1
EXHIBIT 10.2
[XXXX] INDICATES INFORMATION
OMITTED FROM THE EXHIBIT AND
FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A
CONFIDENTIAL TREATMENT REQUEST
RESEARCH AND DEVELOPMENT, RESEARCH SUPPORT
AND LICENSE AGREEMENT
BETWEEN
ANTEX BIOLOGICS INC.
AND
SMITHKLINE ▇▇▇▇▇▇▇ PLC
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TABLE OF CONTENTS
ARTICLE TITLE PAGE
1. DEFINITIONS 4
2. RESEARCH AND DEVELOPMENT 11
3. RESEARCH SUPPORT 16
4. GRANT OF LICENSE 18
5. MILESTONE PAYMENTS AND ROYALTIES 19
6. REVERSION AND ROYALTY FOR TARGETS OUTSIDE OF
THE FIELD 23
7. REVERSION AND NON EXCLUSIVE LICENSE ON TARGETS
WITHIN FIELD 25
8. COMPULSORY LICENSES AND THIRD PARTY LICENSES 26
9. DILIGENCE 27
10. DEVELOPMENT, INDEMNIFICATION AND LIABILITY 29
11. EXCHANGE OF INFORMATION AND CONFIDENTIALITY 30
12. PATENT PROSECUTION AND LITIGATION 33
13. TRADEMARKS 35
14. STATEMENTS AND REMITTANCES 36
15. TERM AND TERMINATION 37
16. RIGHTS AND DUTIES UPON TERMINATION 39
17. WARRANTIES AND REPRESENTATIONS 39
18. FORCE MAJEURE 41
19. GOVERNING LAW/JURISDICTION 42
20. SEPARABILITY 43
21. ENTIRE AGREEMENT 44
22. NO WAIVER 44
23. NOTICES 45
24. ASSIGNMENT 46
25. GENERAL PROVISIONS 46
APPENDIX A
APPENDIX B
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RESEARCH AND DEVELOPMENT, RESEARCH SUPPORT
AND LICENSE AGREEMENT
This Research and Development, Research Support and License Agreement
("Agreement") is dated as of the 13th day of September 1999 and effective as of
the first day of September, 1999, ("Effective Date") between Antex Biologics
Inc., a Delaware corporation having a place of business at ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇ (herein referred to as "ANTEX") and
SmithKline ▇▇▇▇▇▇▇ plc, having a place of business at New Horizons Court,
Brentford, Middlesex TW8 9EP, United Kingdom (herein referred to as "SB").
WITNESSETH THAT:
WHEREAS, MicroCarb Human Vaccines Inc., MicroCarb Inc., (now ANTEX) and
SmithKline ▇▇▇▇▇▇▇ Corporation, an Affiliate of SB have entered into a Research
and Development, Research Support and License Agreement, dated May 6th, 1996
("Original License") under which the parties have entered into a collaboration
dedicated to the development of commercial human vaccine products for infectious
diseases; and
WHEREAS, the parties hereto wish to restate the conditions of the
Original License and to replace the Original License by this Agreement; and
WHEREAS, contemporaneously with the execution of this Agreement,
MicroCarb Human Vaccines Inc., ANTEX, SmithKline ▇▇▇▇▇▇▇ Biologicals
Manufacturing S.A. and SB are entering into an Omnibus Agreement of even date
herewith pursuant to which the parties thereto have agreed, among other things,
to merge MicroCarb Human Vaccines Inc. with and into ANTEX and terminate or
amend certain other agreements between the parties.
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NOW, THEREFORE, in consideration of the covenants and obligations
expressed herein and intending to be legally bound, and otherwise to be bound by
proper and reasonable conduct, the parties hereto agree as follows:
1. DEFINITIONS
1.01 "Affiliate(s)" shall mean any corporation, firm, partnership
or other entity, whether de jure or de facto, which directly
or indirectly owns, is owned by or is under common ownership
with a party to this Agreement to the extent of at least
fifty percent (50%) of the equity (or such lesser percentage
which is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction) having the power to
vote on or direct the affairs of the entity and any person,
firm, partnership, corporation or other entity actually
controlled by, controlling or under common control with a
party to this Agreement.
1.02 "Antex Antigen" shall mean any Antigen [XXXXX] that has been
developed using the Intellectual Property.
1.03 "Antigen" shall mean any active ingredient such as (but not
limited to) live attenuated micro-organisms, whole killed
micro-organisms or sub-unit particles (e.g. polysaccharides,
polysaccharide conjugates, peptides, proteins, recombinant
proteins, glycolipids), that elicits a specific immune
response.
1.04 "Approval" shall mean any final approval granted by the FDA
or other comparable regulatory authority in any country for
the lawful manufacture, marketing, sale, administration,
distribution and use of a Product.
1.05 "Combination" shall mean Product for one (1) or more Targets
in the Field and one (1) or more targets outside the Field.
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1.06 "Confidential Information" shall mean all written or tangible
information which is (or has been in the course of the
discussions leading to this Agreement) designated as
confidential and exchanged between the parties and any such
information disclosed orally or visually that is confirmed in
writing as confidential within thirty (30) days of disclosure
(or if such information was disclosed orally or visually
prior to the date hereof, it shall be deemed Confidential
Information if it was confirmed in writing as confidential on
or before the date hereof).
1.07 "FDA" shall mean the United States Food and Drug
Administration.
1.08 "Field" shall mean any and all prophylactic and/or
therapeutic human vaccines (but excluding development of
commercial products for use in passive immunization) for
infectious diseases caused or exacerbated by the following
Targets: Moraxella catarrhalis, Neisseria meningitidis
including serotypes A, B and C, non-typable Haemophilus
influenzae, Streptococcus pneumoniae and Chlamydia using the
"High Molecular Weight" protein ("HMWP") of Chlamydia.
1.09 "HMWP" means the "High Molecular Weight Protein of Chlamydia
trachomatis described in Patents including ANTEX internal
reference NO. [XXXXX] with title "Chlamydia protein,
gene sequence and uses thereof" and any related foreign
filings including PCT application filed on October 1, 1998
under the application serial number PCT/US98/20737. For
purposes of clarity it is hereby recognized and agreed
[XXXXX].
1.10 "Initial Period" shall have the meaning set forth in
Section 2.01.
1.11 [XXXXX]
1.12 "Intellectual Property" shall mean all Patents and
Technology.
1.13 "Major European Country" shall mean any of Germany, the
United Kingdom, France, Italy and Spain.
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1.14.01 "Net Sales" shall mean gross receipts from sales of
Product in the Territory by SB and/or its sublicensees
under this Agreement less deductions actually taken for:
(i) transportation charges including transportation
insurance; and
(ii) the incremental production costs determined as
standard, excluding royalties or other licence
fees, for formulation, filling and packaging of
diluents, adjuvants and/or vehicles (other than
aluminium hydroxide) and/or any immune enhancing
elements, and for syringes and other administration
devices combined with, or contained in, commercial
packaging of Product; and
(iii) sales and excise taxes and duties levied on a
selling party and any other governmental charges
imposed upon the production, importation, use or
sale of Product, including without limitation,
contributions and payments, required by any
governmental authorities, as liability provisions
and/or made pursuant to injury compensation schemes
and/or as product liability insurance premiums
including in the case of the United States of
America, contributions and payments required to be
made by the United States Government pursuant to
the National Childhood Vaccine Injury Act of 1986;
and
(iv) normal and customary trade, quantity and cash
discounts, commissions to non-Affiliated brokers or
agents and other customary rebates accrued, paid
and/or allowed in accordance with generally
accepted accounting principles consistently
applied; and
(v) amounts repaid or credited to customers or charges
back from customers on account of rejection or
return of Product subject to royalty under this
Agreement or on account of retroactive price
reductions affecting such Product; and
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(vi) royalties payable and/or paid by SB to Third
Parties on the manufacture, use and/or sale of
Product not otherwise deducted or taken into
account pursuant to Article 8 hereunder.
1.14.02 Sales between or among SB and its Affiliates or
sublicensees shall be excluded from the computation of Net
Sales except where such Affiliates or sublicensees are end
users, but Net Sales shall include the subsequent final
sales to Third Parties by such Affiliates or sublicensees.
1.14.03 If Product is sold as part of a Combination, Net Sales for
purposes of determining royalties on Product in the
Combination shall be calculated by excluding the relative
value of vaccines for targets outside the Field , and any
such excluded value shall be calculated on the basis of
the manufacturer's selling price of technically equivalent
vaccines for the same targets . In the event such
manufacturer's selling price is not available, ANTEX and
SB shall negotiate in good faith the relative value of the
vaccines and/or active ingredients included in the
Combination.
1.14.04 In addition to any adjustment to Net Sales pursuant to
Section 1.14.03, if any, in the event that a Product
incorporates for the same [XXXXX] then Net Sales shall be
adjusted on a Target-by-Target basis by multiplying the
Net Sales number calculated pursuant to Sections 1.14.01
and 1.14.02 adjusted if appropriate pursuant to Section
1.14.03 by the [XXXXX], provided that such fraction for
any Target which includes at least an Antex Antigen shall
not be less than [XXXXX] irrespective of the number of
Antigens for such Target included in the Product.
1.15 "Reverted New Targets" shall have the meaning set forth
in Section 7.01.
1.16 "Other Patents" shall mean any patents and/or patent
applications owned and/or controlled by Third Parties
having claims which would be infringed by SB
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importing, making, having made, using, having used,
offering for sale, selling or having sold Products.
1.17 "Pasteur License" shall mean that certain License Agreement,
dated December 1, 1994 by and between ANTEX and Pasteur
Merieux Serums et Vaccins S.A.
1.18 "Patents" shall mean all patents and patent applications
owned and/or controlled and/or used by ANTEX and its
predecessors including MicroCarb Human Vaccines Inc.
(pursuant to license agreement or otherwise) in or applicable
to the Field at anytime prior to the commencement of and
during the term of this Agreement, including any
continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals or extensions (other than SPC)
thereof. The current list of patent applications and patents
encompassed within Patents is set forth in Appendix A
attached hereto and shall be modified from time to time.
1.19 "Period" shall have the meaning set forth in Section 2.01.
1.20 "Proceeds" shall have the meaning set forth in Section 6.03.
1.21 "Product" shall mean any and all products in the Field which
embodies or utilizes any Intellectual Property.
1.22 "R&D Committee" shall have the meaning set forth in
Section 2.02.
1.23 "R&D Program" shall have the meaning set forth in
Section 2.01.
1.24 "Registration" shall mean a filing with an appropriate
authority within any country for the purpose of obtaining
legal and regulatory approval for the marketing of a Product
in such country.
1.25 "Research Support Facilities" shall have the meaning set
forth in Section 3.01.
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1.26 "Research Support Services" shall have the meaning set forth
in Section 3.01.
1.27 "Reverted Target" shall have the meaning set forth in
Section 6.01.
1.28 "Royalty Percentage" shall have the meaning set forth in
Section 5.03.
1.29 "SB" shall mean SmithKline ▇▇▇▇▇▇▇ Corp. and its Affiliates.
1.30 "SPC" shall mean all Supplementary Protection Certificates
for medicinal products and their equivalents provided under
the Council Regulation (EEC) NO. 1768/92 of June 18, 1992.
1.31 "Steering Committee" shall have the meaning set forth in
Section 2.06.
1.32 "Target" shall mean an infectious agent at the genus level
(unless indicated in Section 1.08 to be at the species level)
in the Field and all strains, variants, subtypes and
derivatives thereof. For purpose of clarity, HMWP shall
throughout this Agreement also be considered as a Target
within the Field.
1.33 "Technology" shall include, to the extent they are not
included in Patents, any and all culture media, cell lines,
assay systems, DNA fragments, genes, constructs, plasmids,
vectors, development strains, expression systems, clones,
colonies, promoters, epitopes, micro-organisms, and any
other biological materials and deposits thereof (such as,
for example, deposits made with the American Type Culture
Collection or the European Type Culture Collection under the
Budapest Treaty), any and all copyrights, copyright
registrations and applications for copyright registrations,
any and all inventions, any and all trade secrets, present
and/or future data, technical information, know-how, and
confidential or proprietary information (including without
limitation all chemical, pharmacological, toxicological,
clinical, assay, control and manufacturing data and any
other similar information) and/or improvements to any of the
foregoing, in or applicable to the Field owned and/or
controlled and/or used by ANTEX and its predecessors
including
40
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MicroCarb Human Vaccines Inc., (pursuant to license agreement
or otherwise) at anytime prior to the commencement of and
during the term of this Agreement.
1.34 "Territory" shall mean all the countries and territories of
the world.
1.35 "Third Party(ies)" shall mean any party which is neither a
party to this Agreement nor an Affiliate.
"Interpretive Rules". For purposes of this Agreement, except as
otherwise expressly provided herein or unless the context otherwise
requires : (a) defined terms include the plural as well as the singular
and the use of any gender shall be deemed to include the other gender;
(b) references to "Articles", "Sections" and other subdivisions and to
"Schedules", "Appendices" and "Exhibits" without reference to a
document, are to designated Articles, Sections and other subdivisions
of, and to Schedules, Appendices and Exhibits to, this Agreement; (c)
the use of the term "including" means "including but not limited to";
and (d) the words "herein", "hereof", "hereunder" and other words of
similar import refer to this Agreement as a whole and not to any
particular provision.
2. RESEARCH AND DEVELOPMENT
2.01 Subject to the further terms and conditions set forth in this
Agreement, ANTEX shall, on SB's behalf, conduct a new research
and development program ("R&D Program") for the period from 1st
July 1999 to 31st December 1999 ("Initial Period") directed to
[XXXXX] or other projects as agreed by the R&D Committee and SB
agrees to pay ANTEX on July 1, 1999 and on October 1, 1999, the
amount of six hundred sixty-six thousand six hundred and
sixty-seven US dollars (US $ 666,667) for the performance of
such activities in line with an R&D plan agreed from time to
time by the R&D Committee. At SB's sole discretion this R&D
Program may be extended beyond December 31, 1999, for one (1) or
more periods of no less than one (1) year (each "Period")
41
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unless mutually agreed between the parties and, if SB so elects,
the research activities to be performed, the related budget and
related plan shall be discussed and approved by the R&D
Committee described in Section 2.02 no later than 1st October
1999 and, in the case of any further extension, on October 1st
or ninety(90) days before the end of any Period.
For any such Period elected by SB, SB shall pay to ANTEX,
January 1st and July 1st, one half of the related budget for the
R&D Program agreed upon by the R&D Committee.
2.02 SB and ANTEX hereby establish a new R&D committee (the "R&D
Committee") which shall have all powers which are necessary or
desirable with respect to the implementation and management of
the R&D Program, including without limitation the power to: (i)
prepare and approve at the latest ninety (90) days prior to the
end of the Initial Period or extended Period of the R&D Program
a plan of specific activities to be performed and related
deliverables to be achieved by ANTEX during the next Period of
the R&D Program and the related budget; (ii) make
recommendations to SB and ANTEX to amend the R&D Program in
progress; (iii) make decisions with respect to the preparation,
filing, prosecution and maintenance of Patents; (iv) monitor and
enforce the budget contained in the relevant R&D Program and to
verify that all items within the plan of activities have been in
fact carried out and that the related deliverables have in fact
been achieved; and (v) the power specified in Section 2.08. The
R&D Committee shall have no power to : (x) amend, modify, revise
or waive any provision of this Agreement other than specifically
provided for herein or; (y) bind ANTEX or any other party hereto
to any contract or other commitment with a Third Party or grant
any license or other rights in or with respect to a Product.
2.03 SB's initial appointees to the R&D Committee are ▇▇▇▇ ▇▇▇▇▇ who
shall act as SB liaison representative and ▇▇▇ ▇▇▇▇▇▇▇ and
▇▇▇▇▇' initial appointees to the R&D Committee are ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇ who shall act as ANTEX liaison representative and
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇. Meetings of the R&D Committee shall be
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held periodically at a place mutually agreed upon, but not less
frequently than semi-annually. No meeting of the R&D Committee
shall be convened unless at least two (2) of the members of the
R&D Committee (one each representing SB and ANTEX) are present
in person or by telephone conference call. SB and ANTEX shall
each bear the expenses associated with the attendance at
meetings of the R&D Committee by members of such committee
appointed by it. The R&D Committee shall nominate a Chairman to
call the meetings and a secretary to take the minutes. Other
than for face-to-face meetings, the parties shall make all
reasonable efforts to exchange any information on the R&D
Program and other scientific information to be exchanged between
or communicated to the parties pursuant to this Agreement
through their liaison representatives.
2.04 Each member of the R&D Committee shall be entitled to cast one
(1) vote on each matter presented for approval at any meeting of
the R&D Committee. A matter presented for approval at any
meeting of the R&D Committee shall be considered approved if the
unanimous consent of the members present at such meeting is
given in favor of such matter. In the event that any matter
presented for approval at any meeting of the R&D Committee does
not receive such unanimous consent, the matter not approved will
be submitted for resolution to the Steering Committee described
in Section 2.06 below.
2.05 For so long as a R&D Program is carried out the R&D Committee
shall continue to exercise the powers described in Section 2.02
in accordance with the procedural requirements for approval set
forth in Section 2.04 and continue to be comprised of four (4)
members, two (2) of whom are appointed by each of SB and ANTEX
as described in Section 2.03.
2.06 ANTEX and SB hereby establish a steering committee (the
"Steering Committee") composed of two (2) members, one of whom
shall be appointed by SB and the other appointed by ANTEX, which
shall be responsible for (i) resolving any dispute or
disagreement arising at the level of the R&D Committee and/or
(ii) discussing any business disagreement between the
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parties during the R&D Program or after its termination and/or
(iii) discussing any other matters pertinent to the relationship
of the parties. Meetings of the Steering Committee shall be
called by either member of the Steering Committee whenever a
matter of dispute or disagreement arises between the parties, or
upon request of either SB or ANTEX. Each party agrees to cause
its appointee to the Steering Committee to participate in person
or by telephone conference call in all meetings of the Steering
Committee. SB's initial representative on the Steering Committee
is ▇▇▇▇▇▇ ▇▇▇▇▇▇ and ▇▇▇▇▇' initial representative on the
Steering Committee is ▇▇▇ ▇▇▇▇▇▇▇▇.
2.07 ANTEX shall perform the research and development activities
allocated to it in the R&D Program as from time to time in
effect to the best of its abilities and in accordance with: (i)
this Agreement; and (ii) the scientific, professional and
commercial standards prevailing in the biotechnology industry at
the time that such activities are performed. Subject to Section
2.11, all research and development activities performed by ANTEX
that are funded by SB are performed by ANTEX on behalf of SB.
2.08 The R&D Committee shall also have, at its entire discretion, the
power to allocate and/or switch and/or transfer resources within
ANTEX to alternative projects within the Field. In addition, SB
may in its sole discretion (and without the consent of either
the R&D Committee or ANTEX), at anytime, to transfer any project
within the Field underway at ANTEX to SB facility in Rixensart
or to any other SB facility or to any collaborator of SB. Any
such allocation, switch or transfer will have no impact on the
overall budget funding approved by the R&D Committee for the
next six (6) months of the then current period of the R&D
Program, but ANTEX agrees to apply any unused funds to any other
activity as may be directed or requested by SB. From January
1st, 2000, ▇▇ agrees to give ANTEX an advance notice of one
hundred and twenty (120) days before any such different
allocation or switching of resources or transfer of projects.
2.09 No later than forty-five (45) days after the last day of the
Initial Period and any subsequent Period, ANTEX shall furnish to
SB a written accounting of the
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expenditure of all amounts funded by SB, which accounting shall:
(i) reconcile the expenditure of funds with amounts budgeted for
expenditure in the R&D Program during such Period; and (ii) make
available for SB's review a printed listing of all invoices of
Third Parties related to the expenditure of such R&D Program
and, upon SB's request, shall also make available invoices
themselves. In the event that the amounts budgeted by the R&D
Committee and funded by SB for any such Period of the Research
Program exceed the amounts expended by ANTEX for activities
described in the plan for such Period, ANTEX shall pay SB the
amount of such excess within forty-five (45) days after the last
day of such Period or if, at SB's discretion, the R&D Program
continues for a further Period as indicated in Section 2.01,
such amount shall be reallocated to activities to be performed
during such Period.
2.10 ANTEX shall be eligible to be reimbursed for its actual,
out-of-pocket expenses for clinical trials specifically
requested by SB and conducted by ANTEX for SB in the Field
and/or for GMP manufacturing of preclinical or clinical lots to
be used in said clinical trials which are not covered by the R&D
Program(s) provided ANTEX receives SB's written approval thereof
in advance of their disbursement ("Reimbursable Expenses").
Payment by SB will occur thirty (30) days after SB's approval of
disbursement and documentary evidence of the disbursement will
then be submitted by ANTEX to SB for verification within thirty
(30) days of the disbursement or as soon as possible after
▇▇▇▇▇' receipt of such evidence. In addition, and subject to any
necessary verification by SB, ▇▇ agrees to pay the outstanding
bill for the phase I Helicobacter pylori clinical trial
undertaken pursuant to the Original License, within a reasonable
period of time after invoicing by ANTEX and up to a maximum
amount of [XXXXX].
2.11 Subject to the next sentence, all improvements to the
Intellectual Property resulting from the R&D [XXXXX] will be
owned by ANTEX and shall fall within the scope of the rights and
licences granted by ANTEX to SB in Article 4 below. All
improvements of SB's proprietary adjuvants, biological
material(s), proteins and other materials provided by SB and of
[XXXXX] and work products,
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biological material(s), other intellectual property,
information, materials and all rights related therein, which
arise or are derived from the R&D Program or otherwise from
activities contemplated by or undertaken pursuant to this
Agreement shall be owned solely and exclusively by SB. In
particular, it is understood that the results of the R&D Program
based on [XXXXX] shall be solely and exclusively owned by SBB.
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3. RESEARCH SUPPORT
3.01 ANTEX shall render such research support services (the
"Research Support Services") and provide such research
support facilities (the "Research Support Facilities") as
shall be necessary or desirable to facilitate and implement
the R&D Program as from time to time in effect. For the
period of performance of the R&D Program ANTEX shall be
solely responsible for bearing all expenses relating to
provision of such Research Support Services and Research
Support Facilities.
3.02 ANTEX shall render the Research Support Services to the best
of its ability and in accordance with the scientific,
professional and commercial standards prevailing in the
biotechnology industry at the time that the Research Support
Services are rendered. ANTEX shall comply with all applicable
laws and regulations in rendering the Research Support
Services and shall indemnify and hold harmless SB, its
Affiliates and their respective directors, officers and
employees from any and all liability, loss, damage and
expense arising out of or related to the failure by ANTEX to
comply with all applicable laws and regulations in rendering
the Research Support Services.
3.03 ANTEX shall promptly notify SB if the employment status of
any of the ANTEX employees working on the R&D Program
changes. ANTEX shall not subcontract with any Third Parties
for the performance of the Research Support Services, except
appropriate clinical and preclinical work agreed by the R&D
Committee, including, but not limited to, animal studies, GMP
or pre-GMP pilot lot production, consultations, and human
trials as required. In the case of human trials, trial
protocols must be approved by SB prior to filing and must be
filed with the competent regulatory authority in the name of
SB. ANTEX warrants that it has a binding, written agreement
(in the form substantially similar to the form attached
hereto as Appendix B) with each ANTEX' scientific employee
working on the R&D Program, which agreement shall be in place
prior to such employee performing the Research Support
Services, and which agreement shall obligate such employee to
disclose his work product to
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ANTEX, to not use or disclose such work product to Third
Parties, and to assign to ANTEX, (subject to the rights and
licences granted to SB under this Agreement), all rights in
such work product including without limitation any and all
intellectual property rights.
3.04 ANTEX shall provide the real property required to perform the
R&D Program and all of the required fixtures and personal
property presently located at ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ as the Research Support Facilities.
All of the Research Support Services shall be performed at
the Research Support Facilities, except appropriate clinical
and preclinical work agreed by the R&D Committee, including,
but not limited to, animal studies, GMP or pre-GMP pilot lot
production, consultations, and human trials as required.
ANTEX commits to maintain the Research Support Facilities in
good operating condition and repair and perform all
obligations required to be performed by it under leases,
contracts and other commitments relative to the Research
Support Facilities. ANTEX shall comply with all applicable
laws and regulations in operating the Research Support
Facilities and shall indemnify and hold harmless SB, its
Affiliates and their respective directors, officers and
employees from any and all liability, loss, damage and
expense arising out of or related to the failure by ANTEX to
comply with all applicable laws and regulations in operating
the Research Support Facilities.
3.05 The parties agree that all persons who perform the Research
Support Services shall be employees of ANTEX, and not
employees of SB. ANTEX shall be solely responsible for the
terms and conditions of the employment of such individuals
and the fulfillment of all obligations owed to such
employees. ANTEX shall indemnify and hold harmless SB, its
Affiliates and their respective directors, officers and
employees from any and all liability, loss, damage and
expense arising out of or related to any employment-related
claims asserted against any of them by any of ANTEX'
employees except for any claims that ANTEX demonstrates have
arisen out of or relate to actions taken by SB, its
Affiliates or their respective directors, officers or
employees.
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4. GRANT OF LICENSE
4.01 Subject to the reversion clauses contained in Articles 6 and
7 hereof and all the terms and conditions herein contained,
ANTEX hereby grants to SB an exclusive and perpetual right
and license in the Territory, with the right to grant
sublicenses, under the Intellectual Property and any SPC to
develop, have developed, import, make, have made, use, have
used, offer for sale, sell and have sold any and all Products
in any formulation, combination, configuration and/or
delivery system.
4.02 The grant of license by ANTEX pursuant to Section 4.01 shall
be subject to the rights granted by ANTEX under the Pasteur
License as was in effect on the effective date of the
Original License for so long as such rights continue to
exist.
4.03 Any and all Intellectual Property for use in the Field
including but not limited to any improvements of Intellectual
Property for use in the Field which is developed, conceived,
owned, controlled and/or acquired by ANTEX, whether solely or
jointly with others, at anytime prior to the commencement and
during the term of this Agreement, shall become Intellectual
Property licensed to SB under this Agreement, subject in the
case of Intellectual Property that is licensed or acquired by
ANTEX from Third Parties, or developed in part by Third
Parties, to any contractual obligations of ANTEX to such
Third Parties existing as of the Effective Date or by the
patent laws subsisting in the United States or foreign
countries.
4.04 To the extent not provided for in Section 11.01 ANTEX agrees
to promptly transfer without the payment of any additional
consideration to SB at SB's request, any material, data,
information and/or technology within or covered by
Intellectual Property and SB agrees to confirm receipt of any
such material, data, information and/or technology transfer.
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4.05 SB is free to exercise its rights under the license
described in Section 4.01 in any manner SB may deem
appropriate, including through working with Third Parties
consistent with the terms hereof.
5. MILESTONE PAYMENTS AND ROYALTIES
5.01 SB agrees to make the following one-time milestone payments
to ANTEX with respect to Product in the Field in the
following amounts:
(a) Upon the successful completion of phase I clinical
trials as required for Approval of a Product by the
FDA or substantially similar trials required for
Approval by equivalent regulatory authorities in
any Major European Country, SB shall pay to ANTEX
the amount of [XXXXX].
(b) Upon the successful completion of phase II clinical
trials as required for Approval of a Product by the
FDA or substantially similar trials required for
Approval by the equivalent regulatory authorities
in any Major European Country, SB shall pay to
ANTEX the amount of [XXXXX].
(c) Upon the successful completion of phase III
clinical trials as required for Approval of a
Product by the FDA or substantially similar trials
required for Approval by the equivalent regulatory
authorities in any Major European Country, SB shall
pay to ANTEX the amount of [XXXXX].
(d) Upon Approval of a Product by the FDA, SB shall
pay to ANTEX the amount of [XXXXX].
(e) Upon Approval of a Product by the FDA-equivalent
authorities of any two (2) Major European
Countries, SB shall pay to ANTEX the amount of
[XXXXX].
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For the purposes of this Agreement "successful completion"
shall mean that, based on the success of such clinical trial,
▇▇ decides to enter the next phase of clinical trial or to
seek Registration as appropriate.
5.02 Any milestone payments made by SB pursuant to Section 5.01
shall be credited towards SB's obligation to pay any
royalties, on a dollar for dollar basis, pursuant to Section
5.03 and shall be payable with respect to the first Product
incorporating Antex Antigen(s) against each of the Targets
within the Field. For the sole purpose of clarification, it
is hereby acknowledged and agreed that no milestone payment
shall be required to be paid by SB to ANTEX for products
against Targets which were licensed to SB under the Original
License but which are not within the definition of "Field"
contained in this Agreement.
5.03 As consideration for the license under Intellectual Property
granted to SB under this Agreement, and subject to the
provisions of Sections 5.02, 8.02 and 8.03, SB shall pay to
ANTEX a royalty calculated as a percentage (the "Royalty
Percentage") of Net Sales by SB and its sublicensees
according to one (1) of the following subsections:
(a) If the Product is covered in the particular country
where sales are made by a valid claim of an
enforceable granted Patent or by a patent
application within Patents listed in Appendix A
which has not been pending for more than five (5)
years from the date of filing in such country, the
Royalty Percentage shall be [XXXXX].
(b) If the Product is not covered by a valid claim of
an enforceable granted Patent in the particular
country where sales are made, provided SB actually
uses, for the making, using or selling of such
Product, Technology which is secret, substantial
and has been identified in writing by ANTEX, the
Royalty Percentage shall [XXXXX].
5.04 SB's royalty obligation under Section 5.03 (a) shall become
effective in each country of the Territory at such time as an
enforceable Patent is granted or a
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patent application within Patents listed in Appendix A is
pending for less than five (5) years from date of filing in
such country covering the Product sold and shall terminate
upon the date of lapse, expiration or invalidation of the
last remaining Patent in such country or fifteen (15) years
from first launch of Product, whichever comes first. Subject
to Section 5.03 (b), in the event that any Third Party
initiates any legal or administrative proceeding challenging
the validity, scope or enforceability of a Patent in any
country in the Territory, then such royalty obligation on Net
Sales in such country under 5.03(a) shall be suspended during
pendency of the proceeding in such country and only the
royalty under 5.03(b) shall be paid if applicable. If the
enforceability of claims in the Patent covering Product sold
are upheld by a court or other legal or administrative
tribunal from which no appeal is or can be taken, then the
amount of royalties owed during the period of suspension,
less any amount already paid, shall be promptly paid by SB
with [XXXXX]. If the claims in the Patent are held to be
invalid or otherwise unenforceable by a court or other legal
or administrative tribunal from which no appeal is or can be
taken then the amount of unpaid royalties during the period
of suspension shall be retained by SB and no further
royalties under 5.03(a) shall be owed with respect to such
Patent in such country.
5.05 SB's royalty obligation under Section 5.03 (b) shall
terminate on the seventh (7th) anniversary of the date of the
first commercial sale of such Product in two (2) Major
European Countries or in the U.S.A., whichever is earlier.
5.06 Termination of royalty obligations under Section 5.04 and/or
5.05 in any country of the Territory shall not preclude SB
from continuing to market Product(s) in such country and SB
shall be free to use Technology and other Intellectual
Property in the Field in relation to such Product without any
further financial consideration or royalty payments in
relation to such Product to ANTEX in such country.
5.07 In addition to royalty obligations under Section 5.03(a) as
sole remuneration for [XXXXX], SB shall pay to ANTEX a
Royalty Percentage of [XXXXX]on the
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proportion of net sales (calculated as specified in Section
1.14.01 to 1.14.03) of vaccines incorporating only [XXXXX].
The parties agree that [XXXXX] will be incorporated in
Product only if there are valid data justifying their
preclinical efficacy or if the R&D Committee agrees to the
incorporation or addition of [XXXXX] in Products.
Notwithstanding the foregoing it is understood and agreed
that ▇▇▇▇▇ has assigned and will assign to SB any ownership
or partial ownership of any intellectual property owned
and/or developed by ANTEX when performing work on behalf or
at the request of SB relating to [XXXXX].
For the purpose of clarity,
(a) if a vaccine other than a Product as sold by SB
contains solely [XXXXX], the royalty rate of
[XXXXX] described above shall apply irrespective of
the number of such [XXXXX] therein;
(b) if a Product as sold by SB contains [XXXXX] and
Antex Antigens, the royalty rate shall be
determined as per Article 5, with Net Sales
calculated and adjusted as per Section 1.14;
(c) if a vaccine other than a Product as sold by SB
contains [XXXXX] and at least one other Antigen
which is not an Antex Antigen (i.e. Article 5 does
not apply) then the effective royalty of [XXXXX]
shall be obtained by applying a royalty [XXXXX] to
the net sales of such vaccine calculated as per
Sections 1.14.01 to 1.14.03 and adjusted as
specified in Section 1.14.04.
6. REVERSION AND ROYALTY FOR TARGETS OUTSIDE OF THE FIELD
6.01 SB agrees that SB's rights to use the Intellectual Property
for products against Targets previously licensed to SB under
the Original License and which now fall outside the Field as
defined in this Agreement shall hereby revert to ANTEX. In
exchange for the reversion of such rights with respect to
Helicobacter pylori and Campylobacter ("Reverted Targets")
only, ANTEX agrees to make the following future payments to
SB:
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(a) if any Reverted Target is licensed by ANTEX (or any
of its Affiliates) to any Third Party, SB shall be
entitled to receive [XXXXX] of the Proceeds within
thirty (30) days of ANTEX' receipt thereof; and
(b) if any product against any Reverted Target is
marketed by ANTEX or by a distributor or agent of
ANTEX, SB shall be entitled to receive a royalty of
[XXXXX] covered by a patent or [XXXXX] if covered
by know-how of net sales (calculated as per Section
1.14) of products against the Reverted Target(s)
made by ANTEX and/or its distributors and agents.
6.02 The sharing of Proceeds and/or royalty described in Section
6.01 (a) and (b) above shall apply when ANTEX grants any
right to and/or interest in, including future right and/or
interest, to a Third Party, or uses to develop products
marketed by ANTEX or its distributor and agent relating to
the Reverted Target(s) licensed to SB under the Original
License which is conceived or existing as of the Effective
Date hereof or which was developed and/or improved during a
period of eighteen (18) months after the Effective Date
hereof.
6.03 For purpose of this Article 6, the term "Proceeds" shall mean
any money or other assets at any time received by ANTEX from
a Third Party in respect of the Reverted Targets and shall
include, without limitation, any licence fees, milestone
payments and royalties but shall not include funding received
from that Third Party for R&D work performed by ANTEX in
relation to the Reverted Target so long as ANTEX can
demonstrate to SB that such funding is exclusively used by
ANTEX for R&D activities.
6.04 ANTEX agrees to provide SB with the financial elements of or,
if requested by SB the agreement, redacted if reasonably
necessary, related to any right, interest, license or
sublicense granted by ANTEX to a Third Party relating to the
Reverted Target(s) in order and sufficient for SB to
determine the extent of Proceeds and/or R&D funding, if any.
If the agreement entered by ANTEX and
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the Third Party includes rights to Reverted Targets and other
matters, the Proceeds allocated to Reverted Targets shall be
determined in good faith by the parties according to the
circumstances and shall reflect the relative stage of
advancement (e.g. clinical or preclinical) of each Reverted
Target compared to any such other matters.
6.05 Notwithstanding the foregoing, the parties recognize that the
current formulation of products against the Reverted [XXXXX].
In the latter case, ANTEX and SB agree to negotiate a fair
reduction of the payment SB is entitled to receive pursuant
to Section 6.01 (a) and/or (b), depending upon the planned
extent of the reformulation.
7. REVERSION AND NON EXCLUSIVE LICENSE ON TARGETS WITHIN FIELD
7.01 If at any time during the term of this Agreement SB is no
longer active or is no longer using Intellectual Property at
SB, at ANTEX or elsewhere with respect to a Target within the
Field and this situation has lasted for at least eighteen
(18) months such Target (hereinafter "Reverted New Target")
shall revert on a non-exclusive basis to ANTEX and ANTEX
shall be entitled, after it has made the reversion payment
described in Section 7.01(a) to grant to (a) Third Party(ies)
a non-exclusive license under Intellectual Property with
respect to the development of products against such Reverted
New Target(s) subject to the following conditions :
(a) SB and ANTEX shall negotiate in good faith
reversion payments to be made by ANTEX to SB at the
time of reversion, which reversion payments shall
reflect among other things, the stage of
advancement of the Reverted New Target, funding
provided by SB and data, technology and/or
information with respect to such Reverted New
Target generated and provided by SB to ANTEX.
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(b) Notwithstanding the foregoing, such reversion shall
not take place so long as: (i) SB is funding a R&D
Program at ANTEX relating to that Target within the
Field and for a period of eighteen (18) months
thereafter; (ii) SB is further developing, or
otherwise using Intellectual Property relating to
that Target, (iii) is undertaking, or has
undertaken within a preceding forty-eight (48)
month period clinical trials with a Product
incorporating an Antex Antigen for that Target (iv)
or has launched a Product for that Target on the
market, in which cases SB's license for such
Target(s) remains exclusive in perpetuity.
(c) SB shall in any event retain a non-exclusive
licence with respect to any Reverted New Target
under Intellectual Property existing at the time of
reversion.
(d) For the purpose of clarity only, and subject to the
preceding paragraphs: (i) a reversion may only
occur with respect to a Target within the Field for
which SB has not undertaken clinical trials within
the forty-eight (48) months preceding a possible
date for reversion; [XXXXX].
8. COMPULSORY LICENSES AND THIRD PARTY LICENSES
8.01 In the event that a governmental agency in any country or
territory grants or compels ANTEX to grant a license to any
Third Party for product(s) that compete with Product(s)
through importation or otherwise, SB shall have the benefit
in such country or territory of the terms granted to such
Third Party to the extent that such terms are more favorable
to the Third Party than those granted to SB under this
Agreement to the extent permitted by such governmental
agency.
8.02 The parties recognize that Other Patents may exist. If at any
time during the term of this Agreement and/or the Original
License, SB, at its sole discretion, but after consultation
with ANTEX, deems it necessary to seek a license under
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any Other Patent(s) from any Third Party in order to practice
the right and license granted by ANTEX to SB hereunder and
avoid infringement during such exercise in any particular
country [XXXXX] of any royalties or equivalent fees paid by
SB to such Third Party under such license may be deducted
from royalties otherwise payable by SB to ANTEX under this
Agreement.
8.03 In the event that royalties are payable by SB to Third
Party(ies) on sales of Product, other than pursuant to
Section 8.02 above, ANTEX and SB shall evenly share
responsibility of any and all such Third Party royalty
obligations, which may include, but shall not be limited to,
royalties payable for adjuvants and other technology included
in the Product. ANTEX' contribution to such share shall be
through a reduction in the royalties payable to ANTEX
pursuant to Section 5.03, provided however that the Royalty
Percentage shall not be reduced by more than [XXXXX].
9. DILIGENCE
9.01 SB will, in accordance with SB's reasonable business, legal,
medical, technical and/or scientific judgment, exercise
reasonable efforts and diligence in developing,
commercializing and selling Product and in undertaking
investigations and actions required to obtain appropriate
governmental Approvals to market Product. At SB's request,
ANTEX shall supply to SB reasonable technical assistance in
undertaking such investigations and actions and SB will
reimburse ANTEX for its reasonable out-of-pocket expenses
associated with the provision of such assistance. The level
of effort to be exercised by SB shall be consistent with SB's
usual funding level of similar vaccine programs or Products
currently under development by SB's Belgian Affiliate
SmithKline ▇▇▇▇▇▇▇ Biologicals S.A.
9.02 The parties acknowledge that it is not consistent with
prudent economic behavior and risk management, nor common in
the industry, to pursue development of the Intellectual
Property for all Products at the same time, but rather to
manage the scope and number of development programs and
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respective funding levels as a function of achieving
feasibility milestones of a limited number of priority
programs. As long as SB is developing one (1) Product in the
Field pursuant to the provision of Section 9.01 above, SB
shall be deemed to be in full compliance with the diligence
requirements under this Agreement.
9.03 ANTEX shall provide to SB, at SB's request and without the
payment of additional consideration, technical assistance
concerning development, production and commercialization of
Products in the Field. Provision of such technical assistance
shall include, but not be limited to, visits by ANTEX and/or
ANTEX' personnel to SB at ANTEX' expense, except for
reasonable out-of-pocket expenses which will be reimbursed by
SB, and visits by SB personnel to ANTEX, at SB's expense, at
times and for periods of time upon which the parties will
agree. Such provision shall also include, but not be limited
to, preparation and processing of INDs, NDAs or similar
applications for regulatory Approval and supply of any
Technology together with any technology and know-how ANTEX
will develop or acquire during the provision of such
technical assistance related to the Intellectual Property in
the Field, which SB may reasonably require.
9.04 In the event that SB decides not to pursue Registration or
sell a Product that has been approved for sale in a country,
including pricing approvals and batch release, and SB is
willing to grant distribution rights for such Product in such
country to a Third Party, SB will first offer such
distribution rights to ANTEX, provided that ANTEX can
demonstrate within thirty (30) days of the date that SB
offers such distribution rights that it can effectively serve
as distributor in such country and is willing to make the
necessary commitments to support the selling and distribution
of Product in such country, and provided further that there
are no adverse effects related to such Product and that such
selling activities would not be to the detriment of the
commercialization of the same Product by SB in any other
country. If ANTEX demonstrates that it can effectively serve
as distributor, has made the selling support commitment and
its selling activities will not be
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detrimental to the commercialization of the same Product by
SB in another country, ANTEX shall have a three (3) month
exclusive negotiation period to conclude the distribution
agreement. If after this three (3) month period no agreement
has been concluded, SB is free to pursue Third Parties to
sell such Product in the specified country.
9.05 ANTEX' failure to comply with any of its obligation(s) under
this Agreement, shall be taken into account in establishing
whether SB has satisfied its diligence requirements
hereunder.
10. DEVELOPMENT, INDEMNIFICATION AND LIABILITY
10.01 SB shall be solely responsible for and shall bear all costs
related to the development of Products, including the conduct
of clinical trials, and the commercialization of Products,
including the manufacturing and marketing of Products. SB
shall indemnify and hold harmless ANTEX and its directors,
officers and employees from any and all liability, loss,
damage and expense arising from any claims, suits,
proceedings, demands, recoveries or expenses related to (i)
the development of Products, including, with respect to
products for Reverted Targets, the conduct of clinical trials
initiated by SB or in which SB has been involved between the
effective date of the Original License and the Effective Date
hereof, and for (ii) the commercialization, manufacture, use
or sale of Products, except that ANTEX shall indemnify and
hold harmless SB and its Affiliates and their respective
directors, officers and employees from any and all liability,
loss, damage and expense arising from any claims, suits,
proceedings, demands, recoveries or expenses related to the
commercialization, manufacture, use or sale of Products
resulting from the gross negligence or willful misconduct of
ANTEX. ANTEX shall be solely responsible for any and all
liabilities out of or relating to clinical trials conducted
by or on behalf of ANTEX and/or MicroCarb Human Vaccines
Inc., prior to the effective date of the Original License and
ANTEX shall indemnify and hold harmless SB and its Affiliates
and their respective directors, officers and
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employees from any and all liability, loss, damage and
expense arising out of or relating to clinical trials
conducted by or on behalf of ANTEX and/or MicroCarb Human
Vaccines Inc., prior to the effective date of the Original
License.
10.02 SB shall maintain, at its sole expense, during the term of
this Agreement and for a period of at least five (5) years
after its termination for any reason, product liability
insurance and clinical trial insurance (or a reasonable
program of self-insurance) with respect to all Products
developed pursuant to the R&D Program (but specifically
excluding clinical trial insurance for clinical trials
conducted by or on behalf of ANTEX and/or MicroCarb Human
Vaccines Inc., prior to the effective date of the Original
License ) in amounts comparable to its coverage relating to
its other human vaccine products that are manufactured and
distributed on a worldwide basis.
10.03 ANTEX shall maintain, at its sole expense, during the term of
this Agreement and for a period of at least five (5) years
after its termination for any reason, product liability
insurance with respect to any of the activities it will
perform hereunder which are not covered by SB under Section
10.02.
11. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
11.01 During the term of this Agreement, ANTEX shall promptly
disclose to SB and promptly supply SB with all Technology in
the Field as requested by SB.
11.02 During the term of this Agreement and for five (5) years
thereafter, irrespective of any termination earlier than the
expiration of the term of this Agreement, ANTEX and SB shall
not use or reveal or disclose to Third Parties any
Confidential Information without first obtaining the written
consent of the other party, except as is required to be
disclosed to a governmental agency, or is necessary to file
or prosecute patent applications concerning Product(s) or to
carry out any litigation concerning Product. Any disclosure
required for purposes of investigating, developing,
manufacturing or marketing Product or
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for securing essential or desirable authorizations,
privileges or rights from governmental agencies may be made,
provided that the disclosing party is satisfied that the
proposed Third Party will maintain the confidentiality of the
data and information so disclosed. This confidentiality
obligation shall not apply or shall cease to apply to such
information which is or becomes a matter of public knowledge,
or is already in the rightful possession of the receiving
party without restriction, or is disclosed to the receiving
party without restriction by a Third Party having the right
to do so, or is subsequently and independently developed by
employees of the receiving party or Affiliates thereof who
had no knowledge of nor access to the confidential
information disclosed. The parties shall take reasonable
measures to assure that no unauthorized use or disclosure is
made by others to whom access to such information is granted.
11.03 Nothing herein shall be construed as preventing SB from
disclosing any information received from ANTEX to an
Affiliate, sublicensee or distributor of SB, provided such
Affiliate, sublicensee or distributor has a written
confidentiality undertaking containing confidentiality
obligations no less onerous than those set forth in this
Article 11.
11.04 All Confidential Information disclosed by one party to the
other shall remain the intellectual property of the
disclosing party. In the event that a court or other legal or
administrative tribunal, directly or through an appointed
master, trustee or receiver, assumes partial or complete
control over the assets of a party to this Agreement based on
the insolvency or bankruptcy of such party, the bankrupt or
insolvent party shall promptly notify the court or other
tribunal (i) that Confidential Information received from the
other party under this Agreement remains the property of the
other party and (ii) of the confidentiality obligations under
this Agreement. In addition, the bankrupt or insolvent party
shall, to the extent permitted by law, take all steps
necessary or desirable to maintain the confidentiality of the
other party's Confidential Information and to insure that the
court, other tribunal or appointee maintains such information
in confidence in accordance with the terms of this Agreement.
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11.05 No press release, public announcement or other disclosure to
Third Parties concerning the existence of, the terms of, or
the subject matter covered by, this Agreement, including,
without limitation, regarding work on the Targets in the
[XXXXX] is expressly mentioned in such press release, public
announcement or other disclosure, shall be issued or made,
either directly or indirectly, by either party without first
obtaining the approval of the other party and agreement upon
the nature and text of such announcement or disclosure, which
approval and agreement shall not be unreasonably withheld.
The other party shall give a response within ten (10) working
days which are working days in US, UK and Belgium
simultaneously. The party which is legally required to make a
public announcement shall use all reasonable efforts to
inform the other party of the proposed announcement or
disclosure and to provide the other party with a written copy
thereof within the abovereferred ten (10) working days delay,
in order to allow such other party to comment upon such
announcement.
11.06 Neither SB nor ANTEX shall submit for written or oral
publication any manuscript, abstract or the like related to
the [XXXXX] which includes data or other information
generated and provided by the other party without first
obtaining the prior written consent of the other party, which
consent shall not be unreasonably withheld and shall be
timely provided. The contribution of each party shall be
noted in all publications or presentations by acknowledgment
or co-authorship, whichever is appropriate.
12. PATENT PROSECUTION AND LITIGATION
12.01 ANTEX shall disclose to SB the complete texts of all patent
applications encompassed within Patents filed, owned and/or
controlled by ANTEX directly or indirectly together with all
prosecution files as well as all information received
concerning the institution or possible institution of any
interference, opposition, re-examination, reissue,
revocation, nullification or any official proceeding
involving a Patent anywhere in the Territory. As from the
Effective Date, the R&D Committee shall be responsible for
decisions regarding the preparation,
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filing, prosecution and maintenance at the expense of SB
(which expenses shall be limited to external attorneys' fees
and to fees prepaid to national patent offices) of all
patents and patents applications within Patents in the
Territory. Each party shall have the right to review all such
pending applications and other proceedings and make
recommendations to the R&D Committee concerning them and
their conduct. All Patents shall be filed by a patent counsel
selected by the R&D Committee and issued in the name of ANTEX
and shall be the sole property of ANTEX subject to the rights
and licences granted to SB under this Agreement.
12.02 Until the sum of [XXXXX] has been reimbursed by SB, the R&D
Committee shall also be responsible for decisions regarding
the preparation, filing, prosecution and maintenance of all
patents and patents applications (other than Patents) which
were licensed to SB pursuant to the Original License and
which have now reverted to ANTEX pursuant to Article 6. Such
responsibility shall be exercised pursuant to the conditions
set forth in Section 12.01 above except that SB shall support
[XXXXX] expenses linked to the preparation, filing,
prosecution and maintenance of such patents which expenses
shall be limited to external attorney's fees and to fees
prepaid to national patent offices. Furthermore SB's
contribution to such patent expenses shall be limited to the
expenses incurred during a period [XXXXX] from the Effective
Date, as demonstrated by documentary evidence, shall apply
only to expenses arising out of actions approved in advance
by the R&D Committee, shall not apply to expenses directed to
projects for which ANTEX has received R&D funding from a
Third Party nor to projects in relation to which ANTEX has
granted any rights to a Third Party and shall in no
circumstance [XXXXX]
12.03 SB shall be fully responsible for the filing, prosecution,
maintenance and defense of any patent that may [XXXXX] work
performed by ANTEX on behalf of SB pursuant to this
Agreement. To the extent not provided for under Section 11.01
ANTEX shall promptly disclose to SB any and all data,
materials and/or other information developed or conceived by
ANTEX related to [XXXXX].
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12.04 SB shall have the right to assume sole responsibility for
any Patent or for any part of Patent thereof which ANTEX
intends to abandon or otherwise cause or allow to be
forfeited.
12.05 In the event of the institution of any suit by a Third Party
against ANTEX, SB or its sublicensees for patent infringement
involving the manufacture, use, sale, distribution or
marketing of Product(s) anywhere in the Territory, the party
sued shall promptly notify the other party in writing. SB
shall have the first right but not the obligation to defend
such suit at its own expense. ANTEX and SB shall assist one
another and cooperate in any such litigation at the other's
request without expense to the requesting party.
12.06 In the event that ANTEX or SB becomes aware of actual or
threatened infringement of a Patent anywhere in the
Territory, that party shall promptly notify the other party
in writing. SB shall have the first right but not the
obligation to bring, at its own expense, an infringement
action against any Third Party and to use ANTEX' name in
connection therewith. If SB does not commence a particular
infringement action within ninety (90) days, ANTEX, after
notifying SB in writing, shall be entitled to bring such
infringement action at its own expense. The party conducting
such action shall have full control over its conduct,
including settlement thereof. In any event, ANTEX and SB
shall assist one another and cooperate in any such litigation
at the other's request without expense to the requesting
party.
12.07 ANTEX and SB shall recover their respective actual
out-of-pocket expenses, or equitable proportions thereof,
associated with any litigation or settlement thereof from any
recovery made by any party. Any excess amount shall be shared
between SB and ANTEX, with the party initiating such
litigation receiving [XXXXX] and the other party receiving
[XXXXX] of such excess.
12.08 The parties shall keep one another informed of the status of
and of their respective activities regarding any litigation
or settlement thereof concerning Products.
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12.09 ANTEX hereby authorizes SB to act as ANTEX' agent for the
purpose of making any application for any extensions of the
term of Patents in the Field based on marketing
authorization(s) including SPCs and Waxman Hatch extensions
and shall provide reasonable assistance therefor to SB, at
SB's expense for reasonable out of pocket expenses documented
by ANTEX. (In the United States of America as permitted under
Title 35 of the United States Code). SB shall decide, at its
sole discretion, when and where to file such extensions.
13. TRADEMARKS
13.01 SB, at its expense, shall be responsible for the selection,
registration and maintenance of all trademarks which it
employs in connection with Products and Combinations and
shall solely own and/or control such trademarks. Nothing in
this Agreement shall be construed as a grant of rights, by
license or otherwise, to ANTEX to use such trademarks for any
purpose. During the term of this Agreement, ANTEX will not
register or apply to register, in any country of the
Territory, any trademark, service mark, trade dress or the
like for any good or service related to any Product without
the prior written consent of SB unless such Product has
reverted back to ANTEX pursuant to Article 7.
14. STATEMENTS AND REMITTANCES
14.01 SB shall keep and require its Affiliates and sublicensees to
keep complete and accurate records of all sales of Product
under the licenses granted herein. ANTEX shall have the
right, through a certified public accountant or like person
reasonably acceptable to SB, to examine such records during
regular business hours during the life of this Agreement and
for one (1) year after its termination, at ANTEX' expense
unless such examination reveals a greater than five percent
(5%) discrepancy the resolution of which would favor ANTEX,
in which
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event SB will pay ANTEX its expense, provided, however, that
such examination shall not take place more often than once a
year and shall not cover such records for more than the
preceding five (5) years and provided further that such
accountant shall retain in confidence any information learned
in such examination and report to ANTEX only as to the
accuracy of the royalty statements and payments and shall
simultaneously deliver the same report to SB.
14.02 Within sixty (60) days after the close of each June 30 and
December 31 after launch of the first Product by SB and for
the remaining term of this Agreement, SB shall deliver to
ANTEX a true accounting of all Products sold by SB and its
sublicensees during such six (6) month period and shall at
the same time pay all royalties due. Such accounting shall
show sales on a country-by-country and Product-by-Product
basis.
14.03 Any tax paid or required to be withheld by SB on account of
royalties payable to ANTEX under this Agreement shall be
deducted from the amount of royalties otherwise due. SB shall
secure and send to ANTEX proof of any such taxes withheld and
paid by SB or its sublicensees for the benefit of ANTEX. If
there is any change in the withholding tax arrangement
between Belgium and the United States of America prevailing
at the Effective Date, the parties agree to negotiate in good
faith a modification of this Section 14.03 to restore the
parties to the same position as they were prior to such
change.
14.04 All royalties due under this Agreement shall be payable in
U.S. dollars by wire transfer of immediately available funds
to an account at a commercial bank in the U.S. designated by
ANTEX. If governmental regulations prevent remittances from a
foreign country with respect to sales made in that country,
the obligation of SB to pay royalties on sales in that
country shall be suspended until such remittances are
possible. ANTEX shall have the right, upon giving written
notice to SB, to receive payment in that country in local
currency.
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14.05 Monetary conversions from the currency of a foreign country
in which Product is sold into U.S. currency shall be made at
the exchange rate in force on the last business day of the
period for which the royalties are being paid as published by
the Citibank, N.A., New York, U.S.A., or on another basis
mutually agreed to by both parties in writing.
15. TERM AND TERMINATION
15.01 If a party hereto substantially fails or neglects to perform
covenants or provisions of or a material obligation under
this Agreement and if such default is not corrected within
sixty (60) days after receiving written notice from the other
party with respect to such default, such other party shall
have the right to terminate this Agreement by giving written
notice to the party in default provided the notice of
termination is given within six (6) months of the default and
prior to correction of the default.
15.02 Subject to other provisions herein contained, SB may at its
sole discretion terminate this Agreement with respect to any
country or all countries of the Territory and/or with respect
to any or all Products by giving ANTEX at least thirty (30)
days written notice thereof at any time before SB first
markets Product in such country(ies). After marketing any
Product, SB may terminate this Agreement with respect to any
country or all countries of the Territory or with respect to
any Product or all Products by giving ANTEX at least three
(3) months prior written notice thereof. Upon such
termination, SB shall make the relevant Product(s) available
to ANTEX as per Section 9.04.
15.03 Either party may terminate this Agreement if, at any time,
the other party shall file in any court or agency pursuant to
any statute or regulation of (the United States or of) any
(individual) state or (foreign) country, a petition in
bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee
of the party or of its assets, or if the
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other party proposes a written agreement of composition or
extension of its debts, or if the other party shall be served
with an involuntary petition against it, filed in any
insolvency proceeding, and such petition shall not be
dismissed within sixty (60) days after the filing thereof, or
if the other party shall propose or be a party to any
dissolution or liquidation, or if the other party shall make
an assignment for the benefit of its creditors.
15.04 The parties acknowledge that Section 365(n) of Title 11 of
the United States Code (collectively, the "Bankruptcy Code")
provides, in part that, in the event ANTEX as a licenser of
the Intellectual Property undertakes a bankruptcy proceeding
under the Bankruptcy Code, SB as a licensee of the
Intellectual Property is entitled to retain and continue to
exercise its licenses hereunder in accordance with the terms
of the Bankruptcy Code. All rights and licenses granted to SB
under this Agreement shall be deemed to be for the purpose of
such Section 365(n), licenses of right to "intellectual
property" as defined under Section 101 of the Bankruptcy
Code.
16. RIGHTS AND DUTIES UPON TERMINATION
16.01 Upon termination of this Agreement, ANTEX shall have the
right to retain any sums already paid by SB hereunder. Unless
otherwise provided for hereunder, termination of this
Agreement for any reason shall not affect the rights and
obligations of the parties accrued through the effective date
of termination, including, without limitation, payment and
indemnification provisions relating to Products developed,
manufactured or distributed during the term of this
Agreement.
16.02 Upon termination of this Agreement in its entirety or with
respect to any country, under Sections 15.02 or 15.03, SB
shall notify ANTEX of the amount of Products SB and its
sublicensees and distributors then have on hand, the sale of
which would, but for the termination, be subject to royalty,
and SB and its sublicensees and distributors shall thereupon
be permitted to sell that amount
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of Products provided that SB shall pay the royalty thereon at
the time herein provided for.
16.03 Termination of this Agreement shall terminate all outstanding
obligations and liabilities between the parties arising from
this Agreement except those described in Sections 10.01,
10.02, 10.03, 11.02, 11.03, 11.04, 11.05, 11.06, 12.03,
12.05, 12.06, 12.07, 12.08, 13.01, 14.01, 14.02, 14.03,
14.04, 14.05, 15.03, 16.01, 16.02, 16.03, 17.03, 19.01,
23.01, and 23.02.
17. WARRANTIES AND REPRESENTATIONS
17.01 ANTEX warrants it owns the entire right and title to the
Intellectual Property and has the right to enter into this
Agreement and has not granted to any third party any right
granted to SB under the Original License as of the Effective
Date. Subject to the rights granted to Pasteur Merieux Serums
et Vaccins S.A. pursuant to the Pasteur License ANTEX hereby
further represents and warrants to SB that ANTEX has not
granted any rights or licences to any Third Party which would
interfere with or be in derogation with this Agreement or the
Original License and that the Intellectual Property is free
and clear from any liens and encumbrances for use in the
Field.
17.02 ANTEX makes no representations or warranties as to the
validity or scope of the Patents or that the manufacture,
use, sale or other disposal of the Products will be free from
infringement of patents of Third Parties. However, ANTEX
hereby represents that it has no present knowledge from which
it can be inferred that Patents are invalid or that their
exercise would infringe patent rights of Third Parties. A
holding of invalidity or unenforceability of any Patents,
from which no further appeal is or can be taken, shall not
affect any obligation already accrued hereunder, but shall
only eliminate royalties otherwise due under such Patent from
the date such holding becomes final or the date that such
royalty obligation becomes suspended pursuant to Section
5.03.
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17.03 ANTEX acknowledges that, in entering into this Agreement, SB
has relied upon information supplied by ANTEX (all of such
information being hereinafter referred to collectively as
"Product Information") and ANTEX warrants and represents that
to the best of its knowledge, the Product Information is
accurate in all material respects. ANTEX further warrants and
represents that to the best of its knowledge, it has not, up
through and including the date of this Agreement, omitted to
furnish SB with any information concerning Products or the
transactions contemplated by this Agreement which would be
material to SB's decision to enter into this Agreement and to
undertake the commitments and obligations set forth herein.
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT,
ANTEX AND ITS DIRECTORS, OFFICERS AND EMPLOYEES MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES
OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, AND THE
ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT
DISCOVERABLE, IN NO EVENT SHALL ANTEX AND ITS DIRECTORS,
OFFICERS AND EMPLOYEES BE LIABLE FOR ANY CLAIMS (INCLUDING
CLAIMS FOR ECONOMIC DAMAGE OR INJURY TO PERSON OR PROPERTY OR
FOR LOST PROFITS) ARISING FROM THE PERFORMANCE OF ANY PRODUCT
BASED UPON THE INTELLECTUAL PROPERTY, INCLUDING ITS SAFETY,
EFFECTIVENESS, COMMERCIAL VIABILITY OR MERCHANTABILITY, AND
SB ASSUMES ALL RESPONSIBILITY AND LIABILITY IN THIS REGARD
EXCEPT IN CASES OF GROSS NEGLIGENCE OR WILFUL MISCONDUCT OF
ANTEX.
17.04 ANTEX warrants and represents that it has no present
knowledge of the existence of any pre-clinical or clinical
data or information concerning the Products which suggests
that there may exist toxicity, safety and/or efficacy
concerns which may materially impair the utility and/or
safety of such Products.
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18. FORCE MAJEURE
18.01 If the performance of any part of this Agreement by either
party, or of any obligation under this Agreement, is
prevented, restricted, interfered with or delayed by reason
of any cause beyond the reasonable control of the party
liable to perform, unless conclusive evidence to the contrary
is provided, the party so affected shall, upon giving written
notice to the other party, be excused from such performance
to the extent of such prevention, restriction, interference
or delay, provided that the affected party shall use its
reasonable best efforts to avoid or remove such causes of
non-performance and shall continue performance with the
utmost dispatch whenever such causes are removed. When such
circumstances arise, the parties shall discuss what, if any,
modification of the terms of this Agreement may be required
in order to arrive at an equitable solution.
19. GOVERNING LAW/JURISDICTION
19.01 The form, execution, validity, construction and effect of
this Agreement shall be determined in accordance with the
laws of the State of Delaware.
19.02(a) Any controversy or claim arising out of or relating to
this Agreement or the breach thereof (hereafter
collectively referred to as "Dispute"), shall be first
attempted to be settled by the parties, without
litigation, in good faith, by submitting details of each
such Dispute to the Steering Committee in an effort to
effect a mutually acceptable resolution thereof.
19.02(b) In the event no mutually acceptable resolution of such
Dispute is achieved within a thirty (30) day period as a
result of Sub Section 19.02(a) then, at either party's
request, such Dispute may be submitted to an
unaffiliated expert for resolution. In such event, the
parties shall select a mutually acceptable single
unaffiliated expert within twenty (20) days of the
request of the party invoking this Sub Section 19.02(b).
Each party shall have twenty
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(20) days after selection of the unaffiliated expert to
submit to such individual such assumptions, methodology,
data and information as such party believes necessary to
resolve the Dispute in question, provided that such
party's submission may not exceed one hundred (100)
pages. The unaffiliated expert may then hold a joint
meeting with the parties (including any other experts
that the parties have engaged in respect of that matter)
on the issues that need to be resolved. The
unaffiliated expert shall promptly thereafter make a
recommendation as to the resolution of the Dispute,
which recommendation may either adopt the proposal
of either party or adopt an alternative approach. Each
party shall bear its own expenses in connection with a
procedure under this Sub Section 19.02(b), and the fees
and expenses of the unaffiliated expert shall be borne
equally by the parties regardless of the ultimate
recommendation of such person. The results of a
procedure under this Sub Section 19.02(b) shall be used
by the parties to guide their own decisions, but shall
not have legal effect.
19.02(c) Once the results of the procedure set forth in Sub
Section 19.02(b) are available, if a Dispute still
remains between the parties, then such dispute shall be
settled by arbitration in accordance with the Rules of
the American Arbitration Association in effect at the
time such arbitration is instituted. The arbitration
panel shall be composed of three (3) arbitrators, one
(1) of whom shall be chosen by ANTEX, one (1) of whom
shall be chosen by SB, and one (1) of whom shall be
chosen by the two (2) arbitrators previously designated.
If both or either of ANTEX and/or SB fail(s) to choose
an arbitrator within fourteen (14) calendar days after
receiving notice of commencement of arbitration or if
the two (2) arbitrators fail to choose a third (3rd)
arbitrator within fourteen (14) calendar days of their
appointment, such arbitrator(s) shall be chosen by the
American Arbitration Association. Unless the parties to
the arbitration shall otherwise agree to a different
place of arbitration, the place of arbitration shall be
Washington, D.C. The arbitration award shall be final
and binding upon the parties thereto and may be entered
in any court having jurisdiction. Each party shall bear
(i) its own expenses in connection with such arbitration
and (ii) one-half of the fees and expenses of the
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American Arbitration Association and all arbitrators.
No arbitration award shall contain any provision which
is inconsistent with the preceding sentence.
20. SEPARABILITY
20.01 In the event any portion of this Agreement shall be held
illegal, void or ineffective, the remaining portions hereof
shall remain in full force and effect.
20.02 If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then
such terms or provisions shall be deemed inoperative to the
extent that they may conflict therewith and shall be deemed
to be modified to conform with such statute or rule of law.
20.03 In the event that the terms and conditions of this Agreement
are materially altered as a result of Sections 20.01 or
20.02, the parties will renegotiate those altered terms and
conditions of this Agreement to resolve any inequities.
21. ENTIRE AGREEMENT
21.01 Except for the Confidentiality Agreement between ANTEX and
SmithKline ▇▇▇▇▇▇▇ Biologicals S.A. dated August 11, 1995,
this Agreement, entered into as of the date written above,
constitutes the entire agreement between the parties relating
to the subject matter hereof and, as of the Effective Date,
supersedes all previous writings and understandings including
the Original License. No terms or provisions of this
Agreement shall be varied or modified by any prior or
subsequent statement, conduct or act of the parties, except
that the parties may amend this Agreement by written
instruments specifically referring to and executed in the
same manner as this Agreement.
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22. NO WAIVER
22.01 The failure of either party at any time to exercise any of
their respective rights under this Agreement shall not be
deemed a waiver thereof, nor shall such failure in any way
prevent either party, as the case may be, from subsequently
asserting or exercising such rights.
23. NOTICES
23.01 Any notice required or permitted under this Agreement shall
be sent by registered air mail, return receipt requested and
postage pre-paid, or facsimile confirmed in writing via
courier, to the following addresses and/or fax numbers of the
parties:
if to ANTEX
ANTEX BIOLOGICS INC.,
▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇
Attention: Chief Executive Officer
Facsimile: ▇-▇▇▇ ▇▇▇ ▇▇▇▇
if to SB
SmithKline ▇▇▇▇▇▇▇ Corp.
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, ▇▇▇
Attention: General Counsel US
Facsimile: ▇-▇▇▇ ▇▇▇ ▇▇▇▇
with a copy to: ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ BIOLOGICALS S.A.
▇▇▇ ▇▇ ▇'▇▇▇▇▇▇▇▇ ▇▇
▇-▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
Attention: President, General Manager
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Facsimile: 32-2-656 80 25
23.02 Any notice required or permitted to be given concerning this
Agreement shall be effective upon receipt by the party to
whom it is addressed.
24. ASSIGNMENT
24.01 This Agreement and the right and licenses herein granted
shall be binding upon and inure to the benefit of the
successors in interest of the respective parties. Neither
this Agreement nor any interest hereunder shall be assignable
by either party without the written consent of the others,
provided, however, that SB may assign this Agreement to any
Affiliate or to any corporation with which it may merge or
consolidate, without obtaining the prior written consent of
ANTEX and that ANTEX may assign this Agreement to any
corporation with which it may merge, consolidate or sell all
or substantially all of its assets without the written
consent of SB.
25. GENERAL PROVISIONS
25.01 Except as otherwise provided in this Agreement, each party
shall bear the costs, fees, and expenses incurred by it in
connection with, or in anticipation of, this Agreement or the
consummation of the transactions contemplated hereby.
25.02 The parties hereto shall use reasonable diligence to do all
such things and provide all such reasonable assurances as may
be required to consummate the transactions contemplated
hereby, and each party shall execute and deliver to the other
parties such further documents, instruments, papers and
information as may be reasonably requested by the other
parties in order to carry out the purpose and intent of this
Agreement.
25.03 Notwithstanding Section 19.02, each party acknowledges and
agrees that a breach of any of its covenants or agreements
set forth in this Agreement would
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result in irreparable injury to the other party and that such
other party would not have an adequate remedy at law for such
breach, and therefore, each party agrees that the other party
will be entitled to enforce their respective rights under
such covenants and agreements by injunctive proceedings
restraining the breaching party from such breaches or
threatened breaches without bond.
25.04 For the convenience of the parties, this Agreement may be
executed in two counterparts, each of which when so executed
shall be, and be deemed to be, an original instrument and
such counterparts together shall constitute one (1) and the
same instrument, and notwithstanding their date of execution
shall be deemed to be dated as of the date of this Agreement.
25.05 The descriptive headings of the several Articles and Sections
of this Agreement are inserted for convenience only, do not
constitute a part of this Agreement and shall not affect in
any way the meaning or interpretation of this Agreement.
25.06 Except as otherwise expressly provided herein, nothing
contained in this Agreement, express or implied, is intended
to confer upon any person other than the parties to it and
their respective successors and permitted assigns any rights
or remedies under or by reason of this Agreement.
25.07 SB and ANTEX each agree that they will not solicit for
employment any individual who is employed by the other party
during the term of such individual's employment by the other
party and for a period of two (2) years after the termination
of such individual's employment by the other party. This
restriction shall be limited to those individuals who have
been actively and directly involved in the R&D Program.
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IN WITNESS WHEREOF, the parties, through their authorized officers, have
executed this Agreement as of the date first written above.
Antex Biologics Inc., SmithKline ▇▇▇▇▇▇▇ plc
/s/▇. ▇. ▇▇▇▇▇▇▇▇ /s/▇▇▇▇ ▇▇▇▇▇▇▇▇▇
BY: ▇▇▇ ▇▇▇▇▇▇▇▇ BY: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
TITLE: Chairman and CEO TITLE: Attorney-in-fact
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APPENDIX A
PATENTS
ANTEX CONTROLLED PATENT RIGHTS
[XXXXX]
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APPENDIX B
CONFIDENTIAL DISCLOSURE AND INVENTION AGREEMENTS
CONFIDENTIAL DISCLOSURE AGREEMENT
This Agreement has been entered into on ___________________ by and between Antex
Biologics Inc. ("Employer") a stock corporation organized and existing under the
laws of the State of Delaware, whose principal place of business is at ▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇; and
____________________ ("Employee"), a citizen of the United States of America,
whose domicile is at _________________ and employed by Employer under a separate
agreement.
Intending to be legally bound, the parties have agreed as follows:
1. During the term of this Agreement, Employee will have access to, and
become familiar with Confidential Information such as proprietary
technology and various trade secrets, including without limitation
to, financial plans and reports, lists of customers, business plans,
small business innovation research grants, marketing plans,
scientific analyses, programs, formulas, patterns, devices, methods,
models, processes and compilations of information, research and
development data, patent disclosures and applications, records and
specifications (Confidential Information) which are owned by the
Employer and which are regularly used in the course of business
operations. Employee shall not disclose any of this Confidential
Information, directly or indirectly, nor use it in any way, either
during the term of this Agreement or at any time thereafter, except
as may be required in the course of his/her employment by Employer.
2. Notwithstanding the foregoing, Employee shall not be required to
maintain the confidentiality of any information and technology which
are already known to Employee at the time of its disclosure or which
is or becomes generally available to the public other than as a
result of unauthorized disclosure or is or becomes available to
Employee from a third party not previously, presently, or in the
future, employed by Employer.
3. All files, records, documents, drawings, specifications, programs,
equipment and similar items relating to the business of the Employer
as described above, whether prepared by Employee or otherwise coming
into his/her possession, shall remain the exclusive property of the
Employer.
4. A confidential relationship is hereby established between the
Employer and the Employee.
5. Amendments, additions, or modifications to this Agreement shall be
valid only if made and executed in writing by both parties.
This Agreement shall be governed by the laws of the State of Maryland applicable
to agreements executed therein. IN WITNESS WHEREOF, the parties hereto have
executed this Agreement on the date first written above.
--------------------------------------
Employee
ATTEST Antex Biologics Inc.
_______________________________ by
Witness ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Vice President and
Chief Financial Officer
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INVENTION AGREEMENT
WHEREAS, Antex Biologics Inc., a Delaware corporation (the
"Company"), whose place of business is ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇ ▇▇▇▇▇, is engaged in a continuous program of research, development and
production respecting its business, present and future.
I understand that as part of my employment by the Company, I may
make new contributions and inventions of value to the Company. In consideration
of my employment or continued employment, as the case may be, and the
compensation received by me from the Company from time to time, I hereby agree
as follows:
1. Disclosure of Inventions. I will promptly disclose to the
Company, or any persons designated by it, all improvements, modifications,
developments, documentation, data, inventions, designs, ideas, copyrightable
works, discoveries, trademarks, copyrights, trade secrets, formulae, processes,
techniques, programs, and know-how, whether or not patentable or registrable
under copyright or similar statute, made or conceived or reduced to practice or
learned by me, either alone or jointly with others, during the period of my
employment (whether or not during normal working hours) with the Company
(whether prior to, on or after the date hereof) which are related to or useful
in the actual or anticipated business of the Company, or result from tasks
assigned me by the Company or result from use of premises or equipment owned,
leased or contracted for by the Company (all said improvements, inventions,
designs, ideas, copyrightable works, discoveries, trademarks, copyrights, trade
secrets, formulae, processes, techniques, programs, know-how and data shall be
collectively hereinafter called "Inventions").
2. Assignment of and Assistance on Inventions. I hereby assign to
the Company any rights I may have or acquire in all Inventions and agree that
all Inventions shall be the sole property of the Company and its assigns, and
the Company and its assigns shall be the sole owner of all patents, copyrights,
and other rights in connection therewith. I further agree to assist the Company
in every proper way (but at the Company's expense) to obtain and from time to
time enforce patents, copyrights or other rights on said Inventions in any and
all countries, and to that end I will execute all documents necessary:
(a) to apply for, obtain and vest in the name of the
Company alone (unless the Company otherwise directs) letters patent,
copyrights or other analogous protection in any country throughout
the world and when so obtained or vested to renew and restore the
same; and
(b) to defend any opposition proceedings in respect of
such applications and any opposition proceedings or petitions or
applications for revocation of such letters patent, copyright or
other analogous protection.
In the event the Company is unable, after reasonable effort, to
secure my signature on any letters patent, copyright or other analogous
protection relating to an Invention, whether because of my physical or mental
incapacity or for any other reason whatsoever, I hereby irrevocably designate
and appoint the Company and its duly authorized officers and agents as my agent
and attorney-in-fact, to act for and in my behalf and in good stead to execute
and file any such application or applications and to do all other lawfully
permitted acts to further the prosecution and issuance of letters patent,
copyright or other analogous protection thereon with the same legal force and
effect as if executed by me. My obligation to assist the Company in obtaining
and enforcing patents and copyrights for such Inventions in any and all
countries shall continue beyond the termination of my employment, but the
Company shall compensate me at a reasonable rate after such termination for time
actually spent by me at the Company's request on such assistance.
I acknowledge that all original works of authorship which are made
by me (solely or jointly with others) within the scope of employment and which
are protectable by copyright are being created at the instance of the Company
and are "works made for hire," as that term is defined in the United States
Copyright Act (17 U.S.C.A. Section 101). If such laws are inapplicable or in the
event that such works, or any part thereof, are determined by a court of
competent jurisdiction not to be a work made for hire under the United States
copyright laws, this Agreement shall operate as an irrevocable and unconditional
assignment by me to the Company of all of my right, title and interest
(including, without limitation all rights in and to the copyrights through the
world, including the right to prepare derivative works and the right to all
renewals and extensions) in the works in perpetuity.
3. Remedies for Breach. I agree that any breach of this Agreement by
me would cause irreparable damage to the Company and that, in the event of such
breach, the Company shall have, in addition to any and all
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remedies of law, the right to an injunction, specific performance or other
equitable relief to prevent or redress the violation of my obligations
hereunder.
4. Assignability. This Agreement shall be binding upon me, my heirs,
executors, assigns and administrators, shall inure to the benefit of the
Company, its successors, and assigns, and shall survive the termination of my
employment by the Company, regardless of the manner of such termination.
5. Entire Agreement. This Agreement constitutes the entire agreement
between the parties and supersedes all prior agreements and understandings,
whether written or oral, relating to the subject matter of this Agreement.
6. Applicable Law. This Agreement shall in all respects be governed
by, and contained and enforced in accordance with the laws of the State of
Maryland.
7. In case any provision of this Agreement shall be invalid, illegal
or otherwise unenforceable, the validity, legality and enforceability of the
remaining provisions shall in no way be affected or impaired thereby.
Date:__________________________ By:__________________________________
(Employee)
ACCEPTED AND AGREED TO:
ANTEX BIOLOGICS INC.
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By: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Title: Vice President and
Chief Financial Officer
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