EXHIBIT 10.21
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
AGREEMENT
This agreement ("Agreement") is effective as of the 17th day of September, 2003
("Effective Date") between THE BOARD OF TRUSTEES OF THE XXXXXX XXXXXXXX JUNIOR
UNIVERSITY ("Stanford"), an institution of higher education having corporate
powers under the laws of the State of California, and Alnylam Pharmaceuticals,
Inc. ("Alnylam" or "Licensee"), a corporation having a principal place of
business at 000 Xxxxxxxx Xxxxx, Xxxxx 000, Xxxxxxxxx, XX 00000. Stanford and
Alnylam agree as follows:
1 BACKGROUND
1.1 Stanford has an assignment of "Efficient RNA Transfection to the Livers
of Living Mice" from the laboratory of Xxxx Xxx ("Invention"), as
described in Stanford Docket S00-012 and any Licensed Patent, as
defined below, which may issue to the Invention.
1.2 Stanford wants to have the Invention perfected and marketed as soon as
possible so that resulting products may be available for public use and
benefit.
1.3 Alnylam wants a license under the Invention, and Licensed Patent to
develop, manufacture, use, and sell Licensed Product in the field of
use of Delivery of synthesized siRNA molecules for research and
therapeutic use.
1.4 The Technology and Invention were made in the course of research
supported by the National Institutes of Health (NIH).
2 DEFINITIONS
2.1 "Licensed Patents" means all patent applications filed on the Invention
and all patents issuing thereon including
(A) Stanford's U.S. Patent Application, Serial Number [**]
entitled [**],[**],
(B) Stanford's U.S. Patent Application, Serial Number [**]
entitled [**],
(C) [**]the Continuation-in-Part, Serial Number [**] entitled
[**], and
(D) any divisions, continuations and any foreign patent
application or equivalent corresponding thereto, and any
Letters patent or equivalent thereof issuing thereon or
reissue, reexamination or extension thereof.
(E) Continuation-in-part applications (CIPs) that are offered to
the other co-exclusive licensee will also be offered to
Alnylam for licensing in the Licensed Field of Use.
2.2 "Licensed Product" means any product or part in the Licensed Field of
Use, the manufacture, use, or sale of which:
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(A) is covered by a valid claim of an issued, unexpired Licensed
Patent directed to the Invention in the country in which it is
made, used or sold. A claim of an issued, unexpired Licensed
Patent is presumed to be valid unless it has been held to be
invalid or unenforceable by a final judgment of a court of
competent jurisdiction from which no appeal can be or is
taken; rendered unenforceable through disclaimer or otherwise;
donated to the public; or lost through an interference
proceeding; or
(B) is covered by any claim being prosecuted in a pending
application of Licensed Patents in the country in which it is
made, used or sold unless such claim has been pending in such
application or an earlier application of Licensed Patents for
greater than [**] years.
2.3 "Net Sales" means the gross commercialization revenue derived by
Alnylam and any sublicensee from Licensed Product, less the following
items but only as they actually pertain to the disposition of Licensed
Product by Alnylam and any sublicensee, are included in gross revenue,
and are separately billed:
(A) import, export, excise and sales taxes, and custom duties;
(B) costs of insurance, packing, and transportation from the place
of manufacture to the customer's premises or point of
installation;
(C) costs of installation at the place of use; and
(D) credit for returns, allowances, or trades; and
(E) customary trade, quantity or cash discounts actually allowed
or taken.
(F) Where Licensed Products are not sold separately, but are sold
in combination with or as parts of other therapeutic products,
hereinafter such combinations referred to as a "Combination
Product" and the Licensed Product and each such other product
being referred to as a "Component Product", the Net Sales
price to be used for the purpose of calculating royalties
payable in respect of Combination Products must be determined
by multiplying the Net Sales price of the Combination Product
by the percentage value of the Licensed Product comprising a
Component Product contained in the Combination Product, such
percentage value being determined by dividing the current
market value of the Licensed Product comprising a Component
Product by a sum of the separate current market values of each
of the Component Products which are contained in the
Combination Product. The current market value of each of the
Component Products must be for a quantity comparable to that
contained in the Combination Product and of the same class,
purity and potency. When no current market value is available
for a Component Product, a reasonable hypothetical market
value for such Component Product based upon the allocation of
the same proportions of costs, reasonable overhead and profits
(all of which must be determined on the basis of generally
accepted accounting principles) as are or should be allocated
to similar Component Products and having an ascertainable
market value.
2.4 "siRNA Molecule" means an agent that modulates expression of a target
gene by an RNA interference mechanism.
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2.5 "Licensed Field of Use" means delivery of ex-vivo synthesized siRNA
Molecules for research, development and therapeutic uses (including a
diagnostic necessary for development, sale or reimbursement of a
therapeutic Licensed Product). The Licensed Field of Use specifically
excludes delivery of any system producing in vivo expressed siRNAs for
therapeutic use, including but not limited to episomal and integrated
vectors, and recombinant viruses.
2.6 "Licensed Territory" means worldwide.
2.7 "Co-Exclusive" means that, subject to Article 4, Stanford will only
grant one further license in the Licensed Territory in the Licensed
Field of Use.
2.8 "Affiliate" means any legal entity (such as a corporation, partnership,
or limited liability company) that directly, or indirectly through one
or more intermediaries, controls or is controlled by, or is under
common control with Company and that is bound by the terms and
conditions of this Agreement. For the purposes of this definition, the
term "control" means (i) beneficial ownership of at least fifty percent
(50%) of the voting securities of a corporation or other business
organization with voting securities or (ii) a fifty percent (50%) or
greater interest in the net assets or profits of a partnership or other
business organization without voting securities. For purposes of this
Agreement, the term Alnylam shall include its Affiliates, unless the
context indicates otherwise.
3 GRANT
3.1 GRANT. Stanford grants and Alnylam accepts a license in the Licensed
Field of Use to make, have made, use, have used, sell, have sold,
import and have imported Licensed Product in the Licensed Territory.
3.2 CO-EXCLUSIVITY. The license is Co-Exclusive, including the right to
sublicense pursuant to Article 13, in the Licensed Field of Use for a
term beginning on the Effective Date, and ending, on a
country-by-country basis, on the expiration of the last to expire of
Licensed Patents.
3.3 RETAINED RIGHTS. Stanford may practice the Invention and use the
Technology for its own bona fide research, including sponsored research
and collaborations. Stanford has the right to publish any information
included in Technology and Licensed Patent.
3.4 EXCLUSIVITY.
(A) If the other Co-Licensee discontinues licensing this Field of
Use, then the Field of Use will become exclusive for Alnylam.
(B) If the other Co-Licensee discontinues any other therapeutic
license under the Licensed Patents, Stanford shall so inform
Alnylam and Alnylam shall have the option to obtain an
exclusive, worldwide sublicensable license to such therapeutic
field. The terms of any such license shall be negotiated in
good faith by Stanford and Alnylam. This option may be
exercised by Alnylam by written notice to Stanford at any time
during a period of ninety (90) days after notification by
Stanford.
4 GOVERNMENT RIGHTS
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This Agreement is subject to all of the terms and conditions of Xxxxx 00 Xxxxxx
Xxxxxx Code Sections 200 through 204, including an obligation that Licensed
Product sold or produced in the United States be "manufactured substantially in
the United States." Alnylam will take all reasonable action necessary on its
part as licensee to enable Stanford to satisfy its obligations to the U.S.
Government under Title 35. If Alnylam reasonably desires an exception to the
government requirement of substantial manufacture in the United States then
Stanford shall reasonably cooperate with Alnylam in obtaining such exception.
5 DILIGENCE
5.1 MILESTONES. As an inducement to Stanford to enter into this Agreement,
Alnylam will use all commercially reasonable efforts and diligence to
develop, manufacture, and sell or lease Licensed Product and to
diligently develop markets for the Licensed Product. In particular,
Alnylam will meet the milestones shown in Appendix A, which shall
satisfy Alnylam's diligence obligations. If Alnylam in good faith fails
to meet a milestone set forth in Appendix A, then Alnylam shall have a
[**] period of time to reestablish diligence towards its objectives,
and if Alnylam reestablishes diligence towards its objectives during
this [**] period, any prior lack of diligence will be deemed cured. If
Alnylam does not reestablish diligence towards its objectives during
this [**] period, Stanford may terminate this Agreement if Alnylam has
not met the milestones. Stanford may terminate this Agreement if
Alnylam or a sublicensee has not sold Licensed Product for any [**]
period after Alnylam's or a sublicensee's first commercial sale of
Licensed Product. Efforts by Alnylam's sublicensees or Affiliates shall
be considered efforts of Alnylam under this section.
5.2 PROGRESS REPORT. Alnylam acknowledges that diligent development of
Licensed Product is of utmost importance to Stanford. On or before
September 30 of each year until Alnylam markets a Licensed Product,
Alnylam will make a written annual report in confidence to Stanford
covering the preceding year ending June 30, regarding the progress of
Alnylam toward commercialization of Licensed Product. The report will
include, as a minimum, information (e.g., summary of work completed,
key scientific discoveries, summary of work in progress, current
schedule of anticipated events or milestones and market plans for
introduction of Licensed Product) sufficient to enable Stanford to
satisfy reporting requirements of the U.S. Government and for Stanford
to ascertain progress by Alnylam toward meeting the diligence
requirements of this Article 5.
6 ROYALTIES
6.1 ISSUE ROYALTY. Alnylam will pay to Stanford a noncreditable,
nonrefundable license issue royalty of $[**] on signing this Agreement.
6.2 MINIMUM ROYALTY. Beginning one year from the Effective Date, and each
anniversary thereafter, Alnylam will pay to Stanford a yearly royalty
of $[**]. Yearly royalty payments are nonrefundable, but they are
creditable against earned royalties to the extent provided in Section
6.4.
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6.3 EARNED ROYALTY. In addition, Alnylam will pay Stanford earned royalties
on Net Sales as follows:
(A) [**]% of Net Sales for a Licensed Product subject to the
following;
(B) Such royalty payments shall be reduced up to [**]% (from [**]%
of Net Sales down to [**]% of Net Sales) by the amount of
royalty paid to access additional intellectual property
necessary in order to sell Licensed Products ("Additional
Earned Royalties").
(C) Such royalty payments shall be reduced as follows:
(1) [**]% if Additional Earned Royalties are [**]% or
less.
(2) [**]% if Additional Earned Royalties are greater than
[**]% but less than [**]%.
(3) [**]% if Additional Earned Royalties are equal to or
greater than [**]% but less than [**]%.
(4) [**]% if Additional Earned Royalties are equal to or
greater than [**]% but less than [**]%.
(5) [**]% if Additional Earned Royalties are equal to or
higher than [**]%.
(D) Only one royalty is due on each Licensed Product sold by
Alnylam or its sublicensees regardless of whether its
manufacture, use, importation or sale are or shall be covered
by more than one patent or patent application included in
Licensed Patents under this Agreement, and no further
royalties will be due for use of such Licensed Product by
Alnylam or its sublicensee's customers.
6.4 CREDITABLE PAYMENTS. Creditable payments under this Agreement will be
an offset to Alnylam against each earned royalty payment which Alnylam
would be required to pay under Section 6.3 until the entire credit is
exhausted.
6.5 MILESTONE PAYMENTS.
(A) For the first Licensed Product, Alnylam will make the
following payments for the filing of an IND, initiation of
Phase II trial, initiation of Phase III trial, and approval of
New Drug Application or equivalent in the U.S. ("Milestone
Payments"):
(1) $[**] for filing of the first IND.
(2) $[**] for initiation of the first Phase II trial.
(3) $[**] for initiation of the first Phase III trial.
(4) $[**] for approval of the first New Drug Application
or equivalent regulatory approval in the U.S.
(B) For the second Licensed Product, Alnylam will make the
following Milestone Payments:
(1) $[**] for filing of the first IND.
(2) $[**] for initiation of the first Phase II trial.
(3) $[**] for initiation of the first Phase III trial.
(4) $[**] for approval of the first New Drug Application
or equivalent regulatory approval in the U.S.
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(C) For the third and every subsequent Licensed Product, Alnylam
will make the following Milestone Payments:
(1) $[**] for filing of the first IND.
(2) $[**] for initiation of the first Phase II trial.
(3) $[**] for initiation of the first Phase III trial.
(4) $[**] for approval of the first New Drug Application
or equivalent regulatory approval in the U.S.
(D) Notwithstanding the above, at the time that Stanford receives
a Milestone Payment from Alnylam on behalf of a sublicensee
under Section 13.6, the corresponding Milestone Payment under
this Section 6.5 will not be due.
6.6 OBLIGATION TO PAY ROYALTIES. If this Agreement is not terminated in
accordance with other provisions, Alnylam will be obligated to pay
royalties on all Licensed Product that is either sold or produced under
the license granted in Article 3, whether or not the Licensed Product
is produced before the Effective Date of this Agreement or sold after
the Licensed Patent has expired.
6.7 CURRENCY. The royalty on sales in currencies other than U.S. Dollars
will be calculated using the appropriate foreign exchange rate for the
currency quoted by the Bank of America (San Francisco) foreign exchange
desk, on the close of business on the last banking day of each calendar
quarter. Royalty payments to Stanford will be in U.S. Dollars. All
non-U.S. taxes related to royalty payments will be paid by Alnylam and
are not deductible from the payments due Stanford. Stanford shall
assist Alnylam as reasonably requested by Alnylam and at Alnylam's
expense, in recovering such taxes to the extent possible under
applicable tax laws and treaties.
6.8 PATENT COSTS. Within thirty days after receiving a statement from
Stanford during the Co-Exclusive period, Alnylam will reimburse
Stanford:
(A) [**] of the Licensed Patent patenting expenses incurred by
Stanford before the Effective Date; and
(B) $[**] per year for Licensed Patent patenting expenses incurred
by Stanford after the Effective Date.
(C) If the Field of Use covered in this license becomes Exclusive
for Alnylam, Stanford and Alnylam will negotiate coverage of
patent expenses in good faith.
6.9 PATENT PROSECUTION.
(A) Stanford will be responsible for the filing, prosecution and
maintenance of the Licensed Patents. Alnylam shall be kept
informed of and shall receive copies of all documentation and
substantive actions pertaining to the filing, prosecution and
maintenance of Licensed Patents. Alnylam shall have reasonable
opportunities to participate in decision making and Stanford
will use diligent efforts to incorporate Alnylam's reasonable
suggestion.
(B) Throughout the term of this agreement, Alnylam will retain
rights to any claims that have support in the Licensed Patents
(defined in Section 2.1), whether or not they are in a CIP.
(C) If Stanford elects not to continue to seek or maintain patent
prosecution on any Licensed Patent in any country during the
co-exclusive term of the license despite
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Alnylam's willingness to pay its share of the prosecution
costs, Alnylam shall have the right, at its expense, to
procure, maintain and enforce in any country such Licensed
Patent.
6.10 MOST FAVORED LICENSEE Stanford warrants and represents that it has not
granted a license in the Field of Use to another party and shall not do
so in the future on terms that are more favorable than those hereby
granted to Alnylam.
7 ROYALTY REPORTS, PAYMENTS, AND ACCOUNTING
7.1 QUARTERLY EARNED ROYALTY PAYMENT AND REPORT. Beginning with the first
sale of a Licensed Product, Alnylam will make written reports (even if
there are no sales) and earned royalty payments to Stanford within
thirty days after the end of each calendar quarter. This report will be
in the form of the report of Appendix B and will state the number,
description, and aggregate Net Sales of Licensed Product during the
completed calendar quarter, and resulting calculation pursuant to
Section 6.3 of earned royalty payment due Stanford for the completed
calendar quarter. With each report, Alnylam will include payment due
Stanford of royalties for the completed calendar quarter.
7.2 TERMINATION REPORT. Alnylam will make a written report to Stanford
within ninety days after the license expires under Section 3.2. Alnylam
will continue to make reports after the license has expired, until all
Licensed Product produced under the license have been sold or
destroyed. Concurrent with the submittal of each post-termination
report, Alnylam will pay Stanford all applicable royalties.
7.3 ACCOUNTING. Alnylam will keep and maintain records for a period of
three years showing the manufacture, sale, use, and other disposition
of products sold or otherwise disposed of under the license. Records
will include general-ledger records showing cash receipts and expenses,
and records that include production records, customers, serial numbers,
and related information in sufficient detail to enable Alnylam to
determine the royalties payable under this Agreement.
7.4 AUDIT BY STANFORD. Alnylam will permit an independent certified public
accountant selected by Stanford and acceptable to Alnylam to examine
Alnylam's books and records from time to time (but no more than one
time a year) to the extent necessary to verify reports provided for in
Sections 7.1 and 7.2. Stanford will pay for the cost of such audit,
unless the results of the audit reveal an underreporting of royalties
due Stanford of five percent or more, in which case, Alnylam will pay
the audit costs.
8 NEGATION OF WARRANTIES
8.1 To the best of Stanford's OTL knowledge, Stanford is the sole owner of
Licensed Patent and has the right to enter into this Agreement and to
grant the rights and licenses set forth herein.
8.2 NEGATION OF WARRANTIES. Nothing in this Agreement is construed as:
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(A) Stanford's warranty or representation as to the validity or
scope of any Licensed Patent;
(B) A warranty or representation that anything made, used, sold,
or otherwise disposed of under any license granted in this
Agreement is or will be free from infringement of patents,
copyrights, and other rights of third parties;
(C) An obligation to bring suit against third parties for
infringement, except as described in Article 12;
(D) Granting by implication, estoppel, or otherwise any licenses
or rights under patents or other rights of Stanford or other
persons other than Licensed Patent, regardless of whether the
patents or other rights are dominant or subordinate to any
Licensed Patent; or
(E) An obligation to furnish any technology or technological
information.
8.3 NO WARRANTIES. Except as expressly set forth in this Agreement,
Stanford makes no representations and extends no warranties of any
kind, either express or implied. There are no express or implied
warranties of merchantability or fitness for a particular purpose, or
that Licensed Product will not infringe any patent, copyright,
trademark, or other rights, or any other express or implied warranties.
8.4 SPECIFIC EXCLUSION. Nothing in this Agreement grants Alnylam any
express or implied license or right under or to U.S. Patent 4,656,134
entitled "Amplification of Eucaryotic Genes" or any patent application
corresponding thereto.
9 INDEMNITY
9.1 INDEMNIFICATION. Alnylam will indemnify, hold harmless, and defend
Stanford and Stanford Hospitals and Clinics, and their respective
trustees, officers, employees, students, and agents against all claims
for death, illness, personal injury, property damage, and improper
business practices arising out of the manufacture, use, sale, or other
disposition of Invention, Licensed Patent, Licensed Product, by Alnylam
or any sublicensee, or their customers except to the extent such claims
are due to the gross negligence or willful misconduct of Stanford.
Stanford agreed to promptly notify Alnylam in writing of any such claim
and Alnylam shall manage and control, at its own expense, the defense
of such claim and its settlement. Alnylam agrees not to settle any such
claim against Stanford without Stanford's written consent where such
settlement would include any admission of liability on the part of
Stanford, where the settlement would impose any restriction on the
conduct by Stanford of any of its activities, or where the settlement
would not include an unconditional release of Stanford from all
liability for claims that are the subject matter of such claim.
9.2 NO LIABILITY. Subject to Section 9.1, neither party will be liable to
each other for any loss profit, expectation, punitive or other
indirect, special, consequential, or other damages whatsoever, in
connection with any claim arising out of or related to this Agreement
whether grounded in tort (including negligence), strict liability,
contract, or otherwise.
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9.3 WORKERS' COMPENSATION. Alnylam will at all times comply, through
insurance or self-insurance, with all statutory workers' compensation
and employers' liability requirements covering all employees with
respect to activities performed under this Agreement.
9.4 INSURANCE. Alnylam will maintain, during the term of this Agreement,
Comprehensive General Liability Insurance, including Product Liability
Insurance prior to commercialization, with a reputable and financially
secure insurance carrier to cover the activities of Alnylam and its
sublicensees. Upon initiation of human clinical trials of Licensed
Product, such insurance will provide minimum limits of liability of
Five Million Dollars and will include Stanford and Stanford Hospitals
and Clinics, and their respective trustees, directors, officers,
employees, students, and agents as additional insureds. Insurance will
be written to cover claims incurred, discovered, manifested, or made
during or after the expiration of this Agreement and must be placed
with carriers with ratings of at least A- as rated by A.M. Best.
Alnylam will furnish a Certificate of Insurance evidencing primary
coverage and additional insured requirements and requiring thirty (30)
days prior written notice of cancellation or material change to
Stanford. Alnylam will advise Stanford, in writing, that it maintains
excess liability coverage (following form) over primary insurance for
at least the minimum limits set forth above. All insurance of Alnylam
will be primary coverage; insurance of Stanford and Stanford Hospitals
and Clinics will be excess and noncontributory.
10 MARKING
Before the issuance of Licensed Patents, Alnylam will xxxx Licensed Product (or
their containers or labels) made, sold, or otherwise disposed of by it under the
license granted in this Agreement with the words "Patent Pending," and following
the issuance of one or more patents, with the numbers of the Licensed Patent.
11 STANFORD NAMES AND MARKS
Alnylam will not identify Stanford in any promotional advertising or other
promotional materials to be disseminated to the public or to use the name of any
Stanford faculty member, employee, or student, or any trademark, service xxxx,
trade name, or symbol of Stanford or Stanford Hospitals and Clinics, or any that
is associated with any of them, without Stanford's prior written consent, except
as may be required by law. Any use of Stanford's name will be limited to
statements of fact, e.g., that Stanford has co-exclusively licensed Licensed
Patents to Alnylam, and will not imply endorsement of Alnylam's products or
services.
12 INFRINGEMENT BY OTHERS: PROTECTION OF PATENTS
12.1 INFRINGEMENT ACTION.
(A) The parties will promptly inform each other of any suspected
infringement of any Licensed Patent by a third party.
(B) Stanford, Licensee and the other Co-Exclusive licensee will
meet to discuss the matter during the Co-Exclusive period of
this Agreement.
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(C) If the Field-of-Use becomes Exclusive for Licensee, Stanford
and Licensee will meet to discuss the matter during the
Exclusive period of this Agreement.
(D) If Stanford does not choose to institute suit against said
third party within sixty days of notification, then the suit
may be brought in both Licensee's and the other Co-Exclusive
licensee's names, and Stanford's name if necessary and the
out-of-pocket costs thereof shall be borne equally by Licensee
and the other Co-Exclusive licensee and any recovery or
settlement shall be shared equally between Licensee and the
other Co-Exclusive licensee. In such situation, Licensee and
the other Co-Exclusive licensee shall agree to the manner in
which they exercise control over such action and if either
party desires to also be represented by separate counsel of
its own selection, the fees for such counsel shall be paid by
such party.
(E) If both, Stanford and the other Co-Exclusive licensee, or
Stanford if there is no other Co-Exclusive Licensee, choose
not to institute suit against said third party within sixty
days of notification, then Licensee shall have the right to
institute suit in its own name or if necessary, in Stanford's
name, to enjoin such infringement. Licensee shall bear the
entire cost of such litigation and shall be entitled to retain
the entire amount of any recovery or settlement. However, any
recovery in excess of litigation/settlement costs will be
considered Net Sales and Licensee will pay Stanford royalties
as indicated in Article 6 hereof. Stanford shall provide
reasonable assistance to Licensee in the prosecution of any
such suit brought by Licensee, at Licensee's expense.
13 SUBLICENSING
13.1 PERMITTED SUBLICENSING FOR LICENSED CO-EXCLUSIVE FIELD OF USE. Alnylam
may grant sublicenses in the Co-exclusive Licensed Field of Use during
the Co-Exclusive period:
(A) only in conjunction with intellectual property under Alnylam's
control; and
(B) only if Alnylam is developing or selling Licensed Products in
the Co-Exclusive Licensed Field of Use.
13.2 REQUIRED SUBLICENSING FOR LICENSED CO-EXCLUSIVE FIELD OF USE.
(A) If Alnylam or its sublicensee(s) is unable or unwilling to
serve or develop a potential market or market territory for
which there is a willing sublicensee, Alnylam will, at
Stanford's request, negotiate in good faith a sublicense under
the Licensed Patents, provided that the same request has been
made of the other Co-Exclusive licensee.
(B) Bona fide business concerns of Alnylam will be considered in
any good faith negotiations for a sublicense under this
Agreement and Alnylam shall not be required to
license/sublicense any other intellectual property to such
sublicensee.
(C) If the other Co-Exclusive licensee itself or through its
sublicensees is already developing a product in the market or
market territory for which there is a willing sublicensee,
Alnylam will not be required to sublicense to such party.
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(D) In case that any other issue arises in the context of Required
Sublicensing, Stanford will discuss and try to resolve such
issue with Alnylam in good faith.
13.3 SUBLICENSE REQUIREMENTS. Any sublicense granted by Alnylam under this
Agreement will be subject and subordinate to terms and conditions of
this Agreement, except:
(A) Sublicense terms and conditions will reflect that any
sublicensee will not further sublicense, with the exception
that sublicensee may further sublicense rights under Licensed
Patents only as needed or implied in the course of
distribution or performance of service as required for the
sale to an end user of Licensed Products; and
(B) The earned royalty rate specified in the sublicense may be at
different rates than the rates in this Agreement.
13.4 SUBLICENSES REVERT TO STANFORD. Any sublicense will expressly include
the provisions of Articles 7, 8, and 9 for the benefit of Stanford. If
a sublicensee desires that its sublicense survive the termination of
this agreement, Stanford agrees that the sublicense will revert to
Stanford subject to the transfer of all obligations, including the
payment of royalties specified in the sublicense, to Stanford or its
designee, if this Agreement is terminated.
13.5 COPY OF SUBLICENSES. Alnylam will provide Stanford in confidence a copy
of all relevant portions of any sublicenses granted pursuant to this
Article 13.
13.6 SHARING OF SUBLICENSING INCOME. In addition to the earned royalties
defined in Article 6, Alnylam will pay Stanford [**] percent ([**]%) of
the amount received by Alnylam, that is specifically attributable to
the Licensed Patents, from a sublicensee in
(A) up-front license fees, and
(B) clinical Milestone Payments as defined in Article 6.5.
13.7 ROYALTY-FREE SUBLICENSES. Alnylam may grant royalty-free or noncash
sublicenses or cross-licenses if Alnylam pays all royalties due
Stanford from sublicensee's Net Sales.
14 TERMINATION
14.1 TERMINATION BY ALNYLAM - Alnylam may terminate this Agreement by giving
Stanford notice in writing at least thirty days in advance of the
effective date of termination selected by Alnylam.
14.2 TERMINATION BY XXXXXXXX - Xxxxxxxx may terminate this Agreement if:
(A) Alnylam is:
(1) delinquent on any royalty payment or report;
(2) not diligently developing and commercializing
Licensed Product in accordance with Article 5 hereof;
(3) in breach of any material provision; or
(4) provides any false report; and
(B) Alnylam fails to remedy the breach within sixty days after
written notice by Stanford.
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14.3 SURVIVING PROVISIONS - Surviving any termination or expiration are:
(A) Alnylam's obligation to pay royalties accrued or accruable
based on Licensed Product made, used or sold during the term
of this Agreement;
(B) Any cause of action or claim of Alnylam or Stanford, accrued
or to accrue, because of any breach or default by the other
party; and
(C) The provisions of Articles 6, 7, 8, and 9, 18.8and any other
provisions that by their nature are intended to survive.
15 ASSIGNMENT
15.1 ASSIGNMENT BY ALNYLAM - Alnylam may assign this Agreement to an
Affiliate or, subject to Section 15.2 as part of:
(A) A sale or other transfer of Alnylam's entire business; or
(B) Sale or other transfer of that part of Alnylam's business to
which the license granted hereby relates.
15.2 CONDITIONS OF ASSIGNMENT - Prior to any assignment,
(A) Alnylam must give Stanford written notice of the assignment,
including the new assignee's contact information and;
(B) The new assignee must agree in writing to Stanford to be bound
by this Agreement.
(C) If the new assignee is a pharmaceutical or biotechnology
company having aggregate annual sales revenues of at least 3
times higher than the aggregate annual sales revenues of
Alnylam, Stanford must have received a $40,000 assignment fee.
15.3 AFTER THE ASSIGNMENT - Upon assignment of this Agreement, Alnylam will
be released of liability under this Agreement and the term "Alnylam" as
used in this Agreement will mean the new assignee.
16 ARBITRATION
16.1 DISPUTE RESOLUTION BY ARBITRATION. Any controversy arising under or
related to this Agreement, and any disputed claim by either party
against the other under this Agreement excluding any dispute relating
to patent validity or infringement arising under this Agreement, will
be settled by arbitration in accordance with the Licensing Agreement
Arbitration Rules of the American Arbitration Association.
16.2 REQUEST FOR ARBITRATION. Either party may request arbitration. Stanford
and Alnylam will mutually agree in writing on a third party arbitrator
within thirty days of the arbitration request. The arbitrator's
decision will be final and nonappealable and may be entered in any
court having jurisdiction.
Page: 12 of 16
16.3 DISCOVERY. The parties will be entitled to discovery as if the
arbitration were a civil suit in the California Superior Court. The
arbitrator may limit the scope, time, and issues involved in discovery.
16.4 PLACE OF ARBITRATION. The parties will mutually agree in writing to a
place where arbitration will be held.
17 NOTICES
All notices under this Agreement will be sent by first class mail, registered or
certified with return receipt requested, by reputable overnight courier or
delivered personally and shall be deemed to have been fully given upon receipt:
All general notices to Alnylam will be sent to:
Xxxx Xxxxxxxxxx, Ph.D.
President and Chief Executive Officer
Alnylam Pharmaceuticals, Inc.
000 Xxxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
All financial invoices to Alnylam (i.e., accounting contact) will be sent in
writing to:
Xxxx Xxxxxxxxx
Controller
Alnylam Pharmaceuticals, Inc.
000 Xxxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Page: 13 of 16
All progress report invoices to Alnylam (i.e., technical contact) will be sent
in writing to:
Xxxxxx Xxxxxxxxxxx, Ph.D., X.XX.
Director, Corporate Development
Alnylam Pharmaceuticals, Inc.
000 Xxxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
All general notices to Stanford will be e-mailed or mailed to:
Office of Technology Licensing
000 Xxxxx Xxxx, Xxxxx 000
Xxxx Xxxx, XX 00000-0000
xxxx@xxxxxxx.Xxxxxxxx.xxx
All payments to Stanford will be mailed to:
Stanford University
Office of Technology Licensing
Department #44439
X.X. Xxx 00000
Xxx Xxxxxxxxx, XX 00000-0000
All progress reports to Stanford will be e-mailed or mailed to:
Office of Technology Licensing
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000-0000
xxxx@xxxxxxx.Xxxxxxxx.xxx
Either party may change its address with written notice to the other party.
18 MISCELLANEOUS
18.1 WAIVER AND AMENDMENT. This Agreement may be amended, supplemented or
otherwise modified only by means of a written instrument signed by both
parties. None of the terms of this Agreement can be waived except by
the written consent of the party waiving compliance.
18.2 CHOICE OF LAW. This Agreement will be governed by the laws of the State
of California applicable to agreements negotiated, executed, and
performed within California.
18.3 HEADINGS. The headings in this Agreement are for convenience of
reference only and do not constitute a part of it. The headings do not
affect its interpretation.
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18.4 FORCE MAJEURE. Neither party will be responsible for delays resulting
from causes beyond the reasonable control of such party, including
without limitation fire, explosion, flood, war, strike, or riot,
provided that the nonperforming party uses commercially reasonable
efforts to avoid or remove such causes of nonperformance and continues
performance under this Agreement with reasonable dispatch whenever such
causes are removed.
18.5 BINDING EFFECT. This Agreement shall be binding upon and inure to the
benefit of the parties and their respective permitted successors and
assigns.
18.6 SEVERABILITY In the event that any provision of this Agreement shall be
held invalid or unenforceable for any reason, such invalidity or
unenforceability shall not affect any other provision of this
Agreement, and the parties shall negotiate in good faith to modify the
Agreement to preserve (to the extent possible) their original intent.
18.7 ENTIRE AGREEMENT This Agreement constitutes the entire agreement
between the parties with respect to its subject matter and supercedes
all prior agreements or understandings between the parties relating to
its subject matter.
18.8 CONFIDENTIALITY. Stanford agrees that diligent efforts shall be used to
maintain the confidentiality of reports or documents received from
Alnylam or its Affiliate or sublicensees pursuant to this Agreement.
The parties execute this Agreement in duplicate originals by their duly
authorized officers or representatives.
THE BOARD OF TRUSTEES OF THE XXXXXX
XXXXXXXX JUNIOR UNIVERSITY
/s/ Xxxxxxxxx Xx
Signature __________________________________
Xxxxxxxxx Xx
Name ____________________________________
Director, Technology Licensing
Title ____________________________________
Sept. 17, 2003
Date ____________________________________
LICENSEE
Signature /s/Xxxx Xxxxxxxxxx
_________________________________
Name Xxxx Xxxxxxxxxx
Title President and CEO
September 19, 2003
Date ____________________________________
Page: 15 of 16
APPENDIX A: MILESTONES
1. By the end of the year [**], Alnylam will [**].
2. By the end of the year [**], Alnylam will [**].
3. By the end of the year [**], Alnylam will [**].
Page: 16 of 16
