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Exhibit 10.33 AMENDED AND RESTATED
COLLABORATION AND LICENSE AGREEMENT
This Amended and Restated
Collaboration and License Agreement (the " Agreement ")
is entered into and made effective as of July ___, 2006 (the
"Effective Date" ), by and between Nuvelo, Inc. , a
Delaware corporation having its principal place of business at 201
Industrial Road, Suite 310, San Carlos, CA 94070 ("
Nuvelo "), and Archemix Corp. , 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 ."
Recitals Whereas, 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 Whereas, the
particular aptamer that was the original Development Compound (as
defined in the Original Agreement), ARC 183, has been withdrawn
from Development; and
Whereas, 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
Whereas, 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
Whereas, 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. Now,
Therefore , the Parties agree as follows:
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.
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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 Plan. 2. Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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 in
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 Trials, 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 of
Development Compounds and Licensed Products, validation 3. Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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.
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 a 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 trials 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 Trials
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. Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(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 relevant 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. "Field" [***]: (a) the [***] of
[***]; (b) [***] Aptamer [***] a [***]; (c) [***] Aptamers, [***],
but not [***] to, 5. Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
[***] and/or [***] of an Aptamer [***] of an Aptamer [***] as a
[***]; or (d) [***] of a [***] in [***] with a [***], where
the[***] is [***] to [***] or [***] the [***] of the [***] [***]
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. In Vitro Diagnostics [***]
other [***], the [***] of the [***] or Aptamers or[***] through the
[***] of the [***] in the [***] or [***]: (a) [***] of a [***],
(i) of a [***] in a [***], often to [***] or [***] of a [***],
or to [***] for [***](ii) of a [***] or other [***] in a [***],
often to [***]or [***] the [***] of a [***], or [***] in a [***] or
[***]and (iii) of [***] (as in [***]; (b) of a [***] on a
[***] such as [***] (as in [***] or other [***] of [***] within
[***]; and (c) any [***] in vitro diagnostic [***] of
the [***] or Aptamers or [***] through the [***] of the [***] in 6.
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
[***] for example, [***] and [***], and the [***] of [***] of
Aptamer [***]: (i) to [***], through [***] in [***] or [***]
of [***], and to [***] are [***] for the [***] of [***];
(ii) to [***] of [***] in a [***] of [***] in [***](iii) to
[***] or [***] in[***] to [***] during [***] ( e.g., as
[***] of [***] or [***]; and (iv) to [***] or [***] in [***]
to [***] ( e.g., as [***] of [***] or [***]
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; 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. 7. Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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’s 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 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. 8. Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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 purposes 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 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, Commercialization, manufacture, importation, use or
sale of Candidate Compounds, Development Compounds or 9. Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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 "Nuvelo 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 Technology 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. 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 1
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 10.
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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 Trial" 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 Trial" 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 Trial for a Licensed
Product; or (b) process development for a Licensed Product in
a Phase 4 Trial. 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. 1.70
"Qualified IPO" means Archemix’s firm commitment
underwritten initial public offering on the New York Stock
Exchange, the American Stock Exchange or the NASDAQ National Market
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 thirty million dollars ($30,000,000)
exclusive of the dollar value represented by the Nuvelo IPO Share
Amount. 11. Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
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. 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 12. Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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 [***] 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 the [***] by and between
[***] and [***], the [***] between [***] and [***], and the [***]
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, 13. Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
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
the [***] and [***] by and between [***] and [***] to the [***]
1.93 "URC License Agreement"
means the [***] and [***], by and between [***] and [***]
1.94 "UTC" means [***], the
[***] to the[***] 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 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.
2.1 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 14. Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 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 15. Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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 on-going obligation to fund any
Research by Archemix after the expiration of the Research Program
Term.
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3.
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Management of the Collaboration
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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.
(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 16. Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
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. 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.
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4.
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Development, Manufacture and Commercialization
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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. 17. Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 a 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 that 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.
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5.
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LICENSES AND RELATED RIGHTS
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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 18. Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 nor its Affiliates shall, except
with respect to the Parties’ activities under this Agreement:
(a) [***] any [***] the [***] to [***]or [***] any [***] for [***]
within the [***]; (b) [***] or with a [***] to [***]and [***] any
[***] for [***] within the [***] 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 consistent with
Sections 5.1, 5.2 and Article 10 hereof. In addition,
neither Party may independently or with a Third Party [***] or
[***] any [***] for [***] in the [***] or [***] any [***] so that
[***] the [***] in a [***] or other [***] the [***] from the [***]
so that [***] the [***] in Exhibit C or that [***] the [***]
from the [***] 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 19. Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
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 claim(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. 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.
6.1 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 dosing 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. 20. Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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.
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 21. Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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;
(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; 22. Portions of this Exhibit were omitted and
have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(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 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. 23.
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
(e) "Market Stand-Off" Agreement. Nuvelo agrees that during
the one hundred eighty (180) 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 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.
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Milestone Event
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Payment Amount
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[***]
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[***]
|
|
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[***]
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|
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[***]
|
|
[***]
|
|
|
[***]
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|
|
[***]
|
|
[***]
|
|
|
[***]
|
|
|
[***]
|
|
[***]
|
|
|
[***]
|
|
|
[***]
|
|
[***]
|
|
|
[***]
|
|
|
[***]
|
|
[***]
|
|
|
[***]
|
|
|
[***]
|
|
[***]
|
|
|
[***]
|
|
|
[***]
|
|
[***]
|
|
|
[***]
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|
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Total
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$
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35,000,000
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(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: 24.
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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Portion of Net Sales of Each Licensed Product
during Each
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Calendar Year
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Royalty Rate
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Up to $[***]
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[***]%
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|
|
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The portion of Net Sales that is greater than $[***] and less
than or equal to $[***]
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[***]%
|
|
|
|
|
|
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 $[***]
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[***]%
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(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
the 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 (10th) 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 amount of taxes, if
any, withheld to comply with applicable law; and (D) the exchange
rates used 25. Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
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).
(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 26. Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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
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.
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9.
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INFORMATION, INVENTIONS AND INTELLECTUAL PROPERTY
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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. 27. Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
(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.
(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. 28. Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
(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 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
request, the Non-Filing Party shall be responsible for the cost and
expenses of pursuing 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. 29. Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
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 Archemi
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