|
Exhibit 10.39 LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this
"Agreement"), dated as of October ___, 2003 (the "Effective Date"),
is entered into between Archemix Corp., a Delaware corporation,
having a place of business at 1 Hampshire Street, Cambridge, MA
02139 ("Archemix"), and Regado Biosciences, Inc., a Delaware
corporation, having a place of business at 7030 Kit Creek Road,
RTP, NC 27560, ("Regado"). WHEREAS,
Archemix owns or has rights in certain technology regarding
aptamers and their modifications; and
WHEREAS, Regado desires to obtain a
worldwide license under Archemix’s rights in such technology
to develop and commercialize Licensed Products for use in
therapeutics. NOW, THEREFORE, in
consideration of the foregoing premises and the mutual covenants
herein contained, the parties agree as follows:
|
|
1.1
|
|
" Affiliate " shall mean, with respect to any Person, any
other Person which directly or indirectly controls, is controlled
by, or is under common control with, such Person. A Person shall be
regarded as in control of another Person if it owns, or directly or
indirectly controls, at least fifty percent (50%) of the voting
stock or other ownership interest of the other Person, or if it
directly or indirectly possesses the power to direct or cause the
direction of the management and policies of the other Person by any
means whatsoever.
|
|
|
|
|
|
|
|
1.2
|
|
" Anti-Fibrin Activity " shall mean the elimination or
modulation of fibrin deposition, platelet adhesion and/or platelet
aggregation in humans.
|
|
|
|
|
|
|
|
1.3
|
|
" Anti-Fibrin Antidote Activity " shall mean the
termination or modulation of Anti-Fibrin Activity.
|
|
|
|
|
|
|
|
1.4
|
|
" Aptamers " shall mean oligonucleotides, including any
structural variations and modifications, derivatives, homologs,
analogs and/or mimetics thereof, identified through the SELEX
Process.
|
|
|
|
|
|
|
|
1.5
|
|
" Commercial License " shall have the definition set
forth in Section 2.1(b).
|
|
|
|
|
|
|
|
1.6
|
|
" Controlled " shall mean, with respect to a particular
item of information or intellectual property right, that the
applicable Party owns or has a license to such item or right and
has the ability to grant to the other Party access to and a license
or sublicense (as applicable) under such item or rights as provided
for in this Agreement without violating the terms of any agreement
or other arrangement with any Third Party.
|
|
|
|
|
|
|
|
1.7
|
|
" Damages " shall mean any and all costs, losses, claims,
liabilities, fines, penalties, damages and expenses, court costs,
and reasonable fees and
|
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.
|
|
|
|
disbursements of counsel, consultants and expert witnesses
incurred by a Party hereto (including any interest payments which
may be imposed in connection therewith).
|
|
|
|
|
|
|
|
1.8
|
|
" Excluded Aptamers " shall mean (a) [***], (b)
[***] , and (c) any Aptamer directed to a target for
use outside the Field and (d) the following targets:
|
|
|
i.
|
|
[***];
|
|
|
|
|
|
|
|
ii.
|
|
[***];
|
|
|
|
|
|
|
|
iii.
|
|
[***];
|
|
|
|
|
|
|
|
iv.
|
|
[***];
|
|
|
|
|
|
|
|
v.
|
|
[***];
|
|
|
|
|
|
|
|
vi.
|
|
[***];
|
|
|
|
|
|
|
|
vii.
|
|
[***] ;
|
|
|
|
|
|
|
|
viii.
|
|
[***]; and
|
|
|
|
|
|
|
|
ix.
|
|
[***].
|
|
|
1.9
|
|
" Field " shall mean the use of a Licensed Product for
the treatment of diseases or conditions in humans caused or
characterized by factors involved in, and the modulation of, fibrin
deposition, platelet adhesion and/or platelet aggregation;
provided , however , that the Field shall not include
the treatment of any conditions or diseases of the [***] and [***],
the [***] or the [***]. The Field shall not include the diagnosis
of any diseases or conditions nor any uses relating to the
[***].
|
|
|
|
|
|
|
|
1.10
|
|
" First Commercial Sale " shall mean, with respect to any
Licensed Product, the first sale for use or consumption by the
general public of such Licensed Product.
|
|
|
|
|
|
|
|
1.11
|
|
" Gilead-Archemix License Agreement " shall mean the
License Agreement Between Gilead Sciences, Inc. and Archemix Corp.
dated October 21, 2001.
|
|
|
|
|
|
|
|
1.12
|
|
" Interested Party " shall mean Regado, Archemix or
Gilead and " Interested Parties " shall mean Regado,
Archemix and Gilead.
|
|
|
|
|
|
|
|
1.13
|
|
" In Vitro Diagnostics " shall mean the use of the SELEX
Process or Aptamers 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.
|
|
|
|
|
|
|
|
1.14
|
|
" In Vivo Diagnostic Agent " shall mean any
Licensed Product containing one or more Aptamers that is used for
any human in vivo diagnostic purpose related to,
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
2
|
|
|
|
inter alia, the identification, quantification or
monitoring of the propensity toward, or actual existence of, any
disease state.
|
|
|
|
|
|
|
|
1.15
|
|
" Licensed IP Rights " shall mean, collectively, the
Licensed Patent Rights and the Licensed Know-How Rights.
|
|
|
|
|
|
|
|
1.16
|
|
" Licensed Know-How Rights " shall mean all trade
secrets, know-how, information and data Controlled by Archemix
during the Term that is not generally known (including, but not
limited to, information and data regarding formulae, procedures,
protocols, techniques and results of experimentation and testing),
which is necessary or useful for Regado to practice within the
Field any invention, composition of matter, method or process
claimed or disclosed in any issued patent or pending patent
application within the Licensed Patent Rights.
|
|
|
|
|
|
|
|
1.17
|
|
" Licensed Patent Rights " shall mean any and all patents
or patent applications Controlled during the Term by Archemix that
are necessary or useful for the performance of the SELEX Process or
the manufacture, sale, offer for sale, importation or use of
Aptamers, excluding the Excluded Aptamers, within the Field,
including, without limitation, the Licensed SELEX Patent Rights;
provided , however , that patents and patent
applications claiming the composition or use of specific Aptamers
shall not be included within the definition of "Licensed Patent
Rights" except to the extent they are included within the Licensed
SELEX Patent Rights.
|
|
|
|
|
|
|
|
1.18
|
|
" Licensed Product " shall mean a product that contains
an Aptamer, other than an Excluded Aptamer, with Anti-Fibrin
Activity, and that has, as another component, a nucleic acid that
has Anti-Fibrin Antidote Activity, wherein the discovery,
development, manufacture, use, sale or importation of such product
would infringe a Valid Claim within the Licensed Patent Rights but
for the grant and continuing validity of the license granted by
Archemix to Regado in Section 2.1 hereof. In addition, if
Regado manufactures, uses, sells, offers for sale, has sold or
imports a product that would constitute a Licensed Product but for
the fact that Regado did not discover or develop the Aptamer
contained within such product, then, that product shall be deemed
to be within the definition of the term "Licensed Product" for all
purposes hereunder. For avoidance of doubt, in addition to the
foregoing requirements, a product must have therapeutically
significant levels of both Anti-Fibrin Activity and Anti-Fibrin
Antidote Activity in order to be a "Licensed Product."
|
|
|
|
|
|
|
|
1.19
|
|
" Licensed SELEX Patent Rights " shall mean
(a) those certain patent applications and patents listed on
Schedule A hereto and any patent or patent application
claiming priority therefrom; (b) all patents that have issued
or in the future issue from such patent applications, including
utility, model and design patents and certificates of invention;
and (c) all divisionals, continuations, continuations-in-part,
reissues, renewals, extensions or foreign counterparts or additions
to any such patent applications and patents.
|
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
|
|
1.20
|
|
" NDA " shall mean a New Drug Application, as defined in
the United States Food, Drug and Cosmetic Act and the regulations
promulgated thereunder, or any successor application thereto.
|
|
|
|
|
|
|
|
1.21
|
|
" Net Sales " shall mean, with respect to any Licensed
Product, the invoiced sales price of such Licensed Product billed
to independent customers by Regado and its Affiliates, less
(a) credits, allowances, discounts and rebates to, and
chargebacks from the account of, such independent customers for
spoiled, damaged, out-dated, rejected or returned Licensed Product
or bad debts; (b) actual freight and insurance costs incurred
by Regado in transporting such Licensed Product to such customers;
(c) cash, quantity and trade discounts and other price
reductions; (d) sales, use, value-added and other direct taxes
incurred; and (e) customs duties, surcharges and other
governmental charges incurred by Regado in connection with the
exportation or importation of such Licensed Product.
|
|
|
|
|
|
|
|
1.22
|
|
" Party " shall mean Regado or Archemix and "
Parties " shall mean Regado and Archemix.
|
|
|
|
|
|
|
|
1.23
|
|
" Person " shall mean an individual, corporation,
partnership, limited liability company, trust, business trust,
association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed
herein.
|
|
|
|
|
|
|
|
1.24
|
|
" Phase III Trial " shall mean a clinical trial designed
to demonstrate the safety and efficacy of a Licensed Product as
more fully defined in 21 CFR 312.21(c) or any successor regulation
thereto.
|
|
|
|
|
|
|
|
1.25
|
|
" Proprietary Information " shall mean, subject to the
limitations set forth in Section 9.1 hereof, any confidential
information of a Party disclosed by such Party to the other Party
in the course of negotiating or performing under this Agreement
that is identified as confidential by the disclosing party at the
time of its disclosure.
|
|
|
|
|
|
|
|
1.26
|
|
" Radio Therapeutic " shall mean any Licensed Product for
human therapeutic use that contains one or more Aptamers that
target 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 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.
|
|
|
|
|
|
|
|
1.27
|
|
" Regado Improvements " shall mean any inventions,
patentable or not, information and/or data Controlled by Regado
after the Effective Date and during the term of this Agreement,
that were derived from the practice of the Licensed IP Rights, and
that relate to (a) improvements in the SELEX Process and
(b) improvements made to the Licensed IP Rights.
|
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
|
|
1.28
|
|
" Regado SELEX Technology " shall mean any know-how,
technology, inventions, information or data Controlled by Regado as
of the Effective Date of this Agreement or during the Term, that
constitute a modification or improvement to the SELEX Process.
|
|
|
|
|
|
|
|
1.29
|
|
" Research License " shall have the definition set forth
in Section 2.1(a).
|
|
|
|
|
|
|
|
1.30
|
|
" Royalty Term " shall mean, as determined on a Licensed
Product-by-Licensed Product and country-by-country basis, the
period of time commencing on the date of the First Commercial Sale
of such Licensed Product in such country, and ending upon the
expiration or termination of the last Valid Claim within the
Licensed Patent Rights that covers the development, manufacture,
use, sale or importation into such country of such Licensed
Product.
|
|
|
|
|
|
|
|
1.31
|
|
" SELEX Process " means any process for the
identification of a nucleic acid, which process is disclosed in or
falls within the claimed scope of the Licensed SELEX Patent
Rights.
|
|
|
|
|
|
|
|
1.32
|
|
" Sublicense Income " shall mean the consideration
payable to Regado in connection with a sublicense of any or all of
the rights granted hereunder to Regado by Archemix, including
without limitation, any and all upfront payments, annual fees,
milestone payments, royalties but excluding (a) payment for
research or development to be conducted by Regado or its Affiliates
for the benefit of the Sublicensee to the extent not in excess of
the actual direct cost of performing such research and development,
and (b) proceeds from the sale and issuance of Regado
securities to a Sublicensee to the extent not in excess of the fair
market value of said securities.
|
|
|
|
|
|
|
|
1.33
|
|
" Sublicensee " shall mean a Third Party to whom Regado
grants a sublicense of any or all of the rights granted hereunder
to Regado by Archemix
|
|
|
|
|
|
|
|
1.34
|
|
" Territory " shall mean the world.
|
|
|
|
|
|
|
|
1.35
|
|
" Third Party " shall mean any Person other than
Archemix, Regado and their respective Affiliates.
|
|
|
|
|
|
|
|
1.36
|
|
" URC License Agreement " shall mean the Restated
Assignment and License Agreement, dated July 17, 1991, by and
between University Research Corporation and Gilead as successor in
interest to NeXstar.
|
|
|
|
|
|
|
|
1.37
|
|
" UTC " shall mean University Technology Corporation, the
successor to the University Research Corporation.
|
|
|
|
|
|
|
|
1.38
|
|
" Valid Claim " shall mean (a) a claim of an issued
and unexpired patent within the Licensed Patent Rights, which has
not been held permanently revoked, found unenforceable or invalid
by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or
unenforceable through
|
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.
5
reissue or disclaimer or otherwise, or (b) a claim of a
pending patent application so long as there exists an issued and
unexpired patent meeting the criteria of clause (a) above that
includes a claim covering the discovery, development, manufacture,
use, sale or importation into the country of the Licensed
Product.
|
|
2.1
|
|
License Grants to Regado . Subject to the terms and
conditions set forth herein (including Section 2.5), Archemix
hereby grants to Regado the following licenses during the term of
this Agreement (a) a non-exclusive, non-sublicenseable license
under the Licensed IP Rights, to use the SELEX Process, for the
purpose of identifying and developing anti-protein Aptamers for use
solely as part of a Licensed Product (the "Research License") and
(b) an exclusive, worldwide license under the Licensed IP
Rights, with the right to grant Sublicenses as set forth in
Section 2.2, to develop, manufacture, use, sell, offer for
sale, have sold, and import Licensed Products solely for use in the
Field (the "Commercial License"). For the avoidance of doubt the
Research License shall include the right to test potential Licensed
Products in animal.
|
|
|
|
|
|
|
|
2.2
|
|
Sublicense Rights . Subject to Archemix’s rights
under Article 8, Regado shall have the right to grant
sublicenses solely under the Commercial License. Regado shall give
Archemix prompt written notice of each sublicense under this
Agreement along with a copy of such sublicense. Any such sublicense
shall contain provisions for the assignment to Archemix of
Regado’s interest therein upon termination of this Agreement,
subject to the last sentence of this Section 2.2, unless the
termination of this Agreement arises out of the action or inaction
of such Sublicensee or the Sublicensee is then in breach of its
obligations under such sublicense, in which case Archemix, at its
option, may terminate such sublicense. Notwithstanding this, if in
Regado’s opinion, sublicensee did not materially breach the
agreement, Regado may challenge the termination under the
provisions of Section 8.3. Each sublicense shall also contain
provisions which obligate such Sublicensee to comply with terms,
conditions, agreements and obligations that are consistent with the
terms, conditions, agreements and obligations to which Regado is
subject under this Agreement. Archemix hereby agrees to accept such
assignment and that such sublicense, as assigned, will remain in
full force and effect, provided that Archemix shall have no
obligation thereunder except to maintain the continued
effectiveness of the sublicense.
|
|
|
|
|
|
|
|
2.3
|
|
Negative Covenants.
|
|
|
2.3.1
|
|
Without limiting any of the other terms, conditions and
limitations contained herein, Regado shall not (a) use the
SELEX Process or otherwise select Aptamers against targets for use
outside the Field, (b) perform any research or development on any
Aptamer for use outside the Field (c) provide Aptamers for use
outside the Field to any party that does not possess a valid
license to the Licensed SELEX Patent Rights for the intended use of
the Aptamer, except for evaluation of the aptamer as a
|
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
|
|
|
|
therapeutic; (d) make, use, sell, offer for sale, import or
export any Licensed Products containing any Excluded Aptamers,
(e) make, use, sell, offer for sale, import or export any
Excluded Aptamers, or (f) make, use, sell, offer for sale,
import or export any Aptamers for In Vitro Diagnostics, as In Vivo
Diagnostic Agents or as Radio Therapeutics.
|
|
|
|
|
|
|
|
2.3.2
|
|
Subject to the terms and conditions set forth herein, Archemix
hereby agrees not to develop, or grant to any Third Party the
right, under the Licensed IP Rights, to develop therapeutic
aptamers to modulate the Factor [***] or the Factor [***] [***].
The foregoing restriction shall terminate on the first to occur of
the following events: (a) the [***] anniversary of the
Effective Date; (b) at any time after the [***] anniversary of
the Effective Date upon [***] months prior written notice from
Archemix to Regado, or (c) on a target-by-target basis, if
Regado discontinues active development of Licensed Products against
aptamers used to modulate Factor [***] or the Factor [***].
|
|
|
2.4
|
|
License Grants to Archemix .
|
|
|
2.4.1
|
|
Subject to the terms and conditions hereof, Regado hereby grants
to Archemix, a royalty-free, paid-up, and non-exclusive
nontransferable license under Regado’s intellectual property
rights relating to the Regado Improvements (a) to conduct
internal research solely within Archemix.
|
|
|
|
|
|
|
|
2.4.2
|
|
Subject to the terms and conditions set forth herein (including
Section 2.5), Regado hereby grants to Archemix a royalty-free,
paid-up, non-exclusive license, with the right to grant sublicenses
solely as provided in this Section 2.4.2, under intellectual
property rights Controlled by Regado, as of the Effective Date and
during the Term, that relate to Regado SELEX Technology, for any
and all uses outside of the Field. The license granted under this
Section 2.4.2 shall remain in effect following the expiration
or termination of this Agreement for any reason other than a
termination by Regado under Section 11.2 due to a material
breach by Archemix.
|
|
|
2.5
|
|
Third Party Agreements . The Parties each hereby
acknowledge that certain of the intellectual property rights which
are subject to the licenses granted herein may be Controlled by the
Party granting such license (the "Licensor" and the other Party
under such circumstances is the "Licensee") by virtue of a license
(a "Third Party Agreement") granted to the Licensor by a Third
Party. Except as otherwise set forth in this Section 2.5, the
Parties hereby agree to pay, either to the Licensor or directly to
such Third Party as the Licensor shall determine, any and all
incremental costs (including without limitation, milestones and
royalties) required to be paid under a Third Party Agreement due to
the grant of the license of such rights to the Licensee or the
exercise of those rights by the Licensee (such amounts are "Third
Party Royalties"). Notwithstanding the foregoing, and subject to
the terms and conditions set forth herein, Archemix shall be
responsible for all
|
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.
7
amounts payable to Third Parties for the rights to the Licensed
SELEX Patent Rights and Regado shall be responsible for all amounts
payable to Third Parties for the rights to the intellectual
property licensed to Regado by Duke University (or any of its
Affiliates or agents). The Parties further agree (a) to
provide notice and copies to each other of all Third Party
Agreements that require the payment of Third Party Royalties (with
terms and conditions that are not relevant to the Licensee
redacted), (b) to refrain from breaching, or causing the
Licensor to breach, any Third Party Agreements, and (c) when
acting as Licensor, to refrain from charging or attempting to
charge any fee or royalty to the Licensee in connection with the
grant or exercise of such license, other than Third Party
Royalties, or the amounts due under Section 3 of this
Agreement. The Parties further acknowledge and agree that either of
them, when acting as Licensee, may, by notice to the Licensor,
reject or terminate the licenses granted to them hereunder with
respect to rights under any Third Party Agreement(s), at any time
during the term, without effecting the ongoing effectiveness of
this Agreement.
|
3
|
|
TECHNOLOGY ACCESS FEE; ROYALTIES; MILESTONES
|
|
|
3.1
|
|
Technology Access Fee . In consideration of the licenses
and rights granted to Regado herein, Regado shall, as of the date
immediately preceding the closing (the "Closing") of the first
equity financing of Regado in which Regado is assigned a pre-money
valuation of not less than [***] dollars ($[***]), issue to
Archemix fully-paid and non-assessable shares of common stock of
Regado equal to [***] percent ([***]%) of the total number of
equity shares of Regado, on a fully diluted basis, immediately
prior to the issuance of shares at the Closing. Regado shall
deliver written notice of the Closing to Archemix at least [***]
business days prior to such Closing in accordance with the notice
provisions contained in Section 14.1 of this Agreement.
Archemix and Regado shall enter into such agreements relating to
the issuance of the common stock as are customary under such
circumstances.
|
|
|
|
|
|
|
|
|
|
For the purpose of this Agreement, "fully diluted basis" shall
mean the aggregate of (a) the number of shares of common stock
issued and outstanding on the determination date, (b) the
number of shares of common stock issuable upon exercise, exchange
or conversion of all exercisable, exchangeable or convertible
securities outstanding on the determination date, assuming such
securities were exercised, exchanged or converted on the
determination date (without regard to whether such securities are
actually exercisable, exchangeable or convertible on the
determination date) and (c) the number of shares of common stock
issuable pursuant to any other obligation or agreement of, or right
granted by, Regado, whether vested or unvested, contingent or
otherwise.
|
|
|
|
|
|
|
|
3.2
|
|
Royalty Payments . In consideration for the licenses
granted to Regado herein, Regado shall pay royalties to Archemix
equal to [***] percent ([***]%) of Net Sales of Licensed Products
beginning with the First Commercial Sale by Regado or its
Affiliates and continuing during the Royalty Term, and (ii) [***]
percent
|
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.
8
([***]%) of all Sublicense Income received by Regado or its
Affiliates during the Term. If Regado grants a sublicense to a
Third Party to develop therapeutic aptamers that modulate the
Factor [***] or the Factor [***], then Regado shall pay to
Archemix, an additional [***] percent ([***]%) of all Sublicense
Income received by Regado in connection with that sublicense, for a
total of [***] percent ([***]%) of such Sublicense Income. However,
if Regado grants this sublicense after the completion of a [***],
or if Archemix terminates the period described under
Section 2.3.2 prior to [***] anniversary of the Effective Date
by notice to Regado, then such additional [***] percent ([***]%)
will not be payable hereunder. As further consideration for the
term of exclusivity granted in Section 2.3.2, Regado shall
provide Archemix with an additional [***] percent ([***]%) of all
Sublicense Income. If Archemix terminates the period described
under Section 2.3.2 prior to [***] of the Effective Date by
notice to Regado, then such additional [***] percent ([***]%) will
not be payable hereunder.
|
|
3.3
|
|
Milestones . In consideration for the licenses granted to
Regado herein, Regado shall pay the amounts indicated below to
Archemix within [***] days following the achievement of each of the
events indicated below for Licensed Products developed by Regado to
achieve each such event:
|
|
|
|
|
|
Event
|
|
Milestone Payment Amount
|
|
[***]*
|
|
$[***]
|
|
[***]
|
|
$[***]
|
|
[***]
|
|
$[***]
|
|
[***]
|
|
$[***]
|
*[***] is [***] upon [***] of the [***] in such [***]. Regado
shall provide no less than [***] days prior written notice to
Archemix of the anticipated achievement of each of the
above-described milestone events with respect to each Licensed
Product and written notice of the actual achievement of each of the
above milestone events with respect to each Licensed Product no
later than [***] days following each such achievement. 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
|
4
|
|
ROYALTY REPORTS AND ACCOUNTING
|
|
|
4.1
|
|
Royalty Reports . Following the First Commercial Sale of
a Licensed Product and continuing throughout the term, Regado shall
furnish to Archemix a [***] written report showing in reasonably
specific detail the calculation of royalties owing with respect to
the sale of Licensed Products by Regado and its Affiliates for the
prior quarter. With respect to sales of Licensed Products invoiced
in United States dollars, all amounts shall be expressed in United
States dollars. With respect to sales of Licensed Products invoiced
in a currency other than United States dollars, all amounts shall
be expressed in the domestic currency of the party making the sale
together with the United States dollar equivalent. The United
States dollar equivalent shall be calculated using the average of
the exchange rate (local currency per US$1) published in The Wall
Street Journal, Eastern Edition, under the heading "Currency
Trading" on the last business day of each month during the
applicable calendar quarter. Reports shall be due on the [***] day
following the close of each [***]. Regado shall also furnish to
Archemix a report promptly upon receipt of any Sublicense Income,
showing in reasonably specific detail the calculation of Sublicense
Income (including any deductions from the gross amount received
from the Sublicensee) and the amounts owing with respect to such
Sublicense Income. Regado shall keep complete and accurate records
in sufficient detail to enable the royalties payable hereunder to
be determined.
|
|
|
|
|
|
|
|
4.2
|
|
Audits .
|
|
|
4.2.1
|
|
Upon the written request of Archemix and not more than [***] in
each [***], Regado shall permit an independent certified public
accounting firm of nationally recognized standing selected by
Archemix and reasonably acceptable to Regado, at Archemix’
expense, to have access during normal business hours to such of the
records of Regado as may be reasonably necessary to verify the
accuracy of the royalty reports for any year ending not more than
[***] months prior to the date of such request. The accounting firm
shall disclose to Archemix only whether or not the reports are
correct and the amount of any discrepancies. No other information
shall be shared.
|
|
|
|
|
|
|
|
4.2.2
|
|
If such accounting firm concludes that additional royalties were
owed during such period, Regado shall pay the additional royalties
within [***] days of the date Archemix delivers to Regado such
accounting firm’s written report so concluding. The fees
charged by such accounting firm shall be paid by Archemix;
provided , however , if the audit discloses that the
royalties payable by Regado for the audited period are more than
[***] percent ([***]%) of the royalties actually paid for such
period, then Regado shall, in addition to paying the overdue
amounts, pay the reasonable fees and expenses charged by such
accounting firm.
|
|
|
4.3
|
|
Confidential Financial Information . Archemix shall treat
all financial information subject to review under this
Section 5 as confidential, and shall cause its
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
10
accounting firm to retain all such financial information in
confidence under Section 9 below.
|
|
5.1
|
|
Payment Terms . Royalties shown to have accrued by each
royalty report provided for under Section 5.1 above shall be
due on the date such royalty report is due. Payment of royalties in
whole or in part may be made in advance of such due date. Overdue
amounts shall bear interest at the rate of [***] percent ([***]%)
per month. Acceptance of overdue amounts plus interest shall not
constitute a waiver by Archemix of any other remedies it may have
hereunder or otherwise.
|
|
|
|
|
|
|
|
5.2
|
|
Exchange Control . If at any time legal restrictions
prevent the prompt remittance of part or all royalties with respect
to any country where a Licensed Product is sold, Regado shall
promptly notify Archemix of such fact and shall make such payments
by depositing the amount thereof in local currency in a bank or
other depository institution in such country indicated by
Archemix.
|
|
|
|
|
|
|
|
5.3
|
|
Withholding Taxes . Regado shall be entitled to deduct
the amount of any withholding taxes, value-added taxes or other
taxes, levies or charges with respect to such amounts, payable by
Regado, its Affiliates or Sublicensees, or any taxes required to be
withheld by Regado, its Affiliates or Sublicensees, to the extent
Regado, its Affiliates or Sublicensees pay to the appropriate
governmental authority on behalf of Archemix such taxes, levies or
charges. Regado shall use reasonable efforts to minimize any such
taxes, levies or charges required to be withheld on behalf of
Archemix by Regado, its Affiliates or Sublicensees. Regado promptly
shall deliver to Archemix proof of payment of all such taxes,
levies and other charges, together with copies of all
communications from or with such governmental authority with
respect thereto.
|
|
|
|
|
|
|
|
5.4
|
|
Limitations Imposed by Law . If any amount payable under
Section 3 or Section 5.1 are limited by any applicable
laws, regulations or government order, then the amount payable
shall be deemed to be the highest amount payable under such law,
regulation or government order.
|
|
|
6.1
|
|
Funding Requirement . Regado shall close an equity
financing, or series of financings, having aggregate proceeds of at
least [***] dollars ($[***]) on or before the first anniversary of
the Effective Date. Failure of Regado to close such a financing in
accordance with this Section 6.1 will constitute a material
breach of this Agreement.
|
|
7
|
|
PROGRESS REPORT AND COMMERCIAL APPLICATION
|
|
|
7.1
|
|
Progress Report. On or before February 28 and
August 30 of each year, commencing as of February 28,
2004 and ending on August 30 of the calendar
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
11
|
|
|
|
year following the calendar year in which Regado, its Affiliates
or Sublicensees first begins to market any Licensed Product, Regado
shall provide a semi-annual progress report to Archemix, each
report covering the [***] month period preceding the due date of
the report. Thereafter, Regado shall provide such reports on an
annual basis covering the [***] month period preceding the due date
of the report. Each report shall describe any Regado Improvements,
notice of any patents filed by Regado in connection with any Regado
Improvements and the progress made by Regado, its Affiliates or
Sublicensees toward the commercial development of any Licensed
Products or services utilizing the Licensed IP Rights. Such report
shall include at a minimum, information reasonably sufficient to
enable Archemix to satisfy its reporting obligations to Gilead
under the Gilead-Archemix License Agreement with respect to this
Agreement, including any reporting obligations of the U.S.
Government, and to assess the progress made by Regado toward
meeting the diligence requirements of Section 7.2 below.
|
|
|
|
|
|
|
|
7.2
|
|
Commercial Application. Regado, either directly or with
and through the efforts of its Affiliates and Sublicensees, shall
at all times use commercially reasonable efforts to proceed with
the development, manufacture and sale of Licensed Products,
including, without limitation, maintaining sufficient facilities,
resources and personnel to fulfill its obligations under this
Agreement. In the event that Regado, its Affiliates and
Sublicensees cease reasonable efforts to develop the commercial
applications of the Licensed Products for a period of at least
[***] months Archemix will have the option, at its sole discretion,
to terminate this Agreement pursuant to Section 11.2 below. In
such event, Archemix may exercise its option; provided ,
however , that (a) Archemix delivers advance written
notice of its decision to exercise such option to force a reversion
of the technology to Archemix, and (b) for a period of [***]
months following Regado’s receipt of such notice, Regado, its
Affiliates, and Sublicensees, shall have the right and opportunity
to cure the alleged cessation of such reasonable commercial
development. Further, if Regado or its sublicensee disagrees that
it has ceased reasonable efforts to commercialize a Licensed
Product, or disagrees that it has not sufficiently cured a
cessation of reasonable efforts, it can request arbitration of the
termination decision under the terms of Section 8.3 by written
notice to Archemix within [***] month of a written notice of
termination. Regado acknowledges and agrees that under the URC
License Agreement and the Gilead-Archemix License Agreement,
Archemix rights in the Licensed IP Rights may revert to Gilead or
the UTC if Archemix, its Affiliates and all assignees and
sublicensees cease reasonable efforts to develop the commercial
applications of the Licensed Products and services utilizing the
Licensed IP Rights.
|
|
|
|
|
|
|
|
|
|
Regado further acknowledges and agrees that, in the event of any
termination of the URC License Agreement, the licenses granted to
Regado hereunder shall remain in full force and effect in
accordance with Section 3.4 of the URC License Agreement,
provided that
|
|