EXHIBIT 10.15
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PATENT AND KNOW-HOW
LICENSE AGREEMENT
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This Agreement is entered this 08-day of June 1999 ("Effective Date") into BY
AND BETWEEN:
- PASTEUR MERIEUX SERUMS & VACCINS, - PASTEUR MERIEUX CONNAUGHT COMPANY -,
a company organized and existing under the laws of France having its
registered head office at 00 xxxxxx Xxxxxxx, 00000 Xxxx, Xxxxxx,
Represented by Xx. Xxxxxx XXXXX, its DIRECTEUR GENERAL,
(hereinafter referred to as "LICENSOR")
AND
- DRUG ABUSE SCIENCES INC a corporation existing and organized under the
laws of the United States its registered head office at 0000 X'Xxxxx
Xxxxx, xxxxx X, Xxxxx Xxxx, XX 00000
Represented by Mr Xxxxxxx XXXXXX, its Chief Executive Officer,
(hereinafter referred to as "LICENSEE")
CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
WITNESSETH
WHEREAS, LICENSOR has developed intellectual property, including inventions
which are the subject matter of patents and patent applications and a secret and
substantial know-how, relating to the [********] technology.
WHEREAS, LICENSEE wishes to obtain from LICENSOR a license in order to have the
right to use LICENSOR' inventions relating to the pasteurization for use with
products that are directed toward alleviation of drug addictions, and LICENSOR
is willing to grant such licenses to LICENSEE, subject to the terms of and
conditioned upon this Agreement;
NOW, THEREFORE, in consideration of the respective representations
and covenants of each of the Parties as set forth below, LICENSOR and LICENSEE,
intending to be legally bound, agree as follows
ARTICLE 1 - DEFINITIONS AND INTERPRETATION.
1.1 DEFINITIONS: For the purposes of this Agreement the following words and
phrases shall have the following meanings:
(a) "AFFILIATE" means, with respect to any Person, (i) any other
Person of which the securities or other ownership interests
representing fifty per cent (50%) or more of the equity or fifty
per cent (50%) or more of the ordinary voting power or fifty per
cent (50%) or more of the general partnership interest are, at the
time such determination is being made, owned, Controlled or held,
directly or indirectly, by such Person (a "Subsidiary"), or (ii)
any other Person which, at the time such determination is being
made, is Controlling or under common Control with, such Person. As
used herein, the term "Control", whether used as a noun or verb,
refers to the possession, directly or indirectly, of the power to
direct, or cause the direction of, the management or policies of a
Person, whether through the ownership of voting securities, by
contract or otherwise.
(b) "AGREEMENT" means this agreement, all amendments and supplements
to this Agreement and all schedules to this Agreement, including
the following:
SCHEDULE A - LICENSED PATENTS,
SCHEDULE B - LICENSED KNOW-HOW
(c) "BIOLOGICAL MATERIALS" shall mean any biological materials
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 produces, whether by recombinant
DNA techniques and/or otherwise.
(d) "CALENDAR QUARTER" means any of the three-month periods beginning
January 1, April 1, July 1 and October 1 in any year.
(e) "CONFIDENTIAL INFORMATION" has the meaning ascribed to it in
Section 9.1. of this Agreement.
(f) "EVENT OF FORCE MAJEURE" has the meaning ascribed to it in Article
12 of this Agreement.
(g) "FIELD OF USE" means the treatment of drug addiction.
(h) "FIRST COMMERCIAL SALE" means, in each country of the Territory,
the first sale of a PRODUCT, after obtaining the regulatory
approvals necessary to commercially market such PRODUCT in such
country in the Territory, by LICENSEE, its
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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Affiliates or Sublicensees, to Third-Parties, in each case for use
or consumption of such PRODUCT in such country by the general
public.
(i) "IMPROVEMENTS" means all patentable or non-patentable inventions,
discoveries, technology and information of any type whatsoever,
including without limitation Biological Materials, methods,
processes, technical information, knowledge, experience and
know-how which utilize, incorporate, derive from, are based on or
could not be conceived, developed or reduced to practice but for
the use of the LICENSOR Technology.
(j) "LICENSE" has the meaning ascribed to it in Section 2.1.1. of this
Agreement.
(k) "LICENSED KNOW-HOW" means any and all technical information,
discoveries, Improvements, processes, formulae, data, engineering,
technical and shop drawings, inventions, Biological Materials,
shop-rights, know-how and trade secrets which is useful or
necessary to make, have made, use or sell the PRODUCTS or to
practice under the LICENSED PATENTS in the Field of Use, which
have been, or hereafter are, either developed by LICENSOR or its
Affiliates, or acquired by LICENSOR or its Affiliates and to which
LICENSOR or its Affiliates, to the extent to which it has the
right to do so in the Field of Use.
(l) "LICENSED PATENTS" means:
(i) any existing patents and patent applications listed in
Schedule A to this Agreement;
(ii) any future patents issued from any patent applications
referred to in Paragraph 1.1(1)(i) above and any future
patents issued from a patent application filed in any
country in the Territory which corresponds to a patent or
patent application identified in Paragraph 1.1(1)(i) above;
(iii) any reissues, confirmations, renewals, extensions,
counterparts, divisions, continuations,
continuations-in-part, supplemental protection certificates
or utility models issued, assigned or licensed to LICENSOR
or its Affiliates of or relating to the patents or patent
applications identified in Paragraph 1.1(1)(i) and (ii)
above
(iv) any future patents and patent applications covering
LICENSOR Improvements, solely or jointly owned by LICENSOR
or its Affiliates, or licensed by LICENSOR or its
Affiliates with the right to sublicense.
(m) "NET SALES" shall mean the amount actually received on sales of
PRODUCTS by LICENSEE, and its Affiliates and Sublicensees if the
Sublicensees are Affiliates to the first Third-Party (including
unaffiliated Third-Party distributors, except in the circumstances
referred to in Section 6.3 hereof less), to the extent actually
incurred or allowed and if not already deducted in the amount
invoiced:
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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(i) normal or customary trade and/or quantity discounts,
credits, allowances, rebates, returns (including, but not
limited to, wholesaler and retailer returns);
(ii) retroactive price reductions;
(iii) excise taxes, other consumption taxes, customs duties and
compulsory payments made to governmental authorities;
(iv) sales commissions that are actually paid to Third-Party
distributors and selling agents; and
(v) transportation, transit and insurance for transportation
each to the extent separately invoiced and paid by
LICENSEE.
(n) "Notice of Dispute" has the meaning ascribed to it in Section
16.4.(a) of this Agreement.
(o) "PARTIES" means LICENSEE and LICENSOR, and "Party" means any one
of them.
(p) "PERSON" means an individual, corporation, partnership, trust,
business trust, association, joint stock company, pool, syndicate,
sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed
herein.
(q) "PHASE III" means the first pivotal safety and efficacy clinical
trial relating to a PRODUCT.
(r) "PRODUCTS" means the COC are produced by or under license from
DAS, the manufacture, sale or use of such PRODUCTS which would
have constituted a misappropriation of substantial LICENSED
KNOW-HOW, or LICENSOR Improvements, and/or an infringement of the
LICENSED PATENTS, but for the LICENSE granted in this Agreement.
(s) "ROYALTY TERM" means, with respect to the PRODUCT in each country
in the Territory, the period starting on the date of the First
Commercial Sale of such PRODUCT in such country and ending when
the PRODUCT is no longer commercially sold in such country.
(t) "SUBLICENSEE" means any Person acting pursuant to a sublicense
granted to it by LICENSEE under the terms of this Agreement.
(u) "TERRITORY" means all countries in the world.
(v) "THIRD-PARTY" means any Person other than LICENSEE, LICENSOR and
their respective Affiliates..
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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(w) "VALID PATENT CLAIM" means a claim of an issued and unexpired
patent or patent application included in LICENSED PATENTS which
has not been held permanently revoked, unenforceable or invalid by
a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise. If there
should be two or more decisions within the same country which are
conflicting with respect to the invalidity of the same claim, the
decision of the highest tribunal shall thereafter control.
However, should the tribunals be of equal authority, then the
decision or decisions holding the claim valid shall prevail where
the conflicting decisions are equal in number and the majority of
decisions shall prevail where the conflicting decisions are not
equal in number.
(x) "LICENSOR IMPROVEMENT" means Improvements which are conceived,
developed or reduced to practice during the term of this Agreement
solely or jointly by employees or contractors acting on behalf of
LICENSOR or its Affiliates.
(y) "LICENSOR TECHNOLOGY" means the LICENSED PATENTS, the LICENSED
KNOWHOW and the LICENSOR Improvements.
1.2 CERTAIN RULES OF INTERPRETATION IN THIS AGREEMENT AND THE SCHEDULES:
(a) An accounting term not otherwise defined has the meaning assigned
to it by, and every accounting matter will be determined in
accordance with, generally accepted accounting principles in the
United States of America;
(b) Unless otherwise specified, all references to monetary amounts are
to United States dollars currency (US$);
(c) The descriptive headings of Articles and Sections are inserted
solely for convenience of reference and are not intended as
complete or accurate descriptions of the content of such Articles
or Sections;
(d) The use of words in the singular or plural, or with a particular
gender, shall not limit the scope or exclude the application of
any provision of this Agreement to such Person or Persons or
circumstances as the context otherwise permits;
(e) Whenever a provision of this Agreement requires an approval or
consent by a Party to this Agreement and notification of such
approval or consent is not delivered within the applicable time
limit, then, unless otherwise specified, the Party whose approval
or consent is required shall be conclusively deemed to have
granted its approval or consent;
(f) Unless otherwise specified, time periods within or following which
any payment is to be made or act is to be done shall be calculated
by excluding the day on which the period commences and including
the day on which the period ends and by extending the period to
the next business day following if the last day of the
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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period is not a business day in the jurisdiction of the Party to
make such payment or do such act; and
(g) Whenever any payment is to be made or action to be taken under
this Agreement is required to be made or taken on a day other than
a business day, such payment shall be made or action taken on the
next business day following such day in the jurisdiction of the
Party to make such payment or do such act.
ARTICLE 2 - LICENSE.
2.1 GRANT.
Subject to and conditioned upon the provisions of this Agreement,
LICENSOR hereby grants to LICENSEE, and LICENSEE hereby accepts, a
license ( the "LICENSE") in the Territory to make, have made, use and
sell PRODUCTS under the LICENSED PATENTS and by using LICENSED KNOW-HOW
and LICENSOR Improvements in the Field of Use.
(i) Subject to and conditioned upon the provisions of this
Agreement, the LICENSE granted pursuant to this Article 3
shall be exclusive (exclusive even as to LICENSOR) to
LICENSEE in the Field of Use. Without limiting the
generality of the foregoing, LICENSOR covenants that during
the term of this Agreement, neither LICENSOR nor its
Affiliates shall grant to any other Person any right,
license or privilege to make, have made, use or sell
PRODUCTS or to otherwise exploit LICENSOR Technology, or
any other Biological Matter or chemical substance (or any
derivative or formulation thereof), in the Field of Use.
(ii) For greater certainty, LICENSOR has and retains all rights
in and to the LICENSOR Technology outside the Field of Use
and LICENSEE has no rights in the LICENSOR Technology
outside the Field of Use.
2.2 LICENSEE'S RIGHTS TO SUBLICENSE.
(i) LICENSEE shall have the right, without obtaining the
further consent of LICENSOR, to sublicense in the Field of
Use all or any portion of the rights to the LICENSED
PATENTS, the LICENSED KNOW-HOW and LICENSOR Improvements
granted to it pursuant to this Agreement under the LICENSE
(i) to any of its Affiliates, and (ii) to any Person in any
country of the Territory without PMC's prior approval to
any third party unless such Person is well known as being
actively engaged in the business of researching,
developing, manufacturing and marketing immunoproteins at
the time the sublicense is contemplated, in which case the
grant of the sublicense to such a third party shall be
subject to PMC's prior approval in writing. Such approval
shall only be dependent upon PMC being reasonably satisfied
by the provision that DAS will propose to include in the
sublicense to, and only to, the effect that the Licensed
Technology may not be used and/or exploited by the
prospective
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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sublicensee in the immunoproteine field. For that purpose,
DAS shall provide to PMC a draft along with its request.
PMC shall have fifteen (15) days to confirm in writing its
consent or state in writing the material reasons, made in
good faith, why such provision will not protect the
Licensed Technology from use as restricted in the previous
two sentences, in which case the parties will use their
best efforts to expedite negotiations of an appropriate
provision. PMC shall be deemed to have approved a request
by DAS pursuant to this Section 2.2, if PMC fails to
respond as provided hereunder within the fifteen (15)
period set forth above.
No permitted Sublicensee pursuant hereto shall have the right to
grant further sublicenses to any Third-Party.
(ii) LICENSEE agrees that all sublicenses granted by LICENSEE
hereunder shall expressly bind Sublicensees to the terms of
Article 9, "Confidentiality" and to all other relevant
provisions of this Agreement.
In the event LICENSEE grants sublicenses to its Affiliates,
LICENSEE shall pay royalties to LICENSOR as if Net Sales of the
Sublicensees if such Sublicensees are Affiliates were Net Sales of
LICENSEE and LICENSOR shall be expressly made a Third-Party
beneficiary thereof.
For all other Sublicenses to Third-Parties except for the
standalone Sublicenses as specified herebelow, the amount of
royalties paid by Sublicensee(s) to LICENSEE shall be included
into the amount of Net Sales. It is understood between the
parties, that LICENSOR will be paid by LICENSEE [***] that would
be equivalent to what LICENSOR would have received if LICENSEE has
been selling directly the PRODUCTS. Such percentage shall not
exceed [***] of the amount of revenue actually received by
LICENSEE.
If LICENSEE grants a Sublicense to the LICENSED PATENTS to a
third-party on a standalone basis, LICENSEE shall pay to PMC [***]
of any incremental consideration that LICENSEE may receive from
any Third-Party Sublicensee such as but not limited to license
issue fees, milestone payments and royalties.
(iii) Any sublicenses granted by LICENSEE shall include a
requirement that the Sublicensee maintains records and
permit inspection on terms essentially identical to Section
6.2 hereof. At LlCENSOR's request, LICENSEE shall arrange
for an independent certified public accountant selected by
LICENSOR, and at LlCENSOR's cost, to inspect the records of
Sublicensees for the purpose of verifying royalties due to
LICENSOR and shall cause such accountant to report the
results thereof to LICENSOR.
(iv) Any sublicenses granted by LICENSEE shall provide for the
termination of the sublicense, or, if the Sublicensee is a
Third-Party, at the option of such Sublicensee, the
conversion to a license directly between such
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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Sublicensee and LICENSOR, upon termination of this
Agreement under Article 10 (other than expiration under
Section 10.1 or a termination by LICENSEE further to a
breach by LICENSOR pursuant to Section 10.4). Such
conversion shall be subject to LlCENSOR's approval and
contingent upon acceptance by the Sublicensee of the
remaining provisions of this Agreement.
(vi) LICENSEE shall notify LICENSOR of each sublicense granted
to Third-Parties and shall provide LICENSOR with the name
and address of each Sublicensee and a description of the
PRODUCTS and territory covered by each sublicenses.
2.3 SUBLICENSES TO LICENSEE.
To the extent LICENSED PATENTS have been, or shall be, licensed by
LICENSOR from a Third-Party under an agreement with such Third-Party (a
"Third-Party Licensee), LICENSEE understands and agrees as follows:
(i) The rights sub-licensed to LICENSEE by LICENSOR are subject
to the terms and conditions, restrictions, limitations and
obligations of the relevant Third-Party License that are
imposed upon LICENSOR;
(ii) LICENSEE shall comply with the terms and conditions,
restrictions, limitations and obligations of such
Third-Party License(s) to the extent LICENSEE has been
permitted to review such terms, conditions, restrictions,
limitations and obligations. LICENSOR shall give LICENSEE,
upon request, a reasonable opportunity to review the same
except to the extent that confidentiality obligations
towards Third-Parties may prevent LICENSOR from doing so.
In any event, LICENSOR shall act reasonably in advising
LICENSEE of the scope of LICENSEE's obligations pursuant to
any relevant Third Party License. LICENSOR represents and
warrants that, on the Effective Date, there are no Third
Party Licenses that apply to exploitation of the LICENSOR
Technology.
2.4 SUBCONTRACTING.
Notwithstanding anything herein provided for to the contrary, LICENSEE
shall be allowed to (i) sub-contract in whole or in part PRODUCTS
development to Third-Parties such as, without limitation, clinical
research organizations, (ii) appoint sales agents and distributors to
market and distribute PRODUCTS and (iii) sub-contract manufacturing of
PRODUCTS, or any part thereof, with Third-Parties or with LICENSEE's
Affiliates including LICENSOR acting as toll manufacturer.
2.5 DISCLOSURE OF TECHNOLOGY.
From time to time during the term of this Agreement, LICENSOR shall
disclose or cause its Affiliates to disclose to LICENSEE such LICENSOR
Technology as may be reasonably necessary to enable LICENSEE to develop,
manufacture, commercialize and
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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otherwise exploit the PRODUCTS in the Field of Use on the terms and
subject to the conditions of this Agreement. In addition, during the term
of this Agreement, LICENSOR shall, upon LICENSEE's reasonable request and
with adequate notice to LICENSOR, make available to LICENSEE at
LICENSEE's or its Affiliates' manufacturing facilities or the facility of
a Third Party manufacturer who shall have contracted with LICENSEE to
manufacture PRODUCTS, LICENSOR's or LICENSOR Affiliate's Personnel to
provide technical assistance to LICENSEE's Personnel, or LICENSEE
Affiliates' Personnel or Third-Party manufacturer's Personnel. LICENSEE
shall pay or have paid by its concerned Affiliates all reasonable travel
costs incurred by LICENSOR or its Affiliates in connection with rendering
such technical assistance. Such Personnel shall render such assistance at
the facilities designated by LICENSEE for periods of not less than three
continuous business days per visit. In addition, LICENSOR shall make it
or its Affiliates Personnel reasonable available for telephone
consultation, as requested by LICENSEE.
2.6 PROVISION OF RELATED ASSISTANCE.
(i) In support of LICENSEE'S development and commercialization of
PRODUCTS, LICENSOR shall promptly and timely provide and prepare,
upon reasonable request of DAS and free of charge, relevant
sections pertaining to (i) IND, BLA, PLA and ELA supplements and
other regulatory approvals required by the FDA and other
Regulatory Authorities to commercially market and sell PRODUCTS to
the public in the Territory, and, (ii) such information as
LICENSEE or Regulatory Authorities may request in connection with
(a) LICENSEE's preclinical studies, Phase I, II III and IV studies
for PRODUCTS. LICENSOR shall promptly conduct such manufacturing
process development studies (including but not limited to
stability studies) as are reasonably requested by LICENSEE or
required by Regulatory Authorities in order to fulfill its
obligations under this Agreement, and to permit LICENSEE to
expeditiously submit complete applications to obtain marketing
(and earlier) approvals to commercially develop, market and sell
PRODUCTS in the Territory.
(ii) LICENSOR represents and warrants, to the best of its knowledge,
that the information, data and technical assistance provided to
LICENSEE hereunder shall not contain any material fact or
omission, and shall indemnify and hold LICENSEE harmless from any
liability or damage (including reasonable attorneys' fees arising
from a breach of the foregoing.)
2.7 COMMUNICATION AMONG PARTIES.
Each of LICENSEE and LICENSOR shall appoint (a) specific individual(s)
who shall be available and shall act as (a) liaison Person(s) to
facilitate the day-to-day communications among the Parties. The names and
addresses of the liaison Persons who shall act on behalf of each of the
Parties shall be provided by each of the Parties to the other
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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immediately following the execution of this Agreement. Each of LICENSEE
and LICENSOR agrees to notify the other in accordance with the terms of
Section 16.1 of this Agreement in the event of a change in liaison
Person.
2.8 IDENTIFICATION OF KNOW-HOW.
The Parties agree that all information and Biological Materials comprised
in the LICENSED KNOW-HOW to be transferred to LICENSEE pursuant to this
Agreement shall be so transferred in the case of written information, by
memoranda bearing the mention "Confidential", and, in the case of
Biological Materials, by clearly marked and numbered containers. LICENSEE
shall designate an individual who shall be responsible for receiving
information and Biological Materials from LICENSOR and/or its Affiliates
and the Parties agree that such information and Biological Materials
shall in all cases (except where the Parties agree otherwise) be sent
solely to the attention of such individual. Upon receipt of information
and/or Biological Materials, the designated individual shall, on behalf
of LICENSEE, send an acknowledgement to LICENSOR and/or its Affiliates
confirming receipt of information and/or Biological Materials. The
Parties agree that they shall in good faith work together to establish
and maintain a system to record the transmission of information and/or
materials under this Agreement and make all commercially reasonable
efforts to ensure such system is followed.
2.9 CONFIDENTIALITY.
All information transferred pursuant to this Agreement shall be deemed to
be "Confidential Information" in accordance with Section 9.1 hereof.
ARTICLE 3 - DEVELOPMENT AND COMMERCIALIZATION.
3.1 DEVELOPMENT AND COMMERCIALIZATION EFFORTS.
LICENSEE shall comply with all applicable good laboratory, clinical and
manufacturing practices in the development and commercialization of
PRODUCTS, and shall cause its Affiliates and subcontractors to do the
same. LICENSEE shall be solely responsible for funding all costs incurred
by LICENSEE for the development and commercialization of each PRODUCT.
3.2 DEVELOPMENT AND COMMERCIALIZATION REPORTS.
During the term of this Agreement, LICENSEE shall keep LICENSOR
reasonably informed as to the progress of the development of PRODUCTS by
notifying LICENSOR of completion of PHASE III studies for each such
PRODUCT (to the extent such studies are commenced and completed). All
information disclosed by LICENSEE pursuant to this Section 4.2 shall be
treated as LICENSEE Confidential Information subject to Article 8 hereof.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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ARTICLE 4 - ROYALTIES AND MILESTONES.
4.1 EARNED ROYALTIES.
During the Royalty Term, LICENSEE shall pay to LICENSOR a royalty as
follows:
(i) during the [***]
[***] percent of Net Sales of PRODUCTS.
(ii) As of the [***] and until the [***]:
[***] of Net Sales of PRODUCTS on annual NET SALES below [***];
[***] of Net Sales of PRODUCTS on annual NET SALES above [***]
(iii) As of the [***] following the date of First Commercial Sale:
[***]:
[***] of Net Sales of PRODUCTS
As of the [***] year, LICENSEE shall pay royalties in countries
where there is no [***]; in all other cases, the LICENSE in any
such country shall be royalty free).
4.2 SINGLE ROYALTY: NON-ROYALTY SALES.
In no event shall more than one royalty be payable under Section 4.1.
with respect to a particular unit of PRODUCTS. No royalty shall be
payable under this Section 4 with respect to sales of PRODUCTS among
LICENSEE and its Subsidiaries or Affiliates, or among Sublicensees and
their respective Affiliates, or among LICENSEE and its Sublicensees,
[***]. No royalty shall be payable for (i) PRODUCTS used in clinical
trials, or (ii) PRODUCTS used by LICENSEE, its Affiliates or
Sublicensees, for research, (iii) customary quantities of PRODUCTS
distributed as free samples or (iv) reasonable quantities of PRODUCTS
disposed by LICENSEE as donations to Third-Parties.
4.3 [***].
In those cases where LICENSEE or its Affiliates sell PRODUCTS in bulk to
a Third-Party, [***].
4.4 ROYALTY ADJUSTMENTS.
The royalty due hereunder shall be reduced in the following circumstances
and in the following manner:
(i) Where LICENSEE is required to obtain additional rights to make,
use or sell PRODUCTS and to pay a third party a royalty in order
to obtain such
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
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rights, the royalty hereunder shall be reduced by an amount
[***] to the third party until such time as (a) [***], or (b)
[***].
(ii) At any time (and only for such time) that the sum of (a) the
royalty due hereunder for PRODUCTS, and (b) the transfer price
for PMC Product due LICENSOR pursuant to that certain
Manufacturing and Supply Agreement between the Parties, dated of
even date herewith (the "Combined Price"), [***] (referred to as
the "Margin"), the royalty on such PRODUCT shall be suspended.
Thereafter, LICENSEE shall not owe any royalty on PRODUCTS until
the Combined Price is less than the Margin, and then only to the
extent of the difference between the Combined Price and the
Margin.
(iii) With respect to any PRODUCTS that are not manufactured by
LICENSOR (whether through termination of the Manufacturing and
Supply Agreement, force majeure or otherwise), the royalty due
for such PRODUCTS shall be [***] of the Net Sales received on
the sales of the PRODUCTS manufactured by the Third-Party. For
the avoidance of doubt, LICENSEE shall pay LICENSOR the
royalties mentioned in Section 4.1 of the Net Sales received on
the PRODUCTS manufactured by LICENSOR.
ARTICLE 5 - ROYALTY REPORTS AND ACCOUNTING.
5.1 REPORTS, EXCHANGE RATES.
During the term of this Agreement following the First Commercial Sale,
LICENSEE shall furnish to LICENSOR, with respect to each Calendar
Quarter, a written report showing in reasonably specific detail, for the
European Union, North America, and the rest of the Territory,
respectively: (a) the gross sales of PRODUCTS sold by LICENSEE, its
Affiliates and its Sub-licensees in the Territory during the
corresponding Calendar Quarter and the calculation of Net Sales from such
gross sales; (b) the royalties payable in United States dollars, if any,
which shall have accrued hereunder based upon Net Sales of PRODUCTS; (c)
the withholding taxes, if any, required by law to be deducted in respect
of such royalties; (d) the date of the First Commercial Sale of PRODUCTS
having occurred in each country in the Territory during the corresponding
Calendar Quarter; and (e) the exchange rates used in determining the
royalty amount expressed in United States dollars.
With respect to sales (if any) of PRODUCTS invoiced in United States
dollars, the gross sales, Net Sales, and royalties payable shall be
expressed in United Sates dollars. With respect to sales of PRODUCTS
invoiced in a currency other than United Sates dollars, the gross sales,
Net Sales and royalties payable shall be expressed in the currency of the
invoice issued by the Party making the sale together with the United
States dollars equivalent of the royalty payable, calculated using the
rate of exchange published in the Wall Street Journal for such currency
on the last business day of the concerned Calendar Quarter. Reports and
payments shall be due [***]. LICENSEE shall keep complete and
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
11
accurate records in sufficient detail to properly reflect all gross sales
and Net Sales and to enable the royalties payable hereunder to be
determined.
5.2 AUDITS.
5.2.1. Upon the written request of LICENSOR and not more than once in each
calendar year, LICENSEE shall permit an independent certified public
accounting firm of internationally recognized standing, selected by
LICENSOR and reasonably acceptable to LICENSEE, at LlCENSOR's expense, to
have access during normal business hours to such of the records of
LICENSEE as may be reasonably necessary to [***]. The accounting firm
shall disclose to LICENSOR only whether the records are correct or not
and the specific details concerning any discrepancies. No other
information shall be shared.
5.2.2. If such accounting firm concludes that additional royalties were owed
during such period, LICENSEE shall pay the [***] LICENSOR delivers to
LICENSEE such accounting firm's written report so concluding. The fees
charged by such accounting firm shall be paid by LICENSOR; provided,
however, if the audit discloses that the royalties payable by LICENSEE
for the audited period are more than [***] actually paid for such period,
then LICENSEE shall pay the reasonable fees and expenses charged by such
accounting firm.
5.2.3. LICENSEE shall include in each permitted sublicense granted by it
pursuant to the Agreement a provision requiring the SUBLICENSEE to make
reports to LICENSEE, to keep and maintain records of sales made pursuant
to such sublicense and to grant access to such records by LlCENSOR's
independent accountant to the same extent required with respect to
LICENSEE's records under this Agreement.
5.2.4. Except in the case of circumstances which would have prevented an error
or anomaly from being disclosed during the audit hereabove mentioned,
such as fraud or other failure to provide accurate information, upon the
expiration of [***] following the end of any calendar year, the
calculation of royalties payable with respect to such year shall be
binding and conclusive upon LICENSOR, and LICENSEE, its Affiliates and
Sublicensees shall be released from any liability or accountability with
respect to royalties for such year.
5.3 CONFIDENTIAL FINANCIAL INFORMATION.
LICENSOR shall treat all financial information subject to review under
this Article 5 or under any sublicense agreement as confidential, and
shall cause its accounting firm to retain all such financial information
in confidence.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
12
ARTICLE 6 - PAYMENTS.
6.1 PAYMENT TERM.
Royalties shown to have accrued by each royalty report provided for under
Article 4 of this Agreement shall be due [********]. Payment of royalties
in whole or in part may be made in advance of such due date.
6.2 PAYMENT METHOD.
All payments by LICENSEE to LICENSOR under this Agreement shall be paid
in United States dollars, and all such payments shall be made without
deduction of bank transfer fees by bank wire transfer in immediately
available funds to the following bank account:
[********]
6.3 WITHHOLDING TAXES.
Royalties shall be paid by LICENSEE to LICENSOR, after deduction of any
applicable withholding taxes. Prior to any payment by LICENSEE to
LICENSOR, LICENSEE shall provide to LICENSOR any forms required to attest
LlCENSOR's fiscal domiciliation in order to allow LICENSEE to claim
application of the reduced rate of withholding tax provided for in any
applicable bilateral fiscal convention. LICENSOR shall promptly return
such forms to LICENSEE. In the event LICENSOR fails to promptly return
such forms duly filled and signed, LICENSEE shall declare and pay
withholding tax at the common law rate of the applicable corporate income
tax, and such tax shall then be deducted from the corresponding payment
by LICENSEE to LICENSOR. LICENSEE shall pay withholding tax to the proper
taxing authority and proof of payment of such tax shall be secured and
sent to LICENSOR as evidence of such payment. If, in the opinion of
either Party, the provisions of this Section become extremely burdensome,
the Parties agree to meet and discuss such other options as may be
available to them.
ARTICLE 7 - INVENTIONS AND PATENTS.
7.1 OWNERSHIP OF INVENTIONS.
The entire right and title to technology, whether or not patentable, and
any patent applications or patents based thereon, made or conceived
during the term of this Agreement which directly relates to and are not
severable from LICENSOR Technology and which are Improvements thereto
and/or more generally relate to PRODUCT (a) by employees or others acting
solely on behalf of LICENSOR or its Affiliates shall be
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
13
owned solely by LICENSOR (the LICENSOR Improvements" as more fully
defined in Article 1 hereof), (b) by employees or others acting solely on
behalf of LICENSEE or its Affiliates shall be owned solely by LICENSEE
and (c) by both employees or others acting on behalf of LICENSEE or its
Affiliates, and employees or others acting on behalf of LICENSOR and its
Affiliates shall be jointly owned by LICENSEE and LICENSOR.
LICENSOR and LICENSEE each hereby represents that all employees and other
Persons acting on its behalf in performing its obligations under this
Agreement shall be obligated under a binding written agreement to assign
to it, or as it shall direct, all Improvements conceived or reduced to
practice by such employees or other Persons.
7.2 PATENT PROSECUTION AND MAINTENANCE.
LICENSED PATENTS. LICENSOR shall be responsible for and shall control the
preparation, filing, prosecution, grant and maintenance of all LICENSED
PATENTS. LICENSOR shall prepare, file, prosecute and maintain such
LICENSED PATENTS in good faith consistent with its customary patent
policy and its reasonable business judgement, and shall consider in good
faith the interests of LICENSEE in so doing.
JOINT INVENTIONS. As to any joint inventions made by the Parties during
the term of this Agreement, LICENSEE shall have the first right to file
patent applications with respect to such inventions in the name of both
Parties. LICENSEE may elect not to file and if it does so, LICENSOR shall
have the right to file the patent application in the name of both
Parties. In each case regarding joint inventions, the filing Party shall
give the non-filing Party an opportunity to review the text of the
application before filing, shall consult with the non-filing Party with
respect thereto and shall supply the non-filing Party with a copy of the
applications as filed, together with notice of its filing date and serial
number and [***] the out-of-pocket costs and expenses of the filing Party
shall be reimbursed by the other Party. Both Parties shall keep the other
advised of the status of actual and prospective patent application
filings and upon request, provide advanced copies of any documents
related to such filings and thereafter to the prosecution and maintenance
of all patent applications and patents.
COSTS. With respect to all filings hereunder, the filing Party shall be
responsible for payment of all costs and expenses related to such
filings, prosecution and maintenance, unless relieved of same pursuant to
Section 7.3 hereinafter, and except for jointly owned patents, for which
[***] of all such costs and expenses shall be reimbursed to the filing
Party by the other Party.
7.3 OPTION TO PROSECUTE AND MAINTAIN PATENTS.
LICENSOR shall give notice to LICENSEE of any intention to cease
prosecution and/or maintenance, or not to proceed with an extension, of
LICENSED PATENTS and, in such case, shall permit LICENSEE, at LICENSEE's
sole discretion, to continue prosecution or maintenance or proceed with
the extension at its own expenses. If LICENSEE elects to continue
prosecution or maintenance or to proceed with the extension, LICENSOR
shall execute such documents and perform such acts at LICENSEE's expense
as may be
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
14
reasonably necessary to effect an assignment of such LICENSED PATENTS to
LICENSEE in a timely manner, and more generally to permit LICENSEE to
continue such prosecution and maintenance or to proceed with the
extension. Any patents and patent applications so assigned shall not be
considered as LICENSED PATENTS as of the date of such assignment. No
royalties shall be payable by LICENSEE on sales of PRODUCTS covered only
by a Valid Patent Claim of a LICENSED PATENT which has been assigned to
LICENSEE pursuant to this Section 7.3.
7.4 INTERFERENCE, OPPOSITION, REEXAMINATION AND REISSUE.
(i) The Parties shall use their respective best efforts to
within [***] of learning of any interference, opposition,
reexamination or reissue event, inform the other Party of
any request for, or filing or declaration thereof relating
to LICENSED PATENTS. The Parties shall thereafter consult
and cooperate fully to determine the course of action with
respect to any such proceeding. Both Parties shall have the
right to review and comment on any submission to be made in
connection with any such proceeding.
(ii) LICENSOR shall not institute any reexamination or reissue
proceeding relating to LICENSED PATENTS without having
first consulted LICENSEE.
(iii) In connection with any interference, opposition, reissue or
reexamination proceeding relating to LICENSED PATENTS, the
Parties shall cooperate fully and shall provide each other
with any information or assistance that either Party may
reasonably request. LICENSOR shall keep LICENSEE informed
of developments in any such action or proceeding,
including, to the extent permissible, the status of any
settlement negotiations and the terms of any offer related
thereto.
(iv) LICENSOR shall bear the expense of any interference,
opposition, reexamination or reissue proceeding relating to
LICENSED PATENTS.
7.5 ENFORCEMENT AND DEFENSE.
(i) Each Party shall give the other notice of either (a) any
infringement of LICENSED PATENTS, or (b) any
misappropriation or misuse of LICENSED KNOW-HOW that has
come to its attention. The Parties shall thereafter consult
and cooperate fully to determine a course of action,
including but not limited to the commencement of legal
action by either or both Parties to terminate any
infringement of LICENSED PATENTS or any misappropriation or
misuse of LICENSED KNOW-HOW.
(ii) In the event that LICENSED PATENTS are infringed by any
Third-Party with respect to a PRODUCT in the Field of Use,
LICENSEE, upon notice to LICENSOR, shall for a period of
[***] have the first right, but not the obligation, to
institute and prosecute any action or proceeding under
LICENSED PATENTS with respect to such infringement, by
counsel of
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
15
its choice, or to control the defense of any declaratory
judgment action arising from such infringement or from the
misappropriation or misuse of LICENSED KNOW-HOW, at its own
expense and in the name of both Parties. LICENSEE shall not
otherwise settle, compromise or take any action in such
litigation which diminish, limit or inhibit the scope,
validity or enforceability of LICENSED PATENTS without the
express permission of LICENSOR. LICENSEE shall keep
LICENSOR advised of the progress of such proceedings.
(iii) In the event that a Third-Party is infringing any LICENSED
PATENTS with respect to a PRODUCT in the Field of Use and
LICENSEE does not elect to institute an action, LICENSOR,
upon notice to LICENSEE, shall have the right, but not the
obligation, to institute and prosecute any action or
proceeding under LICENSED PATENTS with respect to such
infringement, by counsel of its choice, or to control the
defense of any declaratory judgment action arising from
such infringement or from the misappropriation or misuse of
LICENSED KNOW-HOW, at its own expense and in the name of
both Parties. LICENSOR shall not settle, compromise or take
any action in such litigation which diminish, limit or
inhibit the scope, validity or enforceability of LICENSED
PATENTS without the prior approval of LICENSEE, which shall
not be unreasonably withheld.
(iv) With respect to any action to terminate any infringement of
LICENSED PATENTS or any misappropriation or misuse of
LICENSED KNOW-HOW, the Parties shall cooperate fully and
shall provide each other with any information and
assistance that either Party may reasonably request. In
particular, either Party shall execute such documents
necessary for the other Party to initiate and prosecute the
action or proceeding and cause its Affiliates, Sublicensees
and LICENSEE to execute all such documents, if required. In
the event that either Party is unable to initiate or
prosecute an action solely in its own name, the other Party
shall then join such action voluntarily. Each Party shall
keep the other informed of the development of any action or
proceeding including, to the extent permissible by law, the
status of any settlement negotiations and the terms of any
offer related thereto.
(v) Any recovery obtained by either or both Parties in
connection with or as a result of any action or proceeding
contemplated by this Section 8.3, whether by settlement or
otherwise, shall be allocated in order as follows:
(a) The Party which initiated and prosecuted the action
shall recoup all of its costs and expenses incurred
in connection with the action (provided that if
LICENSEE was the initiating Party and that the
action proceeds were not sufficient for LICENSEE to
recoup all its costs and expenses, then LICENSEE
shall be allowed to deduct the
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
16
balance of its unrecovered costs and expenses from
royalties payable to LICENSOR under Article 4
hereof);
(b) The other Party shall then, to the extent possible,
recover its costs and expenses incurred in
connection with the action; and
(c) The amounts of any recovery remaining shall then be
allocated between the Parties with LICENSEE
receiving all amounts in respect of damages in the
Field of Use and LICENSOR receiving all amounts in
respect of damages out of the Field of Use, except
that any amounts recovered in connection with
infringement actions relating to jointly-owned
patents shall be equally shared between the Parties.
(vi) LICENSOR shall inform LICENSEE of any certification
regarding any LICENSED PATENTS it has received pursuant to
00 Xxxxxx Xxxxxx Code Sections355(b)(2)(A)(iv) or
(j)(2)(A)(vii)(lV), or any similar provision in other
countries, and shall provide LICENSEE with a copy of such
certification within [***] of receipt. Both Parties rights
with respect to the initiation and prosecution of any legal
action as a result of such certification or any recovery
obtained as a result of such legal action shall be as
defined in paragraphs (a) to (c) of this Section 7.6.
7.6 NOTICE OF PATENT EVENTS.
LICENSOR shall promptly give notice to LICENSEE of the grant, lapse,
revocation, surrender or invalidation of any LICENSED PATENTS.
7.7 PATENT TERM RESTORATION.
LICENSOR shall notify LICENSEE of (a) the issuance of each U.S. patent
included within the LICENSED PATENTS, giving the date of issue and patent
number for each such patent, and (b) each notice pertaining to any patent
included within the LICENSED PATENTS which it receives as patent owner
pursuant to the United Sates Drug Price Competition and Patent Term
Restoration Act of 1984 (hereinafter called the "Act"), including notices
pursuant to Sections 101 and 103 of the Act from Persons who have filed a
biological license application ("BLA") or an abbreviated new drug
application ("ANDA"), whichever is applicable. Such notices shall be
given promptly, but in any event within five (5) calendar days of each
such patent's date of issue or receipt of each such notice pursuant to
the Act, whichever is applicable. LICENSOR shall notify LICENSEE of each
filing for patent term restoration under the Act, any allegations of
failure to show due diligence and all awards of patent term restoration
(extensions) with respect to the LICENSED PATENTS.
Likewise, LICENSOR or LICENSEE, as the case may be, shall inform the
other Party of patent extensions and periods of data exclusivity in the
rest of the world regarding any PRODUCTS and more generally the Parties
shall diligently cooperate with respect to any procedures for patent and
period of data exclusivity extensions, such as but not limited to
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
17
Supplementary Protection Certificates, the above-mentioned Patent Term
Restoration and corresponding GATT regulations.
ARTICLE 8 - GENERAL PROVISIONS.
8.1 CONFIDENTIALITY.
(a) -GENERAL
Except as expressly set forth in this Section 8, each party shall cause
its respective Affiliates, officers, directors, employees, agents and
subcontractors (collectively, "Representatives") to keep confidential any
and all technical, commercial, scientific and other data, processes,
documents or other information (whether in oral form and identified as
confidential within 30 days after the date of disclosure, or if written
form, if marked as "confidential" at the time of disclosure) 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 ) that have
been marked as "confidential" at the time of disclosure) acquired from
the other party (the "Other Party"), its Affiliates or its
Representatives after the Effective Date ("Confidential Information"),
and each party shall not disclose directly or indirectly, and shall cause
its Representatives not to disclose directly or indirectly, any
Confidential Information to anyone outside such Person, in the case of
LICENSEE, its Sublicensees, and each of their Affiliates and their
respective Representatives, except that the foregoing restriction shall
not apply to any information disclosed hereunder to any party, if such
Person (the "Receiving Person") can demonstrate that such Confidential
Information:
(i) is or hereafter becomes generally available other than by
reason of any breach or default by the Receiving Person,
any of its Affiliates or any Representative of the
foregoing with respect to a confidentiality obligation
under this Agreement;
(ii) was already known to the Receiving Person or such affiliate
or Representative;
(iii) is disclosed to the Receiving Person or such affiliate or
Representative by a third party who has the right to
disclose such information;
(iv) is independently developed by the Receiving Person;
(v) based on such Person's good faith judgement with the advice
of counsel, is otherwise required to be disclosed in
compliance with applicable legal requirements to a public
authority.
Whenever the Receiving Person becomes aware of any state of facts which
would or might result in disclosure of Confidential Information pursuant
to subparagraph (v) above, it shall, if possible, promptly notify the
Person making disclosure "Disclosing Person") prior to any such
disclosure so that the Disclosing Person may seek a protective
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
18
order or other appropriate remedy and/or waive compliance with the
provisions of this Agreement.
In any event, if the Receiving Person is unable to promptly notify the
Disclosing Person or if such protective order or other remedy is not
obtained, or if the Disclosing Person waives compliance with the
provisions of this Agreement, the Receiving Person will furnish only that
portion of the information which it is advised by counsel is legally
required and will exercise reasonable efforts to obtain assurance that
confidential treatment will be accorded the Confidential Information.
Each party shall be entitled, in addition to any other right or remedy it
may have, at law or in equity, to an injunction, without the posting of
any bond or other security except as required by the relevant laws,
enjoining or restraining any other party from any violation or threatened
violation of this Section 8.1.
(b) -USE OF CONFIDENTIAL INFORMATION
Each party agrees that no Confidential Information shall:
(i) be used in its own business except as necessary to exercise
the rights and obligations of such Party under this
Agreement;
(ii) be assigned, licensed, sublicensed, marketed, transferred
or loaned, directly or indirectly to any third party other
than a Representative or an Affiliate Representative of
such party, except as necessary or contemplated for the
exercise of the rights and obligations of the Parties under
this Agreement;
The obligations set forth in this Section 8.1 shall extend to
copies, if any, of Confidential Information made by any
Representatives referred to in paragraph (a) and to documents
prepared by such Persons which embody or contain Confidential
Information.
(c) -PROTECTION OF CONFIDENTIAL INFORMATION
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 which shall include, without limitation, ensuring that
only those Persons who have a bona fide need to know such
Confidential Information for purposes permitted or contemplated by
this Agreement shall have access thereto. Each party, shall notify
all of its Representatives who have access to Confidential
Information of its confidentiality and the care therefor required,
and shall obtain from any Affiliate or any agent or subcontractor
who is a Representative that is permitted access to such
Confidential Information in accordance with this Section 8.1, an
agreement of confidentiality incorporating the restrictions set
forth herein.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
19
(d) -SURVIVAL OF OBLIGATIONS
The obligations set forth in this Section 8.1 shall survive the
termination of this Agreement for a period of [***].
(e) -RETURN OF CONFIDENTIAL INFORMATION
Within thirty (30) days after the termination of this Agreement,
the Receiving Person shall (and shall cause its Affiliates'
Representatives and its Affiliates to) return to the Disclosing
Person or destroy all related documents and tangible items then in
its possession which it has received from the Disclosing Person or
any affiliate or Representative thereof pertaining, referring or
relating to the Disclosing Person's Confidential Information, as
well as all copies, summaries, records, descriptions,
modifications, and duplications that it, or any of its Affiliates
or Representatives, has made from the documents or tangible items
received from the Disclosing Person or any affiliate or
Representative thereof; provided, however, that the Receiving
Person may retain one copy of each document in its legal files
solely to permit the Receiving Person to continue to comply with
its obligations hereunder and, in addition, 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
any pending legal proceeding to which such document relates.
Notwithstanding the foregoing, this provision shall not apply with
respect to Confidential Information obtained from LICENSOR that is
comprised of LICENSOR KNOW-HOW, in the event of expiration of the
Agreement in accordance with its terms or termination of this
Agreement for breach by LICENSOR.
8.2 TERM AND TERMINATION.
8.2.1. EXPIRATION.
Unless terminated earlier pursuant to this Article 8, the Agreement shall
expire on the expiration of LICENSEE's obligation to pay royalties under
the Agreement in accordance with the Section 4 of this Agreement.
8.2.2. TERMINATION BY LICENSEE.
LICENSEE shall have the right at any time, in its sole discretion, to
terminate this Agreement, by giving not less than three (3) months prior
written notice to LICENSOR of such termination.
8.2.3. TERMINATION FOR CAUSE.
(i) Either Party may terminate this Agreement, at its option,
upon or after the breach of any material provision of the
Agreement by the other Party, if such breaching Party has
not cured such breach within one-hundred and twenty
(120) days after written notice thereof from the other
Party.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
20
(ii) 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
ninety (90) days after the filing thereof.
(iii) Each of the parties hereto acknowledges and agrees that
this Agreement (i) constitutes a license of Intellectual
Property (as such term is defined in the United States
Bankruptcy Code, as amended (the "Code"), and (ii) is an
executory contract, with significant obligations to be
performed by each party hereto. The parties agree that
LICENSEE as LICENSEE may fully exercise all of its rights
and elections under the Code, including, without
limitation, those set forth in Section 365 (n) of the Code.
The parties further agree that, in the event that LICENSEE
elects to retain its rights as a licensee under the Code,
LICENSEE shall be entitled to complete access to the
LICENSOR Technology licensed to it hereunder and all
embodiments of such technology. Such embodiments of the
LICENSOR 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 the Agreement, or (b) if not delivered
under (a) above, upon the rejection of the Agreement by or
on behalf of LICENSOR.
8.2.4. EFFECT OF EXPIRATION AND TERMINATION.
Expiration or termination of the Agreement shall not relieve the Parties
of any obligation accruing prior to such expiration or termination.
8.3 FORCE MAJEURE.
No Party (or any of its Affiliates) shall be held liable or responsible
to the other Party (or any of its Affiliates) nor be deemed to have
defaulted under or breached the Agreement for failure or delay in
fulfilling or performing any term of the Agreement when such failure or
delay is caused by or results from causes beyond the reasonable control
of the affected Party (or any of its Affiliates) including but not
limited to fire, floods, embargoes, war, acts of war (whether war be
declared or not), insurrections, riots, civil commotions, strikes,
lockouts or other labor disturbances, acts of God or acts, omissions or
delays in acting by any governmental authority or the other Party
(collectively, "Events of Force Majeure"); provided, however, that the
affected Party (i) shall immediately notify the other Party of the
occurrence of any such Event of Force Majeure and (ii) shall exert all
reasonable efforts to eliminate, cure or overcome any such Event of Force
Majeure and to resume performance of its covenants with all possible
speed; and provided, further, that nothing contained herein shall require
any Party to settle on terms unsatisfactory to such Party any strike,
lockout or other labor difficulty, any investigation
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
21
or proceeding by any governmental authority or any litigation by any
Third-Party. Notwithstanding the foregoing, to the extent that an
Event of Force Majeure continues for a period in excess of [***] the
affected Party shall promptly notify in writing the other Party of
such Event of Force Majeure and [***] of the other Party's receipt of
such notice, the Parties agree to negotiate in good faith either (i)
to resolve the Event of Force Majeure, if possible, (ii) to extend by
mutual agreement the time period to resolve, eliminate, cure or
overcome such Event of Force Majeure, (iii) to amend this Agreement to
the extent reasonably 'possible, or (iv) to terminate this Agreement.
8.4 ASSIGNMENT.
This Agreement may not be assigned or otherwise transferred, nor, except
as expressly provided hereunder, may any right or obligations hereunder
be assigned or transferred to any Third-Party by either Party without the
consent of the other Party; PROVIDED, HOWEVER, that either Party may,
without such consent, assign this Agreement and its rights and
obligations hereunder to any of its Affiliates or in connection with the
transfer or sale of all or substantially all of its business, or in the
event of its merger or consolidation or change in control or similar
transaction. Any permitted assignee shall assume all obligations of its
assignor under this Agreement. Without limiting the generality of the
foregoing, without the prior written consent of LICENSEE, LICENSOR shall
not under any circumstances assign or transfer any LICENSOR Technology
unless (i) all of the rights and obligations of LICENSOR under this
Agreement are assigned to the same transferee(s) concurrently therewith,
and (ii) such transferee(s) expressly assume(s) in writing the
performance of all terms and conditions of this Agreement to be performed
by LICENSOR and such assignment shall not relieved the assignor of any of
its obligations under this Agreement. Each Party acknowledges that the
other Party would suffer irreparable injury in the event of any breach of
this Article 8 and that therefore the remedy at law for any breach or
threatened breach hereof by any Party shall be inadequate. Accordingly,
upon a breach or threatened breach hereof by any Party, the other Party
shall, in addition and without prejudice to any other rights and remedies
it may have, be entitled as a matter of right, without proof of actual
damages, to seek specific performance hereof and to such other injunctive
or equitable relief to enforce, or prevent any violations (whether
anticipatory, continuing or future) hereof.
8.5 ADVERSE EXPERIENCE REPORTING.
During the term of the Agreement, each Party shall notify the other
immediately of any information (howsoever obtained and from whatever
source) concerning any unexpected side effect, injury, toxicity or
sensitivity reaction, or any unexpected incidence, and the severity
thereof, associated with the clinical uses, studies, investigations,
tests and marketing of a PRODUCTS. For purposes of this Section 8.5,
"unexpected" shall mean (x) for a nonmarketed PRODUCTS, an experience
that is not identified in nature, severity or frequency in the current
clinical investigator's confidential information brochure, and (y) for a
marketed PRODUCTS, an experience which is not listed in the current
labeling for such PRODUCTS, and includes an event that may be
symptomatically and patho-physiologically related to an event listed in
the labeling but differs from the event because of increased frequency or
greater severity or specificity. Each Party further shall
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
22
immediately notify the other of any information received regarding any
threatened or pending action by an agency which may affect the safety
and efficacy claims of a Product. Upon receipt of any such
information, the Parties shall consult with each other in an effort to
arrive at a mutually acceptable procedure for taking appropriate
action; provided, however, that nothing contained herein shall be
construed as restricting either Party's right to make a timely report
of such matter to any government agency or take other action that it
deems to be appropriate or required by applicable law or regulation.
8.6 SEVERABILITY.
Each Party hereby agrees that it does not intend to violate any public
policy, statutory or common laws, rules, regulations, treaty or decision
of any government agency or executive body thereof of any country or
community or association of countries. Should one or more provisions of
this Agreement be or become invalid, the Parties hereto shall substitute,
by mutual consent, valid provisions for such invalid provisions which
valid provisions in their economic effect are sufficiently similar to the
invalid provisions that it can be reasonably assumed that the Parties
would have entered into this Agreement with such provisions. In case such
provisions cannot be agreed upon, the invalidity of one or several
provisions of this Agreement shall not affect the validity of this
Agreement as a whole, unless the invalid provisions are of such essential
importance to this Agreement that it is to be reasonably assumed that the
Parties would not have entered into this Agreement without the invalid
provisions.
8.7 MISCELLANEOUS.
8.7.1. NOTICES.
Any consent, notice or report required or permitted to be given or made
under this Agreement by one of the Parties hereto to the other shall be
in writing, delivered Personally or by facsimile (and promptly confirmed
by Personal delivery, first class air mail or courier), first class air
mail or courier, postage prepaid (where applicable), addressed to such
other Party at its address indicated below, or to such other address as
the addressee shall have last furnished in writing to the addressor and
(except as otherwise provided in this Agreement) shall be effective upon
receipt by the addressee.
IF TO LICENSOR:
LICENSOR
Pasteur Merieux Serums & Vaccins
00 xxxxxx Xxxxxxx
00000 Xxxx, Xxxxxx
Attention: General Counsel
Telefax: 00.0.00.00.00.00
Telephone: 00.0.00.00.00.00
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
23
IF TO LICENSEE:
LICENSEE
0000 X'Xxxxx Xxxxx, xxxxx X,
Xxxxx Xxxx, XX 00000
XXX
Attention: CEO
Telefax: 000.000.0000
Telephone: 000.000.0000
8.7.2. APPLICABLE LAW.
The Agreement shall be governed by and construed in accordance with the
laws of State of California without regard to the conflict of law
principles thereof.
8.7.3. REPRESENTATIONS, WARRANTIES AND COVENANTS.
8.7.3.1 REPRESENTATIONS AND WARRANTIES OF LICENSEE.
(a) LICENSEE is a corporation duly organized and existing under the
laws of the State of California, 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 or performance of this Agreement will not
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.
8.7.3.2 REPRESENTATIONS, WARRANTIES AND COVENANTS OF LICENSOR.
(a) LICENSOR is a corporation duly incorporated and validly existing
as a corporation in good standing under the laws of France with
the corporate power to own, lease and operate its properties and
to carry on its business as now conducted.
(b) LICENSOR has all necessary corporate power and authority to enter
into this Agreement and to consummate the transactions
contemplated hereby.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
24
(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 agreement or
instrument to which LICENSOR 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
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) All LICENSED PATENTS listed on Schedule A as amended from time to
time have been registered in, filed in or issued by the
appropriate patent offices of each jurisdiction as indicated on
such Schedule A, and in each case is currently in effect and all
maintenance fees and renewals thereof have been duly made with
respect thereto. LICENSOR owns or has full and exclusive rights to
use and exploit under licenses (and to license or sublicense) all
its rights under such LICENSED PATENTS and the LICENSED KNOW-HOW.
There have been no material claims made against LICENSOR asserting
the invalidity or non-enforceability of, or with respect to such
LICENSED PATENTS, the misuse of such LICENSED PATENTS or the
LICENSED KNOW-HOW, nor is LICENSOR aware that any such claims
exist. LICENSOR has not received a notice of conflict of such
LICENSED PATENTS or the LICENSED KNOW-HOW with the asserted rights
of others, or otherwise challenging its rights to use any of such
LICENSED PATENTS, or the LICENSED KNOW-HOW. None of the rights of
LICENSOR under the LICENSED PATENTS or LICENSED KNOW-HOW shall be
adversely affected by the execution, delivery or performance of
this Agreement, or the consummation of the transaction
contemplated herein. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
THIS SECTION, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS
ANY WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING
BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR VALIDITY OF ANY PATENT RIGHTS PENDING.
8.7.4. DISPUTE RESOLUTION.
Any and all disputes arising in connection with this Agreement that will
not be solved on an amicable basis between the parties shall be finally
settled by arbitration under the Rules of Conciliation and Arbitration of
the International Chamber of Commerce, rules that the Parties recognize
that they know. The arbitration shall be conducted in Paris, France, in
English by one arbitrator if the dispute involves a claim of damage of
and [***] appointed in accordance with the said rules. The arbitrator(s)
shall apply French law to the merits of the case. The arbitration shall
be final and binding upon the parties.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
25
in the event of a dispute regarding any payments owing under this
Agreement, all undisputed Agreements shall be paid when due and the
balance, if any, promptly after resolution of the dispute.
8.7.5. ENTIRE AGREEMENT.
This Agreement contains the entire understanding of the Parties with
respect to the subject matter hereof. All express or implied agreements
and understandings, either oral or written, heretofore made, including
but not limited to Option Agreements to the extent, but only to the
extent, they are inconsistent with any provisions of this Agreement (in
which case the relevant provision of this Agreement shall prevail) are
expressly superseded by this Agreement. This Agreement may be amended, or
any term hereof modified, only by a written instrument duly executed by
both Parties hereto.
8.7.6. INDEPENDENT CONTRACTORS.
LICENSOR and LICENSEE each acknowledge that they shall be independent
contractors and that the relationship between the two Parties shall not
constitute a partnership, joint venture or agency. Neither LICENSOR nor
LICENSEE shall have the authority to make any statements, representations
or commitments of any kind, or to take any action, which shall be binding
on the other Party, the prior consent of the other Party to do so.
8.7.7. AFFILIATES.
Each Party shall cause its respective Affiliates to comply fully with the
provisions of this Agreement to the extent such provisions specifically
relate to, or are intended to specifically relate to, such Affiliates, as
though such Affiliates were expressly named as joint obligors hereunder.
8.7.8. WAIVER.
The waiver by either Party hereto of any right hereunder or the failure
to perform or of a breach by the other Party shall not be deemed a waiver
of any other right hereunder or of any other breach or failure by said
other Party whether of a similar nature or otherwise.
8.7.9. NO IMPLIED LICENSE.
Nothing in this Agreement shall be deemed to constitute, by implication
or otherwise, the grant by LICENSEE to LICENSOR, or by LICENSOR to
LICENSEE, of any license to, or interest in, or other rights under any
patent, patent application, proprietary know-how, trade secrets or other
intellectual property rights owned or possessed by LICENSEE or LICENSOR,
whichever is applicable, except as expressly provided for herein. For the
avoidance of doubt, LICENSEE shall at all times own all right, title and
interest in and to COC ab and all intellectual and industrial property
rights relating thereto, in whatever form and however derived or
modified, and LICENSOR shall make any assignments necessary from time to
time to effect such ownership.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
26
8.7.10. LIABILITY LIMITATION.
In no event shall either party be liable with respect to any subject
matter of this agreement under any contract, negligence, strict liability
or other legal or equitable theory for any incidental or consequential
damages, lost profits or lost data.
8.7.11. COUNTERPARTS.
This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute
one and the same instrument.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
27
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.
For LICENSOR.
By: /s/ Xxxxxx Xxxxx
-------------------------------
Name: Xxxxxx XXXXX
Title: DIRECTEUR GENERAL
For LICENSEE.
By: /s/ Xxxxxxx Xxxxxx
-------------------------------
Name: Xxxxxxx XXXXXX
Title: CEO & President
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
28
--------------------------------------------------------------------------------
SCHEDULE A
--------------------------------------------------------------------------------
LICENSED PATENTS
US Patent nDEG. 5.234.991 of August 10, 1993 "POROUS MINERAL SUPPORT COATED
WITH AN ANIMATED POLYSACCHARIDE POLYMER
US Patent nDEG. 4.849.508 of July 18, 1989 "PASTEURIZATION OF IMMUNOGLOBULIN
SOLUTIONS"
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
29
--------------------------------------------------------------------------------
SCHEDULE B
--------------------------------------------------------------------------------
LICENSED KNOW-HOW
[***]
[***]
[***]
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
30
