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CONFIDENTIAL MATERIAL OMITTED
AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
EXHIBIT 10.28
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VIBRIOVEC LICENSE AGREEMENT
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This Agreement is entered as of this 1st day of December, 1997 (the "EFFECTIVE
DATE") into BY AND AMONG:
VIRUS RESEARCH INSTITUTE, INC., a company organized and existing under
the laws of the State of Delaware, having its principal place of
business at 00, Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx, XXX,
(hereinafter referred to as "VRI")
AND
MERIEUX ORAVAX S.N.C., a societe en nom collectif organized and
existing under the laws of the Republic of France, registered at the
Registre du Commerce et des Societes in Lyon under No. RCS Lyon B 404
337 172, with a capital of 52.000.000 French Francs, whose registered
head-office is located at 00, xxxxxx Xxxxxxx, 00000 Xxxx, Xxxxxx,
ORAVAX MERIEUX CO., a general partnership organized and existing under
the laws of the State of Massachussetts, having its principal place of
business at 00, Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxxx, XXX,
(the parties numbered and above are individually and collectively
hereinafter referred to as "LICENSEE" or "HPC")
WITNESSETH
WHEREAS, VRI has developed certain confidential and/or proprietary information,
patents and patent applications and material relating to a vaccine delivery
system that uses an attenuated form of Vibrio cholerae as a vector for the oral
delivery of antigens ("VIBRIOVEC") which may present an interest in connection
with vaccination against, and immunotherapy of, Helicobacter pylori infections;
WHEREAS, HPC are joint venture entities created and equally owned and controlled
by OraVax, Inc. of Cambridge, Massachussetts, USA, ("ORAVAX") and Pasteur
Merieux Serums & Vaccins S.A. -a Pasteur Merieux Connaught company- of Lyon,
France ("PMC") for the purpose of researching, developing, manufacturing and
distributing products for active immunization against Helicobacter pylori
infections and prevention, treatment and cure of associated diseases and
conditions in humans;
WHEREAS, HPC wishes to acquire from VRI certain licenses in order to have the
right to use VibrioVec in connection with vaccines against Helicobacter pylori
infections, and VRI is willing to grant such licenses to HPC, subject to the
terms of and conditioned upon this Agreement;
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NOW, THEREFORE, in consideration of the premises herein and for other good and
valuable consideration, the Parties hereto, intending to be legally bound, agree
as follows:
ARTICLE 1 - DEFINITIONS AND INTERPRETATION
1.1. DEFINITIONS: For the purposes of this Agreement the following words
and phrases shall have the following meanings:
(a) "AFFILIATE" means, with respect to any Person, (i) any other
Person of which the securities or other ownership interests
representing fifty per cent (50 %) or more of the equity or
fifty per cent (50%) or more of the ordinary voting power or
fifty per cent (50%) or more of the general partnership
interest are, at the time such determination is being made,
owned, Controlled or held, directly or indirectly, by such
Person (a "SUBSIDIARY"), or (ii) any other Person which, at
the time such determination is being made, is Controlling, or
under common Control with, such Person. As used herein, the
term "Control", whether used as a noun or verb, refers to the
possession, directly or indirectly, of the power to direct, or
cause the direction of, the management or policies of a
Person, whether through the ownership of voting securities, by
contract or otherwise. For the avoidance of doubt, it is
hereby recorded that, notwithstanding the definition contained
in this Section 1.1.(a), the two HPC entities are Affiliates
of both OraVax and PMC and of each other, and that OraVax and
PMC are each Affiliates of the two HPC entities.
(b) "AGREEMENT" means this agreement, all amendments and
supplements to this Agreement and all schedules to this
Agreement, including the following:
SCHEDULE A - LICENSED PATENTS,
SCHEDULE B - List of HPC Antigens.
APPENDIX A - Terms and conditions applicable to research
contract.
APPENDIX B - Terms and conditions applicable to VECTOR supply.
(c) "CALENDAR QUARTER" means any of the three-month periods
beginning January 1, April 1, July 1 and October 1 in any
year.
(d) "VECTOR" means a vaccine delivery system that uses an
attenuated form of the bacterium Vibrio cholerae as a vector
for the oral delivery of antigens, known as VibrioVec;
(e) "VECTOR IMPROVEMENTS" means all patentable or non-patentable
inventions, discoveries, technology and information of any
type whatsoever, which add to the knowledge of the VECTOR or
its properties in general as a delivery system or an
immunoadjuvant, as the case may be, for use in the Field of
Use, including without limitation compositions, molecules
derived from VECTOR, methods, processes, technical
information, knowledge, experience and know-how.
(f) "CONFIDENTIAL INFORMATION" has the meaning ascribed to it in
Section 8.1. of this Agreement.
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(g) "EVENT OF FORCE MAJEURE" has the meaning ascribed to it in
Article 12 of this Agreement.
(h) "FIELD OF USE" means the use of VRI Technology for the
formulation of products for active immunization against
Helicobacter pylori infections in humans and, by such
immunization, the prevention, treatment and cure of associated
diseases and conditions.
(i) "FIRST COMMERCIAL SALE" means, in each country of the
Territory, the first sale of a PRODUCT in commercial
quantities by LICENSEE, its Affiliates or Sublicensees, to
Third-Parties, in each case for use or consumption of such
PRODUCT in such country by the general public.
(ii) "JOINT INVENTIONS" has the meaning ascribed to it in Section
9.1 hereof.
(j) "LICENSE" has the meaning ascribed to it in Section 2.1.1. of
this Agreement.
(k) "LICENSED KNOW-HOW" means any and all technical information,
discoveries, improvements, processes, formulae, data,
engineering, technical and shop drawings, inventions,
Materials, shop-rights, know-how and trade secrets, in each
case which is Confidential Information at the time of
disclosure according to Article 8, is identified in accordance
with Section 2.3.3. of this Agreement as related to VECTOR and
which is useful or necessary to make, have made, use or sell
PRODUCTS or to practice under the LICENSED PATENTS in the
Field of Use, which have been, or hereafter are, either
developed by VRI or its Affiliates, or the rights to which in
the Field of Use have been acquired by VRI or its Affiliates
and to which VRI or its Affiliates have a transferable
interest. Without prejudice to the generality of the
foregoing, LICENSED KNOW-HOW shall include, with respect to
VECTOR, chemical and analytical methods and data, VECTOR
specifications, and pharmacological and toxicological methods
and data.
(l) "LICENSED PATENTS" means:
(i) any existing patents and patent applications listed
in SCHEDULE A to this Agreement;
(ii) any future patents issued from any patent
applications referred to in Paragraph 1.1.(l).(i)
above and any future patents issued from a patent
application filed in any country in the Territory
which corresponds to a patent or patent application
identified in Paragraph 1.1.(l).(i) above;
(iii) any reissues, confirmations, renewals, extensions,
counterparts, divisions or continuations issued,
assigned or licensed to VRI or its Affiliates of or
relating to the patents or patent applications
identified in Paragraph 1.1.(l).(i) and (ii) above;
(iv) any future patents and patent applications covering
VRI VECTOR Improvements solely or jointly owned or
licensed by VRI or its Affiliates with the right to
sublicense.
(m) "LICENSEE VECTOR IMPROVEMENTS" means VECTOR Improvements which
are conceived, developed or reduced to practice during the
term of this Agreement solely or jointly by employees or
contractors acting on behalf of LICENSEE, its Affiliates or
Sublicensees, to the extent and only to the extent that
LICENSEE now has or hereafter shall have the right to grant
licenses,
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immunities or other rights thereon. For avoidance of doubt,
any technology developed by LICENSEE during the term and
pursuant to this Agreement which relates to any HPC Antigen or
Other Hp Antigen (rather than antigens in general), or to the
combination of such specific antigen with VECTOR, or to the
manufacturing of PRODUCTS shall not be included in LICENSEE
VECTOR Improvements. LICENSEE VECTOR Improvements shall be
deemed to include LICENSEE's interest in any Joint Inventions.
(mm) "LPS" means Helicobacter pylori antigens which are
lipopolysaccharides.
(n) "MANUFACTURING KNOW-HOW" means any and all technical
information, discoveries, improvements, processes, formulae,
data, engineering, technical and shop drawings, inventions,
shop-rights, know-how and trade secrets, in each case which is
Confidential Information at the time of disclosure in the
meaning of Article 8 hereof, is identified in accordance with
Section 2.3.3., which is owned or otherwise possessed by VRI
or VRI's Affiliates and to which VRI or its Affiliates have a
transferable interest, and which is useful or necessary to
make and have made VECTOR or to use VECTOR for the formulation
of PRODUCTS or to practice under the LICENSED PATENTS to the
extent such Patents relates to the manufacturing of VECTOR ;
in particular, but without limiting the generality of the
foregoing, Manufacturing Know-How shall include any and all
information regarding the synthesis, manufacture, up-scaling
and handling of VECTOR, any and all analytical procedures,
procedures for and specifications of quality-assurance and
quality-control.
(o) "MATERIALS" shall mean any biological materials and chemical
VECTOR including but not limited to structural genes, genetic
sequences, promoters, enhancers, probes, linkage probes,
vectors, hosts, plasmids, peptides, polypeptides, transformed
cell lines, transgenic animals, proteins, biological
modifiers, antigens, reagents, hybridomas, antibodies, toxins,
lectins, enzymes, lipids, hormones, viruses, cells or parts of
cells, cell lines, fragments of any of the foregoing and any
other biologically active material or VECTOR, whether or not
occurring naturally or howsoever derived, modified,
conjugated, cross-linked, immobilized, reduced, purified or
produced, whether by recombinant DNA techniques and/or
otherwise.
(p) "NET SALES" shall mean gross sales of PRODUCTS sold by
LICENSEE, its Affiliates and Sublicensees to Third-Parties
(including unaffiliated Third-Party distributors, except in
the circumstances referred to in Section 6.3 hereof, and
provided further that where a distributor is an Affiliate, but
neither a Subsidiary of LICENSEE nor a Subsidiary of OraVax or
PMC (other than HPC), such distributor shall be deemed a
Third-Party for the purpose of calculating Net Sales
hereunder) less, to the extent actually incurred or allowed:
(i) customary trade discounts, credits, rebates, returns
(including, but not limited to, wholesaler and
retailer returns);
(ii) excise taxes, other consumption taxes, customs duties
and compulsory payments made to governmental
authorities;
(iii) transportation, transit and insurance for
transportation each to the extent separately invoiced
and paid by LICENSEE.
(q) "NOTICE OF DISPUTE" has the meaning ascribed to it in Section
17.4.(a) of this Agreement.
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(r) "OTHER HP ANTIGENS" means any antigens of Helicobacter pylori
and genes encoding such antigens other than HPC Antigens and
LPS.
(s) "PARTIES" means LICENSEE and VRI, and "Party" means any one of
them.
(t) "PERSON" means an individual, corporation, partnership, trust,
business trust, association, joint stock company, pool,
syndicate, sole proprietorship, unincorporated organization,
governmental authority or any other form of entity not
specifically listed herein.
(u) "PHASE III" means the first large scale safety and efficacy
clinical trial relating to a PRODUCT.
(v) "PLA" means a product license application filed with the
European Medicines Evaluation Agency or its successor in the
European Union, or any analogous or corresponding application
filed with the governing health authority of any country or
region (such as the Food and Drug Administration in the United
States of America or the Agence du Medicament in France), for
approval to market any PRODUCT for use or consumption in such
country or region.
(vv) "HPC ANTIGENS" means antigens of Helicobacter pylori (other
than LPS), and genes encoding such antigens, which are listed
in SCHEDULE B as being included in LICENSEE's research &
development program, which list may be amended from time to
time by written notice by LICENSEE to VRI (i) to add antigens
which are included in LICENSEE's research & development
program, in which case such antigens shall then become HPC
Antigens and be treated as such for the purpose of this
Agreement, PROVIDED, HOWEVER, that VRI has not previously
granted a non-exclusive license to a Third-Party with respect
to the use of VECTOR in combination with such antigens, or
(ii) to delete antigens which are excluded from such program,
in which case such antigens shall become Other Hp Antigens and
be treated as such for the purpose of this Agreement;
(w) "PRODUCTS" means any and all vaccines for active immunization
intended for use in the Field of Use which contain HPC
Antigens (either alone, combined with each other or combined
with Other Hp Antigens) or Other Hp Antigens (either alone or
combined with each other), in each case formulated in
combination with VECTOR.
(ww) "RESEARCH INVENTIONS" has the meaning ascribed to it in
Section 9.1 hereof which refers to Section 9 of APPENDIX A to
this Agreement.
(x) "ROYALTY TERM" means, with respect to each PRODUCT in each
country in the Territory, the period of time equal to the
longer of (a) ten (10) years from the date of First Commercial
Sale of such PRODUCT in such country or (b) the term for which
a Valid Patent Claim in such country remains in effect and,
but for a license granted by this Agreement, would be
infringed by the manufacture, use or sale of such PRODUCT in
the Field of Use in such country.
(xx) "SUBLICENSEE" means any Person acting pursuant to a sublicense
granted to it by LICENSEE under the terms of this Agreement.
(xxx) "TERRITORY" means all countries in the world.
(y) "THIRD-PARTY" means any Person other than LICENSEE, VRI and
their respective Affiliates.
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(yy) "VALID PATENT CLAIM" means a claim of an issued and unexpired
patent or patent application included in LICENSED PATENTS
which has not been held permanently revoked, unenforceable or
invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and which has not been admitted
to be invalid or unenforceable through reissue or disclaimer
or otherwise.
(z) "VRI VECTOR IMPROVEMENTS" means VECTOR Improvements which are
conceived, developed or reduced to practice during the term of
this Agreement solely or jointly by employees or contractors
acting on behalf of VRI or its Affiliates, to the extent that
VRI has now or hereafter shall have the right to grant
licenses, immunities or other rights thereon. VRI VECTOR
Improvements shall be deemed to include VRI's interest in any
Joint Inventions.
(zz) "VRI TECHNOLOGY" means the LICENSED PATENTS, the VECTOR, the
Manufacturing Know-How, the LICENSED KNOW-HOW and the VRI
VECTOR Improvements.
ARTICLE 2 - LICENSES
2.1. GRANT OF LICENSES TO LICENSEE
2.1.1. GRANT:
Subject to and conditioned upon the provisions of this Agreement, VRI
hereby grants to LICENSEE, and LICENSEE hereby accepts, the following
licenses (collectively, the "LICENSE"):
(i) a license in the Territory to make, have made, use and sell
PRODUCTS under the LICENSED PATENTS and by using LICENSED
KNOW-HOW and VRI VECTOR Improvements; and
(ii) a license in the Territory to make, have made and use the
VECTOR under the LICENSED PATENTS, and by using the
Manufacturing Know-How and VRI VECTOR Improvements, in each
case solely for the purpose of formulating PRODUCTS in the
Field of Use.
2.1.2. EXCLUSIVITY
(i) HPC ANTIGENS. Subject to and conditioned upon the provisions
of this Agreement, the LICENSE granted pursuant to this
Article II shall be exclusive (exclusive even as to VRI) to
LICENSEE in the Field of Use with respect to PRODUCTS
combining any VECTOR with any HPC Antigens (either alone,
combined with each other or combined with Other Hp Antigens).
Without limiting the generality of the foregoing, VRI
covenants that during the term of this Agreement, neither VRI
nor its Affiliates shall grant to any other Person any right,
license or privilege to make, have made, use or sell PRODUCTS
containing HPC Antigens (alone, or in combination with each
other, or in combination with Other Hp Antigens), or to make,
have made or use VECTOR,
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or to otherwise use or exploit VRI Technology, in connection
with such PRODUCTS containing HPC Antigens (alone, or in
combination with each other, or in combination with Other Hp
Antigens).
(ii) OTHER HP ANTIGENS. Subject to and conditioned upon the
provisions of this Agreement, the LICENSE granted pursuant to
this Article II shall be non-exclusive to LICENSEE in the
Field of Use with respect to PRODUCTS combining any VECTOR
with any Other Hp Antigens (alone or combined with each
other), but only with such Other Hp Antigens. Such license
shall be non-transferable and non-sub-licensable.
(iii) For greater certainty, VRI has and retains all rights in and
to the VRI Technology outside the Field of Use and LICENSEE
has no rights in the VRI Technology outside the Field of Use.
Further, the LICENSE shall not apply to nor cover any
combination of an Helicobacter pylori vaccine with any other
vaccine, or any Helicobacter pylori vaccine containing LPS.
2.1.3. LICENSEE'S RIGHTS TO SUBLICENSE
(i) LICENSEE shall have the right, with VRI's prior written
consent (which consent shall not be unreasonably withheld), to
sublicense in the Field of Use to Third-Parties all or any
portion of the rights to LICENSED PATENTS and LICENSED
KNOW-HOW and VRI VECTOR Improvements granted to it pursuant to
this Agreement under the exclusive LICENSE.
(ii) LICENSEE shall have the right, without obtaining the further
consent of VRI, to sublicense in the Field of Use all or any
portion of the rights to the LICENSED PATENTS, the LICENSED
KNOW-HOW, VRI VECTOR Improvements and/or the Manufacturing
Know-How granted to it pursuant to this Agreement under both
the exclusive and the non-exclusive LICENSE (i) to any or all
of its Affiliates, and (ii) to any Person in any country of
the Territory if required to do so by any governmental
authority having jurisdiction in such country.
(iii) LICENSEE agrees that all sublicenses granted by LICENSEE
hereunder shall expressly bind Sublicensees to the terms of
Article 8, "Confidentiality" and to all other relevant
provisions of this Agreement. In the event LICENSEE grants
sublicenses, LICENSEE shall pay royalties to VRI as if Net
Sales of the Sublicensees were Net Sales of LICENSEE and VRI
shall be expressly made a third-party beneficiary thereof.
LICENSEE shall be responsible for the performance by any
Sub-licensee of all such terms, conditions and obligations.
(iv) Any sublicenses granted by LICENSEE shall include a
requirement that the Sublicensee maintains records and permits
inspection on terms essentially identical to Section 5.2
hereof. At VRI's request, LICENSEE shall arrange for an
independent certified public accountant selected by VRI to
inspect the records of Sublicensees, at VRI's expense, for the
purpose of verifying royalties due to VRI and shall cause such
accountant to report the results thereof to VRI.
(v) Any sublicenses granted by LICENSEE shall provide for the
termination of the sublicense, or, if the Sublicensee is a
Third-Party, at the option of such Sublicensee, the conversion
to a license directly between such Sublicensee and VRI, upon
termination of this Agreement under Article 10 (other than
expiration under Section 10.1). Such conversion shall be
subject to VRI's
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approval and contingent upon acceptance by the Sublicensee of
the remaining provisions of this Agreement.
(vi) LICENSEE shall notify VRI of each sublicense granted to
Third-Parties and shall provide VRI with the name and address
of each Sublicensee and a description of the PRODUCTS and
territory covered by each sublicenses.
2.1.4. SUBLICENSES TO LICENSEE.
To the extent LICENSED PATENTS have been, or shall be, licensed by VRI
from a Third-Party under an agreement with such Third-Party (a
"Third-Party In-license"), HPC understands and agrees as follows:
(i)- The rights sub-licensed to HPC by VRI are subject to the terms
and conditions, restrictions, limitations and obligations of
the relevant Third-Party In-license;
(ii)- HPC shall comply with the terms and conditions, restrictions,
limitations and obligations of such Third-Party In-license(s)
to the extent HPC has been permitted to review such terms,
conditions, restrictions, limitations and obligations. VRI
shall give HPC, upon request, a reasonable opportunity to
review the same except to the extent that confidentiality
obligations towards Third-Parties may prevent VRI from doing
so. In any event, VRI shall act reasonably in advising HPC of
the scope of HPC's obligations pursuant to any relevant
Third-Party In-license.
2.1.5 SUBCONTRACTING.
Notwithstanding anything herein provided for to the contrary, LICENSEE
shall be allowed to (i) sub-contract in whole or in part PRODUCTS
development to Third-Parties such as, without limitation, clinical
research organizations, (ii) appoint sales agents and distributors to
promote, market and distribute PRODUCTS and (iii) sub-contract
manufacturing of PRODUCTS and/or VECTOR with Affiliates, Third-Parties
or with VRI, or VRI's Affiliates.
2.2. LICENSES TO VRI.
Subject to and conditional upon the provisions of this Agreement,
LICENSEE shall grant to VRI a non-exclusive, sublicenseable,
royalty-free, worldwide license to LICENSEE VECTOR Improvements for
commercial use outside the Field of Use.
2.3. PROCEDURES FOR PROVISION OF KNOW-HOW.
2.3.1. DISCLOSURE OF TECHNOLOGY.
(a) BY VRI.
From time to time during the term of this Agreement, VRI shall
disclose or cause its Affiliates to disclose to LICENSEE such
VRI Technology as reasonably necessary to enable LICENSEE to
develop, manufacture and commercialize PRODUCTS and to
manufacture, have manufactured or use VECTOR for the
formulation of PRODUCTS in the Field of Use on the terms
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and subject to the conditions of this Agreement. In addition,
during the term of this Agreement, VRI shall, upon LICENSEE's
reasonable request and with adequate notice to VRI, make
available to LICENSEE at LICENSEE's or its Affiliates'
manufacturing facilities or the facility of a Third-Party
manufacturer who shall have contracted with LICENSEE to
manufacture PRODUCTS or VECTOR, VRI's or VRI Affiliate's
personnel to provide technical assistance to LICENSEE's
personnel, or LICENSEE Affiliates' personnel or Third-Party
manufacturer's personnel.
LICENSEE shall pay or have paid by its concerned Affiliates
all expenses incurred by VRI or its Affiliates in connection
with such technical assistance.
The technical assistance to be rendered by VRI and its
Affiliates hereunder may include, upon reasonable request by
LICENSEE, demonstration of Manufacturing Know-How at a VRI's
or a VRI Affiliate's facility and disclosure of any and all
sources of raw material and list and specifications of
equipment and machinery used in the production of VECTOR
according to the Manufacturing Know-How.
(b) BY LICENSEE.
From time to time during the term of this Agreement, LICENSEE
shall disclose to VRI all LICENSEE VECTOR Improvements on the
terms and subject to the conditions of the Agreement and in
particular in accordance with Section 2.2. hereof.
2.3.2. COMMUNICATION AMONG PARTIES.
Each of LICENSEE and VRI shall appoint (a) specific individual(s) who
shall be available and shall act as (a) liaison person(s) to facilitate
the day-to-day communications among the Parties. The names and
addresses of the liaison persons who shall act on behalf of each of the
Parties shall be provided by each of the Parties to the other
immediately following the execution of this Agreement. Each of LICENSEE
and VRI agrees to notify the other in accordance with the terms of
Section 17.1. of this Agreement in the event of a change in liaison
person.
2.3.3. IDENTIFICATION OF KNOW-HOW.
The Parties agree that all information, VECTORS and Materials comprised
in the Licensed Know-How to be transferred to LICENSEE pursuant to this
Agreement shall be so transferred in the case of written information,
by memoranda bearing the mention "Confidential", and, in the case of
Materials, by clearly marked and numbered containers. LICENSEE shall
designate an individual who shall be responsible for receiving
information and Materials from VRI and/or its Affiliates and the
Parties agree that such information and Materials shall in all cases
(except where the Parties agree otherwise) be sent solely to the
attention of such individual. Upon receipt of information and/or
Materials, the designated individual shall, on behalf of LICENSEE, send
an acknowledgement to VRI and/or its Affiliates confirming receipt of
information and/or Materials. The Parties agree that they shall in good
faith work together to establish and maintain a system to record the
transmission of information and/or Materials under this Agreement and
make all commercially reasonable efforts to ensure such system is
followed.
2.3.4. CONFIDENTIALITY.
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All information transferred pursuant to this Agreement shall be deemed
to be "Confidential Information" in accordance with Section 8.1.
2.3.5. SUPPLY OF VECTOR.
VRI hereby represents and warrants that any and all quantities of
VECTOR which may be supplied hereunder by VRI or its Affiliates to
LICENSEE for use in clinical trials in humans shall be manufactured in
accordance with current Good Manufacturing Practices (cGMP) as in force
in the country where such VECTOR shall be manufactured and shall meet
VECTOR specifications as shall be agreed otherwise by the Parties. The
sole and exclusive remedy for LICENSEE under this paragraph shall be
for VRI to provide replacement VECTOR complying with agreed-upon
specifications, free of any charge, in quantity equal to LICENSEE's
original order, except where VRI liability is established to be gross
negligence or willful misconduct (and LICENSEE did not use VECTOR with
knowledge of the non-compliance hereunder), in which case VRI shall
indemnify LICENSEE as provided herein.
ARTICLE 3 - DEVELOPMENT AND COMMERCIALIZATION.
3.1. DEVELOPMENT AND COMMERCIALIZATION EFFORTS.
LICENSEE (i) shall use commercially reasonable efforts to diligently
conduct such preclinical and clinical trials that are necessary or
desirable to obtain all regulatory approvals to develop and
commercialize such PRODUCTS, (ii) shall diligently develop and obtain
necessary approval to market such PRODUCTS (including, as the case may
be, pricing approval), and (iii) shall commence marketing and market
such PRODUCTS in each country in which LICENSEE has received all
applicable regulatory approvals therefor. LICENSEE shall comply with
all applicable good laboratory, clinical and manufacturing practices in
the development and commercialization of such PRODUCTS, and shall cause
its Affiliates and subcontractors to do the same. LICENSEE shall be
solely responsible for funding all costs of the development and
commercialization of each such PRODUCTS.
3.2. SUB-CONTRACTS TO VRI.
LICENSEE and VRI have agreed to have part of the research and
development work with respect to PRODUCTS sub-contracted to VRI
pursuant to and in accordance with the terms and conditions set forth
in APPENDIX A.
LICENSEE and VRI may agree to have VECTOR manufacturing sub-contracted
to VRI, in which case such contract manufacturing shall be subject to
terms and conditions set forth in APPENDIX B.
3.3. DEVELOPMENT AND COMMERCIALIZATION REPORTS.
During the term of this Agreement, LICENSEE shall keep VRI reasonably
informed as to the progress of the development of PRODUCTS by notifying
VRI of completion of each significant step.
In addition, LICENSEE agrees to update the list of HPC Antigens which
constitute the Schedule B to this Agreement, on a quarterly basis, by
indicating in writing
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CONFIDENTIAL TREATMENT
which Other Hp Antigens, if any, are included in such list and which
HPC Antigens, if any, are excluded therefrom and then become Other Hp
Antigens.
All information disclosed by LICENSEE pursuant to this Section 3.3
shall be subject to Article 8 hereof.
ARTICLE 4 - ROYALTIES AND MILESTONES.
4.1. EARNED ROYALTIES.
During the Royalty Term, LICENSEE shall pay to VRI a royalty of [*].
4.2. THIRD-PARTY ROYALTIES.
If LICENSEE, its Affiliates or Sublicensees is required to pay
royalties to any Third-Party in order to make, have made, use or sell a
PRODUCT in a country or to make, have made or use VECTOR for use in
such PRODUCT in such country, then the royalty set-forth in Section 4.1
hereof for such PRODUCT in such country shall be reduced by [*].
4.3. SINGLE ROYALTY: NON-ROYALTY SALES.
In no event shall more than one royalty be payable under Section 4.1.
hereof with respect to a particular unit of PRODUCTS. No royalty shall
be payable under this Article 4 with respect to sales of PRODUCTS among
LICENSEE and its Affiliates (provided that where a distributor is an
Affiliate, but neither a Subsidiary of LICENSEE nor a Subsidiary of
OraVax or PMC -other than HPC-, such distributor shall be deemed a
Third-Party), or among Sublicensees and their Affiliates, or among
LICENSEE and its Affiliates, but a royalty shall be due upon the
subsequent sale of the PRODUCTS to a Third-Party. No royalty shall be
payable for (i) PRODUCTS used by LICENSEE, its Affiliates or
Sublicensees, for research including, without limitation, in clinical
trials, or (ii) customary quantities of PRODUCTS distributed as free
samples.
4.4. MILESTONE PAYMENTS.
As additional consideration for the LICENSE, rights and privileges
granted to it hereunder, LICENSEE shall pay to VRI the following
milestone payments within thirty (30) days of the occurrence of each
event set forth below (unless otherwise specified below), whether such
events are achieved by LICENSEE, its Affiliates or Sublicensees:
(a) [*];
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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CONFIDENTIAL TREATMENT
(b) [*];
(d) [*];
(e) [*];
(f) [*].
The above-mentioned milestone payments shall be payable only once each.
ARTICLE 5 - ROYALTY REPORTS AND ACCOUNTING.
5.1. REPORTS, EXCHANGE RATES.
During the term of this Agreement following the First Commercial Sale,
LICENSEE shall furnish to VRI, with respect to each Calendar Quarter, a
written report showing in reasonably specific detail, on a
country-by-country basis, (a) the gross sales of PRODUCTS sold by
LICENSEE, its Subsidiaries and its Sublicensees in the Territory during
the corresponding Calendar Quarter and the calculation of Net Sales
from such gross sales; (b) the royalties payable in United States
dollars, if any, which shall have accrued hereunder based upon Net
Sales of PRODUCTS; (c) the withholding taxes, if any, required by law
to be deducted in respect of such royalties; (d) the date of the First
Commercial Sale of PRODUCTS having occurred in each country in the
Territory during the corresponding Calendar Quarter; and (e) the
exchange rates used in determining the royalty amount expressed in
United States dollars.
With respect to sales (if any) of PRODUCTS invoiced in United States
dollars, the gross sales, Net Sales, and royalties payable shall be
expressed in United Sates dollars. With respect to sales of PRODUCTS
invoiced in a currency other than United Sates dollars, the gross
sales, Net Sales and royalties payable shall be expressed in the
currency of the invoice issued by the Party making the sale together
with the United States dollars equivalent of the royalty payable,
calculated using the rate of exchange published in the WALL STREET
JOURNAL for such currency on the last business day of the concerned
Calendar Quarter.
Reports and payments shall be due on the forty fifth (45th) day
following the close of each Calendar Quarter. LICENSEE shall keep
complete and accurate records in sufficient detail to properly reflect
all gross sales and Net Sales and to enable the royalties payable
hereunder to be determined.
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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5.2. AUDITS.
5.2.1. Upon the written request of VRI and not more than once in each calendar
year, LICENSEE shall permit an independent certified public accounting
firm of internationally recognized standing, selected by VRI and
reasonably acceptable to LICENSEE, at VRI's expense, to have access
during normal business hours to such of the records of LICENSEE as may
be reasonably necessary to verify the accuracy of the royalty reports
hereunder for any year ending not more than three (3) years prior to
the date of such request. The accounting firm shall disclose to VRI
only whether the records are correct or not and the specific details
concerning any discrepancies. No other information shall be shared.
5.2.2. If such accounting firm concludes that additional royalties were owed
during such period, LICENSEE shall pay the additional royalties within
thirty (30) days of the date VRI delivers to LICENSEE such accounting
firm's written report so concluding. The fees charged by such
accounting firm shall be paid by VRI; PROVIDED, HOWEVER, if the audit
discloses that the royalties payable by LICENSEE for the audited period
are more than one hundred and two percent (102%) of the royalties
actually paid for such period, then LICENSEE shall pay the reasonable
fees and expenses charged by such accounting firm.
5.2.3. LICENSEE shall include in each permitted sublicense granted by it
pursuant to the Agreement a provision requiring the Sublicensee to make
reports to LICENSEE, to keep and maintain records of sales made
pursuant to such sublicense and to grant access to such records by
VRI's independent accountant to the same extent required with respect
to LICENSEE's records under this Agreement.
5.2.4. Except in the case of circumstances which would have prevented an error
or anomaly from being disclosed during the audit hereabove mentioned,
such as fraud or other failure to provide accurate information, upon
the expiration of three (3) years following the end of any calendar
year, the calculation of royalties payable with respect to such year
shall be binding and conclusive upon VRI, and LICENSEE, its Affiliates
and Sublicensees shall be released from any liability or accountability
with respect to royalties for such year.
5.3. CONFIDENTIAL FINANCIAL INFORMATION.
VRI shall treat all financial information subject to review under this
Article 5 or under any sublicense as confidential, and shall cause its
accounting firm to retain all such financial information in confidence.
ARTICLE 6 - PAYMENTS.
6.1. PAYMENT TERMS.
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CONFIDENTIAL TREATMENT
Royalties shown to have accrued by each royalty report provided for
under Article 5 of this Agreement shall be due on the date such royalty
report is due. Payment of royalties in whole or in part may be made in
advance of such due date.
6.2. PAYMENT METHOD.
Except as provided in this Section 6.2., all payments by LICENSEE to
VRI under this Agreement shall be paid in United States dollars, and
all such payments shall be made without deduction of bank transfer fees
by bank wire transfer in immediately available funds to the following
bank account:
------------------------------------------------------
Bank : [*]
Account No. : [*]
Account name : [*]
------------------------------------------------------
or to any other bank account designated in writing from time to time by
VRI to LICENSEE.
6.3. EXCHANGE CONTROL.
If at any time legal restrictions prevent the prompt remittance of part
or all royalties with respect to any country in the Territory where
PRODUCTS are sold, payment shall be made through such lawful means or
method as the Parties reasonably shall determine or, at VRI's
discretion, royalties shall be based on HPC sales (if any) to HPC's
Subsidiary or Sublicensee in such country.
6.4. WITHHOLDING TAXES.
Royalties and milestone payments shall be paid by LICENSEE to VRI,
after deduction of any applicable withholding taxes. Prior to any
payment by LICENSEE to VRI, LICENSEE shall provide to VRI any forms
required to attest VRI's fiscal domiciliation in order to allow
LICENSEE to claim application of the reduced rate of withholding tax
provided for in any applicable bilateral fiscal convention. VRI shall
promptly return such forms to LICENSEE. In the event VRI fails to
promptly return such forms duly filled and signed, LICENSEE shall
declare and pay withholding tax at the common law rate of the
applicable corporate income tax, and such tax shall then be deducted
from the corresponding payment by LICENSEE to VRI. LICENSEE shall pay
withholding tax to the proper taxing authority and proof of payment of
such tax shall be secured and sent to VRI as evidence of such payment.
ARTICLE 7 - INFRINGEMENT ACTIONS BY THIRD-PARTIES.
If LICENSEE, VRI or their respective Affiliates, or LICENSEE's Sublicensees, is
sued by a Third-Party for infringement of a Third-Party's patent because of the
manufacture, use or sale of PRODUCTS or manufacture or use of VECTOR, the Party
which has been sued shall promptly notify the other Party in writing of the
institution of such suit, in which event the other Party shall have the right to
be represented by advisory counsel of its own selection, at its own expense, and
shall cooperate fully in the defense of such suit and furnish to the Party(ies)
that is(are) sued all evidences and assistance in its control.
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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The Party controlling the suit may not settle the suit or otherwise consent to
an adverse judgment in such suit that diminishes the rights or interests of the
non-controlling Party without the express written consent of the non-controlling
Party. Any judgments, awards, settlements or damages payable with respect to
legal proceedings covered by this Article 7 shall be paid by the Party against
whom the award has been made.
ARTICLE 8 - CONFIDENTIALITY.
8.1. NON-DISCLOSURE AND RESTRICTION-OF-USE OBLIGATIONS.
Except as otherwise provided in this Article 8, during the term of this
Agreement and for a period of ten (10) years after termination of this
Agreement under Sections 10.3. or 10.4., each Party shall maintain in
confidence, and use only for purposes as expressly authorized and
contemplated by this Agreement, all information and data supplied by
the other Party under this Agreement, including but not limited to
LICENSED KNOW-HOW, Manufacturing Know-How and VECTOR Improvements. For
purposes of this Article 8, information and data described above shall
be hereinafter referred to as "CONFIDENTIAL INFORMATION".
8.2. PERMITTED DISCLOSURES.
To the extent it is reasonably necessary or appropriate to fulfill its
obligations or exercise its rights under this Agreement, (i) a Party
may disclose Confidential Information it is otherwise obligated under
this Article 8 not to disclose, to its Affiliates, Sublicensees,
consultants, outside contractors and clinical investigators, on a
need-to-know basis, provided that such Persons agree to keep the
Confidential Information confidential and not use the Information for
the same time period and to the same extent as such Party is required;
and (ii) a Party may disclose such Confidential Information to
governmental or other regulatory authorities to the extent that such
disclosure is required by applicable law, regulation or court order, or
is reasonably necessary to obtain patents, copyrights or authorizations
to conduct clinical trials with, or to commercially market PRODUCTS,
provided that the disclosing Party shall provide written notice to the
other Party and sufficient opportunity to object to such disclosure or
to request confidential treatment thereof.
The obligation not to disclose or use Confidential Information shall
not apply to any part of such Information (including LICENSED KNOW-HOW,
Manufacturing Know-How and VECTOR Improvements) that (i) is or becomes
patented, published or otherwise part of the public domain or publicly
available other than by acts of the Party obligated not to disclose
such Information, or of its Affiliates or Sublicensees, in
contravention of this Agreement; (ii) is disclosed to the receiving
Party or its Affiliates or Sublicensees by a Third Party, provided such
Information was not obtained by such Third-Party directly or indirectly
from the other Party, its Affiliates or Sublicensees, under or pursuant
to this Agrement on a confidential basis and otherwise had a lawful
right to disclose the information; (iii) prior to disclosure under
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the Agreement, was already in the possession of the receiving Party or
its Affiliates or Sublicensees, provided such Information was not
obtained directly or indirectly from the other Party under this
Agreement; (iv) is independently developed by the receiving Party
without reliance on the Confidential Information disclosed by the other
Party hereunder, (v) is disclosed in a press release agreed to by both
Parties hereto in accordance with Section 8.4. hereinafter or (vi) both
Parties have agreed to publish.
8.3. TERMS OF THE AGREEMENT.
LICENSEE and VRI shall not disclose any terms or conditions of this
Agreement to any Third-Party without the prior consent of the other
Party, except (a) to Persons with whom LICENSEE or VRI has entered into
or proposes to enter into a business relationship to which this
Agreement is relevant and substantial, provided that such Persons shall
enter into the required confidentiality agreement, or (b) as required
by applicable laws, regulations or a court order, provided that the
disclosing Party shall provide written notice to the other Party and
sufficient opportunity to object to such disclosure or to request
confidential treatment thereof.
8.4. PRESS RELEASES AND OTHER DISCLOSURES TO THIRD-PARTIES
Neither VRI nor HPC shall, without the prior written consent of the
other, issue any press release or make any other public announcement or
furnish any statement to any Person (other than either Parties'
respective Affiliates) concerning the existence of this Agreement and
the transactions contemplated by this Agreement, except for (i) general
statement referring to the existence of this Agreement, specifying the
Field of Use and identity of the Parties but no other details, (ii)
disclosures made in compliance with sections 8.2. and 8.3. hereof,
(iii) attorneys, consultants, and accountants retained to represent
them in connection with the transactions contemplated hereby or as may
be reasonably necessary to either Party's bankers, investors, attorneys
or other professional advisors in connection with a merger or
acquisition, provided such advisors are bound by confidentiality
obligations essentially identical to those provided for herein, and
(iv) occasional, brief comments by the respective officers of HPC,
OraVax, PMC and VRI consistent with such guidelines for public
statements as may be mutually agreed by HPC and VRI made in connection
with routine interviews with analysts or members of the financial
press. In addition, either Party (after consultation with counsel) in
its own right may make such further announcements and disclosures, if
any, as may be required by applicable laws and regulations, in which
case the Party making the announcement or disclosure shall use its best
efforts to give advance notice to, and discuss such announcement or
disclosure with, the other Party.
8.5. Notwihstanding anything else to the contrary, LICENSEE agrees that VRI
Technology shall be used only for the research, development,
manufacture, use and sale of PRODUCTS and that in the event that the
LICENSE is terminated, LICENSEE agrees not to use VRI Technology and
LICENSEE VECTOR Improvements for the research, development,
manufacture, use or sale of any product or process including but not
limited to PRODUCTS.
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ARTICLE 9 - INVENTIONS AND PATENTS.
9.1. OWNERSHIP OF INVENTIONS.
The entire right and title to technology, whether or not patentable,
and any patent applications or patents based thereon, made or conceived
during the term of this Agreement (other than Research Inventions as
defined in APPENDIX A attached hereto, if any), (a) by employees or
others acting solely on behalf of VRI or its Affiliates, shall be owned
solely by VRI, (b) by employees or others acting solely on behalf of
LICENSEE or its Affiliates, shall be owned solely by LICENSEE, and (c)
by both employees or others acting on behalf of LICENSEE or its
Affiliates and on behalf of VRI or its Affiliates shall be jointly
owned by LICENSEE and VRI (the "JOINT INVENTIONS"). Each Party promptly
shall disclose to the other Party the making, conception or reduction
to practice of VECTOR Improvements by employees or others acting on
behalf of such Party. VRI and LICENSEE each hereby represents that all
employees and other Persons acting on its behalf in performing its
obligations under this Agreement shall be obligated under a binding
written agreement to assign to it, or as it shall direct, all VECTOR
Improvements conceived or reduced to practice by such employees or
other Persons. The provisions of this Section 9.1 are subject to
Section 2.2 hereof.
9.2. PATENT PROSECUTION AND MAINTENANCE.
VRI shall be responsible for and shall control the preparation, filing,
prosecution, grant and maintenance of all LICENSED PATENTS. VRI shall
prepare, file, prosecute and maintain such LICENSED PATENTS in good
faith consistent with its customary patent policy and its reasonable
business judgement, and shall consider in good faith the interests of
LICENSEE in so doing. LICENSEE shall re-imburse VRI a share of
reasonable costs of prosecution and maintenance of all LICENSED PATENTS
as far as such costs are borne by VRI in the normal course of business
after the Effective Date and for so long as the LICENSE to the relevant
LICENSED PATENTS continues in effect. Such share shall be an amount
equal to the total of the costs mentioned hereinabove multiplied by a
fraction having as a numerator one (1), and as a denominator the total
number of licences granted by VRI to Third-Parties with respect to
LICENSED PATENTS. VRI shall furnish to HPC an estimated yearly budget
for such costs.
9.3. ENFORCEMENT OF LICENSED PATENTS.
In the event that LICENSED PATENTS are infringed by any Third-Party in
the Field of Use, LICENSEE shall have the right, but not the
obligation, to institute and prosecute any action or proceeding under
LICENSED PATENTS with respect to such infringement, by counsel of its
choice, including any declaratory judgement action arising from such
infringement. Any amounts recovered from Third-Parties with respect to
the LICENSED PATENTS in such action shall be retained by LICENSEE.
LICENSEE shall not have the right to settle, compromise or take any
action in such litigation which diminishes, limits or inhibits the
scope, validity or enforceability of LICENSED PATENTS without the
express permission of VRI. LICENSEE shall keep VRI advised of the
progress of such proceedings.
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In the event that a Third-Party is infringing any LICENSED PATENTS in
the Field of Use and LICENSEE does not elect to institute an action,
VRI shall have the right, but not the obligation, to commence an
infringement suit under the LICENSED PATENTS against such infringer and
shall retain any recovery; provided that it so notifies LICENSEE.
ARTICLE 10 - TERM AND TERMINATION.
10.1. EXPIRATION.
Unless terminated earlier pursuant to this Article 10 or Article 12,
the Agreement shall expire on the expiration of LICENSEE's obligations
to pay royalties under the Agreement in accordance with the Royalty
Term. Thereafter, LICENSEE and Sublicensees shall have a perpetual,
fully paid-up, royalty-free, non-cancellable, worldwide license or
sub-license (whichever is applicable) to the VRI Technology.
10.2. After First Commercial Sale of a PRODUCT or PRODUCTS in a country,
royalties for any other PRODUCT or PRODUCTS introduced into such
country will only be payable if a Valid Patent Claim is in effect in
the United States or Europe at the time such PRODUCT or PRODUCTS are
first offered for sale in such country, provided that if LICENSEE has
ceased to sell a PRODUCT in a country prior to the payment of royalties
in such country for ten (10) years, any additional PRODUCT or PRODUCTS
sold in such country thereafter will be subject to royalties without
regard to the existence of a Valid Patent Claim until VRI has received
at least ten (10) years of Royalty payments in such country.
10.3. TERMINATION BY LICENSEE.
LICENSEE shall have the right at any time as from January 1, 1998, in
its sole discretion, to terminate this Agreement, by giving not less
than three (3) months' prior written notice to VRI of such termination.
10.4. TERMINATION FOR CAUSE.
(i) Either Party may terminate this Agreement, at its option, upon
or after the breach of any material provision of the
Agreement, if the breaching Party has not cured such breach
within ninety (90) days after written notice thereof from the
other Party.
(ii) LICENSEE or VRI may terminate this Agreement upon written
notice to the other party if the other party makes a general
assignment for the benefit of creditors, is the subject of
proceedings in voluntary or involuntary bankruptcy or has a
receiver or trustee appointed for substantially all of its
property; PROVIDED that in the case of an involuntary
bankruptcy proceeding such right to terminate shall only
become effective if the other party consents thereto or such
proceeding is not dismissed within ninety (90) days after the
filing thereof.
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Each of the parties hereto acknowledges and agrees that this
Agreement (i) constitutes a license of Intellectual Property
(as such term is defined in the United States Bankruptcy code,
as amended (the "Code"), and (ii) is an executory contract,
with significant obligations to be performed by each party
hereto. The parties agree that LICENSEE may fully exercise all
of its rights and elections under the Code, including, without
limitation, those set forth in Section 365(n) of the Code. The
parties further agree that, in the event that LICENSEE elects
to retain its rights as a licensee under the Code, LICENSEE
shall be entitled to complete access to any technology
licensed to it hereunder and all embodiments of such
technology. Such embodiments of the technology shall be
delivered to LICENSEE not later than (a) the commencement of
bankruptcy proceedings against VRI, unless VRI elects to
perform its obligations under this Agreement, or (b) if not
delivered under (a) above, upon the rejection of this
Agreement by or on behalf of VRI.
10.5. EFFECT OF EXPIRATION AND TERMINATION.
Expiration or termination of the Agreement shall not relieve the
Parties of any obligation accruing prior to such expiration or
termination. The provisions of Sections 2.1.3.(v) and 9.1. and Articles
8 and 11 shall survive the expiration or termination of the Agreement.
ARTICLE 11 - INDEMNITY.
11.1. DIRECT INDEMNITY.
11.1.1. Each Party shall indemnify and hold harmless the other Party, its
Affiliates, and their respective directors, officers, shareholders,
agents, consultants and employees from and against all Third-Party
claims, demands, liabilities, damages and expenses, including
attorneys' fees and costs (collectively, the "LIABILITIES") arising out
of the breach of any material provision of this Agreement by, or an act
or an omission of, the indemnifying Party, except to the extent such
Liabilities resulted from the gross negligence, recklessness or
intentional acts or omissions of the other Party.
11.1.2. LICENSEE shall defend, indemnify and hold harmless VRI, its Affiliates,
licensors, their respective directors, officers, shareholders, agents,
consultants and employees, from and against all Liabilities suffered or
incurred arising out of any Third-Party claims in connection with the
manufacture, design, testing, possession, distribution, use, sale or
other disposition by or through LICENSEE, its Affiliates or
Sublicensees of any PRODUCTS or VECTOR, except in each case to the
extent such Liabilities resulted from the gross negligence,
recklessness or intentional acts or omissions of VRI, and except where
VRI's liability is established in accordance with EXHIBIT 1 to APPENDIX
B attached hereto as far as supply of VECTOR is concerned.
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11.2. PROCEDURE.
A Party (the "INDEMNITEE") that intends to claim indemnification under
this Article 11 shall promptly notify the other Party (the
"INDEMNITOR") of any Liability or action in respect of which the
Indemnitee intends to claim such indemnification, and the Indemnitor
shall have the right to participate in, and, to the extent the
Indemnitor so desires, jointly with any other Indemnitor similarly
noticed, to assume the defense thereof with counsel selected by the
Indemnitor; PROVIDED, HOWEVER, that the Indemnitee shall have the
right to retain its own counsel, with the fees and expenses to be paid
by the Indemnitor, if representation of such Indemnitee by the counsel
retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between such Indemnitee and any other
Party represented by such counsel in such proceedings.
The indemnity obligations under this Article 11 shall not apply to
amounts paid in settlement of any loss, claim, damage, liability or
action if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld unreasonably. The
failure to deliver notice to the Indemnitor within a reasonable time
after the commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under this Article 11. The Indemnitee, its
Affiliates, employees and agents, shall cooperate fully with the
Indemnitor and its legal representatives in the investigation of any
action, claim or liability covered by this indemnification.
ARTICLE 12 - FORCE MAJEURE.
No Party (or any of its Affiliates) shall be held liable or responsible to the
other Party (or any of its Affiliates) nor be deemed to have defaulted under or
breached the Agreement for failure or delay in fulfilling or performing any term
of the Agreement when such failure or delay is caused by or results from causes
beyond the reasonable control of the affected Party (or any of its Affiliates)
including but not limited to fire, floods, embargoes, war, acts of war (whether
war be declared or not), insurrections, riots, civil commotions, strikes,
lockouts or other labor disturbances, acts of God or acts, omissions or delays
in acting by any governmental authority or the other Party (collectively,
"EVENTS OF FORCE MAJEURE"); PROVIDED, HOWEVER, that the affected Party (i)
shall immediately notify the other Party of the occurrence of any such Event of
Force Majeure and (ii) shall exert all reasonable efforts to eliminate, cure or
overcome any such Event of Force Majeure and to resume performance of its
covenants with all possible speed; and PROVIDED, FURTHER, that nothing
contained herein shall require any Party to settle on terms unsatisfactory to
such Party any strike, lockout or other labor difficulty, any investigation or
proceeding by any governmental authority or any litigation by any Third-Party.
Notwithstanding the foregoing, to the extent that an Event of Force Majeure
continues for a period in excess of six (6) months, the affected Party shall
promptly notify in writing the other Party of such Event of Force Majeure and
within four (4) months of the other Party's receipt of such notice, the Parties
agree to negotiate in good faith either (i) to resolve the Event of Force
Majeure, if possible, (ii) to extend by mutual agreement the time period to
resolve, eliminate, cure or overcome such Event of Force Majeure, (iii) to amend
this Agreement to the extent reasonably possible, or (iv) to terminate this
Agreement.
ARTICLE 13 - ASSIGNMENT.
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This Agreement may not be assigned or otherwise transferred, nor, except as
expressly provided hereunder, may any right or obligations hereunder be assigned
or transferred to any Third-Party by either Party without the consent of the
other Party; PROVIDED, HOWEVER, that either Party may, without such consent,
assign this Agreement and its rights and obligations hereunder to any of its
Affiliates or in connection with the transfer or sale of all or substantially
all of its business, or in the event of its merger or consolidation or change in
control or similar transaction. Any permitted assignee shall assume all
obligations of its assignor under this Agreement.
Without limiting the generality of the foregoing, without the prior written
consent of LICENSEE, VRI shall not under any circumstances assign or transfer
any VRI Technology in the Field of Use unless the assignee expressly agrees in
writing that the LICENSE shall remain in full force and effect pursuant to its
terms and such assignment shall not relieve the assignor of any of its
obligations under this Agreement. Each Party acknowledges that the other Party
would suffer irreparable injury in the event of any breach of this Article 13
and that therefore the remedy at law for any breach or threatened breach hereof
by any Party shall be inadequate. Accordingly, upon a breach or threatened
breach hereof by any Party, the other Party shall, in addition and without
prejudice to any other rights and remedies it may have, be entitled as a matter
of right, without proof of actual damages, to seek specific performance hereof
and to such other injunctive or equitable relief to enforce or prevent any
violations (whether anticipatory, continuing or future) hereof.
ARTICLE 14 - NOTIFICATION OF PATENT TERM RESTORATION - PATENT EXTENSIONS.
VRI shall notify LICENSEE of (a) the issuance of each U.S. patent included
within the LICENSED PATENTS, giving the date of issue and patent number for each
such patent, and (b) each notice pertaining to any patent included within the
LICENSED PATENTS which it receives as patent owner pursuant to the United States
Drug Price Competition and Patent Term Restoration Act of 1984 (hereinafter
called the "Act"), including notices pursuant to sections 101 and 103 of the
Act from Persons who have filed an abbreviated new drug application ("ANDA").
Such notices shall be given promptly, but in any event within five (5) calendar
days of each such patent's date of issue or receipt of each such notice
pursuant to the Act, whichever is applicable. VRI shall notify LICENSEE of each
filing for patent term restoration under the Act, any allegations of failure to
show due diligence and all awards of patent term restoration (extensions) with
respect to the LICENSED PATENTS.
Likewise, VRI or LICENSEE, as the case may be, shall inform the other Party of
patent extensions and periods of data exclusivity in the rest of the world
regarding any PRODUCTS and more generally the Parties shall diligently cooperate
with respect to any procedures for patent and period of data exclusivity
extensions, such as but not limited to Supplementary Protection Certificates,
the above-mentioned Patent Term Restoration and corresponding GATT regulations.
ARTICLE 15 - ADVERSE EXPERIENCE REPORTING.
During the term of the Agreement, each Party shall notify the other immediately
of any information (howsoever obtained and from whatever source) concerning any
unexpected side effect, injury, toxicity or sensitivity reaction, or any
unexpected incidence, and the severity thereof, associated with the clinical
uses, studies, investigations, tests and marketing of PRODUCTS and, to the
extent feasible, any other product containing VECTOR (hereinafter, a "PRODUCT"),
or VECTOR. For purposes of this Article 15, "UNEXPECTED" shall mean (x) for a
non-marketed Product, an experience that is not identified in nature, severity
or frequency in
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the current clinical investigator's confidential information brochure, and (y)
for a marketed Product, an experience which is not listed in the current
labeling for such Product, and includes an event that may be symptomatically and
pathophysiologically related to an event listed in the labelling but differs
from the event because of increased frequency or greater severity or
specificity.
Each Party further shall immediately notify the other of any information
received regarding any threatened or pending action by an agency which may
affect the safety and efficacy claims of a Product. Upon receipt of any such
information, the Parties shall consult with each other in an effort to arrive at
a mutually acceptable procedure for taking appropriate action; provided,
however, that nothing contained herein shall be construed as restricting either
Party's right to make a timely report of such matter to any government agency or
take other action that it deems to be appropriate or required by applicable law
or regulation.
ARTICLE 16 - SEVERABILITY.
Each Party hereby agrees that it does not intend to violate any public policy,
statutory or common laws, rules, regulations, treaty or decision of any
government agency or executive body thereof of any country or community or
association of countries. Should one or more provisions of this Agreement be or
become invalid, the Parties hereto shall substitute, by mutual consent, valid
provisions for such invalid provisions which valid provisions in their economic
effect are sufficiently similar to the invalid provisions that it can be
reasonably assumed that the Parties would have entered into this Agreement with
such provisions. In case such provisions cannot be agreed upon, the invalidity
of one or several provisions of this Agreement shall not affect the validity of
this Agreement as a whole, unless the invalid provisions are of such essential
importance to this Agreement that it is to be reasonably assumed that the
Parties would not have entered into this Agreement without the invalid
provisions.
ARTICLE 17 - MISCELLANEOUS.
17.1. NOTICES.
Any consent, notice or report required or permitted to be given or made
under this Agreement by one of the Parties hereto to the other shall be
in writing, delivered personally or by facsimile and promptly confirmed
by personal delivery, first class air mail or courier, postage prepaid
(where applicable), addressed to such other Party at its address
indicated below, or to such other address as the addressee shall have
last furnished in writing to the addressor and (except as otherwise
provided in this Agreement) shall be effective upon receipt by the
addressee.
~ IF TO VRI:
VIRUS RESEARCH INSTITUTE, INC.
00 Xxxxxxx Xxxxxx
Xxxxxxxxx XX 00000 XXX
Attention: President
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Telefax: (000) 000-0000
Telephone: (000) 000-0000
~ IF TO LICENSEE:
MERIEUX ORAVAX S.N.C.
c/o PASTEUR MERIEUX Serums & Vaccins S.A.
00, xxxxxx Xxxxxxx
00000 Xxxx, Xxxxxx
Attention: Senior Vice-President, Legal & Corporate Affairs and
General Counsel, Legal Department
Telefax: 00.0.00.00.00.00
Telephone: 00.0.00.00.00.00
ORAVAX MERIEUX CO.
c/o ORAVAX, INC.
00, Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000, XXX;
Attention: President & Chief Executive Officer
Telefax: (000) 000-0000
Telephone: (000) 000-0000
17.2. APPLICABLE LAW.
The Agreement shall be governed by and construed in accordance with the
laws of the State of Massachusetts, without regard to the conflict of
law principles thereof.
17.3. REPRESENTATIONS, WARRANTIES AND COVENANTS.
17.3.1. REPRESENTATIONS AND WARRANTIES OF MERIEUX ORAVAX S.N.C.
(a) Merieux OraVax S.N.C. is a Societe en Nom Collectif duly
organized and existing under the laws of France, with the
corporate power to own, lease and operate its properties and
to carry on its business as now conducted.
(b) Merieux OraVax S.N.C. has all necessary corporate power and
authority to enter into this Agreement and to consummate the
transactions contemplated hereby.
(c) The execution, delivery and performance of this Agreement by
Merieux OraVax S.N.C. does not conflict with or contravene the
statuts of Merieux OraVax S.N.C., nor will the execution,
delivery or performance of this Agreement conflict with or
result in a breach of, or entitle any party thereto to
terminate, any material agreement or instrument to which
Merieux OraVax S.N.C. is a party, or by which any of its
assets or properties are bound.
(d) This Agreement has been duly authorized, executed and
delivered by Merieux OraVax S.N.C. and constitutes a legal,
valid and binding agreement of Merieux OraVax S.N.C.,
enforceable against Merieux OraVax S.N.C. in accordance with
its terms, except as enforceability may be limited by
bankruptcy,
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insolvency, moratorium, reorganization or other similar laws
affecting creditors' rights generally.
17.3.2. REPRESENTATIONS AND WARRANTIES OF ORAVAX MERIEUX CO.
(a) OraVax Merieux Co. is a General Partnership duly organized and
existing under the laws of the State of Massachusetts, with
the corporate power to own, lease and operate its properties
and to carry on its business as now conducted.
(b) OraVax Merieux Co. has all necessary corporate power and
authority to enter into this Agreement and to consummate the
transactions contemplated hereby.
(c) The execution, delivery and performance of this Agreement by
OraVax Merieux Co. does not conflict with or contravene the
by-laws of OraVax Merieux Co., nor will the execution,
delivery or performance of this Agreement conflict with or
result in a breach of, or entitle any party thereto to
terminate, any material agreement or instrument to which
OraVax Merieux Co. is a party, or by which any of its assets
or properties are bound.
(d) This Agreement has been duly authorized, executed and
delivered by OraVax Merieux Co. and constitutes a legal, valid
and binding agreement of OraVax Merieux Co., enforceable
against OraVax Merieux Co. in accordance with its terms,
except as enforceability may be limited by bankruptcy,
insolvency, moratorium, reorganization or other similar laws
affecting creditors' rights generally.
17.3.3. REPRESENTATIONS, WARRANTIES AND COVENANTS OF VRI.
(a) VRI is a corporation duly incorporated and validly existing as
a corporation in good standing under the laws of the State of
Delaware, with the corporate power to own, lease and operate
its properties and to carry on its business as now conducted.
(b) VRI has all necessary corporate power and authority to enter
into this Agreement and to consummate the transactions
contemplated hereby.
(c) The execution, delivery and performance of this Agreement by
VRI does not conflict with or contravene its certificate of
incorporation or by-laws, nor will the execution, delivery or
performance of this Agreement conflict with or result in a
breach of, or entitle any party thereto to terminate, any
material agreement or instrument to which VRI is a party, or
by which any of its assets or properties are bound.
(d) This Agreement has been duly authorized, executed and
delivered by VRI and constitutes a legal, valid and binding
agreement of VRI, enforceable against VRI in accordance with
its terms, except as enforceability may be limited by
bankruptcy, insolvency, moratorium, reorganization or other
similar laws affecting creditors' rights generally.
(e) All LICENSED PATENTS listed on SCHEDULE A have been registered
in, filed in or issued by the appropriate patent offices of
each jurisdiction as indicated on such SCHEDULE A, and in each
case is currently in effect and all maintenance
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fees and renewals thereof have been duly made with respect
thereto. VRI owns or has full and exclusive rights to use and
exploit under licenses (and to license or sublicense) all its
rights under such LICENSED PATENTS and the LICENSED KNOW-HOW.
There have been no material claims made against VRI asserting
the invalidity or unenforceability of, or with respect to such
LICENSED PATENTS , the misuse of such LICENSED PATENTS or the
LICENSED KNOW-HOW, nor is VRI aware that any such claims
exist. VRI has not received a notice of conflict of such
LICENSED PATENTS or the LICENSED KNOW-HOW with the asserted
rights of others, or otherwise challenging its rights to use
any of such LICENSED PATENTS, or the LICENSED KNOW-HOW. EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH IN THIS SECTION, NEITHER
PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF
ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED
TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT, OR VALIDITY OF ANY PATENT RIGHTS
ISSUED OR PENDING.
17.4. DISPUTE RESOLUTION.
The Parties agree that if any dispute or disagreement arises between
LICENSEE on the one hand and VRI on the other in respect of this
Agreement, they shall follow the following procedure in an attempt to
resolve the dispute or disagreement.
(a) The Party claiming that such a dispute exists shall give
notice in writing ("NOTICE OF DISPUTE") to the other Party of
the nature of the dispute;
(b) Within twenty eight (28) business days of receipt of a Notice
of Dispute, a nominee or nominees of LICENSEE and a nominee or
nominees of VRI shall meet in person and exchange written
summaries reflecting, in reasonable detail, the nature and
extent of the dispute, and at this meeting they shall use
their reasonable endeavours to resolve the dispute;
(c) If, within a further period of twenty eight (28) business
days, the dispute has not been resolved or if, for any reason,
the required meeting has not been held, then the Parties agree
that any dispute shall be referred to an arbitrator appointed
by agreement of VRI and LICENSEE or, if no such agreement is
reached within sixty (60) business days after a Party
commences the arbitration, then by a panel of three
arbitrators, with each of LICENSEE and VRI to select one
arbitrator and those two arbitrators to select the third. If
all three arbitrators have not been selected within sixty (60)
business days after a Party commences the arbitration, then
the Parties agree to abide by the selection of the remaining
arbitrator to be named by a representative of the
International Chamber of Commerce.
The Parties agree that the Rules of the International Chamber
of Commerce shall govern such arbitration and that any
decision of the arbitrators shall be final and binding and
shall be enforceable in any court of competent jurisdiction
worldwide (regardless of whether one of the Parties fails or
refuses to participate in the arbitration) and shall be
enforced pursuant to the New-York Convention on the
Recognition and Enforcement of Arbitral Awards. The Parties
agree that all arbitrations shall be conducted in the English
language and that the exclusive venue of all arbitrations
shall be in London, England. The Party determined by the
arbitrators to be the Party
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substantially prevailing in the arbitration shall be entitled
to recover its legal and consultants' fees and other costs
reasonably incurred in connection with the arbitration (as
determined by the arbitrators); and
(d) in the event of a dispute regarding any payments owing under
this Agreement, all undisputed amounts shall be paid promptly
when due and the balance, if any, promptly after resolution of
the dispute.
17.5. ENTIRE AGREEMENT.
This Agreement contains the entire understanding of the Parties with
respect to the subject matter hereof. All express or implied agreements
and understandings, either oral or written, heretofore made [-] are
expressly superseded by this Agreement. This Agreement may be amended,
or any term hereof modified, only by a written instrument duly executed
by both Parties hereto.
17.6. INDEPENDENT CONTRACTORS.
VRI and LICENSEE each acknowledge that they shall be independent
contractors and that the relationship between the two Parties shall not
constitute a partnership, joint venture or agency. Neither VRI nor
LICENSEE shall have the authority to make any statements,
representations or commitments of any kind, or to take any action,
which shall be binding on the other Party, without the prior consent of
the other Party to do so.
17.7. AFFILIATES.
Each Party shall cause its respective Affiliates to comply fully with
the provisions of this Agreement to the extent such provisions
specifically relate to, or are intended to specifically relate to, such
Affiliates, as though such Affiliates were expressly named as joint
obligors hereunder.
17.8. WAIVER.
The waiver by either Party hereto of any right hereunder or the failure
to perform or of a breach by the other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure
by said other Party whether of a similar nature or otherwise.
17.9. NO IMPLIED LICENCE.
Nothing in this Agreement shall be deemed to constitute, by implication
or otherwise, the grant by LICENSEE to VRI, or by VRI to LICENSEE, of
any license to, or interest in, or other rights under any patent,
patent application, proprietary
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know-how, trade secrets or other intellectual property rights owned or
possessed by LICENSEE or VRI, whichever is applicable, except as
expressly provided for herein.
17.10. COUNTERPARTS.
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.
For VIRUS RESEARCH INSTITUTE, INC.
By: /S/ J. Xxxxxx Xxxx
-------------------------
Name: J. Xxxxxx XXXX
Title: Chairman & Chief Executive Officer.
For MERIEUX ORAVAX S.N.C.
By: /s/ Xxxx-Xxxxxxx Xxxxxxxx
---------------------------------------
Name: PASTEUR MERIEUX Serums & Vaccins S.A.
Associe Gerant, represented by Xxxx-Xxxxxxx XXXXXXXX,
Chairman, President & Chief Executive Officer
By: /s/ Xxxxx X. Xxxxxx
---------------------------------------
Name: ORAVAX JVM, Inc., Associe, represented by
Xxxxx X. XXXXXX, President and Chief Executive Officer
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For ORAVAX MERIEUX, CO.
By: /s/ Herve Tainturier
---------------------------------------
Name: MERIEUX AMERICA HOLDINGS, Inc.
General Partner, represented by Herve TAINTURIER, President
By: /s/ Xxxxx X. Xxxxxx
---------------------------------------
Name: ORAVAX JVM, Inc., general partner,
represented by Xxxxx X. XXXXXX, President
OraVax and PMC each hereby guarantee that their respective Affiliates, including
but not limited to Merieux OraVax S.N.C. and OraVax Merieux Co., shall perform
all obligations which are expressly imposed upon them pursuant to and in
accordance with this Agreement, and that OraVax and PMC shall each be bound by
the terms and conditions of this Agreement imposed on LICENSEE as if OraVax and
PMC were parties to this Agreement.
For ORAVAX INCORPORATED
By: /s/ Xxxxx X. Xxxxxx
---------------------------------------
Name: Xxxxx X. XXXXXX
Title: President & Chief Executive Officer
For PASTEUR MERIEUX SERUMS & VACCINS S.A.
By: /s/ Xxxx-Xxxxxxx Xxxxxxxx
------------------------------------
Name: Xxxx-Xxxxxxx XXXXXXXX
Title: Chairman, President & Chief Executive Officer.
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CONFIDENTIAL TREATMENT
-----------------------------------
SCHEDULE A
------------
LICENSED PATENTS
-----------------------------------
[*]
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
29
30
CONFIDENTIAL TREATMENT
------------------------------------------------
SCHEDULE B
------------
LIST OF HPC ANTIGENS
------------------------------------------------
[*]
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
30
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-------------------------------------------------
APPENDIX A
------------
TERMS AND CONDITIONS APPLICABLE
TO RESEARCH CONTRACT
-------------------------------------------------
1. OBJECT.
Pursuant to a mutually agreed upon research program which shall be
definitely established by the Research Committee referred to in Section
2. hereinafter on terms substantially in accordance with the draft
research program attached hereto as EXHIBIT+1 (the "RESEARCH PROGRAM"),
VRI agrees to conduct research works described therein and LICENSEE
agrees to support and fund such Research Program in accordance with the
terms and conditions set forth here below.
2. OVERSIGHT OF THE RESEARCH PROGRAM.
2.1. OVERSIGHT. The Research Program shall be overseen and monitored by the
Research Committee as described herein (the "COMMITTEE").
2.2. MEMBERSHIP. VRI and LICENSEE shall each appoint two (2) persons (or
such other number of persons as the Parties may determine) to serve on
the Committee. Such representatives shall be qualified, by reason of
background and experience, to assess the scientific progress of the
Research Program. Each Party shall have the right to change its
representation on the Committee upon written notice sent to the other.
2.3. CHAIR. The Committee shall be chaired by one representative of
LICENSEE.
2.4. RESPONSIBILITIES. The Committee shall have authority to:
(i) review and approve the draft Research Program and establish
the definitive Research Program;
(ii) make recommendations regarding the performance of the Research
Program and the conduct of research works pursuant thereto,
and monitor performance thereunder;
(iii) modify the Research Program as it determines, for each twelve
(12) month period during the term thereof;
(iv) review any and all proposed publication or communication
relating to the Research Program and the results therefrom;
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32
(v) review any and all proposed filings of patent applications in
connection with the Research Program.
2.5. MEETINGS. The Committee shall meet not less than two (2) times a year
during the term of the Research Program, at such dates and times as
agreed to by the Parties. Meetings in person shall normally take place
at VRI's premises or such other place as may be mutually agreed upon.
Meetings may be held by telecommunication means. At such meetings, the
Committee shall discuss the Research Program and the status of
performance by VRI under the Program, evaluate the results thereof and
set priorities therefor. The Committee shall prepare written minutes of
each meeting and a written record of all decisions whether made at a
formal meeting or not. Such minutes shall incorporate semi-annual
research reports prepared by VRI.
3. THE PRINCIPAL INVESTIGATOR.
3.1. PRINCIPAL INVESTIGATOR. The Principal Investigator of the Research
Program shall be Xx Xxxxx XXXXXXX, an employee of VRI ("PRINCIPAL
INVESTIGATOR"). VRI shall consult with LICENSEE regarding any
replacement of the Principal Investigator, PROVIDED, however, that VRI
shall have the right to make, and shall make, the final determination
regarding any such replacement. The Principal Investigator shall be
appointed as a member of the Committee and may be designated by VRI to
act on behalf of VRI as co-chair on such Committee.
3.2. DUTIES. The Principal Investigator shall direct the Research Program
and coordinate the efforts of other researchers involved in the
performance of such Program. The Principal Investigator shall sit with
the Committee as provided in Section 2. hereof, shall contribute to the
performance of the duties set forth hereunder and shall be afforded the
opportunity to actively participate in all Committee deliberations. The
Principal Investigator shall provide reasonably detailed status reports
of the Research Program to the Committee at six-month intervals, as
well as at the earliest practicable time whenever, in the Principal
Investigator's judgment, an invention is created or reduced to
practice. The Principal Investigator shall devote such time and efforts
as may be required to fulfill his duties hereunder and to ensure the
successful administration and coordination of the Research Program.
3.3. REPLACEMENT. The Principal Investigator may be replaced at any time
upon the written request of either Party. In such event, or if the then
existing Principal Investigator is no longer able or is unwilling so to
serve, the Parties shall endeavour to find a mutually acceptable
substitute. If no mutually acceptable substitute can be agreed upon
within a reasonable time, then HPC shall have the right to terminate
forthwith the Research Program, and effect of such termination shall be
as provided for in Section 6.2 hereof, it being understood that
termination of the Research Program shall not entail termination of,
and shall be without any prejudice whatsoever to, the License
Agreement.
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CONFIDENTIAL TREATMENT
4. CONDUCT OF RESEARCH PROGRAM.
4.1. GOOD LABORATORY PRACTICES. The Research Program shall be conducted by
VRI at VRI's laboratories. VRI shall use all reasonable efforts to
complete research works in accordance with the said Program. Any
research work performed by VRI pursuant hereto shall be in compliance
with current Good Laboratory Practices (cGLP) as applicable in the
United States of America.
4.2. LABORATORY NOTEBOOKS. VRI shall cause its employees to maintain
laboratory notebooks. Such laboratory notebooks shall set forth such
work in detail, including a clear description of the purposes for which
the work has been undertaken and the results expected; sufficient
details, diagrams, plans, sketches and identification of materials
used, formulations and operating conditions under which the work was
conducted as may be necessary to understand and reproduce the work
conducted; identification of any intermediate or final results
achieved; and if such laboratory notebooks contain any interpretations
of data, they shall also describe the rough data upon which such
interpretations have been based. VRI shall further cause its employees,
agents and permitted subcontractors maintaining such laboratory
notebooks to have their work corroborated periodically, which
corroboration shall include at least personal witnessing of the
notebooks indicating that the witness has read and understood the
material on the page witnessed on the date that he or she signed it.
5. FINANCIAL CONDITIONS.
5.1. SUPPORT COMMITMENT. In consideration of the work performed by VRI
pursuant to and in accordance with the Research Program, LICENSEE shall
make available to VRI during the Research Program a maximum of [*] (the
"Commitment"). The Commitment shall be inclusive of all costs incurred
by VRI implementing the Research Program.
5.2. PAYMENTS SCHEDULE. Support payments shall be made by LICENSEE to VRI in
one single payment within fifteen (15) days of the Effective Date of
this Agreement.
5.3. REPORTING. VRI shall report and reconcile budgeted versus actual
expenditures on a semi-annual basis. Two copies of the semi-annual
report shall be sent to HPC. Upon reasonable advance request and at
reasonable times (but not on more than two occasions), HPC shall have
the right on demand to receive full and true financial information
regarding any and all matters affecting compliance with Research
Program and any amounts funded hereunder and to inspect the relevant
books and records of VRI relating thereto, at HPC expenses, using
representatives of its choice. VRI's books of account and all necessary
supporting data shall be kept for at least three (3) years following
the end of the fiscal year to which each will pertain. In the event
that amounts funded pursuant hereto exceeds actual
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
33
34
expenditures incurred by VRI, VRI shall promptly reimburse such excess
to HPC, unless the Parties mutually agree on an extension of the
Research Program which would require consummation of such excess.
5.4. NO CONFLICT WITH RESEARCH PROGRAM. VRI agrees that the Commitment
provided by LICENSEE shall be applied to the Research Program and may
not, without LICENSEE prior written approval, be used in support of any
other research at VRI.
5.5. TITLE TO EQUIPMENT. VRI shall retain title to any equipment purchased
with funds provided by LICENSEE under this Agreement, if such purchase
is mutually agreed upon as part of the Research Program budget.
6. TERM OF THE RESEARCH PROGRAM.
6.1. The term of the Research Program shall be twelve (12) months as from
January 1, 1997, unless terminated earlier upon termination of this
Agreement in accordance with Article 10 of the License Agreement.
6.2. HPC shall be entitled to forthwith terminate the Research Program and
cease funding thereof (i) in the event of disagreement between the
Parties as to the replacement of the Principal Investigator under
Section 3.3 hereinabove, and (ii) in the event of a material breach by
VRI of any VRI's obligations and covenants hereunder. In the event of
any such termination, VRI shall reimburse HPC of any amounts paid by
HPC and found in excess of VRI's actual expenditures (reasonable
termination costs excluded) further to an accounting audit conducted in
accordance with Section 5.3 above. VRI's right to receive any unpaid
balance otherwise committed by HPC as support commitment to the
Research Program pursuant to Section 5.1 hereof shall become forfeited
and no further payments with respect to Research Program shall be due
to VRI by HPC. Termination of the Research Program pursuant to this
Section 6.2. shall not entail termination of, and shall be without any
prejudice whatsoever to the License Agreement.
7. CONFIDENTIALITY.
In order to facilitate the Research Program, either Party may disclose
confidential or proprietary information owned or controlled by it to
the other. It is hereby understood and agreed that such information
shall be deemed "CONFIDENTIAL INFORMATION" as defined in Article 8 of
the License Agreement and treated as such.
8. PUBLICATIONS.
Each Party shall have the right to publish or present the Results of
the Research Program and announce scientific progress of the Research
Program, provided such publication, presentation or announcement (and
any revisions thereof, a "Publication") is submitted to the other Party
through the Committee at least sixty (60) days prior to submitting it
to any Third-Party (including any editing person). The other Party
shall have sixty (60) days after receipt of the draft Publication to
review
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35
and comment on such draft. Upon notice within such sixty (60) day
period by the other Party that such Party reasonably believes the
Publication would amount to the public disclosure of a patentable
invention upon which a patent application should be filed prior to any
such disclosure, submission of the concerned Publication to
Third-Parties shall be delayed for a ninety (90) day period from the
date of said notice, or for such longer period which may appear
necessary for appropriately drafting and filing a patent application
covering such invention. If the other Party reasonably believes that
the Publication would amount to the public disclosure of such other
Party's Confidential Information, said other Party may request deletion
of such information from the proposed Publication. In addition, each
Party shall duly take into account comments made by the other Party on
any Publication and shall accept to have employees or others acting on
behalf of the other Party be mentioned as co-authors on any Publication
describing results to which such persons will have contributed.
9. INVENTIONS.
Ownership of inventions, whether or not patentable, and of any patent
applications and patents based thereon, which may result from the
Research Program (the "RESEARCH INVENTIONS") shall be established in
accordance with the following:
(i) Any Research Invention which is solely directed to the VRI
Technology and/or VECTOR, per se, shall be owned by VRI and
automatically licensed by VRI to HPC subject to and in
accordance with the LICENSE, except that if any such invention
is patented, the term of the corresponding patent shall not be
taken into account to determine the Royalty Term;
(ii) Any Research Invention solely directed to an HPC Antigen or an
Other Hp Antigen, shall be owned by HPC;
(iii) Any Research Invention which is directed to the combination of
the VRI Technology and an antigen or antigens or another piece
of technology controlled by HPC rather than antigens in
general, shall be jointly owned by VRI and HPC and be
considered a Joint Invention. VRI's interest in such Joint
Invention shall be deemed automatically licensed by VRI to HPC
subject to and in accordance with the LICENSE, except that if
any such invention is patented, the term of the corresponding
patent shall not be taken into account to determine the
Royalty Term. Except for the rights granted to HPC in the
Field of Use under the LICENSE, neither Party shall exploit a
Joint Invention without the prior agreement in writing of the
other Party, provided VRI may request HPC to enter into good
faith negotiations if VRI wishes to exploit any such Joint
Invention outside the Field of Use or within the scope of the
non-exclusive LICENSE.
(iv) Any Research Invention which is directed to the combination of
VRI Technology and to antigens in general shall be owned by
VRI and automatically licensed by VRI to HPC, subject to and
in accordance with the LICENSE, except that if any such
invention is patented, the term of the corresponding patent
shall not be taken into account to determine the Royalty Term.
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CONFIDENTIAL TREATMENT
-----------------------------------------------
APPENDIX B
-----------
TERMS AND CONDITIONS APPLICABLE TO
VECTOR SUPPLY
-----------------------------------------------
1. THE SUPPLY AGREEMENT. VRI has stated to LICENSEE its current intention
to establish itself as a manufacturer of the VECTOR. Provided VRI can
reasonably demonstrate that it shall be able to timely manufacture
VECTOR under current Good Manufacturing Practice at competitive cost in
sufficient quantities, LICENSEE shall purchase from VRI LICENSEE's
requirements for VECTOR for use in the manufacture of PRODUCTS under
the terms and conditions of a supply agreement (the "SUPPLY
AGREEMENT"), which agreement shall be negotiated in good faith in a
timely fashion by the Parties hereto so as to become effective at least
six months before LICENSEE's expected First Commercial Sale of
PRODUCTS. The Parties agree to negotiate in good faith in a timely
fashion the detailed terms and conditions of the Supply Agreement which
shall include at a minimum the following terms and conditions set forth
in this Article 1, as well as such other terms and conditions as may be
agreed upon by the Parties.
2. VECTOR REQUIREMENTS. The Supply Agreement shall provide that VRI shall
manufacture or have manufactured and LICENSEE shall purchase from VRI,
LICENSEE's entire requirements of VECTOR (clinical lots as well as
commercial lots) for PRODUCTS and that LICENSEE shall purchase such
VECTOR for its own use in manufacturing PRODUCTS only and shall not be
permitted to sell or re-sell VECTOR to any Third-Party.
3. SPECIFICATIONS. The Supply Agreement shall provide for (i)
specifications that VRI shall be obligated to comply with; (ii)
quality control criteria and procedures; and (iii) LICENSEE's
reasonable acceptance criteria for the VECTOR.
4. FORECASTS AND ORDERS. The Supply Agreement shall provide for the
establishment of reasonable rolling forecasts and placement of orders
which shall take into account VRI's need to rationally plan its
manufacturing of VECTOR consistent with its other manufacturing
obligations.
5. PRICE. The price of VECTOR shall be negotiated in good faith by the
Parties and set forth in the Supply Agreement, but in no event shall
such price be for less than [*].
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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37
6. BACK-UP INVENTORIES. Pursuant to the Supply Agreement, VRI shall agree
to supply, and LICENSEE shall agree to maintain inventory of VECTOR in
its own facility sufficient to meet its forecasted needs.
7. WARRANTIES. Pursuant to the Supply Agreement, VRI shall warrant that
(i) VECTOR at the time of delivery shall meet the specifications
referred to in Section 3. hereinabove; (ii) VECTOR shall be
manufactured in accordance with current Good Manufacturing Practices in
effect in the country where it is manufactured or in compliance in all
material respects with the principles of the current Good Manufacturing
Practices in effect in any other country where PRODUCTS are
manufactured and/or sold (if more stringent than cGMP first referred
above) and any relevant establishment and product licenses issued by
any public health authority having jurisdiction. LICENSEE shall inform
VRI of the countries in which PRODUCT is to be licensed to be sold and
of any and all Agency(ies) responsible in such countries. Upon request,
LICENSEE shall provide VRI with information regarding the regulatory
requirements in each such country. VRI SHALL DISCLAIM ANY OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS.
8. QUALITY AUDIT. Pursuant to the Supply Agreement, VRI shall permit
LICENSEE, upon reasonable notice and at reasonable times, at LICENSEE's
expense, to audit in cooperation with VRI's personnel production,
packaging, quality control and forwarding facilities of VRI and any of
its significant suppliers as they relate to VRI's manufacturing
responsibilities under the Supply Agreement.
9. ADVERSE EVENTS REPORTING. Under the Supply Agreement, the Parties shall
establish a procedure for monitoring and reporting adverse drug
experiences, consistent with Article 15 of the License Agreement.
10. ASSURANCE OF SUPPLY. Under the terms of the Supply Agreement, LICENSEE
and VRI shall cooperate to anticipate LICENSEE's reasonable long-term
requirements for VECTOR, and VRI shall take reasonable measures to
assure that LICENSEE's reasonable requirements can be met, which
measures may include the qualification of more than one manufacturing
facility (including one such facility that may be operated by LICENSEE
or an Affiliate of LICENSEE, in which case VRI shall transfer
manufacturing Know-how in accordance with Section 11 hereinafter)
and/or maintenance of safety stocks of VECTOR as provided for in
Section 6 hereof.
11. TRANSFER OF MANUFACTURING TECHNOLOGY.
The Supply Agreement shall contain provisions for the compulsory
transfer of Manufacturing Know-How from VRI to HPC under certain
circumstances such as, but not necessarily limited to, durable failure
to supply by VRI, VRI's Affiliates or contractors, VRI's material
breach of the Supply Agreement or VRI's bankruptcy.
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12. NO ASSIGNMENT ; NO SUB-CONTRACT. VRI shall neither assign nor
sub-contract any part of its rights and obligations under this APPENDIX
B, or any part of its manufacturing responsibility under the Supply
Agreement, to any third Party without the prior written agreement of
LICENSEE which shall not unreasonably withheld.
13. LIABILITIES, INDEMNIFICATION AND INSURANCE. The Supply Agreement shall
include provisions relating to liabilities, indemnification and
insurance substantially similar to the provisions of the Indemnity
Agreement herewith attached as EXHIBIT 1.
---------------------------------------------
EXHIBIT 1
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INDEMNITY AGREEMENT
---------------------------------------------
WHEREAS, HPC (hereinafter called "Purchaser") and VRI (hereinafter called
"Supplier") have entered into a License Agreement (the "License") relating to
the use of a certain VECTOR (the "VECTOR") known as VibrioVec for use as a
delivery system in vaccines against Helicobacter pylori infections, dated as of
December 1, 1997;
WHEREAS, pursuant to the License, Supplier has agreed to sell, and Purchaser has
agreed to purchase, certain quantities of VECTOR, under terms and conditions set
forth in short form in the relevant provisions contained in APPENDIX B of the
License and to be finally established in a Supply Agreement to be negotiated in
good faith in a timely manner by the parties hereto;
WHEREAS, Purchaser is planning to enter into human clinical trials using VECTOR;
WHEREAS, in order to allow these actions to be timely undertaken, the parties
have agreed to set-up terms and conditions applicable to liabilities and
indemnification in connection with the early supply of clinical lots of VECTOR
which have previously been supplied to Purchaser, in advance of entering into
the definitive Supply Agreement.
NOW, THEREFORE, in consideration of the premises herein and for other good and
valuable consideration, the parties hereto agree as follows:
1. PURPOSE.
This Agreement shall set forth the terms and conditions under which
Purchaser shall provide and maintain insurance coverage and indemnify
Supplier in certain circumstances in connection with the use of VECTOR
by Purchaser in human clinical trials.
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2. INSURANCE.
Each party, at its own expense, will maintain, with insurers which are
rated A or better by A.M. BEST, a General Product Liability,
Environmental and, in the case of Purchaser, Clinical Trial insurance
program(s) in an amount commensurate with the risks incurred. Purchaser
will cause (a) Supplier to be named as an additional insured under
Purchaser's General & Product Liability and Environmental Liability
insurance policies (but under those policies only and with coverage
limited to Claims as defined in Section 4 hereof), (b) such insurance
to be designated as primary to any insurance which may be carried by
Supplier, and (e) such insurance to provide that it can only be
cancelled or materially altered upon not less than thirty (30) days
notice to Supplier. Purchaser shall not assert against Supplier and
hereby waives any and all claims against Supplier for losses, damages,
liability, judgments, costs and expenses (including attorney's fees)
imposed upon or incurred by Purchaser as a result of or arising out of
any claim covered by such insurance to the extent of such coverage and
to the extent Purchaser will have agreed to indemnify Supplier pursuant
to Section 4 hereinafter.
3. INSURANCE CERTIFICATES.
Prior to issuing the first purchase order to Supplier and from time to
time thereafter as reasonably required by Supplier, Purchaser shall
furnish Supplier with (an) insurance certificate(s) evidencing
compliance with Insurance Section above, and reciprocally.
4. INDEMNITY.
Notwithstanding the existence or lack of insurance, Purchaser shall, at
its sole cost and expense, defend Supplier from any and all claims,
demands, actions or causes of action, at law or in equity (including
but not limited to claims by Purchaser's employees and customers and
including an environmental liability) (a "Claim") and indemnify and
hold Supplier harmless from all damages, liabilities, losses, costs,
judgments, orders, assessments, interest, penalties, fines, settlement
payments, costs and expenses (including, without limitation, reasonable
attorneys fees and other investigation and defense costs and expenses)
incurred by Supplier which arise out of or result in any way from
bodily injury (including death) or property damage, however arising out
of, or related in any way, to Purchaser's possession, use, sale,
distribution, processing, shipment, storage or disposal of the VECTOR
or any derivative thereof sold or otherwise transferred by Supplier to
Purchaser for the purpose described in the preamble to this Agreement.
Purchaser shall have the duty to defend, indemnify and hold Supplier
harmless against any actual or alleged negligence by Supplier. In the
event that Purchaser fails to promptly and diligently investigate and
defend or settle any Claim then Supplier shall have the right, at
Purchaser's cost, expense and risk, from that time forward to have sole
control of the defense of the Claim and all negotiations for its
settlement or compromise.
Notwithstanding the foregoing, the INDEMNITY provided for hereinabove
shall not apply to the extent that the Claim arises out of, is based
upon or results from the gross negligence or willful misconduct (which
shall include misrepresentation or concealment of data relating to
toxicity of VECTOR) of Supplier, or an event having occurred before
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the time that title to VECTOR (or to any shipment or unit thereof)
passes to Purchaser, in which cases Supplier shall defend, indemnify
and hold Purchaser harmless in the same manner and to the same extent
than provided for hereinabove where Purchaser is the indemnifying
party, and PROVIDED further that, in any event, the INDEMNITY provided
for hereinabove shall not apply to the extent the Claim is a claim for
environmental liability arising out of, based upon or resulting from an
event occurring at a Supplier's facility or a facility of a supplier's
sub-contractor, or at any other place (including during transportation)
prior to the time title to VECTOR (or to any shipment or unit thereof)
passes to Purchaser.
The Indemnity provided for herein shall be limited to Claims relating
to units of VECTOR sold or otherwise transferred by Supplier to
Purchaser for the purpose described in the preamble to this Agreement,
as identified in the invoices and/or control certificates and other
commercial and pharmaceutical documentation issued by Supplier to
Purchaser along with the delivery of such units of VECTOR.
5. COSTS & EXPENSES.
The indemnities in INDEMNITY Paragraph of this Agreement include all
costs and expenses reasonably required to investigate and to defend any
such claim or action, any amount paid or required to be paid to settle
such claim or action, or any amount paid or required to be paid to
settle such claim or action, or any amount finally awarded by a court
as damages or otherwise in any such action, provided that neither party
will have an obligation to pay or to reimburse the other party for the
amount of any internal expenses (including, but not limited to,
compensation paid to its employees) that it may incur in connection
with its cooperation in the investigation and/or defense of such claim
or action.
6. LIMITATION OF LIABILITY.
IN NO EVENT SHALL ANY PARTY HAVE ANY LIABILITY TO THE OTHER PARTY
HEREUNDER OR OTHERWISE FOR ANY LOSS OF PROFITS, COST OR COVER OR ANY
SPECIAL, CONSEQUENTIAL, INCIDENTAL, INDIRECT OR PUNITIVE DAMAGES,
HOWEVER CAUSED, WHETHER BY THE OTHER PARTY'S BREACH OF ANY EXPRESS OR
IMPLIED WARRANTY, NEGLIGENCE, STRICT LIABILITY UNDER LAW OR OTHERWISE.
7. SURVIVAL.
The provisions of this Agreement shall survive the expiration and/or
termination of this Agreement, unless this Agreement is superseded by
the Supply Agreement, in which case the provisions relating to
Liabilities and Indemnification contained in said Supply Agreement will
supersede this Agreement.
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CONFIDENTIAL TREATMENT
CONFlDENTIAL
Exhibit I to Appendix A
RESEARCH PROPOSAL
APPLICATION OF VIBRIOVEC(TM) AND ATTENUATED SALMONELLA AS
LIVE ORAL VECTORS FOR PM-O
PROPRIETARY H. PYLORI ANTIGENS
[*]
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission. A total of 8 pages have been omitted from this
Exhibit 1 to Appendix A.
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