|
<PAGE>
EXHIBIT 10.42
LICENSE AND DEVELOPMENT AGREEMENT
This License and Development Agreement (the "Agreement") is
entered
into by and between INHIBITEX, INC., a Delaware corporation with
its principal
place of business at 9005 Westside Parkway , Alpharetta, GA
30004 (hereinafter
"INX"), 3M COMPANY, a Delaware corporation whose address and
principal place of
business is 3M Center, Saint Paul, Minnesota, U.S.A. 55144
("3M"), and 3M
INNOVATIVE PROPERTIES COMPANY, a Delaware corporation whose
address and
principal place of business is 3M Center, Saint Paul, Minnesota,
U.S.A. 55144
("3M IPC").
RECITALS
3M has developed several proprietary platforms for
diagnostic
applications, particularly in clinical and food safety
applications.
3M has served as the prime contractor under Government Contract
No.
DAAD13-03-C-0047 with a scope of work for development of one of
the above
diagnostic platforms for detection of target microorganisms,
including but not
limited to Staphylococcus aureus.
INX has substantial knowledge and expertise in and holds
significant
intellectual property rights in MSCRAMM proteins (Microbial
Surface Components
Recognizing Adhesive Matrix Molecules) as the result of licenses
and assignments
including but not limited to those listed on EXHIBIT A, attached
hereto.
The Parties entered in a Confidential Disclosure Agreement
effective
September 1, 2004 ("CDA"), Agreement for Materials Transfer
effective September
20, 2004 (First MTA"), Agreement for Materials Transfer
effective October 10,
2004 amended October 20, 2004 ("Second MTA"), and a Feasibility
Agreement
effective September 1, 2005 and amended effective April 28, 2006
and October 25,
2006 (Feasibility Agreement")(collectively "Prior
Agreements").The parties
entered into these Prior Agreements to evaluate biological
materials generated
using the MSCRAMM technology and determine their feasibility for
use in 3M's
diagnostic platforms.
The parties desire to enter into a more extensive agreement
whereby 3M
and 3MIPC obtain (1) a worldwide license under certain INX
MSCRAMM technology
for the development and commercialization of diagnostic devices
in clinical and
food safety applications as described below, and (2) the
opportunity to
collaborate in the development of MSCRAMM technology for use in
diagnostic
applications as described below.
In consideration of these premises and of the mutual promises
set forth
below, the Parties to this Agreement agree as follows:
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY
ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
<PAGE>
ARTICLE I
DEFINITIONS
For purposes of this Agreement, the terms defined in this
Article shall have the
meaning specified and shall be applicable to both the singular
and plural forms
wherever used in this Agreement.
1.1 "3M" means
(a) 3M Company; and
(b) any 3M Affiliate, where an Affiliate means any Person who
or
Entity that in whatever country organized or resident,
directly or indirectly, is controlled by, or is under common
control with, or controls 3M and
(c) any Entity in which 3M or any Entity in which any
individual
or Entity recited in the preceding sub-paragraph (b)
directly
or indirectly has at least a forty percent (40%) ownership
or
voting rights interest (whether through stock ownership,
stock
power, voting proxy, or otherwise), or has the maximum
ownership interest it is permitted to have in the country
where such Entity exists.
For purposes of this Agreement, 3M IPC shall be considered to be
an 3M
Affiliate.
1.2 "3M INVENTIONS" shall mean Inventions made or conceived
solely by
employees or others acting on behalf of 3M under the terms of
this Agreement.
1.3 "3M PATENT RIGHTS" shall mean patents and patent
applications claiming
3M Inventions.
1.4 "510K" shall mean a 510k application or equivalent filed by
or on
behalf of 3M with the FDA or an equivalent regulatory body
outside the U.S. for
approval of manufacturing and sale of any Product.
1.5 "AGREEMENT" means this License and Development Agreement,
any exhibits
hereto and any modification or amendment hereto made in the
manner provided for
herein.
1.6 "BIOLOGICAL MATERIALS" shall mean biological materials
including, but
not limited to, antibodies, cells, cell lines, media, DNA, RNA,
polypeptides,
and proteins.
1.7 "CALENDAR QUARTER" means a three-month period ending March
31, June 30,
September 30 or December 31 of any year.
2
<PAGE>
1.8 "CLFA" means Biological Materials relating to the
Staphylococcus aureus
gene designated clfA and any [ * * * ], as described in U.S.
Patent No. [ * * *
] and [ * * * ], as described in U.S. Patent No. [ * * * ], and
[ * * * ] as
described in U.S. Patent No. [ *** ] and U.S. Patent No.[ * * *
], that can [ *
* * ], or to [ * * * ] of the [ * * * ].
1.9 "CONFIDENTIAL INFORMATION" shall mean information or data
described in
Article 6 below.
1.10 "DETECTION PLATFORM" shall mean a given detection system
comprising:
(1) a Licensed Product that includes a Biological Material which
binds a Target;
(2) a mode of detection; (3) sample acquisition means; and (4)
optionally
hardware. For purposes of clarity, the detection platforms are
differentiated by
the mode of detection. For example, as of the Effective Date, 3M
has [ * * * ]
1.11 "DEVELOPMENT COLLABORATION PLAN" shall mean a written
document
describing a Development Collaboration Program to be performed
by INX and 3M, as
approved in writing by the Development Committee from time to
time, as described
in Article 5. The Development Collaboration Plan approved as of
the Effective
Date is attached hereto as EXHIBIT B.
1.12 "DEVELOPMENT COLLABORATION PROGRAM" shall mean a program
for the
development of Biological Materials for use in Licensed Products
as described in
Article 5 below.
1.13 "DEVELOPMENT COMMITTEE" shall mean the development
committee composed
of representatives of INX and 3M described in Article 5
below.
1.14 "EARNED ROYALTY" means the royalty paid or payable under
Article 4 of
this Agreement on Licensed Product actually sold to an
independent Third Party
by 3M or a permitted sublicensee.
1.15 "EFFECTIVE DATE" means the last signature date below.
1.16 "ENTITY" means any corporation, firm, partnership,
proprietorship, or
other form of business organization.
1.17 "FDA" shall mean the United States Food and Drug
Administration.
1.18 "FEASIBILITY AGREEMENT" shall mean the Feasibility
Agreement between
INX and 3M dated September 1, 2005 and amended on April 28, 2006
and October 25,
2006.
3
<PAGE>
1.19 "FIELD" shall mean in vitro diagnostic devices containing
Biological
Material for use in detection of Targets in [ * * * ] and in [ *
* * ].
1.20 "FIRST COMMERCIAL SALE" shall mean the first bona fide sale
of a
Licensed Product by 3M to an independent Third Party in any
country.
1.21 "FIRST TARGET" means Staphylococcus aureus.
1.22 "INVENTIONS" shall mean all inventions, discoveries,
improvements or
other technology, including Biological Materials, made or
conceived during, and
in the course of, a Development Collaboration Program, whether
made solely or
jointly by employees or others acting on behalf of 3M or INX or
their
Affiliates.
1.23 "INX" means
(a) Inhibitex, Inc.; and
(b) any Affiliate of Inhibitex, Inc. where an Affiliate means
any
Person who or Entity that in whatever country organized or
resident, directly or
indirectly, is controlled by, or is under common control with,
or controls INX;
and
(c) any Entity in which INX or any Entity in which any
individual
or Entity recited in the preceding sub-paragraph (b) directly or
indirectly has
at least a forty percent (40%) ownership or voting rights
interest (whether
through stock ownership, stock power, voting proxy, or
otherwise), or has the
maximum ownership interest it is permitted to have in the
country where such
Entity exists.
1.24 "INX INVENTIONS" shall mean Inventions made or conceived
solely by
employees or others acting on behalf of INX under the terms of
this Agreement.
1.25 "INX KNOW HOW" shall mean all proprietary and confidential
information
and data including, but not limited to, compositions, formulae,
procedures,
protocols, techniques and results of experimentation and
testing, and all
Biological Materials which are necessary or useful to practice
any process or
method related to, or to develop, make, use or sell any Licensed
Product in the
Field, including but not limited to any methods for manufacture
or use of
Biological Materials in a Licensed Product, which INX owns or in
which INX has
an interest, and which is in the possession of INX on the
Effective Date of this
Agreement or thereafter, or which was disclosed to 3M in
connection with the
Prior Agreements, all to the extent and only to the extent that
INX has or
hereafter will have the right to grant licenses to 3M
thereunder. The Parties
agree and acknowledge that the information described in EXHIBIT
C comprises INX
Know-How relating to Biological Materials and their
characteristics,
preparation, assay and use that has been transferred to 3M
during the Prior
Agreements and licensed to 3MIPC hereunder.
4
<PAGE>
1.26 "INX PATENT RIGHTS" shall mean:
(a) the claims of the patent and patent applications listed
in
EXHIBIT A hereto;
(b) all patent applications heretofore or hereafter filed or
having legal force in any country owned by or licensed to INX
(and which INX has
the right to sublicense to 3M) or to which INX otherwise
acquires sublicenseable
rights, which claim a composition (including but not limited to,
Biological
Materials), method or process, which are necessary to practice
any process or
method claimed in the patent and patent applications provided in
Paragraph
1.19(a) in the Field or are necessary, to make, have made, have
used, sell, have
sold, offer for sale, and import any Licensed Product, together
with any and all
patents that have issued or in the future issue therefrom,
including utility,
model and design patents and certificates of invention, and
(c) patents and patent applications claiming INX Inventions;
(d) patents and patent applications added under Paragraph 3.4;
and
(e) all divisionals, continuations, continuations-in-part,
continued prosecution applications, requests for continued
examination,
reissues, renewals and extensions of the patents and patent
applications of
Sections 1.19 (a),(b), (c), (d) and this Section 1.19(e) and any
foreign
counterparts to those patents and patent applications, to the
extent and only to
the extent that INX has or hereafter will have the right to
grant licenses and
sublicenses thereunder.
1.27 "JOINT INVENTION" shall mean an Invention made or conceived
jointly by
one or more employees or others acting on behalf of 3M and by
one or more
employees or others acting on behalf of INX during and in the
course of a
Development Collaboration Program or in the course of work done
under the Prior
Agreements. The parties agree that Joint Inventions shall be
owned jointly by
INX and 3M IPC in accordance with US law, whereby each joint
owner shall have
the right to use, pledge, practice, license, assign and
otherwise transfer and
enjoy its rights to and interests in joint inventions without
permission of or
accounting to the other joint owner(s)), subject to the licenses
granted in
Article 3 below.
1.28 "JOINT PATENT RIGHTS" shall mean:
(a) all claims of patents and patent applications having
legal force in any country which claim a Joint Invention,
together with any and
all patents that issue therefrom, including utility, model and
design patents
and certificates of invention, and
(b) all divisionals, continuations,
continuations-in-part, continued prosecution applications,
requests for
continued examination, reissues, renewals, and extensions or
additions to any
such patents and patent applications and any foreign
counterparts to those
patents and patent applications.
5
<PAGE>
1.29 "LICENSED PRODUCT" shall mean the component of an in vitro
diagnostic
device containing Biological Material for use within the Field,
the manufacture,
use or sale of which, but for the license granted herein, would
infringe at
least one Valid Claim of INX Patent Rights or Joint Patent
Rights in any
country. For purposes of clarity, component means the [ * * * ]
of the [ * * * ]
comprising [ * * * ] but does not include the [ * * * ] or [ * *
* ]. In
addition, Licensed Product includes any Biological Material
whose development or
manufacture used or uses INX Know How.
1.30 "NET SALES" shall mean the amount billed or invoiced on
account of all
sales of Licensed Products to an independent Third Party by 3M
or permitted
sublicensees in bona fide arms' length transactions where full
consideration for
each sale of Licensed Product is reflected in the billed or
invoiced price, less
the following deductions:
(a) trade and/or quantity discounts actually taken by the
customer, or allowances or credits to customers on account of
government
regulations or price adjustments;
(b) any tax, excise, or other governmental charges upon or
measured by the production, sales, transportation, delivery or
use of said
Licensed Products contained therein (Income taxes owed or paid
by 3M shall not
be deducted from Net Sales.);
(c) transportation and insurance charges and discounts other
than
those described above;
(d) amounts repaid or credited by reason of rejections,
recall,
destruction or return or because of price rebates.
1.31 "PARTY" means INX; and/or 3M; and/or 3M IPC. An "Affiliate"
of a
"Party" shall mean, as applicable, INX Affiliate or 3M
Affiliate.
1.32 "PERSON" shall mean an individual, corporation,
partnership, 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.
1.33 "PIVOTAL CLINICAL TRIAL" shall mean the enrollment of the
first human
subject in the first clinical trial designed to generate data to
be included in
an application for Regulatory Approval of a Licensed Product in
any country.
1.34 "REGULATORY APPROVAL" shall mean, in any given country in
which a
Licensed Product is or is to be manufactured, sold or
distributed, the approval
of all government authorities necessary to permit the
manufacture, sale or
distribution of the Licensed Product. In the United States,
Regulatory Approval
may include, without limitation, 510k Approval.
6
<PAGE>
1.35 "ROYALTY YEAR" means the calendar year beginning with the
first January
1 following the Effective Date, and each calendar year
thereafter during the
term of this Agreement.
1.36 "TARGET" shall mean a given species and genus of
microorganism detected
using Licensed Product. For example, [ * * * ] and [ * * * ] are
two distinct
Targets.
1.37 "THIRD PARTY" shall mean a Person or Entity other than INX
and 3M and
their respective Affiliates.
1.38 "VALID CLAIM" shall mean a claim of any pending application
or any
issued and unexpired patent within the INX Patent Rights or
Joint Patent Rights,
so long as such claim shall not have been disclaimed or shall
not have been held
invalid in a final decision rendered by a tribunal of competent
jurisdiction
from which no appeal has been or can be taken.
ARTICLE 2
REPRESENTATIONS, WARRANTIES AND COVENANTS
2.1 PATENT RIGHTS AND INX KNOW HOW. INX represents and warrants
that
EXHIBIT A sets forth all patents and patent applications that
are owned by,
controlled by, or licensed to INX and licensed or sublicensed to
3MIPC in the
Field as of the Effective Date. INX further represents and
warrants that EXHIBIT
C sets forth INX Know-how that is owned by, controlled by, or
licensed to INX
and licensed to 3M IPC pursuant to this Agreement as of the
Effective Date
relating to Licensed Product.
2.2 VALIDITY OF PATENT RIGHTS. INX represents and warrants that
as of the
Effective Date and to the best of its knowledge and belief the
issued patents in
EXHIBIT A hereto are valid and enforceable, and that as of the
Effective Date it
is not aware of any information that it believes would render
such patents
invalid or unenforceable. INX further represents and warrants
that as of the
Effective Date it has not received any notice that any issued
patent in EXHIBIT
A is invalid or unenforceable.
2.3 NOTICE OF INFRINGEMENT OF PATENT RIGHTS. INX represents and
warrants
that as of the Effective Date it has not received any written
notice wherein a
product or process of a Third Party is alleged to infringe any
issued patent in
EXHIBIT A hereto, and that as of the Effective Date INX has
given no such
notice.
2.4 NOTICE OF THIRD PARTY INFRINGEMENT. INX represents and
warrants that as
of the Effective Date it has not received any written notice
from a Third Party
that a product or process in the INX Know-How is alleged to
infringe the
intellectual property rights of a Third Party. INX makes no
representation or
warranty that use of the INX Know How will not infringe
intellectual property
rights of any Third Party. INX makes no representation or
warranty that the
practice of inventions claimed in the INX Patent Rights will not
infringe the
intellectual property rights of any Third Party.
7
<PAGE>
2.5 INFORMATION ACQUIRED SUBSEQUENT TO EFFECTIVE DATE. If,
subsequent to
the Effective Date, INX receives or gives any written notice
described in
sections 2.2, 2.3 or 2.4 above then INX shall promptly advise 3M
IPC of such
notice.
2.6 AUTHORIZATION AND ENFORCEMENT OF OBLIGATIONS. As of the
Effective Date
and during the term of this Agreement each Party represents and
warrants that
it:
(a) has the corporate power and authority and the legal
right to enter into this Agreement and to perform its
obligations hereunder, and
(b) has taken all necessary corporate action on its part
to authorize the execution and delivery of this Agreement and
the performance of
its obligations hereunder. This Agreement has been duly executed
and delivered
on behalf of such Party, and constitutes a legal, valid, binding
obligation,
enforceable against such Party in accordance with its terms.
2.7 AUTHORITY TO GRANT. INX warrants that it has the authority
and right to
convey to 3M the rights granted under this Agreement, including
but not limited
to the rights set forth in Article 3.
2.8 CONSENTS. As of the Effective Date each Party represents and
warrants
that all necessary consents, approvals, and authorizations of
all governmental
authorities and other Persons required to be obtained by such
Party in
connection with entering into this Agreement have been obtained
except for those
the failure of which to obtain would not have a material adverse
effect.
2.9 NO CONFLICT. As of the Effective Date and during the term of
this
Agreement each Party represents and warrants that the execution
and delivery of
this Agreement, including the grant of licenses or sublicenses
hereunder, and
the performance of such Party's obligations hereunder:
(a) do not and will not conflict with or violate or
constitute a default of any requirement of applicable laws or
regulations or
with any material contractual obligation of such Party.
2.10 TRANSFER OF MATERIALS. Each Party represents and warrants
that the
Biological Materials, and any data and information associated
with the
Biological Materials (hereinafter "Materials") delivered to the
other Party
("Recipient")as part of the Development Collaboration Program
will be in
substantially and reasonably in accordance with the Development
Collaboration
Plan as agreed to by the Parties. Otherwise, EACH PARTY
ACKNOWLEDGES THAT ANY
MATERIALS DELIVERED TO IT UNDER THIS AGREEMENT ARE EXPERIMENTAL
IN NATURE.
Except for the limited representations and warranties provided
in this Article
2.10, EACH SUPPLYING PARTY ("SUPPLIER") OF MATERIALS MAKES NO
REPRESENTATIONS
AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, WITH RESPECT
TO THE MATERIALS. THERE ARE NO EXPRESS OR IMPLIED
8
<PAGE>
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. THE SUPPLY OF
MATERIAL IS NOT A REPRESENTATION THAT USE OF THE MATERIALS WILL
NOT INFRINGE ANY
PATENT, COPYRIGHT, TRADE SECRET, TRADEMARK OR OTHER RIGHTS OF
THIRD PARTIES.
Each Recipient of Materials assumes all liability for damages
which may arise
from the Recipient's use, storage, disposal or transfer of the
Materials.
Supplier shall not be liable to the Recipient for any loss,
claim, or demand
made by the Recipient, or made against the Recipient by any
other party, due to
or arising from the use or transfer of the Material by the
Recipient, except
when caused solely by the gross negligence or improper
intentional acts of the
Supplier.
2.11 PRIOR AGREEMENTS. Each party represents and warrants that
as of the
Effective Date it has complied with the material terms and
conditions of the
Prior Agreements and is not in material breach of any Prior
Agreement. Each
Party represents and warrants that to the best of its knowledge,
it has
disclosed to the other Party any Inventions made or conceived
during and in the
course of work under the Prior Agreements.
ARTICLE 3
GRANT
3.1 PATENT AND KNOW HOW RIGHTS. For the term of this Agreement
as provided
in Article 10, INX hereby grants to 3MIPC a worldwide, exclusive
(even as to
INX), royalty-bearing license in the Field, under the INX Patent
Rights, the INX
ownership interest in Joint Patent Rights and Joint Inventions,
INX Know-How and
INX Inventions to make, have made, have used, sell, have sold,
offer for sale,
and import Licensed Products in the Field throughout the world.
This grant
includes the right for 3MIPC to grant sublicenses to 3M
Affiliates without
consent, either directly or through one or more intermediaries.
This grant also
includes the right for 3MIPC to grant sublicenses to Third
Parties with INX's
written consent, which consent shall not to be unreasonably
withheld. This grant
also includes the right for any customers (ultimate or in
privity or other) of
any sublicensee of 3MIPC to use and/or sell (for further use or
resale) the
Licensed Products so made. 3M and its permitted sublicensees
shall not make,
use, sell, market or promote Licensed Product for use outside
the Field. Where
the INX Patent Rights are themselves licensed from a Third
Party, 3M's license
takes the form of a sublicense. Notwithstanding the forgoing,
the sublicense
granted to 3M under U.S. Patent No. [ * * * ] and U.S. Patent
Application Serial
No. [ * * * ] titled "[ * * * ]" within the INX Patent Rights is
a nonexclusive
license.
3.2 RESERVATION OF RIGHTS. Universita delgi Studi di Pavia,
Regents of the
University of Minnesota, University of Illinois, Yale
University, TAMUS, TCD and
BRI each retain an irrevocable, nonexclusive and nontransferable
royalty-free
right to its respective
9
<PAGE>
licensed intellectual property for its own educational and
non-commercial
research purposes. With respect to INX Patent Rights wherein
TAMUS is the
primary licensor, the obligations to TAMUS of paragraphs 10.03
(warranty), 10.06
(representation regarding BRI), 10.07 (representation regarding
University of
Texas), 12.02 (non-use of names) and 12.03 (trademarks) of the
2000 License
Agreement between INX and TAMUS shall be binding upon 3M as if
3M were a party
to that license. A copy of the TAMUS license is attached hereto
as EXHIBIT E.
3.3 RESERVATION OF RIGHTS. Pursuant to 37 C.F.R. 401.14, the
U.S.
Government shall have a nonexclusive, nontransferable,
irrevocable, paid-up
license to practice or have practiced for or on behalf of the
United States
certain INX Patent Rights throughout the world. To the extent
any INX Patent
Rights claim inventions made all or in part with U.S. Government
funding, such
INX Patent Rights may carry additional terms and restrictions
imposed by the
U.S. Government.
3.4 RESERVATION OF RIGHTS. 3M has served as the prime contractor
under
Government Contract No. DAAD13-03-C-0047 with a scope of work
that encompassed
activities performed during the Prior Agreements. INX became a
subcontractor
under Contract No. DAAD13-03-C-0047 and subject to certain
Government Terms and
Conditions as negotiated between the Parties and set forth in
the Prior
Agreements. As a result, the U.S. Government may have certain
rights in 3M
Inventions relating to Materials (as defined in section 2.11
above) provided
pursuant to the Prior Agreements. 3M is actively pursuing
Government contracts
from Government agencies that, if executed, may have an
effective date within
the term of this Agreement and have a scope of work that
encompasses the
activities outlined in a future Development Collaboration
Program of this
Agreement. INX will use its reasonable commercial efforts to
negotiate
appropriate terms with 3M so INX will be subject to terms and
conditions
acceptable to the Government, 3M and INX, for any given future
3M Government
contract.
3.5 ADDITIONAL PATENT RIGHTS. Patents and patent applications
not described
in sections 1.19 (a) through (d) of the INX Patent Rights which
are licensed to
INX by a Third Party after the Effective Date or to which INX
otherwise acquires
rights after the Effective Date during the term of this
Agreement, and in which
INX has the right to grant licenses or sublicenses in the Field,
shall be
disclosed to 3M in writing. For a period of one year from the
date of disclosure
by INX, 3M shall have the right of first negotiation to obtain a
license on
terms to be negotiated. Nothwithstanding the foregoing, U.S
Patent Application
No. [ * * * ] titled "[ * * * ]" shall be automatically added to
the INX Patents
Rights in EXHIBIT A and shall be licensed to 3MIPC under the
terms and
conditions of this agreement in the event that after the
Effective Date INX
acquires sublicenseable rights to this application from the
University of
Illinois.
10
<PAGE>
ARTICLE 4
COMPENSATION
4.1 OVERVIEW OF COMPENSATION. In consideration of the patent and
know how
licenses granted in Article 3 and INX's contributions to the
Development
Collaboration described in Article 5 herein, 3M agrees to make
(1) the license
fee payments as set forth in Article 4.2, (2) the milestone
payments as set
forth below in this Article 4.3; and (3) the earned royalty
payments as set
forth below in this Article 4.4.
4.2 LICENSE FEES.
4.2.1 UP FRONT LICENSE FEE. A nonrefundable upfront license fee
payment of
one million seven hundred fifty thousand dollars ($1,750,000)
shall be made by
3M to INX within sixty (60) days of the Effective Date of this
Agreement. This
4.2.1 up front license fee is consideration for the license
grant of Article 3
with respect to the First Target.
4.2.2 DEFERRED LICENSE FEE. A deferred license fee payment of
one million two
hundred fifty thousand dollars ($1,250,000) shall be made within
sixty (60) days
of the one year anniversary of the Effective Date of this
Agreement as
consideration for the license grant of Article 3 with respect to
all Targets
(other than First Target). This deferred payment will be made
unless 3M and/or
3MIPC terminate the Agreement for cause under Article 10.5
effective before the
one year anniversary of the Effective Date. Otherwise this
obligation to pay the
deferred licensee fee shall survive early termination of this
Agreement by 3M or
3MIPC under Article 10.2.
4.3 MILESTONE PAYMENTS. Milestone payments will be made as
follows:
1) A single milestone payment of [ * * * ] within sixty (60)
days
of First Commercial Sale of Licensed Product for the First
Target in any
country; and
2) A single milestone payment of [ * * * ] within sixty (60)
days
of the First Commercial Sale of Licensed Product for the First
Target where the
Licensed Product is part of a point-of-care Detection Platform
(i.e., a product
for which CLIA is waived under Section 353 of the Public Health
Service (PHS)
Act (42 U.S.C. 263a), as amended by the Clinical Laboratory
Improvement
Amendments of 1988 (CLIA), and implementing regulations of 42
CFR part 493); and
3) A milestone payment to be negotiated between the Parties of
up
[ * * * ] per Target within sixty (60) days of the Regulatory
Approval in any
country of a Licensed Product for each Target (other than First
Target). Only
one single payment is due under this section 4.3 (3) for each
Target (other than
First Target), regardless of the number of different Detection
Platforms in
which the Licensed Product is used.
11
<PAGE>
4.4 EARNED ROYALTIES. 3M IPC shall pay INX an Earned Royalty on
sales of
Licensed Products beginning upon the First Commercial Sale in
any country. A
single Earned Royalty shall be due on the sale of each Licensed
Product without
regard to the number of Valid Claims in the INX Patent Rights
that would be
infringed by the manufacture, use or sale of the Licensed
Product absent the
license granted herein and without regard to the number of
sublicenses hereunder
implicated by the manufacture, use or sale of the Licensed
Product. Further, a
single Earned Royalty shall be due on the sale of each Licensed
Product even
though for example it is made in a country where there is a
Valid Claim in the
INX Patent Rights that would be infringed by its manufacture,
and it is
thereafter sold in a country where there is also a Valid Claim
in the INX Patent
Rights that would be infringed by its sale.
4.4.1 An Earned Royalty shall become due upon the sale of a
Licensed Product
in a country if the manufacture, use or sale of it would
infringe at least one
Valid Claim of INX Patent Rights in the country where it is
manufactured, used
or sold. For any Licensed Product subject to payment of an
Earned Royalty by
virtue of a Valid Claim in a pending application only, the
Earned Royalty shall
only be due and payable for the first five years following the
priority filing
date of such patent application.
4.4.2 For any sale of Licensed Product anywhere worldwide when
no Valid Claim
of INX Patent Rights anywhere covers its manufacture, use or
sale, an Earned
Royalty shall nevertheless become due upon the sale of such
Licensed Product if
the Licensed Product contains ClfA (as defined in Article 1.8),
or if the
manufacture or use of the Licensed Product includes ClfA. The
Earned Royalty
payable under this Article 4.4.2 shall only be due until
expiration of U.S.
Patent No. [ * * * ]. After expiration of U.S. Patent [ * * * ],
the license
grant to 3M of INX Know-how received under this Agreement shall
be considered a
paid-up license and no further Earned Royalties for Licensed
Product shall be
due based solely on INX Know-how. Notwithstanding the foregoing,
no Earned
Royalty shall be due under this Article 4.4.2 on sales made in
any country in
which 3M can show that it is suffering competitive harm due to a
lack of INX
Patent Rights in that country for the Licensed Product sold in
that country. For
so long as such harm persists, no Earned Royalties shall be due
to INX for sales
of such Licensed Product in such country. This section 4.4.2
shall not apply to
the sale of Licensed Product manufactured, used or sold where a
Valid Claim
within the INX Patent Right subsists; rather, section 4.4.1
would apply. For
example, this section 4.2.2 shall not apply to sales of Licensed
Product
manufactured in a country where a Valid Claim within the INX
Patent Right
subsists and would be infringed by the manufacture of such
Licensed Product even
if such Licensed Product is sold in a country where no INX
Patent Rights subsist
which would be infringed by the sale of such Licensed
Product.
4.4.3 The Earned Royalty rate shall be [ * * * ] percent ([ * *
* ]%) of Net
Sales of Licensed Products sold for sales of Licensed Products
totaling up to [
* * * ] worldwide per Royalty Year per Detection Platform.
Thereafter, the
Earned Royalty rate shall be [ * * * ] percent ([ * * * ]%) of
the Net Sales of
Licensed Products sold for sales of Licensed Products over [ * *
* ] worldwide
per Royalty Year per Detection Platform. No Earned Royalty shall
be payable with
respect to the sale of any Licensed Product purchased by
12
<PAGE>
3M from INX or any INX Affiliate. 3M IPC shall make Earned
Royalty payments to
INX on all Net Sales made by 3M's sublicensees as if such Net
Sales were made by
3M. For any Licensed Product subject to payment of Earned
Royalty only by virtue
of Joint Patent Rights, the Earned Royalty shall be calculated
at one-half of
the rate set forth in this Article 4.4.3.
4.4.4 In the event that a license under one or more Third Party
patents (not
part of the INX Patent Rights) is required by 3M to use an INX
Biological
Material covered by at least one Valid Claim in the INX Patent
Rights, then the
Earned Royalty owed to INX for Licensed Product shall be reduced
by the royalty
3M actually pays to such Third Party up to an aggregate maximum
fifty percent
(50%) reduction in the Earned Royalty rate payable to INX.
4.4.5 INX acknowledges that the sublicenses granted to 3M IPC
under this
Agreement are a significant portion of the financial value
associated with this
Agreement. As such, at least three (3) months prior to first
Commercial Sale of
Licensed Product (as described in a written notice to INX from
3M referencing
this paragraph of this Agreement) on any Detection Platform, INX
shall use
reasonable commercial efforts to obtain written confirmation
from the primary
licensor that the sublicense to 3M shall continue in the event
of termination of
INX's primary license for any reason. Further, INX shall use
commercially
reasonable efforts to maintain the primary license in the INX
Patent Rights
containing a Valid Claim that covers the manufacture, use or
sale of such
Licensed Product described in the notice from 3M. In the event
one or more INX
Patent Rights are eliminated from Exhibit A as a result of
termination of a
primary license in the INX Patent Rights for any reason, and if
a royalty had
been due on such terminated INX Patent Rights, and if 3M obtains
a license
directly from the primary licensor for such terminated INX
Patent Rights, then
the Earned Royalty due INX under this Article 4.4 (if any) shall
be reduced by
the royalty rate that would have been due and payable by INX to
the primary
licensor for covered Licensed Products under the primary license
if the primary
license had not been terminated.
4.5 REPORTS AND PAYMENTS. The Earned Royalty shall be paid
quarterly
starting with the end of the Calendar Quarter following the
First Commercial
Sale and shall be made not more than two (2) months following
the end of each
Calendar Quarter. 3M IPC shall furnish INX with a written report
setting forth
the Net Sales of Licensed Products upon which a royalty is
payable under this
Article 4.5 during each Calendar Quarter and the computation of
the royalties
payable with respect thereto. Each report shall be accompanied
by the amount due
in U.S. Dollars, less any taxes that 3M is required to withhold
for the account
of INX pursuant to applicable governmental agencies in respect
to royalties
payable to INX for that Calendar Quarter. The receipt for such
withheld taxes
shall be provided to INX at INX's request. Each report and any
accompanying
payment shall be sent in the manner provided to the address
specified for INX
according to Article 13 (Notices). Payment of any royalties due
to INX Licensors
by virtue of 3M's sublicense shall be the sole responsibility of
INX.
13
<PAGE>
4.6 CURRENCY CONVERSIONS. Royalty payments shall first be
calculated in the
currency of the country in which sales took place and then
directly converted to
U.S. Dollars using the average of the exchange rates applicable
on the date of
payment used by 3M for financial accounting purposes in
accordance with
generally accepted accounting principles.
4.6.1 If by reason of any restrictive exchange laws or
regulations, 3M shall
be unable to convert to U.S. dollars amounts equivalent to the
Earned Royalty
payable by 3M hereunder in respect of Licensed Products sold for
funds other
than U.S. dollars, 3M shall notify INX promptly with an
explanation of the
circumstances. In such event, all royalties due hereunder in
respect of the
transaction so restricted (or the balance thereof due hereunder
and not paid in
funds other than U.S. dollars as hereinafter provided) shall be
deferred and
paid in U.S. dollars as soon as reasonably possible after, and
to the extent
that such restrictive exchange laws or regulations are lifted so
as to permit
such conversion to U.S. dollars, of which lifting 3M shall
promptly notify INX.
At its option INX shall meanwhile have the right to request the
payment (to it
or to a nominee), and upon such request, 3M shall pay, or cause
to be paid, all
such amounts (or such portions thereof as are specified by INX)
in funds, other
than U.S. dollars, designated by INX and legally available to
INX under such
then existing restrictive exchange laws or regulations; provided
however, that
the provisions of this section 4.7.1 shall only apply to amounts
totaling more
than ten thousand United States dollars per Calendar
Quarter.
4.7 RECORDS. 3MIPC shall keep accurate records in sufficient
detail to
enable Earned Royalties payable hereunder to be determined and
shall, upon
written notice by INX to 3M IPC, permit such records to be
inspected (but only
to the extent necessary to verify whether Earned Royalties are
due and the
amount of Earned Royalty payable hereunder) once annually during
normal business
hours by a certified public accountant or firm of certified
public accountants
reasonably acceptable to 3M IPC and appointed by INX at INX's
expense. The
accountants making such inspection shall report to INX only the
amount of Earned
Royalty due and payable and shall be bound by the provisions of
Article V. If
the difference between Earned Royalties reported by 3M and that
reported by the
independent accountants exceeds five percent in a given Royalty
Year, then 3M
shall reimburse INX for the expense of the audit for that
Calendar Year.
Regardless of the amount of the shortfall, 3M shall pay to INX
the full amount
of Earned Royalties owed. Records inspected under this Article
4.8 shall be
retained by 3M until INX and 3M IPC have agreed upon the amount
of Earned
Royalty payable thereon. Except as aforesaid, 3M shall not be
required to retain
any records longer than three (3) years after the end of the
Calendar Quarter in
which such records were prepared.
4.8 LICENSED PRODUCT DISPUTE
4.8.1 The provisions of Article 11 notwithstanding, in the event
of any
dispute between the Parties as to whether or not a product sold
by 3M or 3M
Affiliates is (a) a Licensed Product for which an Earned Royalty
is due or (b)
subject to payment of Earned Royalty only by virtue of Joint
Patent Rights, 3M
IPC shall have the right to submit the dispute to
14
<PAGE>
binding arbitration by a patent attorney acceptable to both
Parties. The
arbitrator will determine whether the product sold falls within
the scope of at
least one Valid Claim of the INX Patent Rights or Joint Patent
Rights, including
but not limited to consideration of issues such as the validity
of patent claims
and the scope of the claims under the doctrine of equivalents.
3M IPC shall not
be entitled to withhold Earned Royalties in dispute during the
pendency of such
arbitration. Each Party shall bear its own expenses associated
with such
arbitration and the Parties shall share equally the fees and
expenses of the
arbitrator. The arbitrator's findings shall be considered
Confidential
Information and attorney client privileged information of both
Parties to the
extent permitted by law. The findings shall apply only to the
specific product
considered by the arbitrator; shall have no precedential value;
and shall not be
used in any subsequent arbitration nor be admissible in any
litigation
4.8.2 In the event the product in dispute is determined not to
be a Licensed
Product, then 3M IPC shall receive a credit for the Earned
Royalties paid during
the pendency of the arbitration, creditable against Earned
Royalties payable
pursuant to this Agreement.
ARTICLE 5
DEVELOPMENT COLLABORATION AND COMPENSATION
5.1 DEVELOPMENT COLLABORATION PROGRAM. From the Effective Date
and in
accordance with the terms of this Agreement, INX and 3M agree to
perform, or
have performed, the Development Collaboration Program as
approved and agreed to
by the Joint Development Committee ("JDC"); provided, however,
that the
obligations of INX to perform such work shall be limited by the
development and
support fees paid by 3M pursuant to Article 5.2. No obligation
to transfer
Materials or information continues beyond the expiration or
termination of the
Development Collaboration Program.
5.2 ANNUAL DEVELOPMENT SUPPORT FEES. For a period of two years
beginning
with the first Calendar Quarter after the Effective Date of this
agreement, 3M
shall make a minimum development support fee payment of [ * * *
] per twelve
month period, payable at the rate of [ * * * ] at the start of
each Calendar
Quarter. To the extent that the parties have agreed to a
Development
Collaboration Plan as set forth below and documented in EXHIBIT
B, the
development support payments shall be applied to affect the
Development
Collaboration Plan. The Parties intend that this level of
funding support [ * *
* ] of INX personnel and transfer of any Materials related to
performance of the
Development Collaboration Plan. In addition to the foregoing
minimum development
support payments, 3M shall have the right but no obligation to
request, at least
ninety days prior to the start of each twelve month period, that
additional
development support at INX be funded by 3M. Any such increase in
the development
support fees shall be made only by prior written agreement of
the Parties.
5.3 DEVELOPMENT COMMITTEE ROLE, DECISIONS. The JDC shall write
the
Development Collaboration Plan, determine and monitor the
Development
Collaboration Program, including making recommendations
regarding the
performance of the
15
<PAGE>
Development Collaboration Plan and generally on the conduct of
research and
development u
|