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CONFIDENTIAL MATERIAL OMITTED
AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
EXHIBIT 10.26
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LICENSE AGREEMENT
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This Agreement is entered this 25th day of March, 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 N[degree symbol] 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 Massachusetts, having its principal place of business
at 00 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx, XXX,
(the parties numbered and above are individually and collectively
hereinafter referred to as "LICENSEE" or "HPC")
WITNESSETH
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WHEREAS, VRI has developed certain confidential and/or proprietary information,
patents and patent applications and material relating to the polymer called
polyphosphazene ("PCPP") as an immunoadjuvant 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, Massachusetts, 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 PcPP in 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 COMPOUND 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) "COMPOUND" means a polymer that is a synthetic polyphosphazene
derivative, including but not limited to the polyphosphazene known
as Adjumer(TM);
(e) "COMPOUND IMPROVEMENTS" means all patentable or non-patentable
inventions, discoveries, technology and information of any type
whatsoever, which add to the knowledge of the COMPOUND 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 COMPOUND, 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 COMPOUND 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 COMPOUND, chemical and
analytical methods and data, COMPOUND 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;
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(iv) any future patents and patent applications covering VRI
COMPOUND Improvements SOLELY OR JOINTLY owned or licensed
by VRI or its Affiliates with the right to sublicense.
(m) "LICENSEE COMPOUND IMPROVEMENTS" means COMPOUND 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, 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 COMPOUND, or to the manufacturing of
PRODUCTS shall not be included in LICENSEE COMPOUND Improvements.
LICENSEE COMPOUND 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 COMPOUND or to use COMPOUND for
the formulation of PRODUCTS or to practice under the LICENSED
PATENTS to the extent such Patents relates to the manufacturing of
COMPOUND; 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 COMPOUND, any and all analytical procedures,
procedures for and specifications of quality-assurance and
quality-control.
(o) "MATERIALS" shall mean any biological materials and chemical
compound 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 compound, 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
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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.
(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 COMPOUND 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,
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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 COMPOUND.
(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.
(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 COMPOUND IMPROVEMENTS" means COMPOUND 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 COMPOUND Improvements
shall be deemed to include VRI's interest in any Joint Inventions.
(zz) "VRI TECHNOLOGY" means the LICENSED PATENTS, the COMPOUND, the
Manufacturing Know-How, the LICENSED KNOW-HOW and the VRI COMPOUND
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"):
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(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 COMPOUND Improvements; and
(ii) a license in the Territory to make, have made and use the COMPOUND
under the LICENSED PATENTS, and by using the Manufacturing
Know-How and VRI COMPOUND 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 COMPOUND 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 COMPOUND, 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 COMPOUND 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 COMPOUND
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 COMPOUND 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
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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 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-
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contract manufacturing of PRODUCTS and/or COMPOUND 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 COMPOUND 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 COMPOUND for the formulation of PRODUCTS in
the Field of Use on the terms 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 COMPOUND, 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 COMPOUND 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 COMPOUND 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
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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, COMPOUNDS 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.
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 COMPOUND.
VRI hereby represents and warrants that any and all quantities of
COMPOUND 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 COMPOUND shall be manufactured and shall meet
COMPOUND 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 COMPOUND 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 COMPOUND with
knowledge of the non-compliance hereunder), in which case VRI shall
indemnify LICENSEE as provided herein.
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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 may agree to have part of the research and development
work with respect to PRODUCTS sub-contracted to VRI, in which case such
research contract shall be subject to the terms and conditions set forth
in APPENDIX A.
LICENSEE and VRI may agree to have COMPOUND 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 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.
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CONFIDENTIAL TREATMENT
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 COMPOUND 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) [*]
(b) [*]
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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CONFIDENTIAL TREATMENT
(c) [*]
(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.
5.2. AUDITS.
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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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.
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.
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CONFIDENTIAL TREATMENT
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 N[degree symbol]: [*]
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 COMPOUND, 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.
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,
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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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 COMPOUND 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 COMPOUND 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 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.
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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. Notwithstanding 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 COMPOUND 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
COMPOUND 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 COMPOUND 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
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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.
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.
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(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.
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 COMPOUND, except in each case to the
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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 COMPOUND is concerned.
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.
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ARTICLE 13 - ASSIGNMENT.
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 Sates
Drug Price Competition and Patent Term Restoration Act of 1984 (hereinafter
called the "Act"), including notices pursuant to secs. 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.
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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 COMPOUND (hereinafter, a
"PRODUCT"), or COMPOUND. 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 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
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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
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: Corporate Vice-President, Secretary 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
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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, 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
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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 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
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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
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 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.
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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
For ORAVAX MERIEUX, CO.
By: /s/ Herve Tainturier
------------------------------------------------------------
Name: MERIEUX AMERICA HOLDINGS, Inc.
General Partner, represented by Herve TAINTURIER,
President
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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.
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CONFIDENTIAL TREATMENT
----------------------------------
SCHEDULE B
----------
LIST OF HPC ANTIGENS
----------------------------------
[*]
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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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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(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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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 accordance with the Research Program, LICENSEE shall
make available to VRI during the Research Program a maximum of ________
United States dollars (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
............ quarterly payments of ....................... in advance
with the first payment to be made within fifteen (15) days of the
Effective Date of this Agreement, and the other payments payable on the
first day of each of the .......... subsequent Calendar Quarters.
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
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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 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.
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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
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 COMPOUND, 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
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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
COMPOUND SUPPLY
-------------------------------
1. THE SUPPLY AGREEMENT. VRI has stated to LICENSEE its current intention
to establish itself as a manufacturer of the COMPOUND. Provided VRI can
reasonably demonstrate that it shall be able to timely manufacture
COMPOUND under current Good Manufacturing Practice at competitive cost
in sufficient quantities, LICENSEE shall purchase from VRI LICENSEE's
requirements for COMPOUND 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. COMPOUND REQUIREMENTS. The Supply Agreement shall provide that VRI shall
manufacture or have manufactured and LICENSEE shall purchase from VRI,
LICENSEE's entire requirements of COMPOUND (clinical lots as well as
commercial lots) for PRODUCTS and that LICENSEE shall purchase such
COMPOUND for its own use in manufacturing PRODUCTS only and shall not be
permitted to sell or re-sell COMPOUND 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 COMPOUND.
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 COMPOUND consistent with its other manufacturing
obligations.
5. PRICE. The price of COMPOUND shall be negotiated in good faith by the
Parties and set forth in the Supply Agreement, but in no event shall
such price be [*].
/*/ Confidential material omitted and filed separately with the Securities and
Exchange Commission.
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6. BACK-UP INVENTORIES. Pursuant to the Supply Agreement, VRI shall agree
to supply, and LICENSEE shall agree to maintain inventory of COMPOUND in
its own facility sufficient to meet its forecasted needs.
7. WARRANTIES. Pursuant to the Supply Agreement, VRI shall warrant that (i)
COMPOUND at the time of delivery shall meet the specifications referred
to in Section 3. hereinabove; (ii) COMPOUND 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 COMPOUND, 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 COMPOUND 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
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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 compound (the "Compound") known as polyphosphazene for use
as an adjuvant and/or a delivery system in vaccines against Helicobacter pylori
infections, dated March ....., 1997;
WHEREAS, pursuant to the License, Supplier has agreed to sell, and Purchaser has
agreed to purchase, certain quantities of Compound, 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
Compound;
WHEREAS, Supplier has already obtained clinical trial supplies of Compound under
a development agreement with a third-party and is planning to set-up a
sub-contract for having Compound manufactured by a third-party manufacturer,
AeroJet General Corporation of Akron, Ohio, United States of America (the
"SUBCONTRACTOR");
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 Compound
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 Compound
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 and Sub-contractor 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 or
Sub-contractor 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 Compound 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 willfull misconduct (which
shall include misrepresentation or concealment of data relating to
toxicity of Compound) of Supplier, or an event having occurred before
the time that title to Compound (or to any shipment or unit thereof)
passes to Purchaser, in which cases Supplier shall defend, indemnify and
hold Purchaser harmless in the
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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 at a Sub-contractor's facility, or a facility of another
Supplier's sub-contractor, or at any other place (including during
transportation) prior to the time title to Compound (or to any shipment
or unit thereof) passes to Purchaser.
The Indemnity provided for herein shall be limited to Claims relating to
units of Compound 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 Compound.
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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