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Exhibit 10.59
AMENDED AND RESTATED
COLLABORATION AND LICENSE AGREEMENT
T HIS A MENDED AND R
ESTATED C OLLABORATION AND L ICENSE A
GREEMENT (the
"Agreement" ) is entered into and made effective as of
July 31, 2006 (the "Effective Date" ), by and between
N UVELO ,
I NC ., a Delaware
corporation having its principal place of business at 201
Industrial Road, Suite 310, San Carlos, CA 94070 ( "Nuvelo"
), and A RCHEMIX C ORP ., a
Delaware corporation having its principal place of business at 300
Third Street, Cambridge, MA 02142 ( "Archemix" ). Nuvelo and
Archemix are sometimes referred to herein individually as a
"Party" and collectively as the "Parties."
R ECITALS
W HEREAS , the Parties
entered into a Collaboration Agreement as of January 12, 2004
(the "Original Agreement" ), for the purpose of identifying
aptamers with anti-thrombin activity (the terms and conditions
contained therein, the "Original Terms"); and
W HEREAS , the particular
aptamer that was the original Development Compound (as defined in
the Original Agreement), ARC 183, has been withdrawn from
Development; and
W HEREAS , on March 4,
2006, Archemix initiated arbitration proceedings with Judicial
Arbitration and Mediation Services, Inc., New York ( "JAMS"
), Case No. 1425000626 (the "Arbitration"), and Nuvelo
submitted counterclaims on May 17, 2006; and
W HEREAS , the Parties wish
to revise their collaboration so that Archemix will be responsible
for the discovery of short-acting aptamers which bind to
specifically defined protein targets causing an anti-coagulation
effect, and Nuvelo will have the exclusive right to develop and
commercialize aptamers so identified by Archemix; and
W HEREAS , the Parties have
by mutual agreement, agreed to supersede the terms of the Original
Agreement, with those set forth in this Agreement as of the
Effective Date.
N OW , T HEREFORE , the Parties agree as
follows:
1. D EFINITIONS
The following terms and those set forth in Exhibit A have the
meanings set forth below or in Exhibit A, as the case may be, as
used in this Agreement:
1.1 "Affiliate" means a person, corporation, partnership,
or other entity that controls, is controlled by or is under common
control with a Party. For the purposes of this Section 1.1,
the word "control" (including, with correlative meaning, the
terms "controlled by" or "under the common control
with" ) means the actual power, either directly or indirectly
through one or more intermediaries, to direct the management and
policies of such entity, whether by the ownership of at least fifty
percent (50%) of the voting stock of such entity, or by
contract or otherwise.
1.2 "Allowable Commercialization
Expenses" means those expenses incurred during the term of
this Agreement which are specifically attributable to the actual or
contemplated Commercialization of a specific Licensed Product(s),
and shall consist of: (a) Costs of Goods; (b) Marketing,
Sales and Distribution Costs; (c) out of pocket costs to
identify potential partners and to negotiate Partnering Agreements;
(d) all patent prosecution, maintenance and litigation
expenses incurred under Article 9 of this Agreement; (e) Post
Launch Research and Development Expenses; (f) Allocated
Administrative Expenses; (g) the costs of engaging Third
Parties to assist with Commercialization; and (h) Currency
Gains or Losses. "Allowable Commercialization Expenses" shall
exclude Development Costs.
1.3 "Aptamer" means any oligonucleotide that binds to a
target through means other than Watson-Crick base-pairing.
1.4 "ARC 2172" means the Aptamer having the nucleotide
sequence set forth in Exhibit D.
1.5 "Archemix Background Technology" means any Technology
used by Archemix, or provided by Archemix for use hereunder and/or
which is otherwise necessary or useful for the Research,
Development, Commercialization, manufacture, importation or use of
any Candidate Compound, Development Compound or Licensed Product
and that is (a) Controlled by Archemix as of the Effective
Date, (b) conceived or first reduced to practice by employees
of, or consultants to, Archemix after the Effective Date other than
in the conduct of Research, Development or Commercialization,
(c) conceived or first reduced to practice in the conduct of
Research, Development or Commercialization and that constitutes
SELEX Inventions or SELEX Technology, or (d) Archemix’s
interest in all Program Technology to the extent it is not Compound
Technology.
1.6 "Archemix Patent Rights" means Patent Rights
Controlled by Archemix claiming or disclosing Archemix Technology.
For clarity, Archemix Patent Rights include all Licensed Patent
Rights.
1.7 "Archemix Product" has the meaning assigned in
Section 12.2(a)(ii).
1.8 "Archemix Program Technology" means any Program
Technology that is conceived or first reduced to practice by or
through employees of, or consultants to, Archemix, alone or with
any Third Party, in the conduct of the Research, Development or
Commercialization of Candidate Compounds, Development Compounds or
Licensed Products.
1.9 "Archemix Technology" means, collectively, Archemix
Background Technology, Archemix’s interest in all Joint
Technology, and Archemix Program Technology. "Archemix Technology"
includes the Compound Technology.
1.10 "Bankrupt Party" has the meaning assigned in
Section 16.2(a).
1.11 "Candidate Compound" means an Aptamer that is a
Short Acting Coagulation Cascade Aptamer that is identified by
Archemix in the course of its Research under this Agreement
pursuant to an approved Research Plain.
2.
1.12 "Coagulation Cascade Protein"
means a protein that is included on the list set forth in Exhibit
B.
1.13 "Collaboration" means all activities performed by or
on behalf of Nuvelo or Archemix in the course of performing the
activities described in, or fulfilling of their obligations
pursuant to, this Agreement.
1.14 "Commercialization" or "Commercialized" means
all activities that are undertaken prior to, during or after
completion of an NDA filing for a particular Licensed Product and
that relate to the commercial manufacture, marketing and sale of
such Licensed Product including but not limited to
pre-commercialization, advertising, education, planning, marketing,
promotion, distribution, market and product support studies, and
Phase 4 Trials.
1.15 "Compound Patent Rights" means Patent Rights to the
extent claiming (a) Compound Technology or (b) ARC
2172.
1.16 "Compound Technology" means any Program Technology
developed solely by Archemix or which is Joint Technology and in
either case to the extent specifically disclosing the composition
of matter, formulation or use in the Field of a Short Acting
Coagulation Cascade Aptamer that is or was discovered or made by
Archemix under this Agreement or the Original Agreement, including
any Candidate Compound, Development Compound or Licensed
Product.
1.17 "Confidential Information" has the meaning assigned
to it is Section 10.1.
1.18 "Contract Year" means (a) the period beginning
on the Effective Date and ending on the first anniversary of the
last day of the calendar month in which the Effective Date falls
and (b) each succeeding twelve (12) month period
thereafter.
1.19 "Control" means, with respect to an item of
Technology, a molecule or an intellectual property right, that a
Party owns or has a license to such item, to a Patent Right
claiming such molecule, or to such right and has the ability to
disclose and grant a license or sublicense as provided for in this
Agreement under such item, Patent Right, or right without the
payment of additional consideration to, and without violating the
terms of any agreement or other arrangement with, any Third
Party.
1.20 "Derived" means identified, obtained, developed,
created, synthesized, designed, derived or resulting from based,
upon, containing, incorporating or otherwise generated from,
conjugated to or complexed with (whether directly or indirectly, or
in whole or in part).
1.21 "Develop" or "Development" means all
activities with respect to a Development Compound or Licensed
Product relating to: (a) the preparation for and conducting of
Phase 1 Trails, Phase 2 Trials, and Phase 3 Trials; (b) the
filing and obtaining of Regulatory Approval for a Licensed Product;
and (c) all activities relating to developing the ability to
manufacture Development Compounds or Licensed Products. This
includes, but is not limited to: (i) preclinical testing,
toxicology, formulation development, clinical studies, regulatory
affairs and outside counsel regulatory legal services; and
(ii) manufacturing process development and scale up for bulk
and final forms or Development Compounds and Licensed Products,
validation documentation, all documentation generated in connection
with the manufacturing or processing activities and manufacturing
and quality assurance technical support activities for such
Development Compounds or Licensed Products prior to first
commercial sale.
3.
1.22 "Development Compound:"
(a) means any Candidate Compound that is discovered or
made by Archemix under the Original Agreement or this Agreement and
selected by Nuvelo for IND-enabling studies and designated by
Nuvelo as Development Compound pursuant to Section 2.2 and 2.3
of this Agreement;
(b) any compound Derived from a Development Compound, as
defined in subsection (a) above, under the Original Agreement
or this Agreement that is a Short Acting Coagulation Cascade
Aptamer (for clarity, any such compound defined in this subsection
(b) shall be designated as a separate Development Compound
under this Agreement); and
(c) ARC 2172.
1.23 "Development Costs:"
(a) means the expenses incurred by Nuvelo or Archemix or
for its account after the Effective Date, and which are
specifically attributable to the Development of Development
Compounds and Licensed Products, including, without limitation:
(i) costs of preclinical design and evaluation of
Candidate Compounds, Development Compounds and Licensed Products,
and costs of studies on the toxicological, pharmacokinetic,
metabolic or clinical aspects of Candidate Compounds, Development
Compounds and Licensed Products (such costs include the costs of
any consultants or other Third Parties engaged by Nuvelo to conduct
such design or evaluation);
(ii) costs of pre-IND studies including the manufacturing
cost of preclinical supplies of Candidate Compounds, Development
Compounds and Licensed Products, including GMP materials;
(iii) costs of conducting clinical trails on Development
Compounds and Licensed Products including the manufacturing cost of
clinical supplies of the Development Compounds and Licensed
Products;
(iv) costs of preparing, submitting, reviewing or
developing data or information for the purpose of submission to a
Regulatory Authority to obtain approval to Commence Phase 1 Trails
or to obtain Regulatory Approval for Development Compounds and
Licensed Products;
(v) fees, including FDA user fees, associated with U.S.
and foreign regulatory filings or other U.S. and foreign
governmental requirements related to Development Compounds and
Licensed Products;
4.
(vi) costs of Third Party licenses
under Patents or other intellectual property rights reasonably
necessary to develop Development Compounds or Licensed Products or
to commercialize Licensed Products;
(vii) external and internal costs of process development,
manufacturing, quality assurance, release testing, and clinical
materials relating to Development Compounds or Licensed Products;
and
(viii) such other costs directly incurred in Development
of Development Compounds or Licensed Products.
(b) Development Costs excludes Nuvelo’s and
Archemix’s overhead expenses and FTE expenses, and any FTE
payments to Archemix hereunder, notwithstanding anything else in
this Section 1.23.
(c) Development Costs will be calculated on an accrual
basis consistent with GAAP except for the expenses incurred by
Nuvelo in manufacturing clinical supplies of each Development
Compound or Licensed Compound, which will be calculated on a cash
basis prior to the Commercialization of the Development Compound or
Licensed Compound.
1.24 "Diligent Efforts" means the carrying out of
obligations or tasks in a reasonable, good faith, and diligent
manner consistent with efforts and resources as commonly used in
the research-based biotechnology industry for a company of a
similar size and a similar market capitalization, for a therapeutic
product at a similar stage of research, development or
commercialization, and having similar market potential, taking into
account issues of safety, efficacy, product profile, the costs to
develop, the competitiveness of alternative products that are or
are expected to be in the relevant marketplace, the proprietary
position of the product, the regulatory structure and the
likelihood of regulatory approval and product reimbursement, the
profitability of the product, and all other commercial factors.
1.25 "Drug Approval Application" means an application for
Regulatory Approval required before commercial sale or use of a
Licensed Product as a drug in a regulatory jurisdiction.
1.26 "EMEA" means the European Medicines Agency, or any
successor thereof.
1.27 "EMEA and Pricing Approval" means approval by the
EMEA to sell a Licensed Product together with pricing approval in
at least one of France, Germany, Italy, Spain or United
Kingdom.
1.28 "FDA" means the United States Food and Drug
Administration, or any successor federal agency thereto.
1.29 "Field" means the use of Short Acting Coagulation
Cascade Aptamers to Modulate blood clotting times in acute
therapeutic applications, including but not limited to coronary
artery bypass graft surgery and percutaneous coronary intervention.
[ *
*
*
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Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.[*] Certain confidential information contained in this
document, marked by brackets, has been omitted and filed separately
with the Securities and Exchange Commission pursuant to Rule 24b-2
of the Securities and Exchange Act of 1934, as amended.
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5.
*
*
] For clarity, if any Short Acting
Coagulation Cascade Aptamers Developed under this Agreement for use
in the "Field" , as described in the previous sentences,
have additional therapeutic uses, those additional therapeutic uses
will also be considered part of the "Field."
1.30 "FTE" means the equivalent of one person working
full time for one 12-month period in a Research, Development,
Commercialization, regulatory or other relevant capacity, for
[ * ]
hours per year. For clarity, a single individual who works more
than [ *
] hours in a single year shall be treated as one FTE
regardless of the number of hours worked.
1.31 "FTE Reimbursement Rate" means the rate at which
Nuvelo shall reimburse Archemix for costs related to FTEs under
this Agreement. Such costs shall cover all salary and benefits, and
facilities and infrastructure costs, travel expenses, laboratory
supplies and materials used internally by Archemix in fulfilling
its obligations under this Agreement and all overhead charges which
are allocable to company departments based on space occupied or
headcount or another activity-based costing method and related to
FTE obligations necessary for performance under this Agreement.
Such FTE Reimbursement Rate shall be [
* ] per FTE.
For clarity, each Party shall be responsible, at its sole cost and
expense, for paying the salaries and benefits of its employees.
1.32 "Generic IP" has the meaning assigned in
Section 5.7.
1.33 "Gilead" means Gilead Sciences, Inc., a Delaware
corporation with its principal offices located at 333 Lakeside
Drive, Foster City, California 94404.
1.34 "Gilead-Archemix Agreement" means the License
Agreement entered into by and between Gilead and Archemix dated
October 23, 2001, as amended September 4, 2003.
1.35 "IND" means: (a) an Investigational New Drug
Application as defined in the Federal Food, Drug and Cosmetic Act
("FDCA") and regulations promulgated thereunder or any successor
application or procedure required to initiate clinical testing of a
Development Compound and/or Licensed Product in humans in the
United States; (b) a counterpart of an investigational New
Drug Application that is required in any other country or region in
the Territory before beginning clinical testing of a Development
Compound and/or Licensed Product in humans in such country or
region; and (c) all supplements and amendments to any of the
foregoing.
1.36 "In Vitro Diagnostics" means the use of the SELEX
Process or Aptamers or PhotoAptamers identified through the use of
the SELEX Process in the assay, testing or determination, outside
of a living organism, of a substance in a test material.
[ *
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[*]
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Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
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6.
*
1.37 "Indemnitees" has the meaning assigned in
Section 14.1.
1.38 "Internal FTE" means an FTE performing activities
related to the Collaboration by Archemix or its Affiliate(s).
1.39 "IPO Price" means the price per share paid by
investors participating in the Qualified IPO.
1.40 "Joint Management Committee" or "JMC" means the
committee described in Section 3.2.
1.41 "Joint Patent Rights" means Patent Rights claiming
Joint Technology.
1.42 "Joint Technology" means any Program Technology
jointly conceived or reduced to practice by employees of or
consultants to Nuvelo and employees of or consultants to Archemix
under this Agreement. For clarity, any jointly developed Technology
that is SELEX Technology or SELEX Inventions shall not be
considered Joint Technology regardless of which Party conceived or
reduced to practice such Technology or Inventions.
1.43 "Licensed Patent Rights" means any Archemix Patent
Rights (a) to the extent claiming any Compound Technology,
Candidate Compound, Development Compound or Licensed Product or the
manufacture thereof or the use thereof in the Field, or
(b) that are necessary or useful for Nuvelo to exercise the
relevant licenses granted to it pursuant to Article 5. For clarity,
the Licensed Patent Rights shall exclude any Patent Rights that
relate to the SELEX Inventions or the SELEX Technology and shall
include, without limitation, the following United States Patents
and their counterparts throughout the world to the extent not SELEX
Inventions or SELEX Technology: 6,334,318 B1; 5,476,766; 5,543,293;
5,582,981; 5,688,291; 5,817,785; 5,840,867; and 6,331,398 B1.
1.44 "Licensed Product" means a product that comprises,
consists of, or which incorporates a Development Compound
regardless of its formulation or mode of administration;
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Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
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7.
provided, that, any Aptamer contained therein is
a Short Acting Coagulation Cascade Aptamer, and provided, further,
that such Short Acting Coagulation Cascade Aptamer is not
formulated, modified or administered such that the Short Acting
Coagulation Cascade Aptamer or the Licensed Product does not
demonstrate the short acting characteristics set forth in Exhibit
C. For clarity, and without limitation, a Licensed Product shall
not include any pegylated Aptamer.
1.45 "Licensed Technology" means any Archemix Technology
that (a) specifically relates to any Candidate Compound,
Development Compound or Licensed Product relevant to the license
grant, or (b) is necessary or useful for Nuvelo to exercise
the relevant licenses granted to it pursuant to Article 5.
1.46 "Licensing Revenue" means any and all forms of
consideration that Nuvelo or any Nuvelo Affiliate receives directly
or indirectly from a Third Party Partner in connection with a
Partnering Agreement, which may include upfront license fees,
annual license or maintenance payments, milestone payments,
royalties, imputed income on interest-free loans received from such
Third Party Partner, the portion of an equity investment in Nuvelo
or a Nuvelo Affiliate that is greater than the fair market value of
Nuvelo’s or its Affiliate stock sold in such investment at
the time of sale and other similar payments; but Licensing Revenue
shall exclude any of the following amounts received by Nuvelo or
its Affiliates under a Partnering Agreement: (a) an equity
investment by such Third Party (but solely to the extent that such
investment is at a price equal to or less than the fair market
value of Nuvelo’s or its Affiliate’s stock sold in such
investment at the time of sale); (b) a loan at reasonable
interest rates for work required to be performed by Nuvelo and
directed to the Development or Commercialization of Licensed
Products subject to the Agreement; (c) research and
development support (at a reasonable FTE value);
(d) reimbursement of patent prosecution, maintenance,
enforcement or defense expenses; or (e) payments directly
attributable to supplying goods (at no more than one hundred
twenty-five percent (125%) of actual manufacturing cost) or
services to such Third Party Partner to enable the
commercialization of the Licensed Product that is subject to the
Partnering Agreement.
1.47 "Losses" has the meaning assigned in
Section 14.1.
1.48 "MHLW" means the Ministry of Health, Labor and
Welfare, otherwise referred to as "Korosho" or any successor
thereto, which governs the scientific review of human
pharmaceutical products in Japan.
1.49 "Minimum FTE Funding Requirement" has the meaning
assigned to it in Section 2.4.
1.50 "Modulate" or "Modulation" means the inhibition or
activation of a Coagulation Cascade Protein using a Short Acting
Coagulation Cascade Aptamer. As used in this definition,
"inhibition" means either (a) inhibition at a therapeutically
useful level of a Short Acting Coagulation Cascade Aptamer by
binding of a Short Acting Coagulation Cascade Aptamer to a
pre-selected Coagulation Cascade Protein or (b) inhibition at
a therapeutically useful level of a Short Acting Coagulation
Cascade Aptamer of a second pre-selected Coagulation Cascade
Protein by binding at a therapeutically useful level of a Short
Acting Coagulation Cascade Aptamer to a first pre-selected
Coagulation Cascade Protein. As used in
8.
this definition, "activation" means either
(a) activation at a therapeutically useful level of a Short
Acting Coagulation Cascade Aptamer by binding of a Short Acting
Coagulation Cascade Aptamer to a pre-selected Coagulation Cascade
Protein or (b) activation at a therapeutically useful level of
a Short Acting Coagulation Cascade Aptamer of a second pre-selected
Coagulation Cascade Protein by binding at a therapeutically useful
level of a Short Acting Coagulation Cascade Aptamer to a first
pre-selected Coagulation Cascade Protein.
1.51 "NDA" means a New Drug Application submitted and
filed with the FDA or the equivalent application or filing filed
with any equivalent agency or government authority outside of the
United States (including any supra-national agency such as in the
European Union) necessary for approval of a drug in such
jurisdiction.
1.52 "Net Sales:"
(a) means the gross amount invoiced by Nuvelo or its
Affiliate or a licensee or sublicensee (at any level, including a
sublicensee of a sublicensee) for sales of Licensed Products to a
Third Party (other than a Third Party Partner or a licensee or
sublicensee) less, to the extent included within the gross amount
invoiced to and paid by the customer, deductions for;
(i) transportation, and customs clearance, duty charges and
insurance relating to such transportation; (ii) sales and
excise taxes, customs and any other governmental charges, all to
the extent imposed upon the sale of the Licensed Products and paid
by the selling party; (iii) distributors fees, rebates or
allowances actually granted or allowed, including government and
managed care rebates; (iv) quantity discounts, cash discounts
or chargebacks actually granted, allowed or incurred in the
ordinary course of business in connection with the sale of the
Licensed Products; and (v) allowances or credits to customers,
not in excess of the selling price of the Licensed Products, on
account of governmental requirements, rejection, recalls or return
of the Licensed Products.
(b) Solely for the purpose of calculating Net Sales of
Licensed Products, if a Party or its Affiliate, or a licensee or
sublicensee, sells such Licensed Products in the form of a
combination product containing any such Licensed Product and one or
more active ingredients or a delivery device (whether combined in a
single formulation or package, as applicable, or formulated or
packaged separately but sold together for a single price) (a
"Combination Product" ), Net Sales of such Combination
Product for the purpose of determining the royalty due to the other
Party pursuant to Sections 7.4(b)(i) and/or 12.2(b) will be
calculated by multiplying actual Net Sales of such Combination
Product as determined in subsection (a) above by the fraction
A/(A+B) where A is the invoice price of such Licensed Product if
sold separately, and B is the total invoice price of the other
active ingredient(s) or the delivery device in the combination if
sold separately. If, on a country-by-country basis, such other
active ingredient or ingredients or delivery device in the
Combination Product are not sold separately in such country, but
the Licensed Product component of the Combination Product is sold
separately in such country, Net Sales for the purpose of
determining royalties due to the other Party pursuant to Sections
7.4(b)(i) and/or 12.2(b) for the Combination Product shall be
calculated by multiplying actual Net Sales of such Combination
Product as determined in subsection (a) above by the fraction
A/C where A is the invoice price of such Licensed Product component
if sold separately, and C is the invoice price of the Combination
Product. If, on a country-by-country basis, such Licensed Product
component is not sold separately in such country, Net Sales for
the
9.
purposes of determining royalties due to the
other Party pursuant to Section 7.4(b)(i) and /or 12.2(b) for
the Combination Product shall be D/(D+E) where D is the fair market
value of the portion of the Combination Products that contains the
Licensed Product and E is the fair market value of the portion of
the Combination Products containing the other active ingredient(s)
or delivery device included in such Combination Product as such
fair market values are determined by mutual agreement of the
Parties.
1.53 "Nuvelo Background Technology" means any Technology
that is (a) Controlled by Nuvelo as of the Effective Date or
(b) conceived or first reduced to practice by Nuvelo after the
Effective Date other than in the conduct of Research, Development
or Commercialization, and in either case is necessary or useful for
the Research, Development or Commercialization, manufacture,
importation, use or sale of Candidate Compounds, Development
Compounds or Licensed Products under this Agreement. Nuvelo
Background Technology does not include Nuvelo Program Technology or
Nuvelo’s interest in Joint Technology. For clarity, any
Program Technology that is SELEX Technology or SELEX Inventions
shall not be considered Nuvelo Background Technology regardless of
which Party conceived or reduced to practice such Technology or
Inventions.
1.54 "Nuveo IPO Share Amount" means that number of shares
of Archemix Common Stock equal to the lesser of (a) Ten
Million Dollars ($10,000,000) divided by the IPO Price or
(b) fifteen percent (15%) of the total gross offering
proceeds (prior to underwriter commissions and expenses) raised by
Archemix in the Qualified IPO divided by the IPO Price.
1.55 "Nuvelo Patent Rights" means Patent Rights
Controlled by Nuvelo claiming or disclosing Nuvelo Technology.
1.56 "Nuvelo Product" has the meaning assigned to it in
Section 12.2(a)(i).
1.57 "Nuvelo Program Technology" means any Program
Technology that is conceived or first reduced to practice by or
through employees of, or consultants to, Nuvelo, alone or with any
Third Party, in the conduct of the Research, Development or
Commercialization of Candidate Compounds, Development Compounds or
Licensed Products. For clarity, any Program Technolgy that is SELEX
Technology or SELEX Inventions shall not be considered Nuvelo
Program Technology regardless of which Party conceived or reduced
to practice such Technology or Inventions.
1.58 "Nuvelo Technology" means, collectively, Nuvelo
Background Technology, Nuvelo Program Technology, and
Nuvelo’s interest in all joint Technology.
1.59 "Partnered Product" means a Licensed Product that is
the subject of a Partnering Agreement.
1.60 "Partnering Agreement " means an executed and
in-force written agreement between Nuvelo and a Third Party or
between a Third Party Partner and another Third Party, wherein such
Third Party is granted the right to Develop or Commercialize, alone
or in collaboration with Nuvelo or another Third Party Partner, a
Licensed Product.
10.
1.61 "Patent Rights" means the rights
and interests in and to (a) a pending application for a patent
anywhere in the world, including without limitation any
provisional, converted provisional, continued prosecution
application, substitution, continuation, divisional or
continuation-in-part thereof; (b) any patent issuing on any of
the foregoing, including any inventor’s certificate, that has
not expired or been declared invalid by a court from which no
appeal can be or has been taken; or (c) any extension,
renewal, reissue or reexamination of any of the foregoing.
1.62 "Phase I Trial" means that portion of the clinical
development program that generally provides for the first
introduction into humans of a product with the primary purpose of
determining safety, metabolism and pharmacokinetic properties and
clinical pharmacology of the product, and that is consistent with
21 CFR §312.21(a) or the applicable rules and regulations of
the jurisdiction in which the clinical trial is conducted.
1.63 "Phase 2 Trail" means that portion of the clinical
development program that provides for a clinical trial of a product
on patients, which may include pharmacokinetic studies, the
principal purpose of which is to make a preliminary determination
that such product is safe for its intended use, to determine
potential doses and to obtain sufficient information about such
product’s efficacy to permit the design of further clinical
trials, and that is consistent with 21 CFR §312.21(b) or the
applicable rules and regulations of the jurisdiction in which the
clinical trial is conducted.
1.64 "Phase 3 Trail" means that portion of the clinical
development program that provides for a pivotal human clinical
trial of a product, which trial is designed to: (a) establish
that a product is safe and efficacious for its intended use;
(b) define warnings, precautions and adverse reactions that
are associated with the product in the dosage range to be
prescribed; and (c) support Regulatory Approval of such
product; and which trial is consistent with 21 CFR §312.21(c)
or the applicable rules and regulations of the jurisdiction in
which the clinical trial is conducted.
1.65 " Phase 4 Costs" means all expenses incurred by
either Party or for its account, and specifically attributable to:
(a) direct support of the performance of a Phase 4 Trail for a
Licensed Product; or (b) process development for a Licensed
Product in a Phase 4 Trail. All Phase 4 Costs shall be treated as
Post Launch R&D Expenses in accordance with Exhibit A.
1.66 "Phase 4 Trial" means a clinical trial of a Licensed
Product commenced in a particular country after receipt of
Regulatory Approval in such country in order to support
commercialization of the Licensed Product.
1.67 "Product Profit and Loss" means the profits or
losses resulting from the Commercialization of Licensed Products
and is equal to Net Sales plus Licensing Revenue less Allowable
Commercialization Expenses.
1.68 "Program Target" means a Coagulation Cascade Protein
identified in Exhibit B that is the subject of an approved Research
Plan.
1.69 "Program Technology" means any Technology that is
generated, conceived or first reduced to practice (actively or
constructively) by either Party or both Parties in the conduct of
the Research, Development or Commercialization of Candidate
Compounds, Development Compounds or Licensed Products.
11.
1.70 "Qualified IPO" means
Archemix’s firm commitment underwritten initial public
offering on the
[
* ]
filed under the Securities Act of 1933, as amended, covering the
offer and sale of Archemix Common Stock, with total gross offering
proceeds to Archemix (prior to underwriter commissions and
expenses) of at least
[ * ] dollars ($
[ * ]) exclusive of
the dollar value represented by the Nuvelo IPO Share
Amount.
1.71 "Radio Therapeutic Aptamer" means any product for
human therapeutic use that contains one or more Aptamers that
targets specifically any diseased tissue, cells or disease-specific
molecules or any tissue or cells which are affected by a disease or
located in the close neighborhood of a disease process and is
linked to or incorporates: (a) radionucleotides; or (b) any
structure or elements which develop therapeutic effects similar to
the effect of linking or incorporating radionucleotides after
submission of any kind of radiation.
1.72 THIS SECTION LEFT INTENTIONALLY BLANK.
1.73 "Regulatory Approval" means any and all approvals
(including supplements, amendments, pre- and post-approvals,
pricing and reimbursement approvals), licenses, registrations or
authorizations of any national, supra-national ( e.g ., the
European Commission or the Council of the European Union),
regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity, that are
necessary for the manufacture, distribution, use or sale of a
Licensed Product in a regulatory jurisdiction.
1.74 "Regulatory Authority" means the FDA or any
counterpart of the FDA outside the United States, or other
national, supra-national, regional, state or local regulatory
agency, department, bureau, commission, council, or other
governmental entity with authority over the distribution,
importation, exportation, manufacture, production, use, storage,
transport or clinical testing or sale of a Licensed Product.
1.75 "Regulatory Documentation" means, with respect to a
Licensed Product, all regulatory filings and supporting documents
created, submitted to the FDA or any equivalent agency or
government authority outside of the United States (including any
supra-national agency such as in the European Union) relating to
such product, and all data contained therein, including, without
limitation, any IND(s), NDA(s), Biologics License Application(s)
("BLA(s)"), Investigator’s Brochures, Drug Master File(s),
correspondence to and from the FDA or any equivalent agency or
governmental authority outside of the United States, minutes from
teleconferences with Regulatory Authorities, registrations and
licenses, regulatory drug lists, advertising and promotion
documents shared with Regulatory Authorities, adverse event files,
complaint files and manufacturing records.
1.76 "Regulatory Filing" means the NDA, BLA, IND, or any
foreign counterparts thereof and any other filings required by
Regulatory Authorities relating to the study, manufacture or
commercialization of any Licensed Product.
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Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
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12.
1.77 "Research" means: (a) the
discovery and identification of Candidate Compounds for use within
the Field; (b) the biological characterization (including,
without limitation, preclinical activities such as in vivo
analysis) of such Candidate Compounds; and (c) any other
activities related to the Field specified in an approved Research
Plan, in each case which are to be conducted pursuant to this
Agreement.
1.78 "Research Plan" means the written plan describing
the Research and any other activities to be carried out by the
Parties during each Contract Year during the Term of this Agreement
as such written plan may be amended, modified or updated in
accordance with the terms of this Agreement. Each Research Plan
shall include a budget and shall specify the number of FTEs to be
utilized by Archemix.
1.79 "Research Program Term" means the period during
which Archemix shall be obligated to conduct Research on
Nuvelo’s behalf hereunder. The Research Program Term shall
begin on the Effective Date and end on the last day of the third
Contract Year or such later date as the Parties may mutually agree
in writing; provided, that, if this Agreement is terminated prior
to the end of the Research Program Term, the effective date of
termination shall be the last day of the Research Program Term.
1.80 "Royalty Period" has the meaning assigned to it in
Section 7.4(b)(iii).
1.81 "SELEX Inventions" means any and all
inventions, including any improvements, made solely by employees or
independent contractors of one Party, or jointly by employees or
independent contractors of each Party, in the course of the
Party’s or Parties’ performance under this Agreement,
specifically relating to the SELEX Technology.
1.82 "SELEX Portfolio" means those Patent Rights
licensed by Gilead to Archemix pursuant to the Gilead-Archemix
Agreement.
1.83 "SELEX Technology" means any Technology or process
for identifying, modifying, optimizing and/or stabilizing an
Aptamer, whether (i) existing as of the Effective Date or
invented thereafter. For clarity for the purposes of this
Section 1.83: (i) the process of "identifying" includes,
without limitation, any process which is disclosed in or falls
within the claimed scope of U.S. Patent Nos. 5,270,163 or
5,843,653" ); and (ii) the processes of "modifying",
"optimizing" and "stabilizing" include, without limitation,
minimization, truncation, conjugation, pegylation, complexation,
substitution, and deletion and/or incorporation of modified
nucleotides. "SELEX Technology" and "SELEX Inventions" does not
include any Compound Technology.
1.84 "Short Acting Coagulation Cascade Aptamer" means ARC
2172 and any other Aptamer that: (a) binds to a pre-selected
Coagulation Cascade Protein identified on Exhibit B; (b) Modulates
the blood coagulant function of any Coagulation Cascade Protein
identified on Exhibit B; and (c) demonstrates the short-acting
characteristics and limitations that are set forth in Exhibit C.
For clarity, Short Acting Coagulation Cascade Aptamers do not
include [
*
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Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
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13.
*
] Nothing in this Section 1.84 will be interpreted to exclude
an Aptamer from the definition of " Short Acting Coagulation
Cascade Aptamer " if it Modulates functions other than the
blood coagulant function of a Coagulation Cascade Protein;
provided, that, it Modulates the blood coagulant function of a
Coagulation Cascade Protein.
1.85 "SomaLogic Agreements" means [
*
]
1.86 "Technology" means, collectively, inventions,
discoveries, improvements, trade secrets, proprietary materials and
proprietary methods, whether or not patentable, including without
limitation: (a) methods of production or use of, and
structural and functional information pertaining to, chemical
compounds; (b) compositions of matter, data, formulations,
processes, techniques, know-how and results (including any negative
results); and (c) any proprietary data, instructions,
processes, methods, formulae, materials, expert opinions and
information including, without limitation, biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and
analytical, clinical, safety, manufacturing and quality control
data and information in the Control of a Party either prior to or
during this Agreement that relates in any way to Research or
Development activities.
1.87 "Term" has the meaning assigned to it in
Section 11.
1.88 "Third Party" means any entity other than:
(a) Nuvelo; (b) Archemix; or (c) an Affiliate of
either of them.
1.89 "Third Party Partner" means a Third Party that has
entered into a Partnering Agreement.
1.90 "Third Party Royalty" has the meaning assigned to it
in Section 7.4(b)(ii).
1.91 "Title 11" has the meaning assigned to it in
Section 16.2(a).
1.92 "ULEHI Agreement" means [
*
]
1.93 "URC License Agreement" means
[ * ]
1.94 "UTC" means
[
*
]
1.95 "Valid Claim" means (a) any claim of a pending
patent application which has been pending for a period of less than
five (5) years from the date of issuance of a first patent
office communication during examination of the first application
related thereto, and shall not have been earlier cancelled,
withdrawn or abandoned on a country-by-country basis, or
(b) an
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Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
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14.
issued unexpired patent that (i) has not
been finally cancelled, withdrawn, abandoned or rejected by any
administration agency or other body of competent jurisdiction,
(ii) has not been permanently revoked, held invalid, or
declared unpatentable or unenforceable in a decision of a court or
other body of competent jurisdiction that is unappealable or
unappealed within the time allowed for appeal, (iii) has not
been rendered unenforceable through disclaimer or otherwise, and
(iv) is not lost through an interference
proceeding.
2. R ESEARCH
2.1 Research Overview . Archemix will conduct Research in the
Field in accordance with an approved Research Plan to generate
Candidate Compounds during the Research Program Term. The Parties
will prepare a Research Plan for Nuvelo’s approval for the
initial twelve (12) months of the Research Program Term within
sixty (60) days of the Effective Date. For the second and
third years of the Research Program Term the Parties shall prepare
an updated Research Plan for discussion by the JMC and approval by
Nuvelo at least ninety (90) days prior to the first and second
anniversaries of the Effective Date. Each Research Plan will
include, without limitation, (a) a prioritized list of the
Coagulation Cascade Protein targets for which Archemix will
generate Aptamers; (b) a target product profile for Short
Acting Coagulation Cascade Aptamers to meet for each Coagulation
Cascade Protein pursued so that such Aptamers can be considered as
Candidate Compounds; and (c) a proposed work plan and resource
allocation plan.
2.2 Diligence . The Parties will use Diligent Efforts to
conduct their respective tasks throughout the Term, and will
conduct all Research, Development and Commercialization activities
in good scientific manner, and in compliance in all material
respects with the requirements of applicable laws, rules and
regulations, to attempt to achieve their objectives efficiently and
expeditiously. Without limiting the generality of the
foregoing:
(a) Nuvelo will: (i) determine whether any Candidate
Compounds should be designated as Development Compounds, and
(ii) use Diligent Efforts to Develop, manufacture and
Commercialize at least one (1) Development Compound and
related Licensed Product for use in the Field.
(b) Archemix will use Diligent Efforts to conduct
Research and Nuvelo will use Diligent Efforts to evaluate in good
faith and decide in a timely manner whether to designate Candidate
Compounds as Development Compounds following receipt of all data
requested by Nuvelo with regard to Candidate Compounds and to
Develop and Commercialize any Development Compound or Licensed
Product.
2.3 Designation of Candidate Compounds and Development
Compounds . Nuvelo will have the sole right to designate a
Candidate Compound as a Development Compound based on whether the
Candidate Compound meets the relevant target product profile
established by Nuvelo and set forth in the Research Plan or as
subsequently modified by Nuvelo in good faith and communicated in
writing to Archemix.
2.4 FTE Funding . Nuvelo shall pay Archemix a minimum of
One Million Seven Hundred Fifty Thousand Dollars ($1,750,000) per
Contract Year (the "Minimum FTE Funding
15.
Requirement ") for Archemix Internal
FTEs dedicated to conducting Research or any Development activities
in accordance with Research Plans approved by Nuvelo, and any other
activities conducted in accordance with an approved Research Plan
or in conducting Development activities approved in writing by
Nuvelo. For clarity, the Minimum FTE Funding shall be paid to
Archemix regardless of whether or not (a) a Research Plan has
been approved by Nuvelo or (b) the number of FTEs contemplated
by the Minimum FTE Funding Requirement are utilized in any Contract
Year, provided, that, to the extent that Nuvelo provides Archemix
with a Research Plan that calls for Archemix Internal FTEs up to
the Minimum FTE Funding Requirement for the purpose of conducting
Research or Development in the Field, Archemix shall be required to
provide the services of such FTEs as a condition to its entitlement
to the Minimum FTE Funding Requirement. To the extent that Nuvelo
requires Archemix Internal FTEs above the amount contemplated by
the Minimum FTE Funding Requirement such obligation to provide
these additional FTE’s shall come only with
(i) Archemix’s prior written consent and (ii) as
part of an approved Research Plan. Unless otherwise stated herein,
Nuvelo will have no other obligation to reimburse Archemix for any
expenses Archemix incurs in connection with Archemix’s
performance of Research under this Agreement. Notwithstanding any
other provision hereof: (y) Archemix will have no obligation
to engage any Third Party in its performance of the Research
hereunder, and Nuvelo will have no obligation to reimburse Archemix
for any such Third Party engagement, unless Nuvelo agrees in
writing to reimburse Archemix for the costs associated with such
Third Party contracts, and (z) Archemix shall have no
obligation to perform any activities not identified in an agreed
Research Plan, and Nuvelo will have no obligation to reimburse
Archemix for any such activities. Nuvelo will have no ongoing
obligation to fund any Research by Archemix after the expiration of
the Research Program Term.
3.1 Overall Management Structure . The Joint Management
Committee ("JMC") will be established as set forth below and will
be responsible for reviewing the Research Plan, and all amendments
thereto, under this Agreement as further described below. If
Archemix exercises its Profit Share Option (as defined below), then
the responsibility of the JMC will expand to include Nuvelo’s
sharing of information relating to its Commercialization activities
with respect to a particular Development Compound, and the Licensed
Products relating thereto, pursuant to Section 6.2.
3.2 Joint Management Committee .
(a) Membership . The JMC shall be composed of six
(6) members, with an equal number of members appointed by each
Party. Immediately following the Effective Date, each Party shall
appoint its initial representatives to the JMC. Each Party may
replace its JMC representatives at any time upon written notice to
the other Party. Nuvelo will designate one of its representatives
as the Chairperson of the JMC. The Chairperson shall be responsible
for scheduling meetings, preparing and circulating an agenda in
advance of each meeting, and preparing and issuing minutes of each
meeting within thirty (30) days thereafter. Minutes of a JMC
meeting shall be final only when approved by the JMC.
16.
(b) Power and Responsibilities. During
the Research Program Term of this Agreement, the JMC shall meet a
minimum two (2) times per year as provided in
Section 3.3. The JMC is responsible for: (i) reviewing
the annual Research Plan; and (ii) receiving updates on
Nuvelo’s Development activities hereunder with regard to any
Development Compounds or Licensed Products then under Development.
If Archemix exercises its Profit Share Option, then the
responsibility of the JMC will expand to include receiving updates
on Nuvelo’s Commercialization activities with respect to
Licensed Products. The JMC shall have no power to amend this
Agreement. Any amendments that alter the terms of this Agreement
shall be implemented pursuant to Section 16.1 below.
3.3 Meetings. The Parties shall endeavor to schedule
meetings of the JMC at least thirty (30) days in advance.
Committee meetings held in person will alternate between sites
designated by each Party, unless otherwise agreed by the Parties.
With the consent, not to be unreasonably withheld, of the
representatives of each Party serving on the JMC, other
representatives of each Party may attend meetings of the JMC as
nonvoting observers. A meeting of the JMC may be held by audio or
video teleconference. Each Party shall be responsible for all of
its own expenses of participating in the meetings of the JMC, and
such expenses shall not be included in the Development Costs or
Allowable Commercialization Expenses if Archemix exercises its
Profit Share Option pursuant to Article 6.
3.4 Decision Making. If the JMC is unable to reach a
unanimous agreement on any matter that the JMC is responsible for,
then Nuvelo shall have the final decision; provided, however, that,
to the extent that a Research Plan contemplates Archemix Research
or Development activities in excess of the minimum commitment
described in Section 2.4, Archemix shall not be required to
perform any Research or Development activities as part of a
Research Plan without its prior written consent. Nuvelo will have
the sole right to designate a Candidate Compound as a Development
Compound based on whether the Candidate Compound meets a target
product profile acceptable to Nuvelo and set forth in an approved
Research Plan or subsequently modified by Nuvelo in good faith and
communicated in writing to Archemix.
3.5 Access to Information. Archemix shall provide Nuvelo
and its authorized representatives with reasonable access during
regular business hours to records, documents, and other information
relating to the Candidate Compounds that Nuvelo may reasonably
require in order to evaluate their potential as Development
Compounds or, following their designation as Development Compounds,
to Develop such Development Compounds pursuant to the exclusive
licenses granted hereunder.
3.6 Research Expenses. Nuvelo will reimburse Archemix for
the Minimum FTE Funding Requirement per year during each Contract
Year during the Research Program Term of this Agreement. Nuvelo
shall pay twenty five percent (25%) of the annual Minimum FTE
Funding Requirement for each Contract Year quarterly in advance;
provided that, in the event that an approved Research Plan sets
forth a number of FTE’s higher than those indicated in the
Minimum FTE Funding Requirement, then Nuvelo shall pay quarterly in
advance twenty five percent (25%) of the annual FTE funding
requirement based on the number of FTEs set forth in the Research
Plan.
17.
3.7 Independence. Subject to the terms
of this Agreement, each Party shall manage its own activities and
resources, acting independently and in its individual capacity. The
relationship between Nuvelo and Archemix is that of independent
contractors and neither Party shall have the power to bind or
obligate the other Party in any manner, other than as is expressly
set forth in this Agreement.
4.1 Designation of ARC 2172. Nuvelo hereby designates ARC
2172 as a Development Compound.
4.2 Development and Commercialization. Nuvelo has sole
and full control, authority and responsibility for conducting,
funding (subject to Sections 6.1 and 7.5) and pursuing all aspects
of the designation, Development and Commercialization of
Development Compounds and Licensed Products throughout the world,
so long as Nuvelo uses Diligent Efforts with respect thereto.
Nuvelo may, at its discretion, contract with or grant sublicenses
to Third Parties in connection with the exercise of its rights with
regard to the Development and Commercialization of Development
Compounds and Licensed Products.
4.3 Abandonment of Development Compounds. Any time after
a Candidate Compound has been designated as a Development Compound,
Nuvelo may determine that Development of such Development Compound
should be abandoned. If Nuvelo decides to abandon Development of
particular Development Compound, and is not pursuing another
Candidate Compound or Development Compound for the same therapeutic
indication for which the first Development Compound was in
Development, or against the same Target to which such abandoned
Development Compound binds, then Archemix will have the right to
continue such Development within the Field either by itself or with
a Third Party only with Nuvelo’s prior, written consent and
upon the terms and conditions, if any, on which the Parties may
agree in writing based on good faith negotiations. In addition,
Archemix shall have the right to continue Development within the
Field either by itself or with a Third Party of ARC 183 (as defined
in the Original Agreement), whose joint Development the Parties
have previously agreed to abandon, with Nuvelo’s prior,
written consent and on terms and conditions, if any, on which the
Parties may agree in writing based on good faith negotiations.
4.4 Regulatory Affairs. With respect to each Development
Compound, at its discretion Nuvelo will prepare, file and own all
right, title and interest in Regulatory Filings and Regulatory
Approvals relating to each such Development Compound.
4.5 Manufacturing. Nuvelo will be responsible for
manufacturing and supplying Development Compounds and Licensed
Products for Development and Commercialization and for making all
decisions with respect thereto in its sole discretion including,
without limitation, decisions relating to process development work
to support quality assurance, improving manufacturing/cost
efficiency and commercial scale-up manufacturing. For clarity,
Nuvelo shall have final decision making authority to fulfill its
regulatory responsibilities over all steps of the manufacturing
process (including bulk, finish and fill, labeling and packaging,
lot release and management of contractors and subcontractors). The
Parties recognize the Nuvelo may use Third Parties to conduct some
or all of Nuvelo’s manufacturing responsibilities hereunder,
and Nuvelo will have sole decision making authority for contracting
with any such Third Parties.
18.
5. LICENSES AND RELATED RIGHTS
5.1 Research Licenses.
(a) Subject to the other terms of this Agreement, Archemix
hereby grants to Nuvelo a worldwide, non-exclusive license, without
the right to grant sublicenses, under the Licensed Technology and
Licensed Patent Rights, for the sole purpose of conducting Research
on Short Acting Coagulation Cascade Aptamers identified by Archemix
in the course of performance of Research.
(b) Subject to the other terms of this Agreement, Nuvelo
hereby grants to Archemix a worldwide, non-exclusive license during
the Research Program Term, without the right to grant sublicenses,
under Nuvelo Technology and Nuvelo patent Rights, for the sole
purpose of conducting Research or Development.
5.2 Commercialization License. Archemix hereby grants to
Nuvelo an exclusive (even as to Archemix), worldwide, sublicensable
license under the Licensed Technology and Licensed Patent Rights,
to Develop, Commercialize, make, have made, use, have used, sell,
have sold, lease, offer for sale or lease, import and export
Development Compounds and Licensed Products within the Field.
5.3 License Grant upon Termination of the Collaboration.
Upon termination the license grants between the Parties of this
Agreement shall be governed under Section 12.2 of this
Agreement.
5.4 License Limitations. Notwithstanding any provision
hereof to the contrary, (a) Archemix does not grant to Nuvelo
a license to the SELEX Technology or SELEX Inventions and Nuvelo
hereby covenants that it will not practice any SELEX Technology or
SELEX Inventions Controlled by Archemix and (b) Nuvelo hereby
covenants that it will not practice any of the rights granted
hereunder to any of the Licensed Patent Rights or Licensed
Technology or use, make, have made, import, sell, have sold, or
offer for sale any Short Acting Coagulation Cascade Aptamer,
Development Compound or Licensed Product for a purpose other than
that expressly permitted in Sections 5.1 and 5.2 hereof.
5.5 Exclusivity. During the Term of this Agreement, and
for a period of one (1) year thereafter, unless otherwise
provided in Section 4.3 or Section 12.2, neither Party
not its Affiliates shall, except with respect to the Parties’
activities under this Agreement [
*
]
or (c) license or otherwise enable any Third Party to perform
any of the activities set forth in subsections (a) through
(c) above. For clarity, nothing herein shall be deemed to
prohibit Archemix from identifying, discovering, researching,
developing, making, using or selling Aptamers that are not Short
Acting Coagulation Cascade Aptamers, so long as such actions
are
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Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
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19.
consistent with Sections 5.1, 5.2 and Article 10
hereof. In addition, neither Party may independently or with a
Third Party [
*
]
5.6 Sharing of Data.
(a) During the Term of this Agreement, Nuvelo will have
reasonable access to all Program Technology (including, without
limitation, all raw data) as it is generated.
(b) The Parties’ access to Program Technology and
Nuvelo Technology after the termination of the Agreement shall be
governed by Section 12.2(a) and Section 9.1.
5.7 Grantback. Notwithstanding anything in this Agreement
to the contrary, Nuvelo hereby grants to Archemix a non-exclusive,
paid-up, royalty-free license to any Nuvelo Technology and Nuvelo
Patent Rights that generically relates to and covers the
manufacturing, formulation, methods of use and/or processing of
Aptamers (such Patent Rights hereinafter referred to as "
Generic IP "). Archemix shall have the right to practice the
Generic IP and to grant sublicenses to the Generic IP to Third
Parties who have a license from Archemix to Archemix technology
and/or intellectual property solely in order to permit Archemix or
such Third Party to research, discover, make, have made, keep, use,
sell and/or have sold, import or export Aptamers which are not
subject to Nuvelo’s exclusive rights hereunder, and to the
extent such actions are consistent with Section 5.5 hereof and for
no other purpose. For clarity, the rights granted to Archemix by
Nuvelo under this Section 5.7 are limited to the claims to
Generic IP and no rights are granted under other claims in any
patent or patent application of Nuvelo that contains the claims(s)
which is (are) Generic IP.
5.8 Sublicenses. Nuvelo has the right to subcontract its
Development and Commercialization responsibilities under this
Agreement (and grant any necessary sublicenses in connection
therewith) without obtaining the written consent of Archemix;
provided, that, Nuvelo shall at all times remain primarily
responsible and liable for all such activities.
With respect to each sublicense granted hereunder: (a) such
sublicense shall be subject to all the material terms and
conditions of the Agreement as applicable; (b) the scope of
such sublicense shall be limited to performing Development or
Commercialization activities hereunder; (c) Nuvelo shall be
liable to Archemix as if Nuvelo is exercising such sublicensed
rights itself under this Agreement; and (d) Nuvelo shall
provide, upon written request by Archemix, reasonable assurance
that its sublicensees are bound by confidentiality, indemnity,
reporting, audit rights, access to data, and information and
inventions assignment obligations substantially the same as those
set forth in this Agreement. Nuvelo shall promptly provide notice
to Archemix of any sublicense granted pursuant to this
Section 5.8.
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Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
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20.
5.9 No Other Rights. No licenses
other than as expressly provided herein are granted by either Party
to such Party’s Technology or Patent Rights.
6. O PTION
6.1 Option Exercise.
(a) With respect to each Development Compound, Archemix
shall have the right, but not obligation, to elect to share in the
expenses incurred and profits obtained in connection with the
Development and Commercialization of such Development Compound and
all Licensed Products comprising such Development Compound (the
"Profit Share Option" ) by providing Nuvelo a written
notification of such election within forty-five (45) days
after receipt from Nuvelo of written notification of the closing of
the first patient in the first Phase 3 Trial for a Licensed Product
comprising, consisting of or incorporating such Development
Compound. For clarity, such Profit Share Option with respect to a
particular Development Compound shall expire after such forty-five
(45) day period.
(b) Within thirty (30) days after Nuvelo receives
notice that Archemix elects to exercise its Profit Share Option
pursuant to (a) above, Nuvelo shall provide Archemix with an
invoice for a payment that equals the sum of twenty-five percent
(25%) of (i) the sum of all costs incurred by Nuvelo in
the Research and all Development Costs incurred by Nuvelo, both as
of the date of invoice, with respect to such Development Compound
and Licensed Product; and (ii) the total for all milestone
payments paid by Nuvelo to Archemix as of the date of the invoice
to Archemix with respect so such Development Compound and Licensed
Product. Archemix shall pay such invoice within ten (10) days
after its receipt in order to effect its exercise of such Profit
Share Option.
6.2 Consequence of Option Exercise.
(a) Upon Archemix exercising its Profit Share Option with
respect to a particular Development Compound, Archemix shall be
responsible for twenty-five percent (25%) of all subsequent
Development and Commercialization Costs with respect to such
Development Compound and all of its related Licensed Products, and
Archemix shall share in the Product Profit and Loss with respect to
such Licensed Products pursuant to Section 7.5 below. Nuvelo shall
have no payment obligations to Archemix for milestone events
pursuant to Section 7.4 which are not yet due as of the date
of exercise of the Profit Share Option with respect to such
Development Compounds or Licensed Products.
(b) Upon Archemix exercising its Profit Share Option with
respect to a particular Development Compound and its related
Licensed Products, Nuvelo will share all Nuvelo Information
reasonably requested by Archemix regarding its Commercialization
activities of any such Licensed Products in connection with the JMC
meetings.
6.3 Option Exercise and Third Party License.
Archemix’s rights to its Profit Share Option hereunder shall
survive and remain in full force and effect relative to any
Development Compound that becomes subject to a Partnering Agreement
for so long as such Partnering Agreement remains in effect.
Further, Archemix shall be entitled to twenty-five percent (25%) of
all Licensing Revenue associated with such Partnering Agreement
regardless of whether such Licensing Revenue is received before or
after Archemix’s exercise of its Profit Share Option.
21.
7. C OMPENSATION
7.1 Obligations Prior to the Effective Date.
Within sixty (60) days of the Effective Date, each Party will
fulfill any and all of its payment obligations accrued and due
under the Original Agreement.
7.2 Upfront Payment . Nuvelo shall pay to Archemix Four
Million Dollars ($4,000,000) within ten (10) days of the
Effective Date by wire transfer of immediately available funds.
7.3 Stock Purchase and Sale.
(a) Stock Purchase . Contingent upon and subject to the
execution and delivery of, and compliance with the terms and
conditions of, this Agreement and the agreements contemplated
herein, and provided that this Agreement is still in effect,
Archemix shall instruct its underwriters to the Qualified IPO to
offer to Nuvelo, subject to the determination by Archemix or the
underwriters, with the advice of counsel, that such offer does not
violate applicable state or federal securities laws or regulations
or any rule, policy or limit imposed by the U.S. Securities and
Exchange Commission, the National Association of Securities
Dealers, any securities exchange or any other applicable regulatory
body (together, the "Applicable Regulations" ), the
opportunity to purchase the Nuvelo IPO Share Amount as an allotment
in any Qualified IPO that closes within five (5) years of the
Effective Date at the IPO Price; provided, however, that if the
underwriters determine in good faith that an allotment of shares in
such manner would be materially detrimental to the success of the
Qualified IPO, then the underwriters may limit all or a portion of
the Nuvelo IPO Share Amount. Should Nuvelo not be offered or elect
not to accept the opportunity to purchase the full Nuvelo IPO Share
Amount as an allotment in any such Qualified IPO, then Nuvelo shall
instead purchase from Archemix, and Archemix shall sell to Nuvelo
in a private placement (the "Private Placement" ),
concurrently with a Qualified IPO that closes within five
(5) years of the Effective Date, the portion of the Nuvelo IPO
Share Amount that is not included in the Qualified IPO at the IPO
Price. The purchase of shares of Archemix Common Stock in the
Private Placement shall be subject to compliance with Applicable
Regulations, including but not limited to compliance with the U.S.
Securities and Exchange Commission’s integration doctrine.
For clarity, if the Qualified IPO occurs prior to the first
anniversary of this Agreement then Nuvelo shall consummate the
stock purchase set forth in this Section 7.3 as a Private Placement
pursuant to Section 7.3(c) below.
(b) Purchase Mechanics.
(i) Notice of Qualified IPO. At least ten (10) days
prior to the anticipated effective date of the registration
statement for the Qualified IPO, Archemix shall deliver to Nuvelo
written notice (the "Qualified IPO Notice" ) specifying:
(1) that Archemix has filed a registration statement for
a Qualified IPO;
22.
(2) the anticipated effective date of
the registration statement for the Qualified IPO;
(3) the anticipated total gross offering proceeds (prior
to underwriter commissions and expenses) expected to be raised by
Archemix in the Qualified IPO;
(4) the anticipated range of the IPO Price; and
(5) the anticipated number of shares of Archemix Common
Stock to be purchased and sold in the Qualified IPO (appropriately
adjusted to reflect stock splits, stock dividends, combinations of
shares and the like).
(ii) Nuvelo Notice of Participation. Nuvelo shall inform
Archemix in writing within eight (8) days of the date of the
Qualified IPO Notice whether Nuvelo wishes to purchase shares of
Archemix Common Stock in the Qualified IPO and the portion of the
Nuvelo IPO Share Amount it wishes to purchase.
(iii) Purchase Notice. Following the pricing of the
Qualified IPO (the "IPO Effective Date" ), Archemix shall
deliver to Nuvelo written notice within one (1) business day
(the "Purchase Notice" ) specifying:
(1) that the registration statement for the Qualified IPO
has been declared effective;
(2) the total gross offering proceeds (prior to
underwriter commissions and expenses) to be raised by Archemix in
the Qualified IPO;
(3) the IPO Price;
(4) the number of shares of Archemix Common Stock
comprising the Nuvelo IPO Share Amount;
(5) if applicable, details for the purchase and
settlement of the portion of the Nuvelo IPO Share Amount to be
purchased by Nuvelo in the Qualified IPO, as specified by the
underwriter(s) to the qualified IPO, and the aggregate purchase
price for such shares (the "Qualified IPO Purchase Price"
);
(6) if applicable, the place and time at which the
Private Placement Closing will occur, the portion of the Nuvelo IPO
Share Amount to be purchased by Nuvelo in the Private Placement,
the aggregate purchase price of such shares (the "Private
Placement Purchase Price" ) and wire transfer instructions for
the payment of the Private Placement Purchase Price.
(c) Private Placement Closing . The closing of the
Private Placement, if applicable, (the "Private Placement
Closing" ) shall take place on the same day as the closing of
the Qualified IPO (the "Private Placement Closing Date" ) at
the place specified in the Purchase Notice; provided,
however , that: (A) if such purchase cannot be consummated
on the Private Placement Closing Date by reason of any applicable
order, judgment, decree or other legal
23.
impediment, then Nuvelo and/or Archemix may
extend the Private Placement Closing Date to a date not more than
ten (10) days after the applicable order, judgment, decree or
other legal impediment has been satisfied; and (B) if prior
notification to or approval of any governmental body is required,
or if any waiting period must expire or be terminated, in
connection with such purchase, then (1) the relevant Party
shall promptly cause to be filed the required notice or application
for approval and shall cause such notice or application to be
processed as expeditiously as possible, (2) the other Party
shall cooperate with the filing Party in the filing of any such
notice or application required to be filed and in the obtaining of
any such approval required to be obtained, and (3) the Private
Placement Closing Date shall be extended to a date not more than
ten (10) days after the latest date upon which any required
notification has been made, any required approval has been obtained
or any required waiting period has expired or been terminated. The
Private Placement Closing shall occur as follows:
(i) On the Private Placement Closing Date, Nuvelo shall
deliver to Archemix the Private Placement Purchase Price by wire
transfer, in immediately available funds, to the bank account
designated by Archemix in the Purchase Notice.
(ii) At the Private Placement Closing, simultaneously
with the delivery of the Private Placement Purchase Price, Archemix
and Nuvelo shall deliver to each other, executed counterparts of
the Stock Purchase Agreement set forth as Exhibit F and the
Registration Rights Agreement set forth as Exhibit G.
(d) Qualified IPO Closing. On the closing date of the
Qualified IPO, Nuvelo shall deliver to the underwriters the
Qualified IPO Purchase Price in accordance with the purchase and
settlement instructions designated by the underwriters.
(e) "Market Stand-Off" Agreement. Nuvelo aggress that
during the
[ * ]
day period following the effective date of the registration
statement for the Qualified IPO, or such other period as requested
of all Archemix executive officers required to file Forms 3 and 4
and directors of Archemix by the underwriters in the Qualified IPO
in order to comply with Rule 2711 of the National Association of
Securities Dealers or otherwise, Nuvelo shall not, to the extent
requested by the Archemix and any underwriter to the Qualified IPO,
sell, pledge, lend, contract to sell, sell any option or contract
to purchase, purchase any option or contract to sell, grant any
options, right or warrant to purchase, or otherwise transfer or
dispose of (other than to donees who agree to be similarly bound),
or enter into any swap, hedging or similar transaction with the
same economic effect as a sale, any shares of Common Stock of
Archemix or any securities convertible into or exercisable or
exchangeable for Common Stock held by Nuvelo at any time during
such period; provided, however, that all executive officers
and directors of Archemix enter into similar market stand-off
agreements.
7.4 Payments for Development Compounds and Licensed Products
for which Archemix has not Exercised its Profit Share
Option.
(a) Milestone Payments. With respect to each Development
Compound, Nuvelo shall pay to Archemix the milestone payments as
set forth below, which shall be due and payable within ten
(10) business days of the occurrence of the event for the
Development Compound for which the payment is due. For clarity,
each milestone payment is due only once
|
[*]
|
Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
|
24.
for each Development Compound, regardless of the
number of Licensed Products Developed or Commercialized under this
Agreement which comprise, consist of or incorporate such
Development Compound. Each milestone payment is due only for
Development Compounds for which Archemix has not exercised its
Profit Share Option.
| |
|
|
|
|
|
|
|
|
Milestone
Event
|
|
Payment
Amount
|
|
[ * ]
|
|
[ * ]
|
|
|
[ * ]
|
|
[ * ]
|
|
[ * ]
|
|
|
[ * ]
|
|
[ * ]
|
|
[ * ]
|
|
|
[ * ]
|
|
[ * ]
|
|
[ * ]
|
|
|
[ * ]
|
|
[ * ]
|
|
[ * ]
|
|
|
[ * ]
|
|
[ * ]
|
|
[ * ]
|
|
|
[ * ]
|
|
[ * ]
|
|
[ * ]
|
|
|
[ * ]
|
|
[ * ]
|
|
[ * ]
|
|
|
[ * ]
|
| |
|
|
|
|
|
| |
|
Total
|
|
$
|
35,000,000
|
| |
|
|
|
|
|
(b) Royalties.
(i) Nuvelo shall pay Archemix royalties on Net Sales of
Licensed Products for which Archemix has not exercised its profit
Share Option at the royalty rates set forth below:
|
[*]
|
Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
|
25.
| |
|
|
|
|
Portion of Net sales of Each Licensed Product
during Each Calendar Year
|
|
Royalty
Rate
|
|
|
Up to $[ * ]
|
|
[
|
*]%
|
|
|
|
The portion of Net Sales that is greater
than
$[ * ] and less than or equal to
$[ * ]
|
|
[
|
*]%
|
|
|
|
The portion of Net Sales that is greater
than
$[ * ] and less than or equal to
$[ * ]
|
|
[
|
*]%
|
|
|
|
The portion of Net Sales that is greater
than
$[ * ] and less than or equal to
$[ * ]
|
|
[
|
*]%
|
|
|
|
The portion of Net Sales that is greater
than
$[ * ]
|
|
[
|
*]%
|
(ii) Third Party Royalties. Nuvelo
shall be responsible for any and all royalties due to a Third Party
in connection with the Development of any Development Compound
and/or Commercialization of any Licensed Product (the "Third
Party Royalty" ), except that Archemix shall be responsible for all
royalties due to ULEHI for payments made by Nuvelo to Archemix with
respect to all Licensed Products. Archemix hereby warrants that the
only Third Party Royalty obligation of which Archemix is aware that
exists as of the Effective Date of this Agreement is set forth in
ULEHI Agreement.
(iii) Royalty Adjustment and Term. The royalty amounts
set forth above shall be due on a Licensed Product-by-Licensed
Product and country-by-country basis for so long as a Valid Claim
of (a) Licensed Patent Rights cover the manufacture, use or
sale of such Licensed Product in such country or (b) Nuvelo
patent Rights that cover Nuvelo Program Technology cover the
manufacture, use or sale of such Licensed Product in such country.
In the event that no such Valid Claim exits, the royalty amounts
set forth above, which shall be due on a country-by-country basis,
shall be reduced by fifty percent (50%) on a Licensed
Product-by-Licensed Product and country-by-country basis until the
tenth (10 th ) anniversary of the first commercial sale of such
Licensed Product in such country if such anniversary has not yet
occurred.
(iv) Royalty Report and Payment. Commencing with the
first commercial sale of a Licensed Product by Nuvelo or its
licensees or sublicensees, Nuvelo or its licensees or sublicensees
making such sales shall make quarterly written reports to Archemix
within sixty (60) days after the end of each calendar quarter
(the "Royalty Period" ), stating in each such report, by
Licensed Products and by country, the number, description and
aggregate Net Sales in U.S. dollars of such Licensed Products sold
during such Royalty Period by Nuvelo and its licensees or
sublicensees, respectively. The report shall also show:
(A) the calculation of Net Sales made by Nuvelo and the
royalty payments due to Archemix on such Net Sales for such Royalty
Period; (B) the calculation of Net Sales made by Nuvelo’s
licensees or sublicensees, the amount of sublicense revenue and
royalty received from such licensees or sublicensees and the
royalty payments due to Archemix on such sublicensee Net Sales for
such royalty period; (C) the
|
[*]
|
Certain confidential information contained in
this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to
Rule 24b-2 of the Securities and Exchange Act of 1934, as
amended.
|
26.
amount of taxes, if any, withheld to comply with
applicable law; and (D) the exchange rates used in calculating
the payments due to the other Party, which exchange rates shall
comply with Section 7.4(b)(vi) below. Simultaneously with the
delivery of each such report, Nuvelo or its licensee or sublicensee
making such sales shall pay to Archemix the total royalties, if
any, due to Archemix for such Royalty Period. If no royalties are
due, Nuvelo or its licensee or sublicensee making such sales shall
so report.
(v) Blocked Currency. In each country where the local
currency is blocked and cannot be removed from the country,
royalties arising from sales made in that country shall be paid in
the country in local currency by deposit in a local bank designated
by Archemix, unless the Parties otherwise agree.
(vi) Foreign Exchange. Conversion of sales recorded in
local currencies to U.S. dollars will be performed using an
exchange rate for conversion of the foreign currency into U.S.
dollars, at the average rate of exchange for the calendar quarter
to which such payments relate, quoted for current transactions for
buying U.S. dollars, as reported in The Wall Street Journal for the
last business day of the week before such payment is due, except as
provided in Section 7.4(b)(v).
7.5 Payments for Development Compounds and Licensed Products
for which Archemix Exercises its Profit Share Option.
(a) Overview. For Licensed Products for which Archemix
has exercised its Profit Share Option, the Parties shall share all
Product Profit and Loss with respect to such Licensed Product so
that Nuvelo shall be entitled to seventy-five percent (75%) of
such Product Profit and Loss and Archemix shall be entitled to
twenty-five percent (25%) of such Product Profit and Loss.
(b) Reporting and Reconciliation.
(i) Within sixty (60) days after the end of each
calendar quarter following the first receipt of revenues under this
Agreement (which may be either from Net Sales or Licensing
Revenue), Nuvelo shall prepare and submit to Archemix a statement
of quarterly Product Profit and Loss, prepared on an accrual basis
in accordance with GAAP in substantially the form attached as
Exhibit H, which shall include a calculation of the equalization
payment which is necessary to cause the ratio of the participation
of Nuvelo and Archemix in the Product Profit and Loss for such
quarter on an accrual basis to be seventy-five percent/twenty-five
percent (75%/25%), respectively (the "Financial Statement"
). The reports and equalization payments for the fourth quarter of
the fiscal year may include reconciliations and year-end
adjustments with respect to previous quarters. All payments
required by this Section 7.5 shall be made concurrently with
the submittal of the Financial Statement or, if a payment is due
from Archemix to Nuvelo, within ten (10) days after receipt
thereof by Archemix. Nuvelo will provide to Archemix such
supporting information for the Financial Statement as Archemix may
reasonably request. Archemix may audit, in accordance with the
procedures set forth in Article 8, the accuracy of Nuvelo’s
submissions pursuant to this Section 7.5(b)(i).
27.
(ii) By way of example, on an accrual
basis, if during a particular quarter Nuvelo realized revenues from
Licensed Products for which Archemix has exercised its Profit Share
Option of One Hundred Million Dollars ($100,000,000) and incurred
Allowable Commercialization Expenses of Thirty Million Dollars
($30,000,000), then the Equalization Payment for such quarter would
be a payment by Nuvelo to Archemix in the amount of Seventeen
Million Five Hundred Thousand Dollars ($17,500,000). For clarity,
the example set forth in this Section 7.5(b)(ii) is calculated
on an accrual basis of accounting.
7.6 Payment Method. All payments due under this Agreement
shall be made by a bank wire transfer in immediately available
funds to an account designated by the receiving Party. All payments
hereunder shall be made in U.S. dollars from the United States.
7.7 Taxes. Each Party shall pay any and all taxes levied
on account of all payments it receives under this Agreement. If
laws or regulations require that taxes be withheld, the paying
Party will: (a) deduct those taxes from the remittable
payment; (b) pay the taxes to the proper taxing authority; and (c)
send evidence of the obligation together with proof of tax payment
to the receiving Party within thirty (30) days following that tax
payment.
Both Parties shall keep complete, true and accurate books of
accounts and records for the purpose of determining the payments to
be made under this Agreement. Such books and records shall be kept
for at least three (3) years following the end of the calendar
quarter to which they pertain. Such records will be open for
inspection during such three (3) year period by independent
accountants, solely for the purpose of verifying payment statements
hereunder. Such inspections shall be made no more than once each
calendar year, at reasonable time and on reasonable notice. If any
errors that favor the inspected Party are discovered in the course
of such inspection, then within thirty (30) days after its
receipt of the inspection report, the inspected Party shall pay the
inspecting Party those amounts (plus interest equal to the Prime
Lending Rate as published in the Wall Street Journal on the
day preceding the inspection plus two hundred (200) basis
points; provided, however, that in no event shall such rate exceed
the maximum annual interest rate permitted under applicable law)
that the inspecting Party would have received in the absence of
such errors. If any errors that favor the inspecting Party are
discovered in the course of such inspection, then within thirty
(30) days after its receipt of the inspection report, the
inspecting Party shall pay the inspected Party those amounts.
Inspections conducted under this Article 8 shall be at the expense
of the inspecting Party, unless a variation or error that favors
the inspected Party exceeding five percent (5%) of the amount
stated for any year covered by the inspection is established in the
course of such inspection, whereupon all costs relating to the
inspection for such period will be paid promptly by the inspected
Party.
9.1 Ownership.
(a) Patent Rights and Technology. Subject to
Section 9.1(b), all Patent Rights will be the property of the
inventing Party, provided that all Joint Patent Rights will be
jointly owned by the Parties with each Party having full rights to
use and license same subject only to the licenses expressly granted
and the terms set forth herein. In all cases, inventorship shall be
determined according to United States Patent law.
28.
(b) SELEX Inventions and SELEX
Technology. Notwithstanding anything to the contrary herein,
the SELEX Inventions and SELEX Technology shall be the property of
Archemix. Nuvelo shall and hereby does assign to Archemix all of
Nuvelo’s right, title and interest in and to all SELEX
Inventions and SELEX Technology.
( c) Technology. Subject to Section 9.1(b), ownership of
all unpatented Technology is and will be the property of the Party
who created it.
(d) Further Acts. Each Party shall perform such
additional actions necessary to affect the intent of this
Section 9.1, and shall reasonably cooperate with the other
Party in doing so.
9.2 Patent Prosecution and Maintenance.
(a) ARC 2172 and Compound Patent Rights. Archemix will transfer
all responsibility for the prosecution and maintenance of the ARC
2172 Patents to Nuvelo promptly after the Effective Date. In
addition, if Archemix discovers any Short Acting Coagulation
Cascade Aptamer for use within the Field or makes any new invention
relating to any Short Acting Coagulation Cascade Aptamer for use
within the Field in the course of its Research under this
Agreement, Archemix will transfer all responsibility for the
filing, prosecution and maintenance of the relevant Compound Patent
Rights to Nuvelo and will provide. Nuvelo with all necessary
documents and information to effect the transfer of responsibility.
For so long as Nuvelo has an exclusive license hereunder to ARC
2172 or such Development Compound, Nuvelo has the right to pursue
worldwide filing, prosecution and maintenance of such ARC 2172
Patents or Compound Patent Rights using mutually acceptable outside
counsel. Unless Archemix exercises its Profit Share Option, in
which event Section 7.5 shall apply, Nuvelo will be solely
responsible for all costs incurred in this Section 9.2(a).
Nuvelo will keep Archemix apprised of all prosecution matters, and
will provide a copy of all official correspondence to Archemix, and
Nuvelo will consider any comments in good faith from Archemix and
incorporate them to the extent possible. Nuvelo shall file,
prosecute and maintain the ARC 2172 Patents and Compound Patent
Rights in Archemix’ name using reasonably diligent efforts
including filing, prosecuting and maintaining the ARC 2172 Patents
and Compound Patent Rights, at a minimum, in the countries listed
on Exhibit E. If Nuvelo decides to not pursue prosecution or
maintenance of any such Patent Rights, control of such Patent
Rights shall be transferred to Archemix at no cost. For purposes of
this Agreement, "ARC 2172 Patents" means the following United
States Patent Applications and their counterparts throughout the
world to the extent not SELEX Inventions or SELEX Technology: U.S.
Patent Application Serial No. 60/711,768 and Serial No.
60/808,590.
(b) SELEX Technology and SELEX Inventions. Archemix shall
have the sole right but not the obligation to file, prosecute and
maintain Patent Rights on SELEX Technology or SELEX Inventions, at
its own expense.
29.
(c) Archemix Technology. Except as set
forth in Section 9.2(a), Archemix shall have the sole right
but not the obligation to file, prosecute and maintain Patent
Rights on Archemix Background Technology and Archemix Program
Technology, at its own expense, including without limitation all
Patent Rights in and to the SELEX Portfolio.
(d) Nuvelo Background Technology. Nuvelo shall have the
sole right but not the obligation to file, prosecute and maintain
Patent Rights claiming Nuvelo Background Technology, at its own
expense.
(e) Nuvelo Program Technology. Nuvelo shall have the
first right but not the obligation to file, prosecute and maintain
Patent Rights claiming Nuvelo Program Technology at its own
expense. If, at any time, Nuvelo elects not to pursue patent
protection for, or maintenance of, any Nuvelo Program Technology,
Archemix shall have the right to pursue patent protection for such
technology for such Technology at Archemix’s sole
expense.
(f) Joint Patent Rights. Archemix has the first right,
but not the obligation, to pursue worldwide patent protection of
all Joint Technology not covered by Section 9.2(a) above. The
Parties will be jointly (on a fifty/fifty (50/50) basis)
responsible for all costs incurred pursuant to this
Section 9.2(f). If Archemix elects to pursue such patent
protection, it will use outside counsel mutually acceptable to the
Parties. Archemix will keep Nuvelo apprised of all prosecution
matters, and will provide a copy of all official correspondence to
Nuvelo. Archemix will consider in good faith any comments from
Nuvelo and incorporate them to the extent possible. If, at any
time, Archemix elects to not pursue patent protection for, or
maintenance of, any such Joint Patent Rights, control of such Joint
Patent Rights shall be transferred to Nuvelo at no cost. For
clarity, Patent Rights claiming any SELEX Technology or SELEX
Invention are governed by Section 9.2(b) and not this
Section 9.2(f).
(g) Information and Cooperation . Each Party that
has responsibility for filing and prosecuting any Patent Rights
under this Section 9.2 (a "Filing Party") shall:
(a) regularly provide the other Party (the "Non-Filing Party")
with copies of all patent applications filed hereunder for Program
Technology and other material submissions and correspondence with
the patent offices, in sufficient time to allow for review and
comment by the Non-Filing Party; and (b) to the extent practicable,
provide the Non-Filing Party and its patent counsel with an
opportunity to consult with the Filing Party and its patent counsel
regarding the filing and contents of any such application,
amendment, submission or response, and the advice and suggestions
of the Non-Filing Party and its patent counsel shall be taken into
consideration in good faith by such Filing Party and its patent
counsel in connection with such filing. Each Filing Party shall
pursue in good faith all reasonable claims and take such other
reasonable actions, as may be requested by the Non-Filing Party in
the prosecution of any Patent Rights under this Section 9.2;
provided, however, if the Filing Party incurs any additional
expense as a result of any such additional claim or taking such
other activities. In addition, Nuvelo (a) agrees that if
Archemix claims any action taken under Section 9.2 would be
detrimental to Patent Rights covering Archemix Background
Technology (including without limitation the SELEX Portfolio),
Archemix shall provide written notice to Nuvelo and the Parties
shall, as promptly as possible thereafter, meet to discuss and
resolve such matter and, if they are unable to resolve such matter,
the Parties shall refer such matter to a mutually agreeable outside
patent counsel for resolution.
30.
9.3 Enforcement of Patent
Rights.
(a) Notice. If a Third Party is apparently infringing any
Patent Right to which exclusive licenses are granted under this
Agreement, the Party first obtaining knowledge of such a claim
shall immediately provide the other Party notice of such claim and
the related facts in reasonable detail.
(b) Enforcement Responsibility. Nuvelo, as exclusive
commercial licensee, has the first right, but not the obligation,
to solely enforce all Compound Patent Rights against any actual or
suspected Third Party infringer in the Field. Such enforcement will
be in Nuvelo’s own name and entirely under its own direction
and control, and Nuvelo may settle any such action, proceeding or
dispute by license, subject to the remainder of this Section
9.3(b). Unless Archemix exercises its Profit Share Option, in which
event Section 7.5 shall apply, or unless otherwise provided below,
Nuvelo will be solely responsible for all costs incurred in this
Section 9.3(b).
(i) Enforcement by Nuvelo . Archemix will, upon
Nuvelo’s request, reasonably assist Nuvelo in any action or
proceeding being prosecuted by Nuvelo under this
Section 9.3(b) if so requested, and shall lend its name to
such actions or proceedings if reasonably requested by Nuvelo or
required by applicable law. Nuvelo shall reimburse Archemix for the
documented external costs Archemix reasonably incurs in providing
such assistance as specifically requested in writing by Nuvelo.
Archemix shall have the right to participate and be represented in
any such suit by its own counsel at its own expense;
provided , that, Nuvelo shall retain overall responsibility
for the prosecution of such suit or proceedings in such event. No
settlement of any such action or proceeding which restricts the
scope, or adversely affects the enforceability, of an Archemix
Patent Right, or which could be reasonably expected to have a
material adverse financial impact on Archemix, may be entered into
by Nuvelo without the prior written consent of Archemix, which
consent shall not be unreasonably withheld, delayed or
conditioned.
(ii) Enforcement by Archemix . If Nuvelo elects
not to settle or bring any action for infringement described in
this Section 9.3(b) and so notifies Archemix, including
following any request by Archemix to do so, then Archemix may
settle or bring such action at its own expense, in its own name;
provided, however, that Archemix agrees not to so settle or
bring such action for infringement upon Nuvelo’s request
based on Nuvelo’s good faith reasonable determination that it
is not in the best interest of the Parties to so settle or bring
such action for infringement. In the case where Archemix proceeds
to settle or bring an action for such infringement, the following
shall apply. Nuvelo shall reasonably assist Archemix in any action
or proceeding being prosecuted if so requested, and shall lend its
name to such actions or proceedings if requested by Archemix or
required by applicable law. Archemix shall reimburse Nuvelo for the
documented external costs Nuvelo reasonably incurs in providing
such assistance as specifically requested in writing by Archemix.
Nuvelo shall have the right to participate and be represented in
any such suit by its own counsel at its own expense;
provided, that, Archemix shall retain overall responsibility
for the prosecution of such suit or proceedings in such event. No
settlement of any such action or proceeding which restricts the
scope, or adversely affects the enforceability, of a Licensed
Patent Right hereunder, or which could be reasonably expected to
have a material adverse financial impact on Nuvelo, may be entered
into by Archemix without the prior written consent of Nuvelo, which
consent shall not be unreasonably withheld, delayed or
conditioned.
31.
(iii) Withdrawal . If either
Party brings an action or proceeding under this Section 9.3(b)
and subsequently ceases to pursue or withdraws from such action or
proceeding, it shall promptly notify the other Party and the other
Party may substitute itself for the withdrawing Party under the
terms of this Section 9.3(b).
(iv) Damages . In the event that either Party
exercises the rights conferred in this Section 9.3(b) and recovers
any damages or other sums in such action, suit or proceeding or in
settlement thereof, such damages or other sums recovered shall
first be applied to all out-of-pocket costs and expenses incurred
by the Parties in connection therewith, including, without
limitation, attorneys fees. Except as otherwise provided in this
Section 9.3(b), each Party will bear its own expenses with
respect to any suit or other proceeding against an infringer. If
such recovery is insufficient to cover all such costs and expenses
of both Parties, it shall be shared in proportion to the total of
such costs and expenses incurred by each Party. If after such
reimbursement any funds shall remain from such damages or other
sums recovered, such funds shall be divided as follows: (i) as
to ordinary damages based on lost sales or profit, Nuvelo shall
retain such funds and Archemix shall receive payment equivalent to
payments that would have been due to Archemix under this Agreement
had the infringing sales that Nuvelo lost to the infringer been
made by Nuvelo; and (ii) as to special or punitive damages,
the Party that brought the enforcement action at its expense shall
be entitled to receive eighty percent (80%) of the amount of
such special or punitive damages and the other Party shall receive
twenty percent (20%) of the amount of such special or punitive
damages.
(c) Archemix Background Technology and SELEX Technology and
SELEX Inventions. Archemix shall have the sole right but not
the obligation to enforce Patent Rights on SELEX Technology and
SELEX Inventions and, subject to Section 9.3(b), on Archemix
Background Technology.
(d) Nuvelo Patent Rights . Nuvelo shall have the sole
right but not the obligation to enforce Nuvelo Patent Rights.
9.4 Defense of Third Party Claims .
(a) Nuvelo will have the first right to defend any claims
by a Third Party alleging infringement of any Third Party Patents
or misappropriation of any Third Party trade secrets in connection
with the Development, manufacture or Commercialization of any
Development Compound or Licensed Product by Nuvelo, its Affiliates,
sublicensees, contractors or consultants. Nuvelo may, at its sole
option, settle any such claim; provided, that, such settlement does
not, or will not have any material adverse effect on Archemix.
(b) Archemix will be solely responsible, at its sole
expense, for defending any claims against it by a Third Party
alleging infringement of any Third Party Patents or
misappropriation of any Third Party trade secrets by Archemix in
connection with its Research activities under this Agreement.
Archemix may, at its sole option, settle any such claim; provided,
that, such settlement does not, or will not, have any material
adverse effect on Nuvelo.
32.
10. C ONFIDENTIALITY
10.1 Nondisclosure of Confidential Information . All Technology
and other information disclosed by one Party to the other Party
pursuant to this Agreement that it is marked or otherwise
identified as "confidential" or "proprietary" shall be
"Confidential Information" of the disclosing Party.
Confidential Information also includes all Technology and other
information developed by either Party in carrying out this
Agreement and disclosed to the other Party, or disclosed by either
Party under the Original Agreement, which agreement is superseded
by this Agreement. The Parties agree that during the Term, and for
a period of five (5) years thereafter, a Party receiving
Confidential Information of the other Party will: (a) maintain
in confidence such Confidential Information to the same extent such
Party maintains its own proprietary industrial information of
similar kind and value; (b) not disclose such Confidential
Information to any Third Party without prior written consent of the
disclosing Party, except
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