President Title: CEO
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EXHIBIT A
DEFINITIONS
1. "AMD Completed Patient Enrollment" means the completion of enrollment of
that number of patients in Eyetech's Pivotal Phase II/III clinical trial
program that is necessary to gain Food and Drug Administration regulatory
approval of EYE001 for the treatment of the wet form of age-related macular
degeneration.
2. "Major Market" means Canada, any European Community member country, Japan
or the United States.
3. "Manufacturing Process" means the process steps [**] set forth in master
batch records for EYE001 in the version existing as of the Effective Date,
including reasonable minor variants and extensions of process steps
thereof.
4. "Net Sales" will mean the gross invoice price of EYE001 sold by EyeTech,
its affiliates and sublicensees to a third party less the following items:
(i) trade discounts, credits or allowances, (ii) credits or allowances
additionally granted upon returns, rejections or recalls (except where any
such recall arises out of EyeTech's or sublicensee's gross negligence,
willful misconduct or fraud), (iii) freight, shipping and insurance
charges, (iv) taxes, duties or other governmental tariffs (other than
income taxes) and (v) government-mandated rebates. EyeTech, its affiliates
or sublicensees will be treated as having sold EYE001 for an amount equal
to the fair market value of EYE001 if: (a) EYE001 is used by EyeTech, its
affiliates or sublicensees without charge or provision of invoice, or (b)
EYE001 is provided to a third party by EyeTech, its affiliates or
sublicensees without charge or provision of invoice and used by such third
party.
5. "EYE001" means EyeTech's EYE001 NX1838 non-antisense therapeutic product
(or any product containing EyeTech's EYE001 NX1838 non-antisense
therapeutic product for the treatment of ophthalmic conditions. EYE001 will
also include any minor chemical modification to EYE001 NX1838.
6. "Patent" or "Patents" means (a) patent applications (including provisional
applications and applications for certificates of invention); (b) any
patents issuing from such patent applications (including certificates of
invention); (c) all patents and patent applications based on, corresponding
to, or claiming the priority date(s) of any of the foregoing; and (d) any
substitutions, extensions (including supplemental protection certificates),
registrations, confirmations, reissues, divisionals, continuations,
re-examinations, renewals and foreign counterparts thereof.
7. "Licensed Patent Rights" means all Patents owned by Isis or controlled by
Isis through the Term which Isis has the right to sublicense with no
obligation to any third party, which claim or cover [**].
8. "Reporting Period" has the meaning set forth in Section 4.1.
9. "Term" has the meaning set forth in Section 8.1.
