EXHIBIT 10.10
OVERVIEW AGREEMENT
THIS AGREEMENT is entered into as of January 25, 1999 by and between
Peptide Therapeutics Limited, a corporation organized and existing under the
laws of England and Wales ("Limited"), and Pasteur Merieux Serums & Vaccins
S.A., a societe anonyme existing and organized under the laws of the Republic of
France ("PMC"). Capitalized terms used but not otherwise defined herein shall
have the meanings assigned to them in that certain Master Agreement dated as of
March 31, 1995 by and between PMC and OraVax, Inc. ("OraVax").
WHEREAS, Peptide Therapeutics Group plc ("Peptide"), Peach Acquisition
Corp. ("Peach") and OraVax, Inc. have entered into an Agreement and Plan of
Acquisition, dated November 10, 1998 (the "Merger Agreement"), whereby OraVax is
to be merged with and into Peach by way of a merger (the "Merger") with OraVax
as the surviving corporation;
WHEREAS, Peptide has transferred all of the issued and outstanding
stock of Peach to Limited;
WHEREAS, effective upon the effective time of the Merger (the
"Effective Time"), OraVax will become a wholly-owned subsidiary of Limited;
NOW, THEREFORE, in consideration of the mutual agreements herein set
forth and for other good and valuable consideration the receipt of which is
hereby acknowledged, the parties hereby agree as follows:
ARTICLE I
COVENANTS, REPRESENTATIONS AND ACKNOWLEDGEMENTS OF LIMITED
1.1 At the Effective Time and subject to satisfaction of the conditions
to effectiveness set forth in Article III hereof, Limited hereby covenants to
cause (i) OraVax to enter into each of the agreements attached hereto as Annexes
A - E (each a "New Agreement" and collectively, the "New Agreements") and (ii)
representatives of OraVax in the Partnerships to approve and cause to be
executed the agreements attached hereto as Annexes B and C.
1.2 Limited covenants and agrees to appoint CT Corporation, 0000
Xxxxxxxx, Xxx Xxxx, Xxx Xxxx as its agent for service of process prior to
February 9, 1999 unless this Agreement has been terminated prior to such time.
1.3 Limited agrees to use its best efforts to cause OraVax to maintain
all of its rights that are being acquired by PMC under the New Agreements until
the Effective Time. Under no circumstances shall Limited or any of its
affiliates authorize, permit or consent to any action by OraVax which could have
the effect of depriving PMC of any of the rights which it is acquiring under the
New Agreements. In the event that Peptide, Limited or OraVax cannot, at the
Effective Time, perform its obligations under any of the license agreements
attached hereto
as Annexes A - C due to any action or omission of Peptide, Limited, or OraVax
(or any of their respective Affiliates), such failure shall constitute a
material breach of this Agreement and any and all other agreements executed
between Limited or Peptide and PMC (or any of their respective Affiliates)
(including, without limitation, any agreement by which PMC (or any of its
Affiliates) purchase any of the ordinary shares or other equity interests in
Peptide).
1.4 Limited hereby represents and warrants that:
(a) Limited owns all of the issued and outstanding shares of Peach
free and clear of any encumbrance and except for the shares of Peach
owned by Limited, there are no shares of any class or series of capital
stock, and no preferred stock, bonds, debentures, notes, debt
instruments, evidences of indebtedness or other securities of any kind
(including, without limitation, any stock options or stock appreciation
rights), of Peach authorized, issued or outstanding. Peach has not
issued any securities in violation of any preemptive or similar rights.
(b) Limited is a corporation duly incorporated and validly
existing and (to the extent applicable) in good standing under the laws
of its jurisdiction of organization, with the corporate power to own,
lease and operate its properties and to carry on its business as now
conducted.
(c) Limited has all necessary corporate power and authority to
enter into this Agreement and to consummate the transactions
contemplated hereby.
(d) The execution, delivery and performance of this Agreement by
Limited does not conflict with or contravene the articles or
certificate of incorporation or by-laws, regulations or partnership
agreement (or other comparable governing instruments with different
names) of Limited, 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 Limited is a party, or by which any of its assets or properties
is bound.
(e) This Agreement has been duly authorized, executed and
delivered by Limited and constitutes a legal, valid and binding
agreement of Limited, enforceable against Limited in accordance with
its terms, except as enforceability may be limited by bankruptcy,
insolvency, moratorium, reorganization or other similar laws affecting
creditors' rights generally.
(f) OraVax is validly existing as a corporation in good standing
under the laws of Delaware, with corporate power to enter into each of
the New Agreements and when executed, each of the New Agreements will
constitute legal, valid and binding obligations of OraVax, enforceable
against OraVax in accordance with their terms, subject to applicable
bankruptcy insolvency, fraudulent conveyance, reorganization,
moratorium and similar laws affecting creditors' rights and remedies
generally, and subject, as to enforceability, to general principles of
equity, including principles of commercial reasonableness, good faith
and fair dealing (regardless of whether enforcement is sought in a
proceeding at law or in equity).
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(g) The execution, delivery and performance of the New Agreements
by OraVax will not result in any violation of any law, rule or
regulation and will not result in the violation of the certificate of
incorporation or bylaws of OraVax or any writ, judgment or decree to
which OraVax is a party.
(h) No authorization or approval or other action by, and no notice
to or filing with, any governmental authority or regulatory body is
required for the execution and delivery of any of the New Agreements
and the performance by OraVax of the transactions contemplated by the
New Agreements.
1.5 Limited acknowledges that: (i) each of the New Agreements has been
negotiated at arms-length, (ii) during such negotiations Limited was represented
by counsel and was free from any undue influence or duress, (iii) the New
Agreements in the forms attached represent the terms and conditions agreed to by
the parties and that there are no other agreements or understandings with
respect to such agreements and such agreements accurately reflect all agreements
required to be reached in respect of the matters discussed therein.
ARTICLE II
SPECIFIC PERFORMANCE; CONSENT TO JURISDICTION
2.1 Limited agrees that, in view of the unique rights which are the
subject of and affected by this Agreement, in the event that Limited breaches
this Agreement, monetary damages could not be calculated and would not fairly
compensate PMC or be an adequate remedy to PMC for the damages resulting from
such breach. Accordingly, Limited agrees that if Limited breaches this
Agreement, PMC is entitled to specific performance requiring Limited to comply
with the terms of the New Agreements hereof as an alternative to any other
remedies available to PMC at PMC's sole discretion, PROVIDED, HOWEVER, that any
such election by PMC shall not limit PMC's right to incidental and/or
consequential damages, if any, caused by Limited's breach of this Agreement. In
any action successfully brought by PMC pursuant to this Section 2.1 for such
breach, Limited agrees to reimburse PMC for any costs or expenses incurred in
connection with such action, including, without limitation, expert witness fees
and reasonable attorneys fees. Limited further agrees and acknowledges that any
such action by PMC for injunctive relief may be brought in federal court for the
Southern District of New York or in the Supreme Court of New York, County of New
York, that there is jurisdiction over Limited in both the federal court for the
Southern District of New York, and the Supreme Court of New York, County of New
York and that Limited will not challenge the jurisdiction or venue of either of
those courts over Limited.
ARTICLE III
CONDITIONS TO EFFECTIVENESS
3.1 The obligations of the parties under Section 1.1 are subject to (i)
the execution and delivery of that certain First Amendment to Facility Agreement
dated of even date herewith between PMC and OraVax JVM, Inc. and (ii) the
execution and delivery of that certain Subscription Agreement dated of even date
herewith between PMC and Peptide and payment of the Subscription Price.
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ARTICLE IV
TERMINATION
4.1 This Agreement may be terminated at any time prior to the Effective
Time:
(a) By mutual written consent of the parties hereto;
(b) By PMC, by written notice to Limited:
(i) upon the public announcement of a tender offer or exchange
offer by any person other than PMC or an affiliate of PMC for
securities of OraVax;
(ii) upon the occurrence of any event under the Merger Agreement
that would entitle Peptide to terminate the Merger Agreement
(irrespective of any waivers that may be given by Peptide to
OraVax under the Merger Agreement and irrespective of any
breach by Peptide of any representations, warranties,
covenants or other agreements contained in the Merger
Agreement);
(iii) upon the public announcement of, or PMC otherwise becoming
aware of, the submission to OraVax by any person other than
PMC or an affiliate of PMC of an Acquisition Proposal (as
defined in the Merger Agreement); or
(iv) if any of the representations and warranties in Article I are
not true and correct at the Effective Time or if the covenant
contained in Section 1.2 has not been performed by
February 9, 1999.
4.2 Limited shall promptly notify PMC of the occurrence, to its
knowledge, of any event referenced in Sections 4.1(b)(ii) above or the
submission of an Acquisition Proposal referenced in Section 4.1(b)(iii) above.
4.3 This Agreement shall terminate automatically upon any termination
of the Merger Agreement.
4.4 No termination of this Agreement shall relieve any party from
liability by reason of any breach by such party of any of its covenants or
representations contained herein occurring prior to the termination of this
Agreement.
ARTICLE V
MISCELLANEOUS
5.1 PUBLICITY. PMC and Peptide shall cooperate in the preparation of a
mutually-agreeable press release and other publicity disclosing the existence of
this Agreement and their business relationship. Except for the information
disclosed in such press release or publicity, neither PMC nor Peptide shall
disclose the existence or any terms of this Agreement
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without the prior written consent of the other party (which consent shall not be
unreasonably withheld), except for such limited disclosure as may be reasonably
necessary to either party's bankers, investors, attorneys or other professional
advisors, or in connection with a merger or acquisition, or as may be required
by law in the offering of securities or in securities or regulatory filings or
otherwise, PROVIDED, THAT, the party disclosing such information shall provide a
copy of the proposed disclosure to the other party before it is disclosed and
afford the other party a reasonable amount of time to provide comments on such
proposed disclosure.
5.2 All notices and other communications required or permitted
hereunder shall be in writing and shall be deemed given when so delivered in
person, by overnight courier, by facsimile transmission (with receipt confirmed
by telephone or by automatic transmission report) or two business days after
being sent by registered or certified mail (postage prepaid, return receipt
requested), as follows:
(a) If to Limited, to:
Peptide Therapeutics Limited
321 Cambridge Science Xxxx
Xxxxxx Xxxx
Xxxxxxxxx XX0 0XX
Xxxxxxx
Attn: Chief Executive
Telephone: 00000 000000
Facsimile: 01223 423341
with a copy to:
Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attn: Xxxxxxx Xxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
(b) If to PMC, to:
Pasteur Merieux Serums & Vaccins S.A.
00, xxxxxx Xxxxxxx
00000 Xxxx, Xxxxxx
Attn: Senior Vice President, Corporate and Legal
Affairs, and General Counsel
Telephone: 000 00 0 00 00 00 84
Facsimile: 011 33 4 37 37 70 61
with a copy to:
Akin, Gump, Strauss, Xxxxx & Xxxx, L.L.P.
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000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attn: L. Xxxxx X'Xxxx, Xx.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Any party may by notice given in accordance with this Section 5.2 to the other
parties designate another address or person for receipt of notices hereunder.
5.3 This Agreement shall be construed in accordance with and governed
by the internal laws of the State of New York, without regard for its conflicts
of laws principles.
5.4 This Agreement may be amended, modified or supplemented only by
written agreement of the parties hereto.
5.5 This Agreement and all of the provisions hereof shall be binding
upon and inure to the benefit of the parties hereto and their respective
successors and permitted assigns. This Agreement is not assignable without the
prior written consent of the other party hereto.
5.6 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.
5.7 This Agreement contains the entire agreement among the parties in
respect of the subject matter contained herein, and supersedes all prior
agreements, written or oral, with respect thereto.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed as of the day and year first written above.
PEPTIDE THERAPEUTICS LIMITED
By: /s/ Xxxxxxx X. Xxxxxxx
---------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Commercial Director
PASTEUR MERIEUX SERUMS & VACCINS S.A.
By: /s/ Xxxx Xxxxxxxxxxx
---------------------------------
Name: Xxxx Xxxxxxxxxxx
Title: Corporate Vice President
ANNEX A TO
EXHIBIT 10.10
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the "Agreement") is effective as of ________
____________, 1999, between OraVax, Inc. ("OraVax"), a corporation organized
and existing under the laws of the State of Delaware, as Licensor
("Licensor") and Pasteur Merieux Serums & Vaccins S.A., a corporation
organized under the laws of France, as Licensee ("Licensee").
W I T N E S S E T H:
WHEREAS, Licensor owns or possesses certain proprietary rights and
know-how relating to the creation of genetically engineered live attenuated
flavivirus vaccines from recombinant yellow fever 17D virus;
WHEREAS, Licensee desires to obtain from Licensor, and Licensor desires
to grant to Licensee, a license under Licensor's proprietary rights and know-how
to research, develop, manufacture, market, sell and distribute Licensed Products
(as defined below);
NOW THEREFORE, in consideration of the covenants, conditions, and
undertakings hereinafter set forth, it is agreed by and among the parties as
follows:
ARTICLE 1
DEFINITIONS
"Affiliate" shall mean, with respect to any Person, (i) any other
Person of which securities or other ownership interests representing fifty
percent (50%) or more of the voting interests of such other Person are, at the
time such determination is made, owned, Controlled or held directly or
indirectly, by such Person, or (ii) any other Person which, at the time such
determination is being made, is Controlling, Controlled by or under common
Control with, such Person. For the purposes hereof, "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.
"Agency" shall mean any supranational, national, regional, state or
local government regulatory authority in the Territory responsible for granting
approvals for the manufacture or sale of Licensed Products.
"Development Costs" shall mean the costs incurred by Licensor in
connection with the performance of Development Work pursuant to any Research and
Development Program.
"Dengue License" means the license agreement by and between Licensee
and OraVax effective as of October 1, 1998.
"Dengue Vaccine" shall mean a vaccine either therapeutically or
prophylactically active against dengue viruses that makes use of, or is based
upon, the Technology licensed to the Licensee pursuant to the Dengue License.
"Development Work" shall mean the research and development activities
to be performed by Licensor pursuant to an agreed-upon Research and Development
Program.
"Fields of Use" shall mean the JEV Field and the TBE Field, and "Field
of Use" shall mean one of them.
"Improvements" shall mean any improvements to the Licensed Product
which are first conceived, discovered or actually reduced to practice during and
after the performance of the Development Work under an agreed-upon Research and
Development Program.
"Intellectual Property" shall mean, collectively, Inventions and
Improvements.
"Inventions" shall mean any inventions, ideas, discoveries which are
first conceived, discovered or actually reduced to practice before, during and
after the performance of the Development Work under an agreed-upon Research and
Development Program and are related to a Licensed Product.
"JEV Field" means shall mean the development and commercialization of
JEV Vaccines.
"JEV Vaccine" shall mean a vaccine either therapeutically or
prophylactically active against Japanese encephalitis viruses that makes use of
Licensor's ChimeriVax technology for the creation of genetically engineered
live attenuated flavivirus vaccines from recombinant yellow fever 17D virus.
"Legal Requirements" shall mean all laws, statutes, ordinances, codes,
rules, regulations, published standards, permits, judgments, decrees, writs,
injunctions, rulings, orders and other requirements of all Public Authorities.
"Licensed Know-How" shall mean any biological materials, and any
research and development information, inventions, know-how, pre-clinical,
clinical and other technical data, in each case which are not generally known or
available, which are owned, licensed or otherwise held by Licensor with the
right to license or sublicense the same to Licensee as of the date hereof or at
any time hereafter and which are necessary or useful for the making, using or
selling of Licensed Products as provided in this Agreement.
"Licensed Product(s)" shall mean any product within the Fields of Use.
"Major Country" shall mean France, Germany, Italy, the United Kingdom
or the United States.
"Net Sales" shall mean the gross invoice price to Third Parties of any
Licensed Product, less: (i) retroactive price reductions and rebates customary
to the trade or required by law, credits for returns and allowances, all to the
extent actually allowed, (ii) sales or other excise taxes or duties imposed upon
and paid by Licensee, or any of its Affiliates or Permitted
2
Sublicensees with respect to such sales, and (iii) transportation charges and
insurance for transportation to the extent separately invoiced or separately
reported on the invoice and paid by the Third Party. Notwithstanding the
foregoing, Net Sales shall not include sales between or among Affiliates for
resale by an Affiliate.
"Patent Rights" shall mean:
(a) all patents and patent applications owned or controlled by
Licensor, or licensed to Licensor with rights to grant sublicenses
thereunder, anywhere in the world as of the date hereof or at any time
hereafter relating to a Field of Use and which are (i) listed on
Schedule A, (ii) issued, assigned or licensed to Licensor at any time
hereafter and that are necessary or useful for the making, using or
selling of Licensed Products as provided in this Agreement, or (iii)
based on any Inventions that are necessary or useful for the making,
using or selling of Licensed Products as provided in this Agreement,
and
(b) any improvement patents, reissues, confirmations, renewals,
extensions, counterparts, divisions, continuations,
continuations-in-part or patent-of-addition issued, assigned or
licensed to Licensor of or relating to the patents or patent
applications described in clause (a) hereof.
"Permitted Sublicensee" shall mean any Affiliate of Licensee, and any
other Person approved in writing by Licensor prior to the granting of the
applicable sublicense.
"Person" shall mean any natural person, corporation, firm, business
trust, joint venture, association, organization, company, partnership or other
business entity, or any government, or any agency or political subdivision
thereof.
"Public Authority" shall mean any supranational, national, regional,
state or local government, court, governmental agency, authority, board, bureau,
instrumentality or regulatory body.
"Research and Development Program" shall have the meaning set forth in
Section 4.1(a).
"TBE Field" shall mean the development and commercialization of TBE
Vaccines.
"TBE Vaccines" shall mean a vaccine either therapeutically or
prophylactically active against tick-borne encephalitis viruses that makes use
of Licensor's ChimeriVax technology for the creation of genetically
engineered live attenuated flavivurus vaccines from recombinant yellow fever
17D virus.
"Technology" shall mean the Patent Rights and Licensed Know-How.
"Territory" shall mean all countries of the world.
"Third Party" shall mean any Person which is not a party or an
Affiliate of a party hereto.
"Valid Claim" shall mean a claim of an issued and unexpired patent
included within the Patent Rights that has not been held unenforceable or
invalid by a court or other governmental
3
agency of competent jurisdiction in a final adjudication from which no appeal
can be taken and that has not been specifically admitted by the Licensor to be
invalid or unenforceable through statements or actions that legally bind the
Licensor to such admission.
ARTICLE 2
GRANT OF RIGHTS
2.1 LICENSE. Subject to the terms and conditions of this Agreement,
Licensor hereby grants to Licensee a right and license, with the right to grant
sublicenses, under the Technology to research, have researched, make, have made,
use, sell, distribute, import and export Licensed Products in the Territory,
which right and license shall be exclusive even as to Licensor; provided that
Licensor shall retain the right to research, have researched, make, have made
and use Licensed Products for all purposes unrelated to the commercialization of
Licensed Products.
2.2 EXCLUSIVITY. In order to assure Licensee of the exclusive rights
under the Technology to commercialize Licensed Products granted in Section 2.1
hereof, Licensor shall not itself sell, distribute, import or export Licensed
Products in the Territory or grant to a Third Party any rights or licenses to
research, have researched, make, have made, use, sell, distribute, import or
export Licensed Products in the Territory, except as provided by this Agreement
and for so long as the rights and licenses granted in Section 2.1 remain in
force pursuant to this Agreement.
2.3 SUBLICENSES.
(a) The rights granted under Section 2.1 may be sublicensed by
Licensee (or any Permitted Sublicensee) to any Permitted Sublicensee.
In the event that Licensee (or any Permitted Sublicensee) desires to
sublicense any rights granted under Section 2.1 to any Third Party,
Licensee shall furnish to Licensor for its approval, which shall not be
unreasonably withheld or delayed, a prior draft of the proposed
sublicense agreement, which shall be on substantially the same terms
(other than Section 3.3) as this Agreement and (y) provide Licensor
with an executed copy of any such approved sublicense agreement. In the
event that Licensee (or any Permitted Sublicensee) desires to amend any
sublicense agreement theretofore approved by Licensor, such amendment
shall similarly require Licensor's prior approval, which similarly
shall not be unreasonably withheld or delayed.
(b) Each sublicense agreement concluded by Licensee hereunder
shall include a requirement that the Permitted Sublicensee maintain
records and permit inspection on terms similar to those set forth in
Section 10.4 of this Agreement. At Licensor's request and subject to
the terms of the applicable sublicense agreement, Licensee shall
arrange for an independent public accountant selected by Licensor to
inspect the records of its Permitted Sublicensee(s) for the purpose of
verifying payments due to Licensor and shall cause such accountant to
report the results thereof to Licensor.
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(c) Each sublicense agreement concluded by Licensee hereunder will
include indemnification provisions similar to those set forth in
Section 8.3 hereof naming Licensee and Licensor (and their respective
officers, directors, employees and agents) as indemnified parties.
(d) All sublicenses granted hereunder shall terminate upon
termination of this Agreement; provided that upon expiration of the
Term pursuant to Section 5.1 hereof (prior to any termination
hereunder), Licensee (or the applicable Permitted Sublicensee) shall
have a fully paid-up, royalty-free, non-cancelable license, subject (in
the case of Licensee's Permitted Sublicensees) to the terms of the
applicable sublicense and the payment by Licensee of amounts accrued
prior to such expiration.
2.4 DISCLOSURE OF TECHNOLOGY. Promptly following the execution of this
Agreement, and periodically thereafter as such information becomes available to
Licensor, Licensor shall provide to Licensee copies of all information and
materials in tangible form related to the Technology that are reasonably
necessary to or useful in the researching, making, using, selling, distributing,
importing or exporting of Licensed Products. Without limiting the generality of
the foregoing, if at any time Licensee elects to manufacture a Licensed Product,
Licensor shall, upon notice from Licensee, transfer Licensed Know-How relating
to manufacturing of the Licensed Product to Licensee, together with seed stock
or other biological materials within the definition of Licensed Know-How.
ARTICLE 3
COMPENSATION
3.1 COMPENSATION FOR PAST RESEARCH AND DEVELOPMENT EXPENSES RELATING
TO LICENSOR'S TBE VACCINE KNOW-HOW. Subject to the following sentence,
Licensee shall pay to Licensor compensation of []* in respect of Licensor's
past research and development expenses relating to TBE Vaccine (the
"Reimbursement Payment"). In the event that the Licensee fails to make the
Reimbursement Payment when due, the license granted hereunder in respect of
TBE Vaccine shall terminate, but the license granted with respect to JEV
Vaccine shall continue in full force and effect. Any payment by Licensee
hereunder shall be made by Licensee by the later to occur of []*
3.2 MILESTONE FEES. Licensee shall pay to Licensor the amounts
specified below within []* following the accomplishment of the
corresponding events specified below (each, a "Milestone"):
(i) []*
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
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(ii) []*
(iii) []*
(iv) []*
(v) []*
(vi) []*
(vii) []*
(viii) []*
(ix) []*
(x) []*
The foregoing amounts shall be paid by Licensee (on behalf of itself,
its Affiliates and Permitted Sublicensees) only once.
3.3 ROYALTIES.
(A) ROYALTY RATES.
(i) Licensee shall pay Licensor a royalty of []* (the
"Patent Royalty") on quarterly Net Sales of Licensed Product by
Licensee, its Affiliates
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
6
and Permitted Sublicensees in countries where at least one Valid
Claim exists during all periods of such existence. Such royalty
shall be payable on a country-by-country basis until the
expiration of the last remaining Valid Claim in any such country.
(ii) In the case of countries in which the Patent Rights
consist solely of patent applications, Licensee shall pay
Licensor the Patent Royalty on quarterly Net Sales of Licensed
Product by Licensee, its Affiliates and Permitted Sublicensees
in such countries until the first to occur of (A) issuance of a
Valid Claim (in which case subsection (i) above shall apply)
and (B) the conclusion of five continuous years after the date
of first commercial sale of Licensed Products in such country
during which the only existing Patent Rights in such country
were one or more patent applications (in which case the
following sentence shall apply. Upon the conclusion of five
continuous years after the date of first commercial sale of
Licensed Products in a country during which the only existing
Patent Rights in such country were one or more patent
applications, Licensee shall pay Licensor a royalty of []* (the
"Know-How Royalty") on quarterly Net Sales of Licensed Product
by Licensee, its Affiliates and Permitted Sublicensees in such
country for two additional years provided, however, that upon
issuance of a Valid Claim in such country at any time
thereafter, Licensee shall pay Licensor in accordance with
subsection (i) above.
(iii) Licensee shall pay Licensor the Know-How Royalty on
quarterly Net Sales of Licensed Product by Licensee, its
Affiliates and Permitted Sublicensees, in countries where no
Patent Rights exist and in countries where the only existing
Patent Rights have, for a period of five continuous years or
longer been patent applications, for a period of seven (7)
years from the date of first commercial sale of Licensed
Product in such country; PROVIDED, HOWEVER, that if at any time
thereafter Patent Rights come to exist in any such country,
Licensee shall pay royalties to Licensor in accordance with
subsection (i) or (ii) above as appropriate. In no event shall
the Know-How Royalty be payable in respect of any Net Sales
upon which the Patent Royalty is payable.
(B) REDUCTION FOR THIRD PARTY ROYALTIES. In the event that
Licensee, its Affiliate(s) or Permitted Sublicensee(s), in its
reasonable judgment, determines it to be necessary or desirable to
license in Third Party patents or technology relating to the Licensed
Product and is required to pay royalties to one or more Third Parties
in respect of such patents or technology (that in the absence of such
royalty payments would be infringed by the researching, making, using,
selling, distributing, importing or exporting of the applicable
Licensed Product) in order to enable Licensee, such Affiliate or such
Permitted Sublicensee to realize Net Sales, then the royalties
otherwise payable to Licensor in respect of such Net Sales shall be
reduced by []* the royalties paid to such Third Parties;
provided, however, that in no event shall such reduction exceed
[]* of the royalties on such Net Sales otherwise due to Licensor.
(C) RIGHT TO CURE CERTAIN THIRD PARTY OBLIGATIONS; OFFSET.
Licensee acknowledges that the patent applications set forth on
Schedule A hereto are co-owned
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
7
by Licensor with St. Louis University, in accordance with the
agreement attached hereto as Schedule B. In the event that
Licensor defaults on its obligations under the agreement attached
hereto as Schedule B, Licensor shall promptly notify Licensee of
such default and shall, at Licensee's request, cooperate with
Licensee to enable Licensee to cure such breach on behalf of
Licensor. Licensee shall be entitled to deduct from the royalties
otherwise payable to Licensor in respect of Net Sales hereunder
all royalties and other expenses incurred under this Section
3.3(c) that are reasonably necessary to ensure that Licensee's
rights under this Agreement are not compromised by such default.
3.4 FUNDING OF RESEARCH AND DEVELOPMENT PROGRAM. The parties agree that
Licensee shall be responsible for funding all research and development costs
with respect to the Licensed Products. With respect to JEV Vaccine, Licensee
shall reimburse Licensor for the Development Costs, including the development
program costs for the JEV Vaccine development program to be carried out by
Licensor through the completion of a Phase I clinical study in adults, in
accordance with the Dengue License. Such JEV Vaccine development program shall
otherwise be conducted and managed consistent with Article 4 hereof. In the
event that Licensee wishes to continue to fund further Development Work, such
further funding shall be made in accordance with the provisions of Article 4
hereof.
3.5 SINGLE ROYALTY; NON-ROYALTY SALES. It is understood that in no
event shall more than one royalty be payable under Section 3.3 with respect to a
particular unit of Licensed Product. No royalty shall be payable under this
Article 3 with respect to sales of Licensed Products among Licensee, its
Affiliates, Permitted Sublicensees and their Affiliates (provided that such
sales are for the purpose of facilitating resales to Third Parties), but a
royalty shall be due upon the subsequent sale of the Licensed Product to a Third
Party. No royalty shall be payable for (i) Licensed Product used in clinical
trials, or (ii) Licensed Product used by Licensee, its Affiliates or Permitted
Sublicensees for research, or (iii) customary quantities of Licensed Product
distributed as free samples.
ARTICLE 4
RESEARCH AND DEVELOPMENT
4.1 RESEARCH AND DEVELOPMENT PROGRAM.
(A) GENERAL. In the event that Licensee so requests, and subject
to agreement by the parties hereto on the research and development
program to be conducted in respect of any Licensed Product (each, a
"Research and Development Program"), Licensor agrees to perform or have
performed for the Licensee the Development Work set forth in any such
Research and Development Program, and Licensee hereby agrees to fund
the Research and Development Program in accordance with the terms and
conditions set forth below. Such research and development programs
shall be generally consistent with the programs established by the
parties for JEV Vaccines and Dengue Vaccines except as may be modified
to account for any differences in the technology of such Licensed
Product. Without limiting the generality of the foregoing, the parties
agree that upon the reasonable request of Licensee (subject to Section
9.1 hereof), Licensor shall prepare
8
clinical constructs in respect of TBE Vaccine, provided that the
parties can agree on the budget therefor (including the number of and
costs of the FTE's assigned to the project).
(B) SUBCONTRACTING. Licensor may subcontract any or all of its
obligations under this Article 4, subject to obtaining the prior
written consent of Licensee, which consent shall not be unreasonably
withheld. In the event that Licensor desires to subcontract any
material part of its obligations under this Article 4 to any Third
Party, Licensor shall (x) furnish to Licensee for its approval a prior
draft of the proposed subcontract agreement, which shall be in form and
substance satisfactory to Licensee, (y) provide Licensee with an
executed copy of any such approved subcontract agreement, and (z) keep
Licensee informed of the status of any such subcontracting
arrangements. In the event that Licensor desires to amend any
subcontract agreement theretofore approved by Licensee, such amendment
shall similarly require Licensee's prior approval. No such subcontract
shall relieve Licensor of its obligations under this Agreement.
(C) RESEARCH AND DEVELOPMENT COMMITTEE, PRINCIPAL INVESTIGATOR.
The Development Work (if any) shall be performed under the supervision
and direction of the Principal Investigator who shall be an employee of
Licensor and shall be chosen by the Research and Development Committee.
The Research and Development Committee shall consist of three
individuals nominated by Licensor and three individuals nominated by
Licensee. The Research and Development Committee shall review the
progress of the Development Work and will approve or reject material
changes to the Development Work plan. The Research and Development
Committee can change its number of members (maintaining equal
representation of both Licensee and Licensor) and its membership upon
the decision of a majority of its members. The Research and Development
Committee shall survive the term of the Research and Development
Program in an advisory role until a time mutually agreeable to Licensee
and Licensor or, in the absence of mutual agreement, until one year
following product licensure of a Licensed Product in a Major Country.
The members of the Research and Development Committee shall be senior
executives from the various research and development disciplines of
Licensor and Licensee. The initial members of the Research and
Development Committee are indicated in Appendix A hereto.
(D) REPLACEMENT OF PRINCIPAL INVESTIGATOR. In the event that the
Principal Investigator is unwilling or unable to perform his or her
duties hereunder, Licensor shall promptly appoint a successor mutually
agreeable to the parties.
(E) REPORTS. The Principal Investigator shall provide written
progress reports, summarizing in reasonable detail the current status
and progress of each Research and Development Program (i) within thirty
(30) days after the end of each calendar quarter and (ii) as soon as
practicable whenever, in the Principal Investigator's judgment, an
Invention has been created or reduced to practice.
(F) VISITATION. Duly authorized representatives of Licensee shall
have the right at reasonable times and upon reasonable notice to visit
the facilities where any Development Work is being performed in order
to monitor progress of the Development Work.
9
4.2 FUNDING.
(A) GENERAL. Licensor shall provide (or cause to be provided)
to Licensee, prior to the beginning of each quarter in which
Development Work is to be performed in accordance with a Research
and Development Plan, an invoice setting forth the projected
Development Costs to be incurred for such quarter in accordance with
any Research and Development Program. Licensee shall pay such
invoice within thirty (30) days of receipt thereof to the extent
that such Development Costs are included in the Research and
Development Plan (as modified from time to time by the Research and
Development Committee). Licensor hereby covenants and agrees that
any funding provided to Licensor under this Section 4.2 shall be
used as contemplated by the applicable Research and Development
Program. Services provided by Licensor at Licensee's request that
are outside the scope of a Research and Development Program shall be
separately invoiced by Licensor and separately funded by Licensee on
the basis for determining costs set forth in Appendix A hereto.
(B) RECONCILIATION. Within thirty (30) days after the end of
each quarter in which Development Work is performed in accordance
with a Research and Development Plan, Licensor shall provide (or
cause to be provided) to Licensee a statement reconciling the
projected Development Costs previously paid by Licensee for such
quarter against the actual Development Costs incurred by Licensor
for such quarter. In the event that such reconciliation demonstrates
that such previous payment exceeded such actual Development Costs,
Licensee shall be entitled to recoup the excess from Licensor. In
the event that such reconciliation demonstrates that such actual
Development Costs exceeded such previous payment, Licensor shall be
entitled to reimbursement of the excess from Licensee. At the option
of the party to whom any such adjustment is owed, such excess shall
be paid to such party by the other party within thirty (30) days
after such statement is provided or an appropriate adjustment shall
be made to the next invoice provided to Licensee setting forth
projected Development Costs (in which case such adjustment shall be
subtracted from or added to actual Development Costs, as
appropriate, for purposes of the subsequent reconciliation relating
to the quarter to which such invoice relates).
(C) COST OF COMPONENTS. Any component that, by mutual agreement of
Licensee and Licensor, is supplied by Licensee to Licensor in
connection with the Development Work to performed hereunder shall be
supplied to Licensor at no cost.
4.3 SUBLICENSE AND LICENSE.
(a) In the event that, and for so long as, any Research and Development
Program is on-going, Licensee hereby grants to Licensor a fully paid,
non-exclusive, royalty-free sublicense, with the right to grant sublicenses
(subject to Section 4.1(b) hereof), under the rights and licenses granted
pursuant to Section 2.1 above to research, develop, make and have made the
applicable Licensed Product in the Territory solely for the purposes of
performing the Development Work pursuant to the applicable Research and
Development Program.
10
(b) In the event that, and for so long as, any Research and Development
Program is on-going, Licensee hereby grants to Licensor a fully paid,
non-exclusive, royalty-free license, with the right to grant sublicenses
(subject to Section 4.1(b) hereof), under the Intellectual Property owned by
Licensee as specified in Sections 4.4(d) and 4.4(e) hereof to research, develop,
make and have made the applicable Licensed Products in the Territory solely for
the purposes of performing the Development Work pursuant to the applicable
Research and Development Program.
4.4 OWNERSHIP OF INVENTIONS AND IMPROVEMENTS.
(a) All Intellectual Property developed solely by Licensor
pursuant to a Research and Development Program shall be owned solely by
Licensor, and such Intellectual Property shall be deemed to be included
in the Technology.
(b) All Intellectual Property developed jointly by Licensor and
Licensee pursuant to a Research and Development Program and solely
relating to a Licensed Product shall be owned jointly by the parties
and Licensee shall have an exclusive right and license to Licensor's
interest in such Intellectual Property pursuant to Section 2.1 above.
(c) All Intellectual Property developed jointly by Licensor and
Licensee pursuant to the Research and Development Program and not
solely relating to a Licensed Product shall be owned jointly by the
parties and both parties shall have the right to use and exploit such
Intellectual Property freely without accounting to one another for such
use and exploitation.
(d) All Intellectual Property developed solely by Licensee
pursuant to a Research and Development Program and solely relating to a
Licensed Product shall be owned solely by Licensee.
(e) All Intellectual Property developed solely by Licensee and
which is not solely related to a Licensed Product shall be owned by
Licensee. The parties shall, at Licensor's request, enter into good
faith negotiations for a grant of licenses to such Intellectual
Property from Licensee to Licensor for use outside of the Fields of
Use.
(f) Licensor agrees to include provisions assuring Licensee's
rights under this Section 4.4 in every sublicense granted pursuant to
Section 4.3 above.
4.5 DISPUTE RESOLUTION.
(a) The parties agree to use their best efforts to resolve
amicably any deadlock between the parties or their respective
representatives, with respect to any scientific matter and will not
take any action inconsistent therewith. The resolution of any deadlock
pursuant to this Section 4.5 shall be binding on the parties for all
purposes.
(b) In the event that the parties or their respective
representatives are deadlocked concerning any scientific matter, the
parties shall thereupon consult with each other in good faith on a
regular basis (including at least one meeting between the Chief
11
Scientific Officer of Licensor and the Chief Scientific Officer of
Licensee for their consideration and resolution, and if no decision is
then reached, at least one meeting between the Chief Executive Officer
of Licensor and the Chief Executive Officer of Licensee) to attempt to
resolve such matters as promptly as practicable and each party hereby
agrees to use its best efforts to schedule such meetings within sixty
(60) days after the occurrence of the deadlock.
(c) In the event that, following the aforementioned consultations,
the parties remain deadlocked regarding any scientific matter, such
deadlock shall be referred, at the election of either party and by
notice in writing to the other party, to a panel of scientific
mediators as provided in this paragraph (c) ("Scientific Mediation").
In any Scientific Mediation, there shall be three scientific experts in
the pharmaceuticals area (without regard to nationality) who shall act
as the mediators (the "Scientific Mediators"). The party requesting
Scientific Mediation shall appoint one individual to serve as one of
the Scientific Mediators, and shall notify the other party of such
appointment in the aforementioned notice. Within fifteen (15) days
after receipt of such notice, the other party shall appoint one
individual to serve as a Scientific Mediator, but if the other party
shall fail to make such appointment within such period, such party may
request the Swedish Arbitration Committee of the ICC to make such
appointment. The two Scientific Mediators shall, within fifteen (15)
days of the appointment of the second Scientific Mediator appoint a
third individual to serve as a Scientific Mediator and chairperson of
the mediation board, but if the two Scientific Mediators shall fail to
make such appointment within such period, then such party or the other
party may request the Swedish Arbitration Committee of the ICC to make
such appointment. No Confidential Information shall be disclosed to
such Scientific Mediators unless and until each such Scientific
Mediator has entered into a confidentiality agreement, in form and
substance satisfactory to both parties. The Scientific Mediators shall
be advised of the positions taken by each of the parties to such
mediation and shall work with them in an effort to resolve the
scientific deadlock within sixty (60) days after the appointment of the
third Scientific Mediator. If the scientific deadlock is not resolved
within such period, there shall be no further Scientific Mediation, but
the Chief Executive Officer of Licensor and the Chief Executive Officer
of Licensee shall consult one more time in an effort to resolve the
deadlock.
ARTICLE 5
TERM AND TERMINATION
5.1 TERM. This Agreement shall become effective as of the date
hereof and, subject to the other provisions of this Article 5, shall continue
in full force and effect on a country-by-country basis until the later of (a)
the date on which no Valid Claim exists in such country, or (b) ten (10)
years from the date of the first commercial sale of a Licensed Product in
such country (or such other period, not to exceed ten (10) years from first
commercial sale of such product, as may be permissible under the applicable
law of any country in which such product is sold) (the "Term"). Upon the
expiration of the Term on a country-by-country basis, Licensee will have a
fully paid, royalty-free, freely sublicensable license to make, have made,
use, sell, distribute, import and export Licensed Products in each such
country, and Licensee
12
shall have no further payment obligation to Licensor, other than for payments
that accrue prior to such expiration, for milestone payments that may accrue
after such expiration and for Development Costs that may be incurred after such
expiration.
5.2 TERMINATION FOR BREACH. In the event of a material breach of this
Agreement (including the breach of a representation or warranty), which breach
is not cured within sixty (60) days after written notice is given by the
non-breaching party to the breaching party specifying the breach, the
non-breaching party, in addition to any other remedy which it may have, shall be
entitled to terminate this Agreement.
5.3 OPTIONAL TERMINATION BY LICENSEE. Licensee may terminate this
Agreement at any time by giving Licensor at least ninety (90) days prior
written notice.
5.4 TERMINATION STANDSTILL. Notwithstanding anything to the contrary
contained herein, Licensee may not terminate this Agreement for any reason
before the earlier of (i) June 30, 2000 or (ii) the completion of the Phase I
JEV Vaccine clinical trial demonstrating safety and seroconversion, as set
forth in the Research and Development Program in respect thereof, all as
described in and pursuant to, the Dengue License.
5.5 RIGHTS ON TERMINATION.
(a) In the event that this Agreement is terminated pursuant to
Section 5.2 due to a material breach by Licensor, (i) the rights and
licenses granted to Licensee in Section 2.1 hereof shall remain in
effect, subject to Licensee's payment of []* of the royalties and []*
of the milestone payments that that would otherwise accrue after such
termination, (ii) the rights and licenses granted to Licensor in
Section 4.3 shall terminate, (iii) subject to Article 7 hereof, any
Confidential Information provided to Licensor in tangible form shall be
promptly returned to Licensee or destroyed, at Licensee's option and
(iv) Licensee shall have the rights set forth in Section 8.3 in respect
of such breach.
(b) In the event that this Agreement is terminated pursuant to
Section 5.2 due to a material breach by Licensee, (i) all licenses
granted hereunder, except the license granted to Licensor pursuant to
Section 4.3(b), shall terminate, (ii) the license granted to Licensor
pursuant to Section 4.3(b) shall be []* (iii) subject to Article 7
hereof, any Confidential Information and Licensed Know-How provided
to Licensee in tangible form shall be promptly returned to Licensor
or destroyed, at Licensor's option, and (iv) Licensor shall have the
rights set forth in Section 8.3 in respect of such breach.
(c) In the event that this Agreement is terminated pursuant to
Section 5.3 at Licensee's option, (i) all licenses granted hereunder,
except the license granted to Licensor pursuant to Section 4.3(b),
shall terminate, (ii) the license granted to Licensor pursuant to
Section 4.3(b) shall be []* (iii) subject to Article 7 hereof, any
Confidential Information and Licensed Know-How provided to Licensee in
13
tangible form shall be promptly returned to Licensor or destroyed, at
Licensor's option, and (iv) Licensor and Licensee shall negotiate in
good faith a percentage royalty to be paid by Licensor to Licensee,
based upon the commercialization of Licensed Products subsequently
undertaken by Licensor, that compensates Licensee for Licensor's
exploitation of Intellectual Property developed during the course of a
Research and Development Program using Licensee's funding at a level
commensurate with the level of royalties Licensor pays to Third Parties
in arm's-length transactions for licenses of intellectual property with
similar commercial value.
(d) In the event that a Research and Development Program is
terminated by Licensee prior to the completion of its term for any
reason, Licensee shall, in addition to any other payments due
hereunder, make a payment equal to the budgeted Development Costs
set forth in the Development Plan for the three (3) month period
following the termination date. Also in the event of such
termination, Licensor shall, and shall cause its employees, agents
and subcontractors (including, without limitation, the Principal
Investigator) performing any Development Work to, wind up as
expeditiously as possible all Development Work that is in progress
at the date of such termination. Following such termination and
winding up, Licensor shall submit to Licensee a final invoice
setting forth the three months' budgeted Development Costs and the
Development Costs (including the winding up costs) associated with
Development Work performed by Licensor (or its subcontractor)
through such termination and winding up and Licensee shall pay such
final invoice within thirty (30) days to the extent that the
budgeted Development Costs and the Development Costs were included
in the Development Plan and the costs of winding up are reasonable
and directly related to the winding up of the Development Work.
(e) In the event Licensee terminates this Agreement, all rights to
Intellectual Property owned jointly pursuant to Section 4.4(c) shall
remain the property of both Licensor and Licensee with divided control
and the parties shall enter into good faith negotiations for the grant
of an exclusive right and license to Licensee's interest in such
Intellectual Property from Licensee to Licensor. In the event of
Licensee's termination of this Agreement, the parties shall also enter
into good faith negotiations for the grant of a license to Intellectual
Property owned by Licensee pursuant to Section 4.4(d) from Licensee to
Licensor.
(f) Articles 7 and 11, and Sections 2.3, 5.1, 5.4, 5.5, 5.6, 8.3,
10.3 and 10.4, shall survive the expiration and any termination of this
Agreement. Except as otherwise provided in this Section 5.5(f), all
rights and obligations of the parties under this Agreement shall
terminate upon the expiration or termination of this Agreement.
(g) Termination of this Agreement for any reason shall not release
either party hereto from any liability which at the time of such
termination has already accrued to the other party.
5.6 In the event that Licensee terminates this Agreement for any
reason, and Licensee decides to continue the development of a Japanese
encephalitis vaccine or a tick-borne encephalitis vaccine other than a Licensed
Product, Licensee shall in good faith, but with no
14
legal obligation, consider maintaining a collaborative relationship with
Licensor relating to such development.
5.7 Subject to applicable law to the contrary, Licensee or Licensor 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 sixty (60) days after the filing thereof. Each of the parties
hereto acknowledges and agrees, subject to applicable law to the contrary, 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, if any, including, without limitation,
those set forth in Section 365(n) of the Code. The parties further agree that,
in the event that Licensee retains its rights as a licensee under the Code
pursuant to such an exercise, Licensee shall be entitled to complete access to
any technology licensed to it hereunder and all embodiments of such technology.
Subject to applicable law to the contrary, such embodiments of the technology
shall be delivered to Licensee not later than (a) the commencement of bankruptcy
proceedings against Licensor, unless Licensor 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 Licensor.
ARTICLE 6
PATENTS AND INFRINGEMENTS
6.1 PURSUIT AND MAINTENANCE OF PATENT RIGHTS. Licensor shall, at its
own expense, file, prosecute and maintain Patent Rights. Licensor agrees to keep
Licensee informed as to the status of the Patent Rights and shall provide
Licensee with copies of all filings and correspondence of a substantive nature
with respect to patents or patent applications relating to the Patent Rights to
be made or sent to the United States Patent and Trademark Office or its
counterpart in any country of the Territory and copies of all correspondence of
a substantive nature that Licensor receives from such Persons with respect to
the Patent Rights. In the event that Licensor chooses not to prosecute a patent
in the Territory in the case of certain Intellectual Property or chooses not to
prosecute a patent in a certain country in the Territory that is based upon the
same patentable subject matter upon which Patent Rights are based, then Licensee
shall be entitled to prosecute such patent and Licensor shall reasonably
cooperate with Licensee in such prosecution; provided however that the
prosecution by Licensee of any patent pursuant to this Section shall not create
any ownership interest in such Intellectual Property or in such patentable
subject matter by Licensee that Licensee would not otherwise have hereunder.
6.2 NOTICE OF INFRINGEMENT. Each party shall promptly notify the other
of any conflicting use or any act of infringement or appropriation of any Patent
Right by unauthorized Persons which comes to its attention.
15
6.3 ENFORCEMENT AND DEFENSE. Upon becoming aware of a conflicting use
or an act of infringement, and communicating about the same pursuant to Section
6.2 above, Licensee shall discuss with Licensor the nature of and circumstances
surrounding such conflicting use or act of infringement. Subject to the consent
of Licensor, which consent shall not be unreasonably withheld, Licensee shall
thereafter, at its own expense, have the right but not the obligation to
initiate actions and take steps relating to such conflicting use or act of
infringement. Licensee may settle any dispute with a Third Party regarding such
conflicting use or act of infringement; provided that Licensee shall not have
the right to settle, compromise or take any action in any dispute which
diminishes, limits or inhibits the scope, validity or enforceability of the
Patent Rights without the express written consent of Licensor. In the event that
Licensee exercises its rights under this Section 6.3, Licensee agrees to keep
Licensor fully informed of all developments in connection with any settlements
and negotiations and to consult with Licensor prior to making any final
settlement, consent judgment or other voluntary disposition of the matter. If
Licensee chooses not to take or continue any action or step relating to such
conflicting use or act of infringement, Licensor shall have the right to engage
in negotiations and proceedings relating to such conflicting use or act of
infringement solely at its own expense; provided that it keeps Licensee fully
informed of the progress of such negotiations and proceedings and consults with
Licensee prior to making any final settlement, consent judgment or other
voluntary disposition of the matter. Each party agrees to cooperate with the
other to the fullest extent possible with respect to any negotiations or
proceedings under this Section 6.3.
6.4 EQUITABLE DIVISION OF RECOVERIES BY LICENSEE. In the event that
Licensee elects to initiate actions or take steps relating to a conflicting use
or act of infringement pursuant to Section 6.3 above, and Licensee is thereby
able to recover from a Third Party by settlement or otherwise any damages or
other compensation in respect of such conflicting use or act of infringement,
such damages and other compensation shall be divided equitably between Licensee
and Licensor in a manner commensurate with the division of economic benefits
relating to sales of Licensed Products contemplated by this Agreement.
ARTICLE 7
CONFIDENTIALITY
7.1 Except as expressly set forth in this Article 7, each party shall,
and shall cause its Affiliates and its and their respective officers, directors,
employees, agents and subcontractors (collectively, "Representatives") to, keep
confidential any and all technical, commercial, scientific and other proprietary
data, processes, documents or other information (whether in oral, written or
electronic form) or physical object (including, without limitation, intellectual
property, marketing data, agreements between any party and a Third Party,
license applications, and business plans and projections of any party) acquired
from the other party, its Affiliates or any of their respective Representatives
in respect of the transactions contemplated by this Agreement and which relate
(in the case of a party) to the other party or any of its Affiliates or their
respective businesses or products ("Confidential Information"), and each party
shall not disclose directly or indirectly, and shall cause its respective
Affiliates and Representatives not to disclose directly or indirectly, any
Confidential Information to anyone outside such Person, such Affiliates and
their respective Representatives, except that the
16
foregoing restriction shall not apply to any information disclosed hereunder to
any Person if such Person (the "Receiving Person") can demonstrate that such
Confidential Information:
(a) is or hereafter becomes generally available to the trade or
public other than by reason of any breach hereof;
(b) was already known to the Receiving Person or such Affiliate or
Representative as shown by written records;
(c) is disclosed to the Receiving Person or such Affiliate or
Representative by a third party who has the right to disclose such
information;
(d) is developed by or on behalf of the Receiving Person or any of
its Affiliates independently, without reliance on Confidential
Information received hereunder; or
(e) is, based on such Person's good faith judgment with the advice
of counsel, otherwise required to be disclosed in compliance with
applicable Legal Requirements by a Public Authority (and, in such case,
such information shall remain Confidential Information for all other
purposes unless and until subparagraphs (a) through (d) above otherwise
apply).
7.2 Except in furtherance of their respective rights and obligations
hereunder, each party agrees that it shall not (and shall not permit any of its
Affiliates to) at any time use any Confidential Information in the conduct of
its businesses without the prior written consent of the other party. The
obligations set forth in this Article 7 shall extend to copies, if any, of
Confidential Information made by any of the Persons referred to in Section 7.1
and to documents prepared by such Persons which embody or contain Confidential
Information, and to any electronic data files containing Confidential
Information.
7.3 Each party shall deal with Confidential Information so as to
protect it from disclosure with a degree of care not less than that used by it
in dealing with its own information intended to remain exclusively within its
knowledge and shall take reasonable steps to minimize the risk of disclosure of
Confidential Information.
7.4 The obligations set forth in this Article 7 shall survive the
expiration, termination or assignment of this Agreement for a period of
fifteen (15) years thereafter.
7.5 Within thirty (30) days after the termination of this Agreement,
any Receiving Person shall (and shall cause its Affiliates and Representatives
to), at the option of the person making disclosure (the "Disclosing Person"),
return to the Disclosing Person or destroy all Confidential Information in its
or their possession; provided, however, that the Receiving Person may, upon
notice to the Disclosing Person, retain in its legal files or in the office of
outside legal counsel one copy of any document solely for use in legal
proceedings to which such document relates and for archival purposes. Such
notice shall set forth, in reasonable detail, a list of the documents so
retained.
17
7.6 Licensor agrees to use reasonable efforts to protect the
confidentiality, if applicable, of Technology that it licenses outside the Field
of Use in a manner commensurate with the manner in which such confidentiality is
protected hereunder.
ARTICLE 8
REPRESENTATIONS, WARRANTIES AND COVENANTS
8.1 Representations and Warranties of Licensee.
(a) Licensee is a corporation duly incorporated and validly
existing and (to the extent applicable) in good standing under the laws
of its jurisdiction of organization, with the corporate power to own,
lease and operate its properties and to carry on its business as now
conducted.
(b) Licensee 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
License does not conflict with or contravene the articles or
certificate of incorporation or by-laws, regulations or partnership
agreement (or other comparable governing instruments with different
names) of Licensee, 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 Licensee is a party, or by which any of its assets or properties
is bound.
(d) This Agreement has been duly authorized, executed and
delivered by Licensee and constitutes a legal, valid and binding
agreement of Licensee, enforceable against Licensee in accordance with
its terms, except as enforceability may be limited by bankruptcy,
insolvency, moratorium, reorganization or other similar laws affecting
creditors' rights generally.
8.2 REPRESENTATIONS, WARRANTIES AND COVENANTS OF LICENSOR.
(a) Licensor is a corporation duly incorporated and validly
existing as a corporation and 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) Licensor 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
Licensor 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 Licensor is a party, or by which any of its assets
or properties is bound. No Third Party has any right, title or interest
in or to any Technology in the Fields of Use.
18
(d) This Agreement has been duly authorized, executed and
delivered by Licensor and constitutes a legal, valid and binding
agreement of Licensor, enforceable against Licensor 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) Licensor owns or has rights to use and exploit under licenses
(and to license or sublicense) all of its rights under the Technology.
There have been no material claims made against Licensor asserting the
invalidity or unenforceability of, or with respect to the Patent
Rights, the misuse of, the Patent Rights or Licensed Know-How, nor is
Licensor aware that any such claims exist. Licensor has not received a
notice of conflict of the Technology with the asserted rights of
others, or otherwise challenging its rights to use any of the
Technology. None of the rights of Licensor under the Patent Rights or
Licensed Know-How will be adversely affected by the execution, delivery
or performance of this Agreement, or the consummation of the
transactions contemplated herein.
(f) Licensor has not filed for protection under the United States
Bankruptcy Code, as amended (the "Code"), nor does it have any
intention of doing so. No Third Party has filed or commenced, nor to
the knowledge of Licensor has any Third Party threatened to file or
commence, a proceeding under the Code against Licensor.
8.3 INDEMNIFICATION.
(A) INDEMNITY BY LICENSEE. Licensee hereby agrees to indemnify,
defend and hold harmless Licensor, its officers, directors,
employees and agents from and against any liabilities, claims,
damages, costs, expenses (including reasonable attorneys' fees),
judgments payable or incurred in respect of claims by or claims
asserted or threatened by Third Parties (collectively, "Damages")
arising out of, based upon or resulting from (i) the development,
manufacture, sale or use of any Licensed Product, (ii) a breach of
this Agreement (including the breach of a representation or
warranty) by Licensee, or (iii) the negligence or willful misconduct
of Licensee, except to the extent that in any case any such Damages
arise out of, are based upon or result from (i) a breach of this
Agreement (including the breach of a representation or warranty) by
Licensor, or (ii) the negligence or willful misconduct of Licensor.
(B) INDEMNITY BY LICENSOR. Licensor hereby agrees to indemnify,
defend and hold harmless Licensee, its officers, directors,
employees and agents from and against any Damages arising out of,
based upon or resulting from (i) a breach of this Agreement
(including the breach of a representation or warranty) by Licensor,
or (ii) the negligence or willful misconduct of Licensor, except to
the extent that in either case any such Damages arise out of, are
based upon or result from (i) a breach of this Agreement (including
the breach of a representation or warranty) by Licensee, or (ii) the
negligence or willful misconduct of Licensee.
19
(C) INDEMNIFICATION PROCEDURES.
(i) Any party entitled to indemnification under paragraph (a)
or (b) of this Section 8.3 (an "Indemnified Party") shall promptly
notify the party potentially responsible for such indemnification
(the "Indemnifying Party") upon becoming aware of any claim or
claims asserted or threatened against such Indemnified Party which
could give rise to a right of indemnification under this
Agreement; PROVIDED, HOWEVER, that the failure to give such notice
shall not relieve the Indemnifying Party of its indemnity
obligation hereunder except to the extent that such failure
prejudices its rights hereunder.
(ii) the Indemnifying Party shall have the right to
defend, at its sole cost and expense, such claim by all
appropriate proceedings, which proceedings shall be prosecuted
diligently by the Indemnifying Party to a final conclusion or
settled at the discretion of the Indemnifying Party; PROVIDED,
HOWEVER, that the Indemnifying Party may not enter into any
compromise or settlement unless (x) the Indemnified Party
consents thereto, which consent shall not be unreasonably
withheld, or (y) such compromise or settlement includes as an
unconditional term thereof the giving by each claimant or
plaintiff to the Indemnified Party of a release from all
liability in respect of such claim.
(iii) The Indemnified Party may participate in, but not
control, any defense or settlement of any claim by the
Indemnifying Party pursuant to this Section 8.3 and shall bear its
own costs and expenses with respect to such participation;
PROVIDED, HOWEVER, that the Indemnifying Party shall bear such
costs and expenses if counsel for the Indemnifying Party shall
have reasonably determined that such counsel may not properly
represent both the Indemnifying Party and the Indemnified Party.
(iv) If the Indemnifying Party fails to notify the
Indemnified Party within twenty (20) days after receipt of notice
of a claim in accordance with Section 8.3(c)(i) hereof that it
elects to defend the Indemnified Party pursuant to this Section
8.3(c), or if the Indemnifying Party elects to defend the
Indemnified Party but fails to prosecute or settle the claim
diligently, then the Indemnified Party shall have the right to
defend, at the sole cost and expense of the Indemnifying Party,
the claim by all appropriate proceedings, which proceedings shall
be diligently prosecuted by the Indemnified Party to a final
conclusion or settled; PROVIDED, HOWEVER, that in no event shall
the Indemnifying Party be required to indemnify the Indemnified
Party for any amount paid or payable by the Indemnified Party in
the settlement of any such claim agreed to without the consent of
the Indemnifying Party, which shall not be unreasonably withheld.
20
ARTICLE 9
DILIGENCE IN COMMERCIALIZING LICENSED PRODUCTS
9.1 GENERAL. Licensee shall use commercially reasonable efforts to
promptly and fully research, develop, register, market and sell and to continue
to market and sell Licensed Product in each country in which Licensee reasonably
determines that there is a market potential for such Licensed Product.
9.2 NOTIFICATION. Licensee shall promptly notify Licensor in writing if
at any time Licensee ceases to promptly and fully research, develop and/or
obtain regulatory approval for and/or market and sell a Licensed Product in any
country.
9.3 REVERSION OF RIGHTS TO LICENSOR. If, at any time subsequent to the
payment of the Reimbursement Payments, Licensee fails to use commercially
reasonable efforts to promptly and fully research, develop, register, market and
sell and to continue to market and sell Licensed Product in any country, the
rights and licenses granted to Licensee with respect to such country shall
terminate, upon [ ]* days prior written notice to Licensee from Licensor,
subject to Licensee's right to reestablish in good faith its efforts pursuant to
Section 9.1 above with respect to such country within such [ ]* period.
ARTICLE 10
ACCOUNTING AND RECORDS
10.1 REPORTS. Licensee agrees to make quarterly written reports to
Licensor within ninety (90) days after the end of each calendar quarter in which
royalties are due under this Agreement, stating in each such report with respect
to Licensed Products, the number, description, and aggregate Net Sales of
Licensed Products sold during the calendar quarter and upon which a royalty is
payable under Article 3 above.
10.2 PAYMENT. Concurrently with the making of each such report of
Section 10.1, Licensee shall pay to Licensor the royalties at the rate specified
in Section 3.3, if any such royalties are due. All payments by Licensee to
Licensor hereunder shall be made in United States dollars. If any currency
conversion shall be required in connection with the calculation of royalties or
the payment of other compensation hereunder, such conversion shall be made by
using the rate of exchange published in The Wall Street Journal for the last
business day of the applicable calendar quarter.
10.3 WITHHOLDING TAXES. The payments referred to in Article 3 above
shall be net of all withholding taxes and other taxes that Licensee or any of
its Affiliates are required by law to withhold or pay; PROVIDED, HOWEVER, that
if, in regard to any withholding tax paid by Licensee, Licensor is able to
realize a benefit in the form of a corresponding tax credit that it is actually
able to use to reduce its tax payments, then Licensor shall reimburse Licensee
for such withholding tax to the extent of such realized benefit. Licensor shall
furnish Licensee with appropriate documents supporting application of the most
favorable rate of withholding tax
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
21
available under applicable tax treaties and shall use commercially reasonable
efforts to secure all tax credits in respect of withholding taxes paid by
Licensee hereunder available to it.
10.4 RECORDS; INSPECTION.
(a) Licensee shall keep complete, true and accurate books of
account and records for the purpose of determining the amounts payable
to Licensor under this Agreement. Such books and records shall be kept
at Licensee's principal place of business for at least three (3) years
following the end of the calendar quarter to which they pertain, and
will be open for inspection during such three (3) year period by an
independent public accountant not providing accounting services to
Licensor, Licensee or any of their respective Affiliates that is
reasonably acceptable to both parties, for the purpose of verifying
Licensee's quarterly written reports. Such inspections may be made no
more than once each calendar year, during normal business hours and
upon thirty (30) days prior notice. Any such information shall be
considered to be Confidential Information of Licensee.
(b) Inspections conducted under this Section 10.4 shall be at the
expense of Licensor, unless an underpayment exceeding five percent (5%)
of the royalties paid during the period covered by the inspection is
established in the course of any such inspection, whereupon all costs
relating thereto, as well as any unpaid royalties due and owing to
Licensor, shall be paid by Licensee within thirty (30) days after the
notification by Licensor to Licensee that an underpayment has been
discovered.
ARTICLE 11
MISCELLANEOUS
11.1 PUBLICITY. Licensee and Licensor shall cooperate in the
preparation of a mutually-agreeable press release and other publicity disclosing
the existence of this Agreement and their business relationship. Except for the
information disclosed in such press release or publicity, neither Licensee nor
Licensor shall disclose the existence or any terms of this Agreement without the
prior written consent of the other party (which consent shall not be
unreasonably withheld), except for such limited disclosure as may be reasonably
necessary to either party's bankers, investors, attorneys or other professional
advisors, or in connection with a merger or acquisition, or as may be required
by law in the offering of securities or in securities or regulatory filings or
otherwise.
11.2 WAIVER. It is agreed that no waiver by any party hereto of any
breach or default of any of the covenants or agreements herein set forth shall
be deemed a waiver as to any subsequent and/or similar breach or default.
11.3 INDEPENDENT CONTRACTORS. The relationship of the parties hereto is
that of independent contractors. Neither Licensor nor Licensee hereto is an
agent, partner or joint venturer of the other for any purpose.
11.4 COMPLIANCE WITH LAWS. In exercising their rights under this
Agreement, both parties shall fully comply with the requirements of any and all
applicable laws, regulations,
22
rules and orders of any governmental body having jurisdiction over the exercise
of rights under this Agreement.
11.5 NOTICES. Any notice required or permitted to be given to the
parties hereto shall be deemed to have been properly given if delivered in
person or when received if mailed by first class certified mail or sent by
facsimile to the other party at the address or facsimile number, as applicable,
indicated below or to such other addresses or facsimile numbers as may be
designated in writing by the parties from time to time during the term of this
Agreement.
Licensor: OraVax, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xxxxx Xxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to: Xxxxxxx X. Xxxxxx, Esq.
Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Licensee: Pasteur Merieux Serums & Vaccins S.A.
00, xxxxxx Xxxxxxx
00000 Xxxx, Xxxxxx
Attention: Senior Vice President, Corporate
and Legal Affairs, and General
Counsel
Telephone: 011.33.4.37.37.77.84
Facsimile: 011.33.4.37.37.70.61
with a copy to: L. Xxxxx X'Xxxx, Xx., Esq.
Akin, Gump, Strauss, Xxxxx & Xxxx, L.L.P.
000 Xxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
11.6 COMPLETE AGREEMENT. It is understood and agreed among the parties
that this Agreement and the Dengue License constitute the entire agreement with
respect to the subject matter of this Agreement, both written and oral, among
the parties, and that all prior
23
agreements respecting the subject matter hereof, either written or oral,
expressed or implied, shall be abrogated, canceled, and are null and void and of
no effect. No amendment or change hereof or addition hereto shall be effective
or binding on any of the parties hereto unless reduced to writing and executed
by the respective duly authorized representatives of each of the parties hereto.
11.7 SEVERABILITY. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and effect
without said provision and the parties shall exert their best efforts to amend
this Agreement to include a provision which is valid, legal and enforceable and
which carries out the original intent of the parties.
11.8 COUNTERPARTS AND HEADINGS. This Agreement may be executed in
counterparts, each of which shall be deemed to be an original and both together
shall be deemed to be one and the same agreement. All headings and any cover
page or table of contents are inserted for convenience of reference only and
shall not affect the Agreement's meaning or interpretation.
11.9 GOVERNING LAW. All matters affecting the interpretation, validity
and performance under this Agreement shall be governed by the internal laws of
the State of New York, without regard for its conflict of laws principles.
11.10 FORCE MAJEURE. No party shall be liable to the other, or be in
default under the terms of this Agreement, for its failure to fulfill its
obligations hereunder to the extent such failure arises for any reason beyond
its control including, without limitation, strikes, lockouts, labor disputes,
acts of God, acts of nature, acts of governments or their agencies, fire, flood,
storm, power shortages or power failure, war, sabotage, inability to obtain
sufficient labor, raw materials, fuel or utilities, or inability to obtain
transportation (each, an "Event of Force Majeure"); provided that the party
relying on the provisions of this Section 11.10 shall forthwith give to the
other notice of its inability to observe or perform the provisions of this
Agreement and the reasons therefor; and provided further that the suspension of
the obligations of the party so affected shall continue only for so long as such
Event of Force Majeure continues.
11.11 ASSIGNMENT. This Agreement shall not be assignable by any party
without the prior written consent of the other (which consent shall not be
unreasonably withheld), except that any party may assign this Agreement to an
Affiliate or to a successor in interest or transferee of all or substantially
all of its assets.
11.12 SUCCESSORS. Subject to the limitations on assignment herein, this
Agreement shall be binding upon and inure to the benefit of the successors in
interest and assigns of Licensor and Licensee. In order for such assignment to
be effective any such assignee of a party's interest shall expressly assume in
writing the performance of all the terms and conditions of this Agreement to be
performed by said party and such assignment shall not relieve the assignor of
any of its obligations under this Agreement.
11.13 EXPENSES. Licensee and Licensor shall each bear its own expenses,
including, without limitation, the fees and disbursements of its respective
counsel and
24
accountants, in connection with the negotiation and execution of this Agreement
and the consummation of the transactions contemplated hereby.
25
IN WITNESS WHEREOF, the parties hereto have executed this Agreement, in
one or more counterparts, on the day and year first above written.
ORAVAX, INC. PASTEUR MERIEUX SERUMS & VACCINS S.A.
By: By:
------------------------ ------------------------
Name: Name: Xxxx Xxxxxxxxxxx
Title: Title: Corporate Vice President
APPENDIX A
INITIAL MEMBERSHIP OF RESEARCH AND DEVELOPMENT COMMITTEE*
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
SCHEDULE A
PATENT RIGHTS
[]*
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
ANNEX B TO
EXHIBIT 10.10
U.S. HEPATITIS C LICENSE AGREEMENT
This LICENSE AGREEMENT (the "Agreement" or "License") is entered
into as of __________, 1999 by and between ORAVAX MERIEUX CO., a general
partnership organized under the laws of Massachusetts, ("Licensee") and ORAVAX,
INC., a corporation organized under the laws of the State of Delaware, ("OraVax"
or "Licensor").
W I T N E S S E T H
WHEREAS, Licensor owns or possesses certain proprietary rights and
know-how relating to vaccines for the prevention, treatment or cure of hepatitis
C in humans (the "Field");
WHEREAS, Licensee desires to obtain from Licensor, and Licensor
desires to grant to Licensee, a license under Licensor's proprietary rights and
know-how to research, develop, manufacture, market, sell and distribute Target
Products (as defined below);
NOW, THEREFORE, in consideration of the mutual promises, conditions,
covenants and undertakings hereinafter set forth, the parties hereto, intending
to be legally bound, hereby agree as follows:
1. DEFINITIONS.
All capitalized terms used in this Agreement and not otherwise defined
herein shall have the meanings set forth in the Master Agreement (as defined
below) and such definitions are incorporated herein by reference.
1.1 "Affiliate" shall mean, with respect to either OraVax or
Licensee, (i) any Person (including a partnership) of which securities or other
ownership interests representing 50% or more of the equity or 50% or more of the
ordinary voting power are, at the time such determination is being made, owned,
Controlled or held, directly or indirectly, by such Party, or (ii) any other
Person which, at the time such determination is being made, is Controlling,
Controlled by or under common Control with, such Party.
1.2 "Basic Technology" shall mean the inventions described in the
patents and patent applications set forth on SCHEDULE A attached hereto.
1.3 "Collaboration" refers to the time period during which the U.S.
Partnership is in effect.
1.4 "Control", whether used as a noun or verb, shall mean 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
1.5 "Improvements" shall mean any Technology which enhances the
effectiveness of or is an improvement upon any aspect of the OraVax Technology,
which is conceived, discovered, actually reduced to practice, obtained by,
licensed (with right to sublicense) or otherwise acquired by one or more of the
Parties and/or one or more of the Partnerships, or by one or more of their
Controlled Affiliates after the date of this Agreement and prior to the
termination of the Collaboration. Improvements shall include, by way of
illustration but not limitation, enhancements in the form of improving the
process for making the Target Products so that they are made in a less expensive
or more expeditious manner, increasing the immunological or therapeutic
effectiveness of the Target Products, discovering additional biological
information as it relates to the expression of the Target Products, discovering
additional substitutions in the Target Products which increase immunological or
therapeutic effectiveness and discovering new applications of the Target
Products in other fields of use.
1.6 "Independent Improvement" shall mean any Improvement conceived,
discovered, developed, licensed or otherwise acquired after the date of this
Agreement but prior to any termination of the Collaboration, which was
conceived, discovered, developed, licensed (with the right to sublicense) or
otherwise acquired by either Licensee, OraVax or their Controlled Affiliates due
to funding outside of the Programs by such Party or its Controlled Affiliate.
1.7 "Licensed Technology" shall mean, collectively, the OraVax
Technology and OraVax' Independent Improvements.
1.8 "Master Agreement" shall mean that certain Master Agreement by
and between PMC and OraVax dated as of March 31, 1995, as amended by that
certain Amendment Agreement dated November 2, 1998 and that certain Amendment
Agreement dated as of the date hereof.
1.9 "Net Sales" shall mean with respect to sales of the product
concerned for any period for which the applicable calculation is being made, the
gross amount invoiced to customers less (i) returns and allowances, (ii) trade
and/or quantity discounts, (iii) sales, use, value-added, excise taxes and
similar taxes and duties, (iv) an additional amount which would reasonably
approximate the actual cash discounts, if any, given to customers.
1.10 "OraVax Technology" shall mean the Basic Technology and any
other Technology other than Severable Technology which (i) relates and is useful
to research, development, use and exploitation of Target Products and (ii) is
owned, licensed or otherwise held by OraVax or any of its Controlled Affiliates
at the date of this Agreement with the right to license or sublicense the same
to the Partnerships.
1.11 "OraVax Technology Agreement" shall mean any agreement or
understanding pursuant to which OraVax has acquired rights to any of the
Licensed Technology.
1.12 "Partnership(s)" shall mean, collectively, the SNC and the U.S.
Partnership and, individually, either the SNC or the U.S. Partnership.
1.13 "Person" shall mean any natural person, corporation, firm,
business trust, joint venture, association, organization, company, partnership
or other business entity, or any government, or agency or political subdivision
thereof.
2
1.14 "PMC" shall mean Pasteur Merieux Serums & Vaccins S.A., a French
SOCIETE ANONYME, whose registered head office is located at 00, xxxxxx Xxxxxxx,
00000 Xxxx, Xxxxxx.
1.15 "Proprietary Rights" shall mean patent rights (including, but not
limited to, all granted patents and pending patent applications), copyrights,
trade secret rights and similar rights, and licenses and sublicenses under such
rights.
1.16 "Severable Technology" shall mean any Technology, which (i) is
not Licensed Technology, and (ii) results during the Collaboration from funding
outside the Collaboration and has or was expected to have applications and uses
outside of the Field but (iii) is useful or potentially useful to the research,
development, manufacture, use or exploitation of Target Products. Severable
Technology shall include, by way of illustration but not limitation, adjuvants,
microencapsulation techniques or any innovation allowing a change in the means
of delivery or the addition of another antigen for use against hepatitis C.
Without limiting the generality of the foregoing, the parties agree that
PMC's vero cell technology constitutes Severable Technology.
1.17 "SNC" shall mean the SOCIETE EN NOM COLLECTIF established by
OraVax and PMC under French law to pursue the Collaboration outside the United
States.
1.18 "Sublicensed Affiliate" shall mean, with respect to either OraVax
or Licensee, any Affiliate with an express or implied (e.g., under a
distribution agreement) license or sublicense to research, develop, make, have
made, market, sell, distribute or use Target Products.
1.19 "SNC License Agreement" shall mean that certain license agreement
of even date herewith by and between OraVax, as licensor, and the SNC, as
licensee.
1.20 "Target Product" shall mean any vaccine for the prevention,
treatment or cure of hepatitis C infections in humans; provided, however, that
any product containing one or more antigens for use against indications other
than hepatitis C shall not be a Target Product unless both Parties shall agree
in writing to extend the definition to include such product. In addition, no
product shall be deemed a Target Product unless either (i) such product utilizes
a method, vaccine or composition described in whole or in part in any of the
patents or any of the original patent applications of the pending patent
applications listed in SCHEDULE A attached hereto or (ii) the research,
development, manufacture or use of such product has or will use Technology
described in whole or in part in any of the patents or any of the original
patent applications of the pending patent applications listed in SCHEDULE A
attached hereto. All references in this definition to patents and patent
applications are solely for the purpose of incorporating the descriptions of the
method, vaccine, composition and/ or Technology contained therein and shall not
be deemed to require that a patent shall issue from any pending patent
application or deemed to require that any patent, whether existing or
subsequently issued, shall be valid or enforceable. Any product that is not a
Target Product shall be deemed a Target Product only if during the term of the
Collaboration the Executive Committee determines to extend the definition of
Target Product to such product.
3
1.21 "Technology" shall mean:
(a) the subject matter of any and all relevant patents and/or pending
patent applications, including, but not limited to, the information contained in
such patents and patent applications, any divisions, continuations, and
continuations-in-part based thereon, any patents which may issue therefrom and
any reissues, patents of addition or importation; and
(b) any and all relevant inventions (whether or not patentable),
ideas, processes, formulas, technical information, trade secrets, developments,
discoveries, data, the subject matter of any and all copyrights, drawings,
techniques, documents, laboratory note books, pre-clinical and clinical case
reports and report forms, scientific and medical reports, models, and know-how,
including by way of example and in no way limiting the foregoing, any biological
materials and chemical compounds 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.
1.22 "United States" shall mean the United States of America and its
dependent territories and possessions.
1.23 "U.S. Partnership" shall mean the partnership established by PMC
and OraVax to pursue the Collaboration in the United States.
2. LICENSE GRANT.
2.1 ORAVAX LICENSE TO THE U.S. PARTNERSHIP. Subject to all of the
terms and limitations of this Agreement, OraVax hereby grants to the U.S.
Partnership, a nationwide license under its Proprietary Rights to use the
Licensed Technology in the Field to research, develop, make, have made, market,
sell, distribute and use the Target Products in the United States. The foregoing
license is limited, and may be exercised solely as provided herein; provided,
however, that any such limitation is without prejudice to the U.S. Partnership's
exercise of any rights it may now hold or hereafter obtain independently in
respect of any Technology other than the Licensed Technology.
2.2 UNDERTAKINGS. Except as provided herein, the licensee granted
under Section 2.1 hereof shall be exclusive in the Field. The U.S. Partnership
undertakes that during the term of the Collaboration it shall commercially
exploit its interest in the Licensed Technology within the Field in the United
States.
3. COMPENSATION.
3.1 LICENSE FEE. In consideration of the licenses granted hereunder,
Licensee shall pay to Licensor a license fee of []* on the later to
occur of []*
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
4
[]*
3.2 MILESTONE FEES. Licensee shall, with the exception of clause
(vi) hereof, pay to Licensor the amounts specified below within []* following
the accomplishment by Licensee, of the corresponding event set forth below
(each, a "Milestone"):
(i) []*
(ii) []*
(iii) []*
(iv) []*
(v) []*
(vi) []*
The foregoing amounts shall be paid by Licensee only once.
3.3 ROYALTIES. Licensee shall pay Licensor a minimum royalty of []*
which shall be payable in any year when the U.S. Partnership have any sales of
Target Products in the United States, which shall be paid with reasonable
promptness upon receipt of an invoice following the close of the year concerned.
3.4 TAXES. Licensee may withhold from any payments due the Licensor
under this Agreement the appropriate withholding taxes, if any, applicable to
such payments. Licensee shall remit the withheld taxes to the appropriate taxing
authorities, and shall provide to Licensor an official certificate of payments
of such taxes or any other documentation and evidence necessary to verify
payment thereof.
3.5 RECORDS, ACCOUNTING. If the Collaboration is terminated pursuant
to Section 11 hereof, PMC and OraVax and their successors and assigns shall keep
and maintain detailed and accurate books and records with regard to Net Sales,
royalties, payments received from sublicensees and payments due to the other and
the calculation thereof.
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
5
4. ORAVAX' RETAINED RIGHTS. Except for the license granted to the U.S.
Partnership under Section 2.1 hereof, and the license granted to the SNC
pursuant to the SNC License Agreement, OraVax retains all right, title and
interest to the Licensed Technology, subject to all the terms, conditions,
limitations and restrictions of this Agreement, the SNC License Agreement and
the Master Agreement. OraVax' retained rights include, but are not limited to,
(a) the right to use the Licensed Technology for research, development and
manufacturing the Target Products in the Field on behalf of the Collaboration,
and (b) the right to use and exploit the Licensed Technology outside the Field.
5. LIMITED RIGHT TO GRANT SUBLICENSES. During the term of the
Collaboration the U.S. Partnership shall only be entitled to grant sublicenses
to use the Licensed Technology within the Field for the purposes and benefit of
the Collaboration.
6. THIRD PARTY AGREEMENTS. The U.S. Partnership agrees to comply with
all terms, conditions and restrictions applicable to it imposed by the OraVax
Technology Agreements as the same exist as of the date hereof and any agreements
with third parties relating to any OraVax Independent Improvements.
7. IMPROVEMENTS; DISCLOSURE.
7.1 INDEPENDENT IMPROVEMENTS. Any and all Proprietary Rights to any
Independent Improvement conceived, discovered, developed, licensed or otherwise
acquired during the term of the Collaboration, shall, as between the Licensee
and OraVax, be owned by the party that expended the funding for the Independent
Improvement. Notwithstanding the foregoing, any OraVax Independent Improvement
during the term of the Collaboration shall automatically be included within the
license granted under Section 2.1 hereof and automatically included in any
sublicenses granted in accordance with this Agreement without any change or
adjustment to the payments due between the parties hereunder.
7.2 DISCLOSURE. OraVax and the Licensee agree to promptly disclose to
each other any Improvement which either party conceives, discovers, develops,
licenses or otherwise acquires rights to, during the term of the Collaboration;
provided, however, that if OraVax or the Licensee is offered or obtains
something which would otherwise be an Improvement from a third party but which
is subject to restrictions on disclosure and use, then such party shall notify
the other party of the existence and restrictions on the disclosure and use of
the Improvement and shall consult with the other party on a good faith basis as
to whether the parties need to jointly negotiate a license to obtain disclosure
and use of the Improvement for the purposes of the Collaboration; and, provided,
further, that except as set forth in the foregoing proviso, there shall be no
restrictions on the right of the Licensor to receive Improvements hereunder,
including, but not limited to, pursuant to Section 6 above.
8. SEVERABLE TECHNOLOGY. OraVax and PMC hereby agree that Severable
Technology is not subject to, or included in, any license granted under this
Agreement. Severable Technology shall be owned by the party that conceives,
discovers, develops, licenses or otherwise acquires the same.
6
9. CONFIDENTIALITY. The terms of this Agreement and all Licensed
Technology, Improvements, and all other information disclosed pursuant to this
Agreement shall be subject to the provisions of Article 21 of the Master
Agreement.
10. PATENT MATTERS. Any and all matters relating to patent prosecution
and protection of a party's Proprietary Rights with respect to the Licensed
Technology and Independent Improvements thereto shall be determined in
accordance with Section 7.5 of the Master Agreement.
11. TERM AND TERMINATION.
11.1 TERM. The term of this Agreement shall commence on the date
hereof and shall continue until the Partnership is terminated and dissolved as
set forth in the Master Agreement. In the event that the Partnership is
dissolved (i) both OraVax and PMC shall have co-exclusive rights to the Licensed
Technology, (ii) neither PMC nor OraVax shall have the right to grant
sublicenses of the Licensed Technology, and (iii) neither PMC nor OraVax shall
have the right, either on its own or pursuant to any agreement or arrangement
with a third party to manufacture, have manufactured, sell, have sold, market,
develop or distribute a product derived from the Licensed Technology without the
written consent of the other.
11.2 TERMINATION. This Agreement shall terminate and all rights
granted by Licensor hereunder shall revert to the Licensor in the event that
[(a) PMC, either alone or in collaboration with a third party, owns or has
worldwide rights to a vaccine for the prevention, treatment or cure of
hepatitis C in humans that is in Phase II clinical trials, and (b) PMC
refuses to permit the Partnership (i) to develop and commercialize a Target
Product either by itself or in collaboration with a third party when it
would be commercially reasonable to do so or (ii) to sublicense the rights
licensed hereunder to a third party in a commercially reasonable transaction.]
This Agreement shall also terminate and all rights granted by Licensor
hereunder shall revert to Licensor in the event that PMC fails to make a
required capital contribution necessary to permit the Partnership to make the
payments set forth in Section 3.1 or 3.2 hereof.
11.3 INCORPORATION BY REFERENCE AND SURVIVAL. Any accrued rights to
payment and any cause of action or remedies for breach of this Agreement shall
survive termination. Section 7.5 (Patent Matters) and Articles 17 (Arbitration),
18 (Indemnification) and 21 (Confidentiality) of the Master Agreement are hereby
incorporated herein by reference and shall survive for the purposes hereof in
accordance herewith without regard to any termination of the Master Agreement.
Without limiting the generality of the foregoing, the parties agree that this
Agreement constitutes a "Future Agreement" within the meaning of the Master
Agreement.
11.4 TRANSFER OF TECHNOLOGY ON TERMINATION. Upon termination of this
Agreement, any documents, records, materials or other tangible manifestations of
the Licensed Technology shall be transferred, returned or retained in accordance
with the relevant provisions of the Master Agreement.
11.5 REMEDIES. Termination is not the sole remedy under this Agreement
and, whether or not termination is effected, all other remedies will remain
available.
7
12. ARBITRATION. Any and all disputes in relation to any aspect of this
Agreement shall be settled by final and binding arbitration pursuant to
applicable provisions set forth in Article 17 of the Master Agreement.
13. PROPRIETARY RIGHTS. As of the Effective Time: (a) OraVax or one or
more of its Affiliates owns or has rights to use and exploit all OraVax
Technology; (b) there have been no material claims made against OraVax or any of
its Affiliates asserting the invalidity, unenforceability of, or misuse of, any
of OraVax' Proprietary Rights to the OraVax Technology; (c) neither OraVax nor
any of its Affiliates has received a notice from a third party indicating that
any aspect of the OraVax Technology may conflict with the asserted rights of
others, or otherwise challenging OraVax' rights to use any of the OraVax
Technology; (d) to OraVax' best knowledge, the present use by OraVax or any of
its Affiliates of such OraVax Technology does not violate or infringe in any
material respect any such rights of others or constitute a material breach under
any agreement with a third party; (e) the OraVax Technology Agreements are the
only agreements to which OraVax or any of its Affiliates are a party pursuant to
which payments may be due in respect of OraVax Technology; (f) the agreements
listed and described on Annex A hereto are the only agreements to which OraVax
or any of its Affiliates is a party affecting OraVax' rights to use and exploit
all of the OraVax Technology; (g) OraVax is in full compliance in all material
respects with the terms and conditions of each of the OraVax Technology
Agreements; (h) each of the OraVax Technology Agreements constitutes the valid
and binding obligations of OraVax and each other party thereto and shall be
enforceable against OraVax and, against each other party thereto in accordance
with its terms (subject, however, to any limitations with respect to enforcement
which may be imposed in connection with bankruptcy, insolvency, reorganization,
moratorium or other laws affecting the enforcement of creditors' rights
generally, and except that no representation or warranty is made as to the
availability of any equitable remedy in connection with the enforcement of any
term thereof). None of the rights of OraVax or any of its Affiliates to such
OraVax Technology will be adversely affected by the execution, delivery or
performance of this Agreement. OraVax and its Affiliates have taken all action
reasonably necessary, using its current standard business practices, to protect
such OraVax Technology.
EXCEPT AS SPECIFICALLY PROVIDED FOR IN THIS SECTION 13, ORAVAX DISCLAIMS ALL
WARRANTIES RELATING TO THE LICENSED TECHNOLOGY, EXPRESS OR IMPLIED, INCLUDING,
BUT NOT LIMITED TO, ANY WARRANTIES AGAINST INFRINGEMENT OF THIRD PARTY RIGHTS,
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
14. CERTAIN COVENANTS RELATING TO ORAVAX TECHNOLOGY. OraVax hereby
covenants to indemnify and hold PMC and the U.S. Partnership harmless against
any and all claims, costs and damages in the event that, at any time or from
time to time, the amount of any and all royalties and license or other fees
which may be payable under the OraVax Technology Agreements to the extent
that any such royalties exceed [ ]* of net sales.
OraVax covenants and agrees at all times during the Collaboration, and
thereafter so long as PMC or its Affiliates or successors and assigns has any
rights to any of the OraVax Technology, (i) to take all action reasonably
necessary to protect all of its rights to the OraVax Technology, including, but
not limited to, the OraVax Technology Agreements, (ii) to comply
----------
* This portion of the Exhibit has been omitted pursuant to
a Request for Confidential Treatment under Rule 406 of the
Securities Act of 1933, as amended. The complete Exhibit,
including the portions for which confidential treatment has been
requested, has been filed separately with the Securities and
Exchange Commission.
8
fully with the terms and conditions of each of the OraVax Technology Agreements
(including, but not limited to any royalty or license (or other) fee
obligations) and otherwise maintain such Agreements in full force and effect;
(provided that OraVax shall not be responsible for adverse effects on the OraVax
Technology Agreements to the extent caused, by the actions of PMC or its
Controlled Affiliates or their successors and assigns unless expressly licensed
or authorized by OraVax pursuant to the Master Agreement or any Closing or
Future Agreement); and (iii) to promptly furnish PMC with copies of any and all
written notices OraVax or any of its directors, officers, employees, agents or
representatives may at any time receive in connection with any of the OraVax
Technology Agreements.
15. INDEMNIFICATION. Each of OraVax and the Licensee shall defend
indemnify and hold harmless the other and their respective Affiliates to the
full extent provided in Article 18 of the Master Agreement.
16. ASSIGNMENT. The rights and obligations of the parties under this
Agreement may not be assigned or transferred without the prior written consent
of the other.
17. EXPORT REGULATIONS. The U.S. Partnership hereby agrees to comply with
all export laws and restrictions and regulations of the Department of Commerce
of the United States or other United States, French or any other country's
agency or authority, and not to knowingly export, or allow the export or
re-export of any Technology, Target Product or any derivative or direct product
thereof, in violation of any such restrictions, laws or regulations, or, without
all required licenses and authorizations to Afghanistan, the People's Republic
of China or any Group Q, S, W, Y or Z country specified in the then current
Supplement No. 1 to Section 770 of the U.S. Export Administration Regulations
(or any successor supplement or regulations).
18. IMPORT REGULATIONS. This Agreement is subject to all of the United
States', France's (or any other country's, as appropriate) laws and regulations
controlling the import of drugs and biological products, technical data,
laboratory prototypes and other commodities and Technology.
19. NOTICES.
Any notice or other communication required or permitted hereunder
shall be in writing and shall be deemed given when so delivered in person, by
overnight courier, by facsimile transmission (with receipt confirmed by
telephone or by automatic transmission report) or two business days after being
sent by registered or certified mail (postage prepaid, return receipt
requested), as follows:
9
(a) if to Licensor, to:
OraVax, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attn: Xxxxx Xxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to:
Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attn: Xxxxxxx Xxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
(b) if to Licensee, to:
OraVax Merieux Co.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attn: Xxxxx Xxxxxx
with a copy to:
Pasteur Merieux Serums & Vaccins S.A.
00, xxxxxx Xxxxxxx
00000 Xxxx, Xxxxxx
Attn: Senior Vice President,
Legal and Corporate Affairs and General Counsel
Telephone: 011.33.4.37.37.77.84
Facsimile: 011.33.4.37.37.70.61
with a copy to:
Akin, Gump, Strauss, Xxxxx & Xxxx, L.L.P.
000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attn: L. Xxxxx X'Xxxx, Xx., Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Any party may by notice given in accordance with this Section 19 to
the other parties designate another address or person for receipt of notices
hereunder.
10
20. WAIVER. Any term or condition of this Agreement may be waived or
qualified at any time by either Party by a written instrument executed by such
Party. No omission, delay or failure on the part of any Party in exercising any
rights hereunder, and no partial or single exercise hereof, will constitute a
waiver of such rights or of any other rights hereunder.
21. MODIFICATIONS. This Agreement may be amended, modified or supplemented
only by a written instrument duly executed by both parties which instrument
shall specifically indicate that it is the desire of the parties to amend,
modify or supplement the Agreement.
22. GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York, without giving effect to its
conflict of law rules.
23. SEVERABILITY. If any provision of this Agreement is ultimately held to
be invalid, illegal or unenforceable, the validity, legality and enforceability
of the remaining provisions hereof shall not in any way be affected or impaired
thereby, unless the absence of the invalidated provision materially adversely
affects the substantive rights of the parties. To the extent permitted by
applicable law, each Party waives any provision of law which renders any
provision hereof invalid, illegal or unenforceable in any respect. In the event
that any provision of this Agreement shall be held to be invalid, illegal or
unenforceable, the parties shall in such an instance use their best efforts to
replace the invalidated provision by a valid, legal and enforceable provision
which, insofar as practical, implements the purposes hereof.
24. AFFILIATES. Each of OraVax and PMC shall cause its respective
Controlled Affiliates to comply fully with the provisions of this Agreement to
the extent such provisions specifically relate, or are intended to specifically
relate, to such Controlled Affiliates, as though such Controlled Affiliates were
expressly named as joint obligors hereunder.
25. EXECUTION. This Agreement may be executed in several counterparts,
each of which shall be deemed to be an original.
26. HEADINGS. The Section headings in this Agreement are solely for the
convenience and reference of the Parties and are not intended to be descriptive
of the entire contents of, or to affect, any of the terms or provisions hereof.
[The remainder of this page intentionally left blank]
11
IN WITNESS WHEREOF, this LICENSE AGREEMENT has been executed by each
of the parties on the date first above written.
ORAVAX, INC.
By:_______________________________________
Name:
Title:
ORAVAX MERIEUX CO.
By:_______________________________________
Name:
Title:
By:_______________________________________
Name:
Title:
ANNEX C TO
EXHIBIT 10.10
S.N.C. HEPATITIS C LICENSE AGREEMENT
This LICENSE AGREEMENT (the "Agreement" or "License") is
entered into as of __________, 1999 by and between MERIEUX ORAVAX S.N.C., a
French SOCIETE EN NOM COLLECTIF, whose registered head office is at 00, xxxxxx
Xxxxxxx, 00000 Xxxx, Xxxxxx, ("Licensee") and ORAVAX, INC., a corporation
organized under the laws of the State of Delaware, ("OraVax" or "Licensor").
W I T N E S S E T H
WHEREAS, Licensor owns or possesses certain proprietary rights
and know-how relating to vaccines for the prevention, treatment or cure of
hepatitis C in humans (the "Field");
WHEREAS, Licensee desires to obtain from Licensor, and
Licensor desires to grant to Licensee, a license under Licensor's proprietary
rights and know-how to research, develop, manufacture, market, sell and
distribute Target Products (as defined below);
NOW, THEREFORE, in consideration of the mutual promises,
conditions, covenants and undertakings hereinafter set forth, the parties
hereto, intending to be legally bound, hereby agree as follows:
1. DEFINITIONS.
All capitalized terms used in this Agreement and not otherwise
defined herein shall have the meanings set forth in the Master Agreement (as
defined below) and such definitions are incorporated herein by reference.
1.1 "Affiliate" shall mean, with respect to either OraVax or Licensee,
(i) any Person (including a partnership) of which securities or other ownership
interests representing 50% or more of the equity or 50% or more of the ordinary
voting power are, at the time such determination is being made, owned,
Controlled or held, directly or indirectly, by such Party, or (ii) any other
Person which, at the time such determination is being made, is Controlling,
Controlled by or under common Control with, such Party.
1.2 "Basic Technology" shall mean the inventions described in the
patents and patent applications set forth on SCHEDULE A attached hereto.
1.3 "Collaboration" refers to the time period during which the S.N.C.
is in effect.
1.4 "Control", whether used as a noun or verb, shall mean 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
1.5 "Improvements" shall mean any Technology which enhances the
effectiveness of or is an improvement upon any aspect of the OraVax Technology,
which is conceived, discovered, actually reduced to practice, obtained by,
licensed (with right to sublicense) or otherwise acquired by one or more of the
Parties and/or one or more of the Partnerships, or by one or more of their
Controlled Affiliates after the date of this Agreement and prior to the
termination of the Collaboration. Improvements shall include, by way of
illustration but not limitation, enhancements in the form of improving the
process for making the Target Products so that they are made in a less expensive
or more expeditious manner, increasing the immunological or therapeutic
effectiveness of the Target Products, discovering additional biological
information as it relates to the expression of the Target Products, discovering
additional substitutions in the Target Products which increase immunological or
therapeutic effectiveness and discovering new applications of the Target
Products in other fields of use.
1.6 "Independent Improvement" shall mean any Improvement conceived,
discovered, developed, licensed or otherwise acquired after the date of this
Agreement but prior to any termination of the Collaboration, which was
conceived, discovered, developed, licensed (with the right to sublicense) or
otherwise acquired by either Licensee, OraVax or their Controlled Affiliates due
to funding outside of the Programs by such Party or its Controlled Affiliate.
1.7 "Licensed Technology" shall mean, collectively, the OraVax
Technology and OraVax' Independent Improvements.
1.8 "Master Agreement" shall mean that certain Master Agreement by and
between PMC and OraVax dated as of March 31, 1995, as amended by that certain
Amendment Agreement dated November 2, 1998 and that certain Amendment Agreement
dated as of the date hereof.
1.9 "Net Sales" shall mean with respect to sales of the product
concerned for any period for which the applicable calculation is being made, the
gross amount invoiced to customers less (i) returns and allowances, (ii) trade
and/or quantity discounts, (iii) sales, use, value-added, excise taxes and
similar taxes and duties, (iv) an additional amount which would reasonably
approximate the actual cash discounts, if any, given to customers.
1.10 "OraVax Technology" shall mean the Basic Technology and any other
Technology other than Severable Technology which (i) relates and is useful to
research, development, use and exploitation of Target Products and (ii) is
owned, licensed or otherwise held by OraVax or any of its Controlled Affiliates
at the date of this Agreement with the right to license or sublicense the same
to the Partnerships.
1.11 "OraVax Technology Agreement" shall mean any agreement or
understanding pursuant to which OraVax has acquired rights to any of the
Licensed Technology.
1.12 "Partnership(s)" shall mean, collectively, the SNC and the U.S.
Partnership and, individually, either the SNC or the U.S. Partnership.
1.13 "Person" shall mean any natural person, corporation, firm,
business trust, joint venture, association, organization, company, partnership
or other business entity, or any government, or agency or political subdivision
thereof.
2
1.14 "PMC" shall mean Pasteur Merieux Serums & Vaccins S.A., a French
SOCIETE ANONYME, whose registered head office is located at 00, xxxxxx Xxxxxxx,
00000 Xxxx, Xxxxxx.
1.15 "Proprietary Rights" shall mean patent rights (including, but not
limited to, all granted patents and pending patent applications), copyrights,
trade secret rights and similar rights, and licenses and sublicenses under such
rights.
1.16 "Severable Technology" shall mean any Technology, which (i) is not
Licensed Technology, and (ii) results during the Collaboration from funding
outside the Collaboration and has or was expected to have applications and uses
outside of the Field but (iii) is useful or potentially useful to the research,
development, manufacture, use or exploitation of Target Products. Severable
Technology shall include, by way of illustration but not limitation, adjuvants,
microencapsulation techniques or any innovation allowing a change in the means
of delivery or the addition of another antigen for use against hepatitis C.
Without limiting the generality of the foregoing, the parties agree that
PMC's vero cell technology constitutes Severable Technology.
1.17 "SNC" shall mean the SOCIETE EN NOM COLLECTIF established by
OraVax and PMC under French law to pursue the Collaboration outside the United
States.
1.18 "Sublicensed Affiliate" shall mean, with respect to either OraVax
or Licensee, any Affiliate with an express or implied (e.g., under a
distribution agreement) license or sublicense to research, develop, make, have
made, market, sell, distribute or use Target Products.
1.19 "Target Product" shall mean any vaccine for the prevention,
treatment or cure of hepatitis C infections in humans; provided, however, that
any product containing one or more antigens for use against indications other
than hepatitis C shall not be a Target Product unless both Parties shall agree
in writing to extend the definition to include such product. In addition, no
product shall be deemed a Target Product unless either (i) such product utilizes
a method, vaccine or composition described in whole or in part in any of the
patents or any of the original patent applications of the pending patent
applications listed in SCHEDULE A attached hereto or (ii) the research,
development, manufacture or use of such product has or will use Technology
described in whole or in part in any of the patents or any of the original
patent applications of the pending patent applications listed in SCHEDULE A
attached hereto. All references in this definition to patents and patent
applications are solely for the purpose of incorporating the descriptions of the
method, vaccine, composition and/ or Technology contained therein and shall not
be deemed to require that a patent shall issue from any pending patent
application or deemed to require that any patent, whether existing or
subsequently issued, shall be valid or enforceable. Any product that is not a
Target Product shall be deemed a Target Product only if during the term of the
Collaboration the Executive Committee determines to extend the definition of
Target Product to such product.
1.20 "Technology" shall mean:
(a) the subject matter of any and all relevant patents and/or pending
patent applications, including, but not limited to, the information contained in
such patents and patent applications,
3
any divisions, continuations, and continuations-in-part based thereon, any
patents which may issue therefrom and any reissues, patents of addition or
importation; and
(b) any and all relevant inventions (whether or not patentable), ideas,
processes, formulas, technical information, trade secrets, developments,
discoveries, data, the subject matter of any and all copyrights, drawings,
techniques, documents, laboratory note books, pre-clinical and clinical case
reports and report forms, scientific and medical reports, models, and know-how,
including by way of example and in no way limiting the foregoing, any biological
materials and chemical compounds 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.
1.21 "United States" shall mean the United States of America and its
dependent territories and possessions.
1.22 "US License Agreement" shall mean that certain license agreement
of even date herewith by and between OraVax, Inc., as licensor, and the U.S.
Partnership, as licensee.
1.23 "U.S. Partnership" shall mean the partnership established by PMC
and OraVax to pursue the Collaboration in the United States.
2. LICENSE GRANT.
2.1 ORAVAX LICENSE TO THE SNC. Subject to all of the terms and
limitations of this Agreement, OraVax hereby grants to the SNC, a worldwide
license, except in the United States, under its Proprietary Rights to use the
Licensed Technology in the Field to research, develop, make, have made, market,
sell, distribute and use the Target Products worldwide, except in the United
States. The foregoing license is limited, and may be exercised solely as
provided herein; provided, however, that any such limitation is without
prejudice to the SNC's exercise of any rights it may now hold or hereafter
obtain independently in respect of any Technology other than the Licensed
Technology.
2.2 UNDERTAKINGS. Except as provided herein, the licensee granted under
Section 2.1 hereof shall be exclusive in the Field. The SNC undertakes that
during the term of the Collaboration it shall commercially exploit its interest
in the Licensed Technology within the Field worldwide, except in the United
States.
3. COMPENSATION.
3.1 LICENSE FEE. In consideration of the licenses granted hereunder,
Licensee shall pay to Licensor a license fee of []* on the later to occur
of []*
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
4
[]*
3.2 MILESTONE FEES. Licensee shall, with the exception of clause
(vi) hereof, pay to Licensor the amounts specified below within []* following
the accomplishment by Licensee, of the corresponding event set forth below
(each, a "Milestone"):
(i) []*
(ii) []*
(iii) []*
(iv) []*
(v) []*
(vi) []*
The foregoing amounts shall be paid by Licensee only once.
3.3 ROYALTIES. Licensee shall pay Licensor a minimum royalty of []*
which shall be payable in any year when the SNC have any sales of Target
Products anywhere in the world (except in the United States), which shall be
paid with reasonable promptness upon receipt of an invoice following the close
of the year concerned.
3.4 TAXES. Licensee may withhold from any payments due the Licensor
under this Agreement the appropriate withholding taxes, if any, applicable to
such payments. Licensee shall remit the withheld taxes to the appropriate taxing
authorities, and shall provide to Licensor an official certificate of payments
of such taxes or any other documentation and evidence necessary to verify
payment thereof.
3.5 RECORDS, ACCOUNTING. If the Collaboration is terminated pursuant to
Section 11 hereof, PMC and OraVax and their successors and assigns shall keep
and maintain detailed and accurate books and records with regard to Net Sales,
royalties, payments received from sublicensees and payments due to the other and
the calculation thereof.
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
5
4. ORAVAX' RETAINED RIGHTS. Except for the license granted to the SNC
under Section 2.1 hereof, and the license granted to the U.S. Partnership
pursuant to the U.S. License Agreement, OraVax retains all right, title and
interest to the Licensed Technology, subject to all the terms, conditions,
limitations and restrictions of this Agreement, the U.S License Agreement and
the Master Agreement. OraVax' retained rights include, but are not limited to,
(a) the right to use the Licensed Technology for research, development and
manufacturing the Target Products in the Field on behalf of the Collaboration,
and (b) the right to use and exploit the Licensed Technology outside the Field.
5. LIMITED RIGHT TO GRANT SUBLICENSES. During the term of the
Collaboration the SNC shall only be entitled to grant sublicenses to use the
Licensed Technology within the Field for the purposes and benefit of the
Collaboration.
6. THIRD PARTY AGREEMENTS. The SNC agrees to comply with all terms,
conditions and restrictions applicable to it imposed by the OraVax Technology
Agreements as the same exist as of the date hereof and any agreements with third
parties relating to any OraVax Independent Improvements.
7. IMPROVEMENTS; DISCLOSURE.
7.1 INDEPENDENT IMPROVEMENTS. Any and all Proprietary Rights to any
Independent Improvement conceived, discovered, developed, licensed or otherwise
acquired during the term of the Collaboration, shall, as between the Licensee
and OraVax, be owned by the party that expended the funding for the Independent
Improvement. Notwithstanding the foregoing, any OraVax Independent Improvement
during the term of the Collaboration shall automatically be included within the
license granted under Section 2.1 hereof and automatically included in any
sublicenses granted in accordance with this Agreement without any change or
adjustment to the payments due between the parties hereunder.
7.2 DISCLOSURE. OraVax and the Licensee agree to promptly disclose to
each other any Improvement which either party conceives, discovers, develops,
licenses or otherwise acquires rights to, during the term of the Collaboration;
provided, however, that if OraVax or the Licensee is offered or obtains
something which would otherwise be an Improvement from a third party but which
is subject to restrictions on disclosure and use, then such party shall notify
the other party of the existence and restrictions on the disclosure and use of
the Improvement and shall consult with the other party on a good faith basis as
to whether the parties need to jointly negotiate a license to obtain disclosure
and use of the Improvement for the purposes of the Collaboration; and, provided,
further, that except as set forth in the foregoing proviso, there shall be no
restrictions on the right of the Licensor to receive Improvements hereunder,
including, but not limited to, pursuant to Section 6 above.
8. SEVERABLE TECHNOLOGY. OraVax and PMC hereby agree that Severable
Technology is not subject to, or included in, any license granted under this
Agreement. Severable Technology shall be owned by the party that conceives,
discovers, develops, licenses or otherwise acquires the same.
6
9. CONFIDENTIALITY. The terms of this Agreement and all Licensed
Technology, Improvements, and all other information disclosed pursuant to this
Agreement shall be subject to the provisions of Article 21 of the Master
Agreement.
10. PATENT MATTERS. Any and all matters relating to patent prosecution
and protection of a party's Proprietary Rights with respect to the Licensed
Technology and Independent Improvements thereto shall be determined in
accordance with Section 7.5 of the Master Agreement.
11. TERM AND TERMINATION.
11.1 TERM. The term of this Agreement shall commence on the date hereof
and shall continue until the Partnership is terminated and dissolved as set
forth in the Master Agreement. In the event that the Partnership is dissolved
(i) both OraVax and PMC shall have co-exclusive rights to the Licensed
Technology, (ii) neither PMC nor OraVax shall have the right to grant
sublicenses of the Licensed Technology, and (iii) neither PMC nor OraVax shall
have the right, either on its own or pursuant to any agreement or arrangement
with a third party to manufacture, have manufactured, sell, have sold, market,
develop or distribute a product derived from the Licensed Technology without the
written consent of the other.
11.2 TERMINATION. This Agreement shall terminate and all rights granted
by Licensor hereunder shall revert to the Licensor in the event that (a) PMC,
either alone or in collaboration with a third party, owns or has worldwide
rights to a vaccine for the prevention, treatment or cure of hepatitis C in
humans that is in Phase II clinical trials, and (b) PMC refuses to permit the
Partnership (i) to develop and commercialize a Target Product either by
itself or in collaboration with a third party when it would be commercially
reasonable to do so or (ii) to sublicense the rights licensed hereunder to a
third party in a commercially reasonable transaction. This Agreement shall
also terminate and all rights granted by Licensor hereunder shall revert to
Licensor in the event that PMC fails to make a required capital contribution
necessary to permit the Partnership to make the payments set forth in Section
3.1 or 3.2 hereof.
11.3 INCORPORATION BY REFERENCE AND SURVIVAL. Any accrued rights to
payment and any cause of action or remedies for breach of this Agreement shall
survive termination. Section 7.5 (Patent Matters) and Articles 17 (Arbitration),
18 (Indemnification) and 21 (Confidentiality) of the Master Agreement are hereby
incorporated herein by reference and shall survive for the purposes hereof in
accordance herewith without regard to any termination of the Master Agreement.
Without limiting the generality of the foregoing, the parties agree that this
Agreement constitutes a "Future Agreement" within the meaning of the Master
Agreement.
11.4 TRANSFER OF TECHNOLOGY ON TERMINATION. Upon termination of this
Agreement, any documents, records, materials or other tangible manifestations of
the Licensed Technology shall be transferred, returned or retained in accordance
with the relevant provisions of the Master Agreement.
11.5 REMEDIES. Termination is not the sole remedy under this Agreement
and, whether or not termination is effected, all other remedies will remain
available.
----------
* This portion of the Exhibit has been omitted pursuant to a request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The Complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
7
12. ARBITRATION. Any and all disputes in relation to any aspect of this
Agreement shall be settled by final and binding arbitration pursuant to
applicable provisions set forth in Article 17 of the Master Agreement.
13. PROPRIETARY RIGHTS. As of the Effective Time: (a) OraVax or one or
more of its Affiliates owns or has rights to use and exploit all OraVax
Technology; (b) there have been no material claims made against OraVax or any of
its Affiliates asserting the invalidity, unenforceability of, or misuse of, any
of OraVax' Proprietary Rights to the OraVax Technology; (c) neither OraVax nor
any of its Affiliates has received a notice from a third party indicating that
any aspect of the OraVax Technology may conflict with the asserted rights of
others, or otherwise challenging OraVax' rights to use any of the OraVax
Technology; (d) to OraVax' best knowledge, the present use by OraVax or any of
its Affiliates of such OraVax Technology does not violate or infringe in any
material respect any such rights of others or constitute a material breach under
any agreement with a third party; (e) the OraVax Technology Agreements are the
only agreements to which OraVax or any of its Affiliates are a party pursuant to
which payments may be due in respect of OraVax Technology; (f) the agreements
listed and described on Annex A hereto are the only agreements to which OraVax
or any of its Affiliates is a party affecting OraVax' rights to use and exploit
all of the OraVax Technology; (g) OraVax is in full compliance in all material
respects with the terms and conditions of each of the OraVax Technology
Agreements; (h) each of the OraVax Technology Agreements constitutes the valid
and binding obligations of OraVax and each other party thereto and shall be
enforceable against OraVax and, against each other party thereto in accordance
with its terms (subject, however, to any limitations with respect to enforcement
which may be imposed in connection with bankruptcy, insolvency, reorganization,
moratorium or other laws affecting the enforcement of creditors' rights
generally, and except that no representation or warranty is made as to the
availability of any equitable remedy in connection with the enforcement of any
term thereof). None of the rights of OraVax or any of its Affiliates to such
OraVax Technology will be adversely affected by the execution, delivery or
performance of this Agreement. OraVax and its Affiliates have taken all action
reasonably necessary, using its current standard business practices, to protect
such OraVax Technology.
EXCEPT AS SPECIFICALLY PROVIDED FOR IN THIS SECTION 13, ORAVAX DISCLAIMS ALL
WARRANTIES RELATING TO THE LICENSED TECHNOLOGY, EXPRESS OR IMPLIED, INCLUDING,
BUT NOT LIMITED TO, ANY WARRANTIES AGAINST INFRINGEMENT OF THIRD PARTY RIGHTS,
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
14. CERTAIN COVENANTS RELATING TO ORAVAX TECHNOLOGY. OraVax hereby
covenants to indemnify and hold PMC and the SNC harmless against any and all
claims, costs and damages in the event that, at any time or from time to
time, the amount of any and all royalties and license or other fees which may
be payable under the OraVax Technology Agreements to the extent that any such
royalties exceed [ ]* of net sales.
OraVax covenants and agrees at all times during the
Collaboration, and thereafter so long as PMC or its Affiliates or successors and
assigns has any rights to any of the OraVax Technology, (i) to take all action
reasonably necessary to protect all of its rights to the OraVax Technology,
including, but not limited to, the OraVax Technology Agreements, (ii) to comply
----------------------
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as
amended. The complete Exhibit, including the portions for which confidential
treatment has been requested, has been filed separately with the Securities
and Exchange Commission.
8
fully with the terms and conditions of each of the OraVax Technology Agreements
(including, but not limited to any royalty or license (or other) fee
obligations) and otherwise maintain such Agreements in full force and effect;
(provided that OraVax shall not be responsible for adverse effects on the OraVax
Technology Agreements to the extent caused, by the actions of PMC or its
Controlled Affiliates or their successors and assigns unless expressly licensed
or authorized by OraVax pursuant to the Master Agreement or any Closing or
Future Agreement); and (iii) to promptly furnish PMC with copies of any and all
written notices OraVax or any of its directors, officers, employees, agents or
representatives may at any time receive in connection with any of the OraVax
Technology Agreements.
15. INDEMNIFICATION. Each of OraVax and the Licensee shall defend
indemnify and hold harmless the other and their respective Affiliates to the
full extent provided in Article 18 of the Master Agreement.
16. ASSIGNMENT. The rights and obligations of the parties under this
Agreement may not be assigned or transferred without the prior written consent
of the other.
17. EXPORT REGULATIONS. The SNC hereby agrees to comply with all export
laws and restrictions and regulations of the Department of Commerce of the
United States or other United States, French or any other country's agency or
authority, and not to knowingly export, or allow the export or re-export of any
Technology, Target Product or any derivative or direct product thereof, in
violation of any such restrictions, laws or regulations, or, without all
required licenses and authorizations to Afghanistan, the People's Republic of
China or any Group Q, S, W, Y or Z country specified in the then current
Supplement No. 1 to Section 770 of the U.S. Export Administration Regulations
(or any successor supplement or regulations).
18. IMPORT REGULATIONS. This Agreement is subject to all of the United
States', France's (or any other country's, as appropriate) laws and regulations
controlling the import of drugs and biological products, technical data,
laboratory prototypes and other commodities and Technology.
19. NOTICES.
Any notice or other communication required or permitted hereunder shall
be in writing and shall be deemed given when so delivered in person, by
overnight courier, by facsimile transmission (with receipt confirmed by
telephone or by automatic transmission report) or two business days after being
sent by registered or certified mail (postage prepaid, return receipt
requested), as follows:
9
(a) if to Licensor, to:
OraVax, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attn: Xxxxx Xxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to:
Xxxxxx & Dodge LLP
Xxx Xxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Attn: Xxxxxxx Xxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
(b) if to Licensee, to:
Merieux OraVax S.N.C.
00 xxxxxx Xxxxxxx
00000 Xxxx, Xxxxxx
Attn: Gerant
with a copy to:
Pasteur Merieux Serums & Vaccins S.A.
00, xxxxxx Xxxxxxx
00000 Xxxx, Xxxxxx
Attn: Senior Vice President,
Legal and Corporate Affairs and
General Counsel
Telephone: 011.33.4.37.37.77.84
Facsimile: 011.33.4.37.37.70.61
with a copy to:
Akin, Gump, Strauss, Xxxxx & Xxxx, L.L.P.
000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attn: L. Xxxxx X'Xxxx, Xx., Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Any party may by notice given in accordance with this Section 19 to the
other parties designate another address or person for receipt of notices
hereunder.
10
20. WAIVER. Any term or condition of this Agreement may be waived or
qualified at any time by either Party by a written instrument executed by such
Party. No omission, delay or failure on the part of any Party in exercising any
rights hereunder, and no partial or single exercise hereof, will constitute a
waiver of such rights or of any other rights hereunder.
21. MODIFICATIONS. This Agreement may be amended, modified or
supplemented only by a written instrument duly executed by both parties which
instrument shall specifically indicate that it is the desire of the parties to
amend, modify or supplement the Agreement.
22. GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York, without giving effect to its
conflict of law rules.
23. SEVERABILITY. If any provision of this Agreement is ultimately held
to be invalid, illegal or unenforceable, the validity, legality and
enforceability of the remaining provisions hereof shall not in any way be
affected or impaired thereby, unless the absence of the invalidated provision
materially adversely affects the substantive rights of the parties. To the
extent permitted by applicable law, each Party waives any provision of law which
renders any provision hereof invalid, illegal or unenforceable in any respect.
In the event that any provision of this Agreement shall be held to be invalid,
illegal or unenforceable, the parties shall in such an instance use their best
efforts to replace the invalidated provision by a valid, legal and enforceable
provision which, insofar as practical, implements the purposes hereof.
24. AFFILIATES. Each of OraVax and PMC shall cause its respective
Controlled Affiliates to comply fully with the provisions of this Agreement to
the extent such provisions specifically relate, or are intended to specifically
relate, to such Controlled Affiliates, as though such Controlled Affiliates were
expressly named as joint obligors hereunder.
25. EXECUTION. This Agreement may be executed in several counterparts,
each of which shall be deemed to be an original.
26. HEADINGS. The Section headings in this Agreement are solely for the
convenience and reference of the Parties and are not intended to be descriptive
of the entire contents of, or to affect, any of the terms or provisions hereof.
[The remainder of this page intentionally left blank]
11
IN WITNESS WHEREOF, this LICENSE AGREEMENT has been executed by each of
the parties on the date first above written.
ORAVAX, INC.
By:_________________________________
Name:
Title:
MERIEUX ORAVAX S.N.C.
By:_________________________________
Name:
Title:
By:_________________________________
Name:
Title:
By:_________________________________
Name:
Title:
ANNEX D TO
EXHIBIT 10.10
AMENDMENT AGREEMENT
This Amendment Agreement (the "Amendment Agreement") is
entered into as of this ___ day of ________, 1999 by and between:
1. PASTEUR MERIEUX Serums & Vaccins S.A., a SOCIETE ANONYME
existing and organized under the laws of France, registered under number RCS
LYON B 349 505 370, whose registered head office is located at 00, xxxxxx
Xxxxxxx, 00000 Xxxx, Xxxxxx (hereinafter referred to as "PMC");
AND
2. ORAVAX, Inc., a corporation existing and organized under
the laws of the State of Delaware, having its principal place of business at 00
Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx, Xxxxxx Xxxxxx of America (hereinafter
referred to as "OraVax").
Capitalized terms used but not defined herein shall have the
same meanings assigned to them in the Master Agreement dated March 31, 1995 as
amended by that certain Amendment Agreement dated November 2, 1998 (the "Master
Agreement").
WITNESSETH
WHEREAS, OraVax and PMC have entered into the Master Agreement
with respect to the development of products for the treatment and/or prevention
of Helicobacter pylori infections; and
WHEREAS, the Master Agreement provides that the parties may
extend the scope of the Collaboration to include products for the prevention of
other infections; and
WHEREAS, the Executive Committees of each of the Partnerships
have agreed to extend the scope of the Collaboration to include vaccines for the
prevention of Hepatitis C in humans and in connection therewith each of the
Partnerships has entered into license agreements with PMC for certain technology
relating to vaccines for the prevention of Hepatitis C (collectively, the
"Hepatitis C License Agreements"); and
WHEREAS, in connection with entering into the Hepatitis C
License Agreements, the parties desire to amend certain terms of the Master
Agreement to include vaccines for the prevention of Hepatitis C within the Field
of the Collaboration;
NOW, THEREFORE, in consideration of the mutual promises,
conditions, covenants and undertakings hereinafter set forth, the parties
hereto, intending to be legally bound, hereby agree as follows:
1. Section 1.1 of the Master Agreement is hereby amended to
include vaccines for the prevention of hepatitis C in humans which utilize the
Technology set forth in the Hepatitis C License Agreements within the Field of
the Collaboration.
2. The definition of "OraVax Technology" in Section 1.2 of the
Master Agreement shall, for all purposes other than Article 5 of the Master
Agreement, be amended to include the Technology licensed to PMC from OraVax
relating to vaccines for the prevention of Hepatitis C in humans pursuant to
that certain OraVax / PMC Hepatitis C License Agreement dated as of the date
hereof.
3. The definition of "Target Products" in Section 1.2 of the
Master Agreement shall be amended to include products for the prevention,
treatment or cure of Hepatitis C in humans which utilizes the Technology
licensed to the Partnerships pursuant to the Hepatitis C License Agreements.
4. A new Section 7.3(c) is hereby added which reads in its
entirety as follows:
"(c) Notwithstanding the foregoing, the Parties agree that
Sections 7.3(a) and 7.3(b) hereof shall not apply to any
license given by OraVax to the Partnerships with respect
to hepatitis C."
5. A new Section 7.7 is hereby added which reads in its
entirety as follows:
"7.7 RESEARCH, DEVELOPMENT AND MANUFACTURE OF TARGET PRODUCTS.
In the event that the Program Committee determines that
PMC's vero cell technology is useful or necessary for the
research, development and/or manufacture of a Target Product,
PMC agrees to research, develop and/or manufacture such
Target Product using such vero cell technology on
commercially reasonable terms at no additional royalty to
the Partnerships. Notwithstanding the foregoing (but subject
to the obligation of PMC to apply such technology at no
additional cost), the Parties agree that PMC's vero cell
technology constitutes Severable Technology."
6. Except as expressly amended hereby, the Master Agreement
and all rights and obligations of the parties thereunder, shall remain in full
force and effect. This Amendment Agreement shall not be deemed to be a consent
to any waiver or modification of any other terms or provisions of the Master
Agreement.
IN WITNESS WHEREOF, this Amendment Agreement has been executed
by each of the parties on the date first above written.
PASTEUR MERIEUX Serums & Vaccins S.A.
By: ___________________________________
Name:
Title:
ORAVAX, INC.
By: ___________________________________
Name:
Title:
ANNEX E TO
EXHIBIT 10.10
MILESTONE DEFERRAL AGREEMENT
This Milestone Deferral Agreement (the "Milestone Deferral Agreement")
is entered into as of this ____ day of ______, 1999 by and between:
1. PASTEUR MERIEUX SERUMS & VACCINS S.A., a SOCIETE ANONYME existing
and organized under the laws of France, registered under number RCS LYON B 349
505 370, whose registered head office is located at 00, xxxxxx Xxxxxxx, 00000
Xxxx, Xxxxxx (hereinafter referred to as "PMC");
2. ORAVAX, Inc., a corporation existing and organized under the laws of
the State of Delaware, having its principal place of business at 00 Xxxxxx
Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx, Xxxxxx Xxxxxx of America (hereinafter referred
to as "OraVax");
3. MERIEUX ORAVAX S.N.C., the SOCIETE EN NOM COLLECTIF established by
OraVax and PMC under French law (hereinafter referred to as "SNC"); and
4. ORAVAX MERIEUX CO., a general partnership organized under the laws
of Massachusetts (hereinafter referred to as the "U.S. Partnership").
WITNESSETH
WHEREAS, PMC and OraVax have entered into a license agreement related
to vaccines against dengue viruses effective as of October 1, 1998 (the "Dengue
License");
WHEREAS, PMC and Peptide Therapeutics Limited ("Limited") have entered
into an agreement effective as of January 22, 1999 (the "Overview Agreement")
under which, among other things, Limited agrees, in accordance with the terms
and conditions thereof, to cause OraVax to enter into this Agreement and certain
license agreements;
WHEREAS, OraVax JVM, Inc. and Connaught Laboratories have entered into
an amendment effective as of January 22, 1999 to the Facility Agreement dated as
of November 2, 1998 (the "Loan Amendment").
NOW, THEREFORE, in consideration of the mutual promises, conditions,
covenants and undertakings hereinafter set forth, the parties hereto, intending
to be legally bound, hereby agree as follows:
1. As used herein, the following terms shall have the following
meanings:
"Hepatitis C Licenses" means, collectively, the License Agreement
between OraVax and the U.S. Partnership dated as of the date hereof and the
License Agreement between OraVax and SNC dated as of the date hereof.
1
"JEV/TBE License" means the License Agreement between OraVax and PMC
dated as of the date hereof.
"Master Agreement" means the Master Agreement between OraVax and PMC
dated March 31, 1995 and amended November 2, 1998 and further amended as of the
date hereof.
2. As consideration for and an inducement to PMC to enter into the
JEV/TBE License and for SNC and the U.S. Partnership to enter into the
Hepatitis C Licenses and in consideration of the research funding, milestone
payments and royalties to be received by OraVax under the Dengue License, the
JEV/TBE License, the Hepatitis C Licenses and the Master Agreement and the
loan deferral under the Loan Amendment, the parties hereby agree that PMC or
SNC or the U.S. Partnership (as the case may be) may, at its sole option and
on written notice to OraVax, defer in the aggregate up to three million
United States dollars ($3,000,000) (the "Deferral Credit") in milestone
payments payable to OraVax under the Master Agreement, Dengue License,
JEV/TBE License and Hepatitis C Licenses. The amount of any milestone payment
in respect of any licensed product under any such Agreement deferred by PMC
or SNC or the U.S. Partnership (the "Product Deferral") shall be added to the
last four remaining milestones relating to such licensed product at a rate of
twenty-five (25%) of the Product Deferral per milestone.
3. Except as expressly provided hereunder, the Dengue License,
Hepatitis C Licenses, JEV/TBE License, Master Agreement and Loan Amendment and
all rights and obligations of the parties thereunder, shall remain in full force
and effect.
[Remainder of page intentionally left blank]
2
IN WITNESS WHEREOF, this Milestone Deferral Agreement has been executed
by each of the parties on the date first above written.
PASTEUR MERIEUX Serums & Vaccins S.A.
By: ___________________________________
Name:
Title:
ORAVAX, Inc.
By: ___________________________________
Name:
Title:
MERIEUX ORAVAX S.N.C.
By: ___________________________________
Name:
Title:
By: ___________________________________
Name:
Title:
ORAVAX MERIEUX CO.
By: ___________________________________
Name:
Title:
By: ___________________________________
Name:
Title:
3
