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Exhibit 10.45 C O N F
I D E N T I A
L LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("
Agreement ") is made and entered into effective as of
July 23, 2007 (the " Effective Date "), by and
between Archemix Corp. , having principal offices at 300
Third Street, Cambridge, Massachusetts 02142 ("
Archemix "), and Isis Pharmaceuticals, Inc. ,
having principal offices at 1896 Rutherford Road, Carlsbad,
California 92008 (" Isis "). Archemix and Isis each
may be referred to herein individually as a "Party,"
or collectively as the "Parties."
WHEREAS , Isis is a
recognized leader in the development of antisense oligonucleotides,
and Archemix is a recognized leader in the development of Aptamers
(as defined below); WHEREAS ,
Isis has developed proprietary chemistries and know-how that may
accelerate the successful commercialization of Aptamers, and
Archemix is developing know-how that may reciprocally inform the
development of other oligonucleotides (including antisense); and
WHEREAS , this Agreement
establishes a strategic alliance between Isis and Archemix which
enables the Parties to benefit from Isis’ proprietary
chemistries and their mutual proprietary expertise to facilitate
their respective discovery, development, and commercialization
efforts; NOW, THEREFORE, the
Parties do hereby agree as follows: ARTICLE 1
DEFINITIONS Capitalized terms used in this Agreement and not
otherwise defined herein have the meanings set forth in
Appendix 1. ARTICLE 2
GRANT OF RIGHTS
Section 2.1 License Grants .
2.1.1
Subject to the terms and conditions of this Agreement, Isis hereby
grants to Archemix for use outside of the Excluded
Field:
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(x)
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a worldwide, royalty-bearing, non-exclusive license under the
Isis Analytical Patents solely to research, make (but not have
made), use, import, offer to sell and sell and otherwise discover,
develop, and commercialize Licensed Products;
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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(y)
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a worldwide, royalty-bearing, nonexclusive license under the
Isis Manufacturing Patents solely to research, make (but not have
made), use, import, offer to sell and sell and otherwise discover,
develop, and commercialize Licensed Products; and
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(z)
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a worldwide, royalty-bearing, exclusive (subject to Section
2.1.2) license under the Isis Chemistry Patents, with the right to
grant sublicenses subject to Section 4.4, to research, make,
have made, use, import, offer to sell and sell and otherwise
discover, develop, and commercialize Licensed Products.
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Archemix will have no right to sublicense or otherwise transfer
to any Third Party any rights in or to the licenses to the Isis
Analytical Patents or to the Isis Manufacturing Patents granted to
Archemix under Section 2.1.1(x) or 2.1.1(y), respectively. For
the avoidance of doubt, and subject to the field restriction set
forth in the first sentence of Section 2.1.1, Archemix’s
conduct through its own employees or consultants of in-house tests
on Aptamer Products made by Third Parties shall be deemed to fall
within Archemix’s rights to "make" Licensed Products under
Sections 2.1.1(x) and 2.1.1(y) as applicable, and shall not
constitute "having made."
2.1.2
Upon the occurrence of any Conversion Event, the exclusive license
granted to Archemix under Section 2.1.1(z) will automatically
become non-exclusive, subject to the following: (a) Such
license will remain exclusive with respect to any Target and any
Licensed Product that binds to such Target for which Archemix (or
an Archemix Affiliate or Archemix Sublicensee) has achieved the
[***] milestone and has timely paid Isis the applicable milestone
payment under Section 5.2 below prior to the occurrence of the
first Conversion Event. (b) If, following the occurrence of
the first Conversion Event, such exclusive license converts to a
non-exclusive license pursuant to this Section 2.1.2, such
license will convert back to an exclusive license (regardless of
the intervening period of non-exclusivity) with respect to any
Target and any Licensed Product that binds to such Target for which
Archemix (or an Archemix Affiliate or Archemix Sublicensee) has
achieved the [***] milestone and has timely paid Isis the
applicable milestone payment under Section 5.2 below;
provided, that Isis has not, after the first Conversion
Event but prior to Archemix’s (or an Archemix
Affiliate’s or Archemix Sublicensee’s) achievement of
the [***] Milestone and payment of the applicable milestone
payment, granted a license to a Third Party that would prevent Isis
from granting an exclusive license with respect to such Target and
Licensed Product to Archemix. (c) Any license that remains or
becomes exclusive pursuant to clauses (a) or (b) above
following a Conversion Event will remain exclusive as long as
Archemix (or an Archemix Affiliate or Archemix Sublicensee) is
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
2
actively researching, developing or commercializing the Licensed
Product that is the subject of the license, or another Aptamer for
such Target. For the avoidance of doubt, if Archemix (or an
Archemix Affiliate or Archemix Sublicensee) discontinues its
activities with respect to a Licensed Product that is the subject
of an exclusive license pursuant to clause (a) or (b) above,
Archemix (or an Archemix Affiliate or Archemix Sublicensee) will
still be deemed to be actively researching or developing a Licensed
Product for such Target if it begins research or development
activities relating to a back-up product that is intended to be a
Licensed Product for such Target within [***] days thereafter.
2.1.3
Notwithstanding the foregoing, Isis retains the right under the
license granted to Archemix under Section 2.1.1(z) above to
fulfill its obligations under any licenses granted by Isis prior to
the Effective Date, and to grant Permitted Licenses, and the
exclusivity of the license granted to Archemix under
Section 2.1.1(z) is limited by any such licenses granted prior
to and after the Effective Date. For the avoidance of doubt, no
Permitted License shall grant any Third Party exclusive rights
under the Isis Patents to research, make, have made, use, import,
offer to sell or sell, or otherwise discover, develop, or
commercialize Licensed Products.
Section 2.2 Know-How License Grants.
2.2.1
License Grant to Archemix . Subject to the terms and
conditions of this Agreement, Isis grants to Archemix a worldwide,
fully paid, royalty-free, non-exclusive license, with the right to
sublicense subject to the last two sentences of this
Section 2.2.1, under all Know-How disclosed by Isis to
Archemix under this Agreement, to use such Know-How solely to
research, make, have made, use, import, offer to sell and sell and
otherwise discover, develop and commercialize Aptamer Products.
Archemix will have no right to sublicense or otherwise transfer any
rights in or to the license granted to Archemix under this
Section 2.2.1 to any Know-How covering information related to
Isis’ manufacturing or analytical technology. Any Sublicense
granted under this Section 2.2.1 will (i) be subject to
Section 4.4 below, and (ii) require the Archemix
Sublicensee to maintain the confidentiality of the sublicensed
Know-How in accordance with confidentiality provisions at least as
protective as those set forth in Article 7 herein.
2.2.2
License Grant to Isis . Subject to the terms and
conditions of this Agreement, Archemix grants to Isis a worldwide,
fully paid, royalty-free, non-exclusive license, with the right to
sublicense subject to the last sentence of this Section 2.2.2,
under all Know-How disclosed by Archemix to Isis under this
Agreement, to use such Know-How solely to research, make, have
made, use, import, offer to sell and sell and otherwise discover,
develop and commercialize products other than Aptamer Products. Any
sublicense granted under this Section 2.2.2 will require the
sublicensee to maintain the confidentiality of the sublicensed
Know-How in accordance with confidentiality provisions at least as
protective as those set forth in Article 7 herein.
2.2.3
Additional Licenses . In addition to the licenses
granted in Sections 2.1.1 and 2.2.1, Isis agrees, at
Archemix’s request, to negotiate in good faith with Archemix
for the Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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grant of a license to Archemix under any Patents not licensed to
Archemix hereunder, or additional rights under Patents that are
licensed hereunder, that are, at the time of such request, owned or
Controlled by Isis, to research, make, have made, use, import,
offer to sell and sell and otherwise discover, develop, and
commercialize Licensed Products, subject to any Third Party rights
or other contractual limitations. ARTICLE 3 SCOPE OF
COLLABORATION; COLLABORATION ACTIVITIES
Section 3.1 Scope of
Collaboration; Research Management Committee . To assist
the development of each Party’s commercial focus,
representatives from Isis and Archemix will meet regularly, as
mutually agreed, to share Know-How and coordinate basic research
efforts that have the potential to impact each Party’s
development efforts (the "Collaboration" ). In
particular, a jointly composed research management committee (
"RMC" ) will meet at least [***] per [***] during the
term of the Collaboration, alternating venues between the
vicinities of Cambridge, Massachusetts and Carlsbad, California, to
coordinate the exchange of know-how and research planning. Meetings
of the RMC will be by telephone or by video conference if desired
by either Party. Intellectual property representatives of each
Party may participate in RMC meetings and such meetings will
provide a forum to discuss intellectual property issues relevant to
the Collaboration.
Section 3.2 Collaboration Activities . To the
extent that the Parties agree to conduct any joint activities under
the Collaboration, the Parties will use Commercially Reasonable
Efforts to conduct their respective Collaboration research and
development activities in a good scientific manner, and in
compliance in all material respects with all Applicable Law, and
will cooperate reasonably with the other Party to achieve the goals
of the Collaboration. Each Party will bear the sole responsibility
for funding its own Collaboration research and development
activities, unless otherwise agreed by the Parties.
Section 3.3 Term of
Collaboration Activities . The Collaboration will remain in
effect for a period [***] years following the Effective Date, and
may be continued thereafter with the mutual agreement of both
Parties. Section 3.4
Consulting Activities . Archemix may request Isis to
perform certain research and development activities to aid in the
advancement of Licensed Products. Isis will be under no obligation
to perform such consulting activities requested by Archemix. Any
mutually agreed upon consulting work will be performed under an
agreed upon work plan, which will include estimates of Isis’
FTE time to be expended. Isis will be compensated by Archemix for
the performance of any such consulting work by Isis at the FTE
Rate. ARTICLE 4
LICENSED PRODUCT DEVELOPMENT; CONDITIONS TO LICENSES
Section 4.1
Development/Commercialization/Regulatory Responsibilities .
Archemix is solely responsible for the development and
commercialization of Licensed Products. Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
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Archemix will comply with all Applicable Laws in connection with
the development and commercialization of the Licensed Products.
Section 4.2
Reports . Archemix will provide to Isis [***] reports (each
an " R&D Report ") summarizing which Isis
chemistries and analytical methods are actively being used in
Archemix’s programs, subject to Archemix’s
confidentiality obligations to Third Parties. Archemix will not be
required to disclose specific Targets in any R&D Report. The
R&D Reports will be the Confidential Information of Archemix.
Section 4.3 Safety
Reporting and Notification. Subject to confidentiality
obligations to Third Parties, each Party will notify the other
Party as soon as practicable (and, if possible, provide as much
advance notice as possible) of any event or other information of
which such Party becomes aware that is materially related to the
safety of the Licensed Products (such as serious adverse events).
Notwithstanding the foregoing, regardless of whether Isis provides
such safety-related information to Archemix, in no event will Isis
have any liability under this Agreement with respect to any
Licensed Product.
Section 4.4 Conditions to Sublicenses .
4.4.1
Prior to the first Conversion Event, Archemix may enter into
Sublicenses of the rights under Section 2.1.1(z).
4.4.2
Following the first Conversion Event, Archemix may enter into
Sublicenses of the rights under Section 2.1.1(z) with respect
to (i) any Target that remains exclusive, without limitation,
and (ii) any Target that is non-exclusive, solely in
connection with development and commercialization of a Licensed
Product to such Target.
4.4.3
For purposes of clarification, the Sublicenses described in
Section 4.4.1 and Section 4.4.2 may be entered into with
(i) any licensee or sublicensee of Archemix under any Patents
of Archemix or a Third Party that Archemix is entitled to
sublicense, including any Third Party licensee of Archemix’s
SELEX or other technology, or (ii) an Affiliate of Archemix.
Further, for the avoidance of doubt, Archemix will have the right
to offer, but shall not be obliged to grant, a Sublicense to any
entity that is a development or commercialization partner or
licensee of Archemix as of the Effective Date (each, a "
Legacy Licensee ") that desires to take a license to
any of the Isis Chemistry Patents and/or the Isis Know-How. Any
Sublicense granted to a Legacy Licensee will be consistent with,
and expressly made subject to, this Agreement. [***]
ARTICLE 5
FINANCIAL PROVISIONS
Section 5.1 Warrant Grant . On the Effective
Date of this Agreement, Archemix will grant to Isis a seven-year
warrant to acquire 600,000 shares of Archemix’s common stock
at a purchase price of twenty-five cents ($0.25) per share (subject
to adjustment in the event of a stock split, reverse stock split or
other similar events), by executing the warrant attached hereto as
Appendix 5 (the "Warrant" ). Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
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Section 5.2 Milestone
Payments by Archemix . Archemix will pay to Isis each
milestone payment not more than [***] days after first achievement,
by Archemix, its Affiliates or an Archemix Sublicensee, of each of
the events for each Licensed Product as follows:
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Event
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Payment
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[***]
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$[***] (U.S.)
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[***]
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$[***] (U.S.)
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[***]
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$[***] (U.S.)
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[***]
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$[***] (U.S.)
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5.2.1
Any milestone payments paid by Archemix to Isis for a particular
Licensed Product are creditable against Sublicense Revenue payable
to Isis for such Licensed Product, subject to Section 5.4.1 and
will be accompanied by a statement to Isis indicating to which
Licensed Product and Target such milestone payment applies. For
purposes of illustration, (a) if Archemix has paid a milestone
payment to Isis for a Licensed Product prior to sublicensing such
Licensed Product, such milestone payment will not also be payable
by the Archemix Sublicensee, and such milestone payment will be
creditable against the portion of Sublicense Revenue payable to
Isis for such Licensed Product (subject to Section 5.4.1 ).
[***] milestone will be [***] for any Target, [***] Licensed
Product is [***] that binds to such Target.
Section 5.3 Sublicense
Revenue Sharing .
5.3.1
Sublicenses Involving Licensed Product(s). In the event that
Archemix enters into a Sublicense for any Licensed Product,
Archemix will pay Isis the following percentages of all Sublicense
Revenue received: (a) [***]% of all Sublicense Revenue from any
Sublicense of any Licensed Product entered into [***] the [***] a
[***] for such Licensed Product; (b) [***]% of all Sublicense
Revenue from any Sublicense of any Licensed Product entered into
[***] the [***] a [***] for such Licensed Product but [***] the
[***] a [***] for such Licensed Product; and (c) [***]% of all
Sublicense Revenue from any Sublicense of any Licensed Product
entered into [***] the [***] a [***] for such Licensed Product.
5.3.2
Sublicenses Prior to a Licensed Product. In the event that
Archemix enters into a Sublicense that does not involve any
Licensed Products at the time of such Sublicense, Archemix will pay
Isis [***] percent ([***]%) of all Sublicense Revenue received from
such Sublicense. Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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Notwithstanding the foregoing , in cases where Archemix
enters into a Sublicense with a Legacy Licensee that does not
involve any Licensed Products at the time of such Sublicense, in
addition to payment of the applicable percentage of Sublicense
Revenue (excluding up-front consideration) under either of
Sections 5.3.1 or 5.3.2 above, Archemix will pay Isis [***]
percent ([***]%) of any up-front consideration received by Archemix
from any such Sublicense for the extension of such license.
5.3.2
Any payment to Isis for its portion of Sublicense Revenue due under
this Section 5.3 will be due within [***] days of the date
such Sublicense Revenue is earned; provided, however ,
within [***] days after any calendar quarter in which Sublicense
Revenue is earned, Archemix will send Isis a written statement of
the amount of Isis’ portion of such Sublicense Revenue.
Section 5.4 Royalty
Payments by Archemix .
5.4.1
In consideration of Isis’ collaborative efforts and the
licenses granted hereunder, Archemix will pay Isis a royalty of
[***]% of Net Sales of each Archemix-Marketed Licensed Product. For
any Licensed Products sold by an Archemix Sublicensee pursuant to a
Sublicense, in consideration of Isis’ collaborative efforts
and the licenses granted hereunder, Archemix will pay Isis a
royalty on Net Sales of such Licensed Products equal to the greater
of (i) the applicable Sublicense Revenue rate set forth in
Section 5.3.1 or 5.3.2 above multiplied by the [***] Archemix
is [***] under such Sublicense, or (ii) [***]% of Net Sales of such
Licensed Products. Notwithstanding the foregoing, in the
event that of all of the Isis Patent Rights licensed hereunder the
only Patent used with respect to a particular Licensed Product is
an Isis Manufacturing Patent, then the Parties will negotiate in
good faith a [***] Net Sales of such Licensed Product.
5.4.2
Reduction of Royalties . If the exclusive license granted to
Archemix under Section 2.1.1(z) becomes non-exclusive with respect
to a Licensed Product, during the period of non-exclusivity the
otherwise applicable royalty rate on Net Sales for such Licensed
Product payable to Isis under Section 5.4.1 will be reduced by
[***]%; provided, however , that in no event will the
royalty payable to Isis on Net Sales of Licensed Products be
reduced to less than [***]%.
5.4.3
Royalty Term for Licensed Products . Archemix will pay Isis
a royalty on Net Sales of Licensed Products, in each country in
which the Licensed Products are manufactured, used or sold, from
the date of first commercial sale of the Licensed Products until
the expiration of the last-to-expire Valid Claim within an Isis
Patent in such country that covers (a) the manufacture, use,
or sale of the Licensed Product, and/or (b) a method used in
the discovery, identification or characterization of the Licensed
Product. For purposes of clarity, notwithstanding the immediately
preceding sentence, if a Licensed Product is made in a country
where, but for the licenses granted hereunder, it would infringe a
Valid Claim of an Isis Patent, then Archemix will be obligated to
pay a royalty on Net Sales of such Licensed Product in any country.
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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Section 5.5 Timing of
Royalty Payments . The royalties from Archemix to Isis set
forth in Section 5.4 are due and payable within [***] days
after each respective Royalty Due Date and will be calculated based
on the Net Sales in the calendar quarter immediately preceding the
applicable Royalty Due Date.
Section 5.6 Payment Method . Any amounts due to
Isis under this Agreement will be paid in U.S. dollars, by wire
transfer in immediately available funds to an account designated by
Isis. Any payments or portions thereof due hereunder which are not
paid on the date such payments are due under this Agreement will
bear simple interest at a rate of [***]% per month, or the maximum
rate permitted by Applicable Law, whichever is lower, calculated on
the number of days such payment is delinquent.
Section 5.7 Currency;
Foreign Payments . If any currency conversion will be
required in connection with any payment hereunder, such conversion
will be made by using the exchange rate for the purchase of U.S.
dollars as published in The Wall Street Journal, Eastern Edition,
on the last Business Day of the calendar quarter to which such
payments relate. If at any time legal restrictions prevent the
prompt remittance of any payments in any jurisdiction, Archemix may
notify Isis and make such payments by depositing the amount thereof
in local currency in a bank account or other depository in such
country in the name of Isis or its designee, and Archemix will have
no further obligations under this Agreement with respect thereto.
Section 5.8 Taxes
. Archemix may deduct from any amounts it is required to pay to
Isis pursuant to this Agreement an amount equal to that withheld
for or due on account of any taxes (other than taxes imposed on or
measured by net income) or similar governmental charge imposed by a
jurisdiction based on such payments to Isis ( "Withholding
Taxes" ). Archemix will provide Isis a certificate
evidencing payment of any Withholding Taxes hereunder within [***]
days of such payment and will reasonably assist Isis, at
Isis’ expense, to obtain the benefit of any applicable tax
treaty. Section 5.9
Records Retention; Audit .
5.9.1
Record Retention. Archemix will maintain (and will
contractually require that the Archemix Sublicensees maintain)
complete and accurate books, records and accounts that fairly
reflect Net Sales with respect to the Licensed Products, in each
case in sufficient detail to confirm the accuracy of any payments
required hereunder and in accordance with GAAP, which books,
records and accounts will be retained by Archemix until the later
of (i) [***] years after the end of the period to which such books,
records and accounts pertain, and (ii) the expiration of the
applicable tax statute of limitations (or any extensions thereof),
or for such longer period as may be required by Applicable Law.
5.9.2
Audit. Isis will have the right to have an independent
certified public accounting firm of nationally recognized standing,
reasonably acceptable to Archemix, have access during normal
business hours, and upon reasonable prior written notice, to
Archemix’s records as may be reasonably necessary to verify
the accuracy of Net Sales or Sublicense Revenue, as applicable, for
any calendar quarter or calendar year ending not more than [***]
months prior to the date of such request; provided, however
, that Isis will not have the right to Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
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conduct more than one such audit in any Calendar Year except as
provided below or more than one such audit covering any given time
period. Isis will require such accounting firm to enter into a
confidentiality agreement with Archemix in a form reasonably
acceptable to Archemix prior to the conduct of any audit. The
accounting firm will disclose to Isis only whether the Net Sales
and/or Sublicense Revenue has been correctly reported, the specific
detail concerning any discrepancies, and the corrected amount of
Net Sales and/or Sublicense Revenue payments. Isis will bear the
cost of such audit unless the audit reveals an underpayment to Isis
of more than [***]%, in which case Archemix will bear the cost of
the audit. In any agreement for a Sublicense granted by Archemix
hereunder, Archemix will use Commercially Reasonable Efforts to
secure a similar right on the part of Archemix to audit its
Archemix Sublicensee, and, if reasonably requested in writing by
Isis, will enforce such audit right and disclose its audit report
to Isis’s auditors.
5.9.3
Payment of Additional Amounts. If, based on the results of
such audit, additional payments are owed by Archemix under this
Agreement, Archemix will make such additional payments, with
interest as set forth in Section 5.6, within [***] days after
the date on which such accounting firm’s written report is
delivered to such Party.
5.9.4
Confidentiality. Isis will treat the financial information
subject to review under this Section 5.9 in accordance with
the confidentiality provisions of Article 7. ARTICLE 6
PRESS RELEASES & PUBLICATIONS
Section 6.1 Press
Releases .
6.1.1
Press Releases — Generally . Each provision of this
Section 6.1.1 is subject to Section 6.1.2 below. Press
releases or other similar public communication by either Party
relating to this Agreement, will be approved in advance by the
other Party, which approval will not be unreasonably withheld or
delayed, except for those communications required by Applicable
Law, disclosures of information for which consent has previously
been obtained, and information of a similar nature to that which
has been previously disclosed publicly with respect to this
Agreement, each of which will not require advance approval, but
will be provided to the other Party as soon as practicable after
the release or communication thereof.
6.1.2
Press Releases – Licensed Product Safety . Subject to
any confidentiality obligations to Third Parties, each Party will
notify the other Party within the time frames required by
Applicable Law of any event of which it becomes aware materially
related to the safety of Licensed Products (including any
Regulatory Approval) so that the Parties may analyze the need to or
desirability of publicly disclosing or reporting such event;
provided, that, Archemix will be required to so notify Isis only if
such event is reasonably determined by Archemix to be related to
the Isis Chemistries. Archemix will have the right to disclose any
such safety information supplied by Isis to any of the Archemix
Sublicensees that are Researching, developing or commercializing
Licensed Products, and to any Third Party as required by Applicable
Law. Notwithstanding Section 6.1.1 above, (a) any press
release or other similar public communication by either Party
related to a Licensed Product’s safety, except for those
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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communications required by Applicable Law, will be submitted to
the other Party for review and approval at least [***] hours in
advance (if reasonably practicable) of such proposed public
disclosure, which approval will not be unreasonably withheld,
conditioned or delayed and (b) Archemix will have the sole right to
issue any press release or other similar public communication
related to a Licensed Product’s safety unrelated to the Isis
Chemistries. Section 6.2
Publications . At least [***] days prior to a Party’s
submission of any material related to any Collaboration research or
development activities conducted hereunder pursuant to
Section 3.2 for publication or presentation, such Party (the "
Submitting Party ") will provide to the other Party
(the " Commenting Party ") a draft of such material
for its review and comment. Such drafts will be subject to
Article 7. The Commenting Party will provide any comments to
the Submitting Party within [***] days of receipt of such
materials. No publication or presentation with respect to any such
Collaboration research or development activities hereunder will be
made unless and until any information determined by the Commenting
Party to be the Commenting Party’s Confidential Information
has been removed. If requested in writing by the Commenting Party,
the Submitting Party will withhold material from submission for
publication or presentation for a reasonable time, but no more than
[***] days, to allow for the filing of a patent application.
ARTICLE 7
CONFIDENTIALITY
Section 7.1 Disclosure and Use Restriction .
Except pursuant to an Authorized Disclosure, the Parties agree
that, for the Term and for [***] years thereafter, each Party will
keep completely confidential and will not publish, submit for
publication or otherwise disclose, and will not use for any
purpose, except for the purposes contemplated by this Agreement,
any Confidential Information received from the other Party.
Section 7.2 Terms of
Agreement . Either Party may disclose (i) an
unredacted copy of this Agreement on a confidential basis to its
Affiliates, prospective and actual sublicensees, its legal,
business and financial advisors, bankers and accountants, and its
prospective lenders, investors, or acquirers, and (ii) the
terms of this Agreement as required under applicable securities
laws or regulations (including without limitation under rules or
regulations of any securities exchange or NASDAQ). Except as set
forth in the preceding sentence, neither Party will disclose the
terms of this Agreement or any part thereof to any Third Party.
Section 7.3
Sublicensing. In the case of any Sublicense permitted under
this Agreement, or other permitted transfers to a Third Party by
Archemix of any Confidential Information received by Archemix under
this Agreement, the following conditions apply: (A) Archemix
will obtain an agreement from any such Archemix Sublicensee or
Third Party that receives Isis’ Confidential Information from
Archemix that such Archemix Sublicensee or Third Party will be
bound by confidentiality and non-use provisions at least as
protective of Isis’ Confidential Information as the
provisions of this Agreement, and (B) in the event of a
conflict between the non-use or confidentiality provisions in this
Agreement and the non-use or confidentiality provisions of a
Sublicense properly granted hereunder, such Sublicense provisions
will prevail. Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
10
ARTICLE 8
INTELLECTUAL PROPERTY
Section 8.1 Ownership of Intellectual Property .
In the event the Parties agree to conduct research and/or
development activities under the Collaboration, such activities
will be performed in accordance with a mutually agreed upon written
Collaboration plan, which will include, among other relevant
things, provisions regarding ownership of any intellectual property
arising under the Collaboration, and the Parties’ respective
rights and responsibilities regarding the filing, prosecution, and
maintenance of any Patents coving such intellectual property. This
Agreement will be understood to be a joint research agreement to
discover Licensed Products and associated uses in accordance with
35 U.S.C. § 103(c)(3).
Section 8.2 Prosecution of Patents . Each Party
will have the [***] right, [***] cost and expense and [***]
discretion, to obtain, prosecute and maintain throughout the world
any Patents solely owned or Controlled by such Party, including
with respect to Isis, the Isis Chemistry Patents, the Isis
Manufacturing Patents and the Isis Analytical Patents.
Section 8.3 Enforcement
of Patents .
8.3.1
Rights and Procedures. If Isis or Archemix determines that
any Patent licensed hereunder is being infringed by a Third
Party’s activities and that such infringement could affect
the exercise by the Parties of their respective rights and
obligations under this Agreement, it will promptly notify the other
Party in writing, unless doing so would constitute a breach of a
duty of confidentiality to such Third Party that arose prior to the
date that Isis or Archemix, as applicable, became aware of the
infringing activities. The Party controlling the Patent(s) which
are allegedly being infringed will have the sole right, but not the
obligation, to remove such infringement, including with respect to
Isis, the Isis Chemistry Patents, the Isis Manufacturing Patents,
and the Isis Analytical Patents, and Archemix, as the exclusive
licensee to the license granted under Section 2.1.1(z) above,
agrees to cooperate with and assist Isis in the resolution and
removal of any such infringement, including, without limitation,
negotiating in good-faith with such Third Party with respect to the
rights granted to Archemix under Section 2.1.1(z) above.
ARTICLE 9
TERM; CONSEQUENCES OF TERMINATION
Section 9.1 Term
. Unless earlier terminated in accordance with the provisions of
Article 10, the term of this Agreement (the "Term
" ) commences upon the Effective Date and will continue until
the expiration of all obligations to pay royalties on all Licensed
Products. Section 9.2
Rights in Bankruptcy . All rights and licenses granted
under or pursuant to this Agreement by Isis or Archemix are, and
will otherwise be deemed to be, for purposes of Section 365(n) of
the United States Bankruptcy Code, licenses of rights to
"intellectual property" as defined under Section 101 of the
United States Bankruptcy Code. The Parties agree that the Parties,
as licensees of such rights under this Agreement, will retain and
may fully exercise all of their rights and elections under the
United States Bankruptcy Code. The Parties further agree Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
11
that, in the event of the commencement of a bankruptcy
proceeding by or against a Party under the United States Bankruptcy
Code, the Party hereto that is not a Party to such proceeding will
be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of
such intellectual property, which, if not already in the
non-subject Party’s possession, will be promptly delivered to
it (a) upon any such commencement of a bankruptcy proceeding
upon the non-subject Party’s written request therefor, unless
the Party subject to such proceeding elects to continue to perform
all of its obligations under this Agreement or (b) if not
delivered under clause (a) above, following the rejection of
this Agreement by or on behalf of the Party subject to such
proceeding upon written request therefor by the non-subject Party.
Section 9.3 Consequences
of Termination .
9.3.1
Licenses. Upon early termination of this Agreement in its
entirety pursuant to Article 10, the licenses granted hereunder
will terminate.
9.3.2
Return of Information and Materials. Upon early termination
of this Agreement in its entirety pursuant to Article 10, each
Party will return all data, files, records and other materials in
its possession or control relating to the other Party’s
Patents or otherwise containing or comprising the other
Party’s Confidential Information (except one copy of which
may be retained for archival purposes).
9.3.3
Transfer of Sublicenses . Any sublicenses granted by
Archemix in accordance with Section 2.1.1 and/or 2.2.1 prior to the
date of the corresponding notice of termination under
Section 10 issued by Isis will survive if the relevant
Sublicensee agrees in writing to be bound by the terms of this
Agreement as such terms apply to such Sublicensee (in which event,
such Sublicensee will be deemed a direct licensee of Isis);
provided, further, that any such Sublicensee will only be
responsible for any payments that become due as a result solely of
such Sublicensee’s activities after the effective date of any
such termination.
Section 9.4 Accrued Liabilities; Surviving
Obligations .
9.4.1
Accrued Rights & Liabilities. Termination or expiration
of this Agreement for any reason will be without prejudice to any
liabilities, rights, or financial compensation that will have
accrued to the benefit of a Party prior to such termination or
expiration. Such termination or expiration will not relieve a Party
from obligations that are expressly indicated to survive the
termination or expiration of this Agreement.
9.4.2
Survival. Articles and Sections 1, 6, 7, 8.1, 8.2, 9,
10, 12 and 14 of this Agreement will survive expiration or
termination of this Agreement for any reason. Section 5.1
(Warrant Grant) will survive any permitted termination of this
Agreement by Isis. ARTICLE 10
MATERIAL BREACH OF THIS AGREEMENT
Section 10.1 Material
Breach . If a Party materially breaches this Agreement and
such breach is not cured within [***] days after the receipt of a
notice of such breach from the other Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
12
Party (or, if such breach cannot be cured within such [***]-day
period, if the defaulting Party does not commence actions to cure
within such period and diligently continues such actions), the
Party not in default may, without limiting any of its other rights
under this Agreement, invoke Section 14.4 below; provided,
however, that in the event of a good faith dispute with respect to
the existence of a default, the [***]-day cure period will be
stayed until the dispute is resolved under Section 14.4.
Notwithstanding anything to the contrary in this Agreement, in the
event Archemix breaches its obligations under Article 5, and
such breach is not cured within [***] days after Archemix’s
receipt of notice of such breach, Isis may terminate this Agreement
by providing written notice to Archemix; provided, however ,
that in the event of a good faith dispute with respect to the
existence of a default, the [***]-day cure period will be stayed
until the dispute is resolved under Section 14.4. If either
Party materially breaches this Agreement, the other Party shall be
entitled to suspend the obligations of the Parties under
Sections 3.1, 3.2 and 3.3 and any Collaboration plans then in
effect pursuant to Section 12.5. Such suspension shall be
without prejudice to any rights or remedies of a Party under such
Collaboration plan(s) accruing prior to the date of the suspension.
ARTICLE 11
[RESERVED] ARTICLE 12
INDEMNIFICATION AND INSURANCE
Section 12.1 Indemnification of Isis . Archemix
will indemnify Isis, its Affiliates, and each of their respective
directors, officers, employees and agents ( "Isis
Parties" ) and defend and hold each of them harmless, from
and against any and all losses, damages, liabilities, costs and
expenses (including reasonable attorneys’ fees and expenses)
to the extent arising from or occurring as a result of any and all
liability suits, investigations, claims or demands by a Third Party
(collectively, "Losses" ) arising from or occurring
as a result of or in connection with (a) any use by Archemix, its
Affiliates, agents or Archemix Sublicensees of any information,
technology (including Know-How) of Isis, or Isis Patent Rights, or
(b) whether or not negligence is found or alleged, the
manufacture, use, handling, storage, sale or other disposition of a
Licensed Product or other compound by Archemix, its Affiliates,
agents or Archemix Sublicensees. Notwithstanding the foregoing,
Archemix will have no obligations under this Section 12.1 to
the extent a Loss is covered by an Isis indemnification obligation
under Section 12.2 below.
Section 12.2 Indemnification of Archemix. Isis
will indemnify Archemix, its Affiliates, and each of their
respective directors, officers, employees and agents (
"Archemix Parties" ) and defend and hold each of them
harmless, from and against any and all Losses arising from or
occurring as a result of or in connection with any use by Isis, its
Affiliates, agents or sublicensees of any information or technology
(including Know-How) of Archemix. Notwithstanding the foregoing,
Isis will have no obligations under this Section 12.2 to the
extent a Loss is covered by an Archemix indemnification obligation
under Section 12.1 above. Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
13
Section 12.3
Conditions to Indemnity . Each of Isis’ and
Archemix’s agreement to indemnify, defend and hold the
Archemix Parties or the Isis Parties respectively (each, an "
Indemnitee ") harmless is conditioned in each case
upon the Indemnitee (i) providing written notice to the
indemnifying Party (the " Indemnitor ") of any claim,
demand or action arising out of the indemnified activities within
[***] days after the Indemnitee has knowledge of such claim, demand
or action, (ii) permitting the Indemnitor to assume full
responsibility for and control over the investigation, preparation
and defense of any such claim or demand, (iii) assisting the
Indemnitor, at the Indemnitor’s reasonable expense, in the
investigation, preparation and defense of any such claim or demand;
and (iv) not compromising or settling such claim or demand
without the Indemnitor’s prior written consent; provided
that, if the Indemnitee entitled to indemnification fails to
promptly notify the Indemnitor pursuant to the foregoing clause
(i), the Indemnitor will only be relieved of its indemnification
obligation to the extent prejudiced by such failure.
Section 12.4
Insurance . Archemix will have and maintain such types and
amounts of liability insurance as is normal and customary in the
industry generally for parties similarly situated, including
product liability insurance and clinical trials insurance for
Licensed Products (each of which will name Isis as an additional
insured), and will upon request provide Isis with a certificate of
insurance. Archemix will promptly notify Isis of any material
change in insurance coverage or lapse in coverage in that regard.
Section 12.5
Collaboration Activities. In the event the Parties agree to
conduct research and/or development activities under the
Collaboration, such activities will be performed in accordance with
a mutually agreed upon written Collaboration plan, which will
include, to the extent deemed appropriate by the Parties,
additional indemnification obligations relevant to such
Collaboration activities. ARTICLE 13
REPRESENTATIONS AND WARRANTIES
Section 13.1 Representations, Warranties, and
Covenants . Each Party hereby represents, warrants, and
covenants to the other Party as of the Effective Date as follows:
13.1.1
Corporate Authority. Such Party (a) has the power and
authority and the legal right to enter into this Agreement
(including the Warrant) and perform its obligations hereunder, and
(b) has taken all necessary action on its part required to
authorize the execution and delivery of this Agreement (including
the Warrant) and the performance of its obligations hereunder. This
Agreement (including the Warrant) has been duly executed and
delivered on behalf of such Party and constitutes a legal, valid
and binding obligation of such Party and is enforceable against it
in accordance with its terms subject to the effects of bankruptcy,
insolvency or other laws of general application affecting the
enforcement of creditor rights and judicial principles affecting
the availability of specific performance and general principles of
equity, whether enforceability is considered a proceeding at law or
equity.
13.1.2
Consents, Approvals, etc. All necessary consents, approvals
and authorizations of all Regulatory Authorities and other parties
required to be obtained by such Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
14
Party in connection with the execution and delivery of this
Agreement (including the Warrant), and the performance of its
obligations hereunder have been obtained.
13.1.3
Conflicts. The execution and delivery of this Agreement
(including the Warrant) and the performance of such Party’s
obligations hereunder (a) do not conflict with or violate any
requirement of Applicable Law or any provision of the articles of
incorporation, bylaws or any similar instrument of such Party, as
applicable, in any material way, and (b) do not conflict with,
violate, or breach or constitute a default or require any consent
not already obtained under, any contractual obligation or court or
administrative order by which such Party is bound.
Section 13.2 Isis
Representations, Warranties, and Covenants . Isis hereby
represents, warrants, and covenants to Archemix as of the Effective
Date as follows:
13.2.1
IP Ownership . To the best of Isis’ knowledge, Isis
has sufficient legal and/or beneficial title and ownership of the
Isis Pat
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