** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
EXHIBIT 10.2
INTELLECTUAL PROPERTY TRANSFER AND LICENSE AGREEMENT
This Intellectual Property Transfer and License Agreement (this
"Agreement") is made by and between Xxxxxxx & Xxxxxxx Consumer Companies, Inc.,
a New Jersey corporation having an address at 000 Xxxxxxxxx Xxxx, Xxxxxxxx, Xxx
Xxxxxx 00000 (hereinafter referred to as "JJCC") and Barrier Therapeutics, Inc.,
a Delaware corporation having an address at 0 Xxxxxx Xxxxx, Xxxxxxxxxx,
Xxx Xxxxxx 00000 (hereinafter referred to as "Barrier").
W I T N E S S E T H
WHEREAS, JJCC is the owner of (i) patents and patent applications recited
in Schedules 1.1 and 1.3 and (ii) know-how and tangible property relating to the
Diaper Dermatitis Product and the Sebderm Product (each as defined below);
WHEREAS, Barrier wishes to acquire (i) a license (as set forth below)
under such patents and patent applications from JJCC, (ii) a license (as set
forth below) to use such know-how from JJCC, and (iii) copies of such JJCC
Tangible Property (defined herein);
WHEREAS, in consideration of (i) the issuance of shares of Series A
Preferred Stock of Barrier to JJCC (or its designated Affiliate) under the
Securities Acquisition Agreement (defined herein) and (ii) the obligations of
Barrier hereunder, JJCC is willing to grant such licenses and transfer such
tangible property to Barrier, in each case subject to the terms and conditions
of this Agreement; and
WHEREAS, contemporaneously with the execution and delivery hereof, Barrier
is entering into the Related License Agreement (defined herein).
NOW, THEREFORE, in consideration of the above premises and the covenants
contained herein, the parties agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the following terms, when used with initial
capital letters, shall have the following meanings, and the singular shall
include the plural and vice-versa. Certain defined terms, generally used in
exclusively one article hereof, are not defined in this Article 1.
1.1 "`683 Patent Rights" shall mean U.S. Patent No. 6,238,683, as well
as all continuations, continuations-in-parts, divisions, and renewals thereof,
all patents which may be granted thereon, and all reissues, reexaminations,
extensions, patents of additions, and patents of importation thereof together
with any foreign counterparts of any of the foregoing. Schedule 1.1
** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
sets forth all of the patents and patent applications that comprise the `683
Patent Rights as of the date hereof.
1.2 "`683 Product" shall mean a Pharmaceutical Product, the making,
using, selling, offering to sell, or importation of which would infringe a Valid
Claim of a patent within the `683 Patent Rights but for the licenses granted
herein.
1.3 "`932 Patent Rights" shall mean U.S. Patent No. 4,911,932, as well
as all continuations, continuations-in-parts, divisions, and renewals thereof,
all patents which may be granted thereon, and all reissues, reexaminations,
extensions, patents of additions, and patents of importation thereof, together
with any foreign counterparts thereof. Schedule 1.3 sets forth all of the
patents and patent applications that comprise the `932 Patent Rights as of the
date hereof.
1.4 "`932 Product" shall mean a Pharmaceutical Product, the making,
using, selling, offering to sell, or importation of which would infringe a Valid
Claim of a patent within the `932 Patent Rights but for the licenses granted
herein.
1.5 "`932 Territory" shall mean the world with the exception of the JJCC
Countries.
1.6 "Active Clinical Development" shall mean that Barrier is diligently
engaging in one or more of the following development activities for the Licensed
Product that it has selected to develop: (i) study/protocol design activity;
(ii) awaiting protocol approval from the applicable institutional review board,
FDA or other Regulatory Authority; (iii) patient recruitment, patient treatment,
data analysis, and report writing for any clinical trial; (iv) manufacturing
scale-up and validation; or (v) regulatory file(s) being drafted or pending.
1.7 "Affiliate" shall mean any entity that directly or indirectly
controls, is controlled by, or is under common control with a party to this
Agreement, and for such purpose of this definition, "control" shall mean the
possession, direct or indirect, of the power to direct or cause the direction of
the management or the policies of the entity, whether through the ownership of
voting securities, by contract, or otherwise. The direct or indirect ownership
of greater than fifty percent (50%) of the voting securities of a business
entity or an interest in the assets, profits, or earnings of a business entity
shall be deemed to constitute control of the business entity. Notwithstanding
the foregoing, Barrier shall not be considered an Affiliate of JJCC for purposes
of this Agreement.
1.8 "Closing Date" shall have the meaning set forth in Section 11.5.
1.9 "Commercialization Agreement" is defined in Section 5.1 of the
Agreement.
1.10 "Control" or "Controlled" shall mean the right to grant a license or
sublicense to intangible property rights (including patent rights, know-how
and/or trade secret information) as permitted under the terms of any
pre-existing agreement or other arrangement with any third party. For the
purposes of this Agreement, JJCC does not Control any intangible property rights
of its Affiliates unless there is a written agreement granting such rights.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
1.11 "Diaper Dermatitis Product" shall mean the `932 Product described in
NDA No. [**] that was developed by JJCC pursuant to IND No. [**] for the use
in treating diaper dermatitis.
1.12 "Execution Date" of this Agreement shall mean the later of the
execution dates appearing below the parties' signature lines at the end of this
Agreement. The rights and obligations of the parties under Articles 2, 3, 8, and
9 of this Agreement, however, shall not become effective until Barrier satisfies
all of the conditions of the capital financing transactions set forth in Section
13.15 of this Agreement.
1.13 "FDA" shall mean the United States Food and Drug Administration or
any successor entity.
1.14 "Foreign Country" shall mean any country or territory that is not
the United States and its territories and possessions.
1.15 "JJCC Countries" shall mean Argentina, Australia, Belgium, Denmark,
Germany, Indonesia, Luxembourg, New Zealand, Peru and Venezuela.
1.16 "JJCC IP Rights" shall mean the JJCC Patent Rights and the JJCC
Know-How.
1.17 "JJCC Know-How" shall mean all know-how, information, trade secrets,
experience, data, formulae, processes or procedures, excluding the JJCC Patent
Rights, owned or otherwise Controlled by JJCC as of the Execution Date of this
Agreement relating to the Diaper Dermatitis Product and the Sebderm Product.
Such information includes JJCC Tangible Property.
1.18 "JJCC Patent Rights" shall mean the `932 Patent Rights and the `683
Patent Rights.
1.19 "JJCC Tangible Property" shall mean a copy of all items set forth on
Schedule 1.19.
1.20 "Licensed Product" shall mean a `683 Product (including without
limitation the Sebderm Product) or a `932 Product (including without limitation
the Diaper Dermatitis Product).
1.21 "Manufacturing Agreement" is defined in Section 5.4 of the
Agreement.
1.22 "Materials" is defined in Section 3.2(c) of this Agreement.
1.23 "Optioned Territory" is defined in Section 5.1(a) of this Agreement.
1.24 "Pharmaceutical Product" shall mean a product, which if marketed in
the United States, would require Regulatory Approval from the FDA prior to such
marketing.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
1.25 "Phase II Clinical Studies" shall mean that portion of the clinical
development program carried out beyond Phase I which provides for the clinical
studies conducted in patients and designed to indicate clinical efficacy for a
Licensed Product for one or more indications and its safety, as well as to
obtain an indication of the dosage regimen required as more fully defined in 21
C.F.R. 312.21(b).
1.26 "Regulatory Approval" shall mean the technical, medical and
scientific licenses, registrations, authorizations and approvals (including,
without limitation, approvals of NDAs, supplements and amendments, pre- and
post- approvals, pricing and third party reimbursement approvals, and labeling
approvals) of any national, supra-national, regional, state or local regulatory
agency, department, bureau, commission, council or other governmental entity,
necessary for the development (including the conduct of clinical trials),
manufacture, distribution, marketing, promotion, offer for sale, use, import,
export or sale of Licensed Product(s) in a regulatory jurisdiction.
1.27 "Regulatory Authority" shall mean any national (e.g., the FDA),
supra-national (e.g., the European Commission or the European Agency for the
Evaluation of Medicinal Products), regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity responsible
for the granting of Regulatory Approval.
1.28 "Related License Agreement" shall mean that certain Intellectual
Property Transfer and License Agreement between Barrier and Ortho-XxXxxx
Pharmaceutical, Inc. and Xxxxxxx Pharmaceutica Products, LP., dated the date
hereof.
1.29 "Sebderm Product" shall mean the `683 Product that was developed by
JJCC for the use in treating seborrheic dermatitis under IND No. [**].
1.30 "Securities Acquisition Agreement" shall mean the Barrier
Therapeutics, Inc. Series A Securities Acquisition Agreement, of even date, by
and among JJCC, Barrier, Xxxxxxx Pharmaceutica Products, LP, Ortho-XxXxxx
Pharmaceutical, Inc., and Xxxxxxx & Xxxxxxx Development Corporation.
1.31 "Valid Claim" shall mean a claim in any unexpired, issued patent
within the JJCC Patent Rights which has not been held invalid or unenforceable
by a non-appealed or unappealable decision by a court or other appropriate body
of competent jurisdiction, and which is not admitted to be invalid through
disclaimer or dedication to the public.
ARTICLE 2
GRANT OF PATENT RIGHTS
2.1 Barrier's License under the `932 Patent Rights. Subject to Section
2.2, JJCC hereby grants to Barrier the exclusive (even as to JJCC and its
Affiliates), royalty-free license with the unrestricted right to grant
sublicenses (subject to Section 2.6 and Article 5), under the `932 Patent Rights
to (i) import, use, sell, offer for sale, and have sold `932 Products in the
`932 Territory and (ii) make and have made `932 Products anywhere in the world
to import, use, sell, offer for sale, and have sold `932 Products in the `932
Territory. For avoidance of doubt, there
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
shall be no field-of-use limitation on the license granted pursuant to this
Section 2.1(a) regarding indications for which `932 Products may be used.
2.2 JJCC's Retained Rights Under the `932 Patent Rights. JJCC retains
all rights under the `932 Patent Rights, including the unrestricted right to
grant sublicenses, to (i) import, use, sell, offer for sale, and have sold `932
Products in the JJCC Countries, (ii) make and have made the `932 Products
anywhere in the world to import, use, sell, offer for sale, and (iii) have sold
such `932 Products in the JJCC Countries and retains the non-exclusive right,
including the unrestricted right to grant sublicenses, to make, have made,
import, use, sell, offer for sale, and have sold products (other than the Diaper
Dermatitis Product) for which JJCC or its Affiliates can show through tangible
dated evidence was under development (having at least performed in vivo studies)
or marketed by JJCC or such Affiliate prior to the Execution Date. For avoidance
of doubt, there shall be no field-of-use limitation on the rights retained under
this Section 2.2 regarding indications for which products may be used.
2.3 License Under the `683 Patent Rights.
(a) Subject to Sections 2.3(b) and 2.4, JJCC hereby grants to
Barrier the exclusive (even as to JJCC and its Affiliates), royalty-free,
worldwide license, with the unrestricted right to grant sublicenses (subject to
Section 2.6 and Article 5), under the `683 Patent Rights to make, have made,
import, use, sell, offer for sale, and have sold `683 Products. For avoidance of
doubt, there shall be no field-of-use limitation on the license granted pursuant
to this Section 2.3(a) regarding indications for which `683 Products may be
used.
(b) Barrier's license under Section 2.3(a) and Article 3 shall not
include the right to make, have made, import, use, sell, offer for sale, and
have sold human dandruff shampoo products in Germany that can be legally sold
without a prescription.
2.4 JJCC's Retained Rights Under the `683 Patent Rights. JJCC retains
the non-exclusive right under the `683 Patent Rights, including the unrestricted
right to grant sublicenses, to make, have made, import, use, sell, offer for
sale, and have sold products (other than the Sebderm Product) for which JJCC or
its Affiliates can show through tangible dated evidence was under development or
marketed by JJCC or such Affiliate prior to the Execution Date. For avoidance of
doubt, there shall be no field-of-use limitation on the rights retained under
this Section 2.4 regarding indications for which such products may be used.
2.5 Freedom to Operate.
(a) To the extent JJCC owns or otherwise Controls any patents or
patent applications as of the Execution Date, other than those listed in
Schedule 1.1, that generally or specifically claim a Sebderm Product, methods of
manufacturing a Sebderm Product, or methods of using a Sebderm Product for the
treatment of sebhorrheic dermatitis, JJCC hereby grants (if and to the extent
JJCC has the right to do so) to Barrier a non-exclusive, worldwide, royalty-free
license or sublicense, with the right to grant sublicenses (subject to Section
2.6 and Article 5) under such patents and patent applications, to make, have
made, import, use, sell, offer for sale, and have sold the Sebderm Product.
Where JJCC's rights are subject to a license with a third
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
party, Barrier's rights under such license are subject to Barrier negotiating
with JJCC and/or the applicable holder of the license and entering into an
appropriate sublicense arrangement.
(b) To the extent JJCC owns or otherwise Controls any patents or
patent applications as of the Execution Date, other than those listed in
Schedule 1.3, that generally or specifically claim a Diaper Dermatitis Product,
methods of manufacturing a Diaper Dermatitis Product, or methods of using a
Diaper Dermatitis Product for the treatment of diaper dermatitis, JJCC hereby
grants (if and to the extent JJCC has the right to do so) to Barrier a
non-exclusive, royalty-free license or sublicense, with the right to grant
sublicenses (subject to Section 2.6 and Article 5) under such patents and patent
applications, to make, have made, import, use, sell, offer for sale and have
sold the Diaper Dermatitis Product in the `932 Territory and to make and have
made the Diaper Dermatitis Product anywhere in the world to import, use, sell,
offer for sale and have sold the Diaper Dermatitis Product in the `932
Territory. Where JJCC's rights are subject to a license with a third party,
Barrier's rights under such license are subject to Barrier negotiating with JJCC
and/or the applicable holder of the license and entering into an appropriate
sublicense arrangement.
2.6 Sublicensing. Barrier shall provide JJCC with notice of the identity
of any sublicensee that enters into a sublicense agreement permitted hereby, and
any such sublicense shall be subject to the terms and conditions of this
Agreement.
ARTICLE 3
LICENSE OF KNOW-HOW RIGHTS
3.1 License to JJCC Know-How. JJCC hereby grants to Barrier the
non-exclusive, worldwide, royalty-free license, with the unrestricted right to
grant sublicenses (subject to Section 2.6 and Article 5), to the JJCC Know-How
to make, have made, import, use, sell, offer for sale, and have sold Licensed
Products.
3.2 JJCC Tangible Property.
(a) JJCC hereby agrees to promptly provide a copy to Barrier of
the JJCC Tangible Property to any facility identified in writing by Barrier.
(b) JJCC hereby agrees to assign to Barrier (i) NDA No. [**] and
IND No. [**], relating to the Diaper Dermatitis Product, (ii) IND No. [**],
relating to the Sebderm Product, and (iii) any other Regulatory Approvals and
submissions to a Regulatory Authority owned by JJCC for the Diaper Dermatitis
Product and the Sebderm Product (other than those with respect to the Diaper
Dermatitis Product in the JJCC Countries).
(c) Subject to Section 3.2(d), at any time, and from time to time,
following the Execution Date, upon Barrier's reasonable request, (i) JJCC shall
provide Barrier with copies of specifically identified materials, information
and/or reports in its Control with regards to the Diaper Dermatitis Product or
the Sebderm Product (including without limitation, correspondence with
Regulatory Authorities, side effect reports, internal question and answer and
audit reports, and post marketing surveillance reports) (collectively,
"Materials") which Barrier needs in
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
connection with Barrier's submissions to a Regulatory Authority for Licensed
Products and (ii) JJCC shall grant Barrier a "Right of Reference or Use" as that
term is defined in 21 C.F.R. Section 314.3(b) to any requested Materials.
(d) Notwithstanding Section 3.2(c), JJCC shall be entitled to deny
any request for copies of Materials and/or deny any request for a "Right of
Reference or Use" to such Materials if JJCC has a reasonable reason for doing so
and such reason is communicated to Barrier in writing within a reasonable period
of time following JJCC's receipt of such request.
ARTICLE 4
FINANCIAL PROVISIONS
4.1 Purchase Price. In exchange for the licenses granted hereunder
Barrier shall issue to JJCC (or its designated Affiliate) shares of Barrier
Series A Convertible Preferred Stock, par value $0.0001 per share, at $3.00 per
share for a total purchase price of Six Million One Hundred Thousand U.S.
Dollars ($6,100,000.00), pursuant to the Securities Acquisition Agreement.
ARTICLE 5
JJCC'S AND BARRIER'S RIGHTS REGARDING LICENSED PRODUCTS
5.1 JJCC Right of First Negotiation.
(a) Barrier shall not negotiate, enter into, or agree to enter
into, with any third party other than JJCC or an Affiliate of JJCC, an agreement
for the marketing or sale in a territory(ies) ("Optioned Territory") of a
Licensed Product (a "Commercialization Agreement") unless Barrier first offers
in writing to JJCC the right to enter into an agreement pursuant to which,
consistent with Section 5.3 below, Barrier would grant to JJCC an exclusive
license to develop, market, sell, and have sold such Licensed Product in such
Optioned Territory. Such written offer (a "Section 5.1 Notice") shall specify
(i) the Licensed Product(s) which Barrier intends to have developed or
commercialized subject to such Commercialization Agreement and the Optioned
Territory, and (ii) all reasonably relevant pre-clinical and clinical data
relating to such Licensed Product(s). Within ninety (90) days after provision of
a Section 5.1 Notice, if JJCC or an Affiliate of JJCC desires to enter into a
Commercialization Agreement contemplated by such Section 5.1 Notice, JJCC shall
send a written reply to such effect (a "Section 5.1 Reply") which identifies (x)
the territories (the "Selected Territories") to which JJCC would like such
Commercialization Agreement to apply, and (y) the prospective party thereto,
whether JJCC or an Affiliate of JJCC (the "Section 5.1 J&J Party"). Upon receipt
of a Section 5.1 Reply, the Section 5.1 J&J Party and Barrier shall negotiate
the terms thereof in good faith for a period not to exceed ninety (90) days,
which period may be extended or shortened if mutually agreed to in writing by
the parties (the "Section 5.1 Negotiation Period"). If the Commercialization
Agreement is only for certain territories, then Barrier shall retain its rights
for the rest of the world other than the territories licensed in the
Commercialization Agreement. This Section 5.1 shall not apply to, and there
shall be no restriction on, Barrier's ability to market and sell Licensed
Products itself or with the assistance of a Contract Marketing and Sales
Organization. As used herein, a "Contract Marketing and Sales Organization"
shall mean an organization
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
which is not itself or an Affiliate of a company that is engaged in the research
or development of pharmaceuticals.
(b) If JJCC fails to send a Section 5.1 Reply or, if after
providing a Section 5.1 Reply, the Section 5.1 J&J Party never delivers to
Barrier a single term sheet, then Barrier shall be free to enter into an
agreement with respect to such Licensed Product with any third party without
restriction for such Optioned Territories.
(c) Barrier agrees not to negotiate and agrees not to enter into
such an Commercialization Agreement for a Licensed Product with a third party
with respect to the Selected Territories during the ninety (90) day period after
the Section 5.1 Notice or during the Section 5.1 Negotiation Period. If the
Section 5.1 J&J Party and Barrier, despite their good faith efforts, do not
enter into a Commercialization Agreement within the Section 5.1 Negotiation
Period, then Barrier may enter into such an agreement with a third party during
the [**] following either (i) the expiration of the 90-day period following the
Section 5.1 Notice, in the event JJCC fails to send a Section 5.1 Reply, or (ii)
the expiration of the Section 5.1 Negotiation Period; provided, however, that if
the terms and conditions of such agreement with such third party would, taken as
a whole, be materially less favorable to Barrier than the last written offer
proposed by the Section 5.1 J&J Party, then Barrier shall deliver a new Section
5.1 Notice to JJCC, whereupon JJCC shall have another 45-day period to send a
new Section 5.1 Reply and, if it does so, another 60-day Section 5.1 Negotiation
Period therefor. The parties hereby acknowledge and agree that neither the
Section 5.1 J&J Party nor Barrier shall have an obligation to enter into a
Commercialization Agreement.
(d) If Barrier does not enter into an agreement with a third party
during the [**] period following the expiration of the Section 5.1 Negotiation
Period, for such Licensed Product as set forth in Section 5.1(c), then prior to
entering into an agreement with a third party with regards to such Licensed
Product Barrier shall deliver a new Section 5.1 Notice to JJCC, whereupon JJCC
shall have a forty-five (45) day period to send a new Section 5.1 Reply and, if
it does so, a 60-day Section 5.1 Negotiation Period therefor. However, if (i)
JJCC fails to send a new Section 5.1 Reply within the forty-five (45) day period
after the new Section 5.1 Notice sent or (ii) the Section 5.1 J&J Party and
Barrier, despite their good faith efforts, do not enter into a Commercialization
Agreement within the sixty (60) day Section 5.1 Negotiation Period, then Barrier
may enter into such an agreement in the Optioned Territories of the new Section
5.1 Notice with any third party and such agreement may contain material terms or
conditions of such agreement that are materially less favorable to Barrier.
5.2 Timing of Section 5.1 Notice. The Section 5.1 Notice for the Diaper
Dermatitis Product and the Sebderm Product cannot be made to JJCC prior to the
date of the initial closing of the financing transaction described in Section
13.15. For other Licensed Products, the Section 5.1 Notice cannot be made to
JJCC prior to the end of the first Phase II Clinical Study for such Licensed
Product. For clarity, with respect to any Licensed Product that is the subject
of a Commercialization Agreement with a third party, Barrier shall not be
required to deliver any Section 5.1 Notices in the event Barrier desires to
enter into subsequent agreements with respect to the same Licensed Product with
the same third party regardless of whether such Licensed Product is for
different indications or is for a different formulation.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
5.3 Terms of the Commercialization Agreement. The terms of any
Commercialization Agreement may include: [**] and (viii) other terms and
conditions that are customary in agreements of a nature similar to the
Commercialization Agreement.
5.4 JJCC Rights to Manufacture Other Licensed Products.
(a) If a Section 5.1 J&J Party has entered into a
Commercialization Agreement with respect to a Licensed Product in which the
Section 5.1 Party does not have the right to manufacture or have manufactured
the Licensed Product and/or active pharmaceutical agent, then Barrier shall not,
subsequent to the date that Barrier enters into a Commercialization Agreement
with a Section 5.1 J&J Party with respect to such Licensed Product, commence
manufacturing nor enter into or agree to enter into, with any person or entity
other than JJCC or an Affiliate of JJCC, a manufacturing agreement with respect
to the clinical or commercial supply of such Licensed Product and/or an active
pharmaceutical agent to be contained within a such Licensed Product for sale in
the territories covered by the Commercialization Agreement (hereinafter, a
"Manufacturing Agreement") without first giving written notice thereof to JJCC
(a "Section 5.4 Notice"). A Section 5.4 Notice shall specify (i) the Licensed
Product and/or active pharmaceutical agent to be contained within a Licensed
Product which Barrier intends to have manufactured subject to such Manufacturing
Agreement, (ii) all relevant know-how regarding the chemical, pharmaceutical,
and analytical development of the such Licensed Product and/or pharmaceutical
agent and (iii) the long term volume forecasts for such Licensed Product and/or
pharmaceutical agent. Within ninety (90) days after a Section 5.4 Notice, if
JJCC or a JJCC Affiliate desires to enter into a Manufacturing Agreement
contemplated by such Section 5.4 Notice, JJCC shall send a written reply to such
effect (a "Section 5.4 Reply") which identifies (x) the prospective party
thereto, whether JJCC or a JJCC Affiliate (the "Section 5.4 J&J Party") and (y)
the fees, terms, conditions and other material provisions which the Section 5.4
J&J Party desires to be contained in the Manufacturing Agreement. Upon receipt
of a Section 5.4 Reply, the Section 5.4 J&J Party and Barrier shall negotiate
the terms thereof in good faith for a period not to exceed ninety (90) days,
which period may be extended if mutually agreed to in writing by the parties
(the "Section 5.4 Negotiation Period").
(b) If (i) JJCC fails to send a Section 5.4 Reply within the
ninety (90) day period after the Section 5.4 Notice or (ii) the Section 5.4 J&J
Party fails to enter into a Manufacturing Agreement with Barrier within the
Section 5.4 Negotiation Period, Barrier may enter into such a Manufacturing
Agreement with a third party; provided, however, that if the terms and
conditions of such agreement with such third party would, taken as a whole, be
materially less favorable to Barrier than the last written offer proposed by
Barrier to the Section 5.4 J&J Party, Barrier shall deliver a new Section 5.4
Notice to JJCC specifying such variations, whereupon JJCC shall have another
forty-five (45) day period to send a new Section 5.4 Reply and if it does so,
another sixty (60) day Section 5.4 Negotiation Period therefor.
(c) Except as described in Section 5.4 above, if a Section 5.1 J&J
Party has not entered into a Commercialization Agreement with respect to a
Licensed Product, then prior to entering into a Manufacturing Agreement with a
third party with respect to such Licensed Product, Barrier shall deliver a
Section 5.4 Notice to JJCC, whereupon JJCC shall be entitled to submit a
proposal or bid in the same manner as the other third parties.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
5.5 Certain Manufacturing of Clinical Supplies. Following the Execution
Date, representatives of Barrier and JJCC (or the applicable JJCC Affiliate)
will discuss in good faith the manufacturing of clinical supplies of the Sebderm
Product and the Diaper Dermatitis Product. Within sixty (60) days after the
Execution Date, Barrier shall deliver to JJCC a non-binding, estimated two (2)
year forecast of its clinical requirements for each of the two products. Within
sixty (60) days of JJCC's receipt of such forecast, JJCC shall indicate to
Barrier in writing which, if any, of the products JJCC (or one of its
Affiliates) desires to manufacture. For those products which JJCC (or one of its
Affiliates) expresses interest in manufacturing, Barrier and the applicable JJCC
Affiliate shall negotiate an appropriate supply agreement. For those products
for which JJCC (or an Affiliate) has not expressed an interest in manufacturing,
or for which the parties cannot reach agreement on an appropriate supply
agreement, JJCC shall transfer, or use its reasonable efforts to cause to be
transferred, to Barrier copies of all formulation and manufacturing procedures
and any analytical methods that have been developed, that are necessary for
Barrier to manufacture such products itself, or through a third party. Such
manufacturing know-how, however, shall not include know-how relating to the
manufacturing of ingredients which are commercially available from other third
parties.
ARTICLE 6
BARRIER'S DILIGENCE
6.1 Development Plan. Barrier shall have the sole responsibility for all
pre-clinical and clinical development of Licensed Products. Within one hundred
eighty (180) days after the Execution Date, Barrier shall submit to JJCC a
written clinical development plan containing [**]. Barrier shall, at its sole
cost, update JJCC on its progress with respect to timelines and milestones for
Licensed Products at least every six (6) months; provided that such obligation
to provide such update shall terminate (i) with respect to `683 Products
contemporaneously with the termination of JJCC's rights under Section 6.2 and
(ii) with respect to `932 Products contemporaneously with the termination of
JJCC's rights under Section 6.3. Barrier shall have no obligation to provide
information to JJCC under this Section 6.1 for (i) any Licensed Product which is
the subject of a Commercialization Agreement with a third party, (ii) any
Licensed Product for which all of JJCC's Section 5.1 rights have been satisfied
and (iii) any Licensed Product which is being commercialized by Barrier.
6.2 Active Clinical Development for `683 Product. Subject to the
provisions of Section 6.4, in the event that Barrier is not conducting Active
Clinical Development on a `683 Product, or has not obtained Regulatory Approval
to market a `683 Product, by [**], JJCC shall be entitled, but not obligated, to
terminate (i) Barrier's License to the `683 Patent Rights under Section 2.3 and
(ii) Barrier's License to JJCC Know-how relating to the Sebderm Product under
Section 3.1. In the event that Barrier is conducting Active Clinical
Development, or has obtained Regulatory Approval to market a `683 Product, by
[**] JJCC's termination rights under this Section 6.2 shall terminate.
6.3 Active Clinical Development for `932 Product. Subject to the
provisions of Section 6.4, in the event that Barrier is not conducting Active
Clinical Development on a `932 Product, or has not obtained Regulatory Approval
to market a `932 Product, by [**] JJCC shall be entitled, but not obligated, to
terminate (i) Barrier's License to the `932 Patent Rights under
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
Section 2.1 and (ii) Barrier's License to JJCC Know-how relating to the Diaper
Dermatitis Product under Section 3.1. In the event that Barrier is conducting
Active Clinical Development on a `932 Product, or has obtained the Regulatory
Approval to market a `932 Product, by [**], JJCC's termination rights under this
Section 6.3 shall terminate.
6.4 JJCC Election to Terminate. Barrier shall send to JJCC during the
month of [**] a report on the status of its development of `683 Products and
`932 Products indicating whether Barrier has obtained Regulatory Approval or is
in Active Clinical Development for the `683 and `932 Products (the "Section 6.4
Report"). In the event that (i) Barrier has not obtained Regulatory Approval or
Barrier is not conducting Active Clinical Development on a `683 Product or a
`932 Product as contemplated in Section 6.2 or 6.3, and (ii) JJCC desires to
exercise its termination rights pursuant to Section 6.2 or Section 6.3 above,
then, no later than two months following the receipt of such Section 6.4 Report,
JJCC shall send to Barrier written notice of its election to do so. In the event
that JJCC does not so exercise its right to terminate, then JJCC shall be deemed
to have waived its right to terminate such `683 Patent Right or `932 Patent
Rights, as applicable, and the related JJCC Know-how; provided, however, that in
the event that such failure to obtain Regulatory Approval or conduct Active
Clinical Development is continuing as of [**] then JJCC's termination rights
contained in Section 6.2 or 6.3, as applicable, shall be reinstated. Barrier
shall send to JJCC a new Section 6.4 Report during the month of [**] and if JJCC
desires to exercise such rights, then JJCC shall send to Barrier written notice
of its election to do no later than two months following the receipt of such new
Section 6.4 Report, with a similar waiver and reinstatement occurring on an
annual basis until Barrier commences Active Clinical Development or obtains
Regulatory Approval.
ARTICLE 7
CONFIDENTIALITY AND PUBLICITY
7.1 Confidentiality. All information, including without limitation trade
secrets, disclosed by one party to the other in connection with this Agreement
shall be maintained by the receiving party as confidential and used by the
recipient only for the purposes of this Agreement in accordance with this
Article 7. Each party may also disclose the other's information to an Affiliate,
agent, or consultant, who is under an obligation of confidentiality and non-use
at least substantially equivalent to the obligations of this Article 7. Each
party shall guard such information as it normally guards any of its own
confidential, proprietary information, but in no event with less than a
reasonable standard of care.
7.2 Notwithstanding the foregoing, each party shall be relieved of the
confidentiality and limited use obligations of this Agreement if:
(a) the information was previously known to the receiving party
from sources other than the disclosing party as evidenced by the prior written
records of such party;
(b) the information is or becomes generally available to the
public through no fault of the receiving party;
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
(c) the information is acquired in good faith in the future by the
receiving party from a third party not under an obligation of confidence to the
disclosing party with respect to such information; or
(d) the information is developed independently by or for the
receiving party without making use of the confidential information received from
the disclosing party as evidenced by the written records of the receiving party.
7.3 Permitted Uses of Information. Notwithstanding the above obligations
of confidentiality and non-use a party may:
(a) disclose information to a Regulatory Authority that is
necessary to obtain Regulatory Approval of a Licensed Product in a particular
jurisdiction;
(b) disclose information to a government agency if the disclosure
is necessary to protect the health and safety of the party's workers or the
public or as required by law;
(c) disclose information reasonably required in connection with
the development, manufacture, use, sale, external testing or marketing trials of
products in accordance with the terms of this Agreement; or
(d) disclose information by filing patent applications, the filing
of which is contemplated by this Agreement, without violating the above secrecy
provision; it being understood that publication of such filings occurs in some
jurisdictions within eighteen (18) months of filing, and that such publication
shall not violate the above secrecy provision.
In making such disclosures under this Section 7.3, the disclosing party shall,
where reasonably possible, obligate the recipient to obligations of
confidentiality no less restrictive than those set forth in this Article 7.
7.4 Confidentiality of this Agreement. Except as required under Section
13.12 of this Agreement and except for the filing of a copy of this Agreement
with the Securities and Exchange Commission ("SEC") to the extent required by
law and such other public announcements as may hereafter become required by law,
no party hereunder shall disclose the terms of this Agreement or the fact of its
existence or make any public announcement or filing concerning this Agreement or
the subject matter hereof without the prior written consent of the other;
provided, however, that the parties shall be free to disclose the existence and
terms of this Agreement and the nature of the licenses granted hereunder under
an obligation of confidentiality at least as stringent as set forth in this
Article 7 to their respective Affiliates, investment bankers, any strategic or
financial investor who has expressed a bona fide interest in investing at least
Three Million U.S. Dollars ($3,000,000) in Barrier, qualified institutional
buyers as defined under Rule 144(a) promulgated under the Securities Act of
1933, as amended, and prospective sublicensees. Prior to any such filings with
the SEC, Barrier shall deliver a copy hereof to JJCC and, if requested in
writing by JJCC within five (5) business days after such delivery, request that
the SEC under the applicable rules give such portions hereof as JJCC has
requested confidential treatment.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
7.5 Effect on Prior Confidentiality Agreement. To the extent the parties
hereto previously entered into any written confidentiality agreement with
respect to information covered hereby and subject to the confidentiality
provisions hereof, this Agreement shall govern.
7.6 Survival of Confidentiality Terms. The rights and affirmative
obligations of Sections 7.1, 7.2, and 7.3 shall remain in effect during the term
of this Agreement and shall survive termination or expiration of this Agreement
for a period of five (5) years.
ARTICLE 8
PATENT PROSECUTION, MAINTENANCE, AND ENFORCEMENT
8.1 Discretionary Duty to Prosecute and Maintain. JJCC shall, at its
discretion and sole cost prosecute or cause to be prosecuted to allowance or
final rejection in the United States and in Foreign Countries the patent
applications included in the JJCC Patent Rights. JJCC shall issue and maintain
as a patent, at its sole cost, each such application prosecuted to allowance in
the JJCC Patent Rights.
8.2 Right to Consult. JJCC shall copy Barrier, or have Barrier copied,
on all correspondence to and from patent offices relating to such patent
applications that it is prosecuting, or causing to be prosecuted, such that the
other Party can comment on such correspondences, and JJCC agrees to consider in
good faith such comments from Barrier. In furtherance of and not in limitation
of the foregoing, JJCC shall provide Barrier a draft copy of each U.S. and WIPO
patent application to be filed by it relating to the JJCC Patent Rights in
order, and sufficiently in advance, to obtain comments from Barrier's patent
counsel. JJCC shall provide to Barrier as filed copies of all U.S. and WIPO
patent applications promptly after the filing of such applications. JJCC shall
provide to Barrier a copy of each U.S. Patent and Trademark Office "Office
Action", sufficiently in advance of the response due date, to obtain substantive
comment of Barrier's patent counsel.
8.3 Abandonment of Prosecution by JJCC. JJCC shall notify Barrier in the
event it decides at any time to discontinue the prosecution of any patent
applications or maintenance of any patents included in the JJCC Patent Rights in
the United States or in any Foreign Country. Such notification shall be given at
least sixty (60) days prior to the date on which such patent application(s) or
patent(s) will become abandoned. Barrier shall then have the option, exercisable
upon written notification to JJCC, to assume full responsibility, at its
discretion and sole cost, for prosecution of the affected patent applications(s)
or maintenance of any the affected patent(s) in such country or countries. JJCC
shall provide all assistance reasonably necessary to allow Barrier to assume the
prosecution of such affected patent application(s) or maintenance of such
affected patent(s). In the event Barrier does not elect to exercise such option
with respect to any patent application, such affected patent application(s) or
patent(s) shall no longer be part of the JJCC Patent Rights. In the event
Barrier does elect to exercise such option with respect to any patent or patent
application, then JJCC shall grant to Barrier a non-exclusive, royalty-free,
worldwide license, with the right to grant sublicenses, to all of JJCC's
remaining rights under such patent or patent application (subject to Section
2.3(b)).
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
8.4 Patent Term Extensions. Barrier shall have the right to request that
JJCC file all applications and take actions necessary to obtain patent extension
pursuant to 35 USC 156 or like foreign statutes for the JJCC Patent Rights
licensed to Barrier hereunder. If JJCC declines to pursue such patent
extensions, then Barrier shall have the right on behalf of JJCC to file all such
applications and take all such actions necessary to obtain such patent
extensions. JJCC agrees to sign such further document and take such further
actions (all at Barrier's expense) as may be requested by Barrier in this
regard.
8.5 Patent Marking. Barrier and its sublicensees and Affiliates shall
xxxx all Licensed Products made under this Agreement with a notice in accordance
with 35 U.S.C.Section 287 and similar marking provisions in Foreign Countries.
8.6 Suits for Infringement of the JJCC Patent Rights. If JJCC or Barrier
becomes aware of infringement of any patent included in the JJCC Patent Rights
by a third party selling (i) a `932 Product in the `932 Territory or (ii) a `683
Product, such party shall promptly notify the other party in writing to that
effect. If, prior to the expiration of four (4) months from said notice, JJCC
has not obtained a discontinuance of such infringement or brought suit in such
country against the third party infringer, then, Barrier shall have the right to
bring suit in such country against such infringer and join JJCC as a party. The
foregoing shall not preclude the parties from jointly seeking such
discontinuance or bringing suit and, in any event, each party will cooperate
with the other in any suit and will have the right to consult with the other and
be represented by its own counsel at its own expense. Prior to disposition of
any moneys recovered, the expenses of the parties in bringing suit shall be
reimbursed out of the moneys recovered, with the party bringing the suit being
reimbursed first, then [**] percent ([**]%) of the remainder, if any, of moneys
recovered by either party upon final judgment or settlement of any infringement
suit shall be retained by the party bringing the suit, and [**] percent ([**]%)
shall be paid to the other party. No settlement by a party bringing a suit shall
diminish the rights or interests of the other party without the other party's
written consent.
ARTICLE 9
REGULATORY ISSUES
9.1 Regulatory Matters. Except with respect to Licensed Products which
become the subject of a Commercialization Agreement with JJCC or an Affiliate of
JJCC (which shall be governed by the terms of such a Commercialization
Agreement), Barrier will have control over, and authority and responsibility
for, the regulatory strategies relating to the development and commercialization
of all Licensed Products. Barrier shall monitor and coordinate all regulatory
actions, communications and filings with and submissions to (including but not
limited to any supplements and amendments thereof) any Regulatory Authority with
respect to any Licensed Product. Barrier shall be responsible for interfacing,
corresponding and meeting with all Regulatory Authorities with respect to any
Licensed Product. Barrier also agrees to fulfill its obligations relating to the
reporting of Adverse Events for Licensed Products containing miconazole and/or
ketoconazole pursuant to Article 11 of the Related Agreement.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
ARTICLE 10
WARRANTIES, REPRESENTATIONS AND ACKNOWLEDGEMENTS
10.1 Warranties and Representations Regarding the JJCC Patent Rights.
JJCC expressly warrants and represents as of the Execution Date that:
(a) (i) JJCC exclusively owns or Controls by agreement or license
all of the rights, title and interest in and to the JJCC Patent Rights licensed
to Barrier pursuant to Article 2; (ii) JJCC owns or controls by agreement or
license all of the rights, title and interest in and to the JJCC Know-How
licensed to Barrier pursuant to Article 3; and (iii) JJCC has the full right and
authority to enter into this Agreement and to carry out the transactions
contemplated herein;
(b) JJCC has not previously assigned, transferred, conveyed or
otherwise encumbered its right, title and interest in the JJCC Patent Rights and
there are currently no existing license agreements for the JJCC Patent Rights
that are in conflict with the licenses granted to Barrier under Article 2; and
(c) There are no claims, judgments or settlements against or
pending with respect to the JJCC Patent Rights, and to JJCC's knowledge, no such
claims, judgements or settlements are threatened.
10.2 No Warranties or Representations Regarding JJCC IP Rights and JJCC
Tangible Property. Except as expressly set forth in Section 10.1, JJCC makes no
representations and extends no warranties or conditions of any kind, either
express or implied, with respect to the JJCC Patent Rights, the JJCC Know-How,
and the JJCC Tangible Property, including, but not limited to, the validity or
enforceability of the JJCC Patent Rights or the accuracy or any warranties of
merchantability or fitness for a particular purpose of the JJCC Know-How or the
JJCC Tangible Property.
10.3 JJCC's Relationship to Xxxxxxx & Xxxxxxx Affiliates. JJCC is one of
several Affiliates of Xxxxxxx & Xxxxxxx that sell pharmaceutical and/or cosmetic
products, including but not limited to the sale of products containing zinc
oxide for, e.g., sun protection, diaper dermatitis, and diaper rash, and
miconazole and ketoconazole for, e.g., the treatment of indications such as
systemic fungal infections, tinea corporis, tinea cruris, tinea pedis, tinea
versicolor, cutaneous candidiasis, seborrheic dermatitis, dandruff, and nail
micosis. Subject to the licenses granted to Barrier herein, nothing shall
prevent JJCC, or its Affiliates, from continuing such activities or developing
or acquiring products which may serve a similar cosmetic/therapeutic function or
compete with Licensed Products.
10.4 No Conflicting Obligations. Each party expressly warrants and
represents to the other that it has no agreement nor any other obligation to any
third party that would in any way interfere, hamper, or limit its ability to
carry out and fulfill its obligations under this Agreement.
10.5 Authority to Enter into Agreement. Each party represents and
warrants to the other as of the Execution Date that it has full right and
authority to enter into this Agreement and to carry out the transactions
contemplated herein.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
10.6 No Implications by JJCC and/or Barrier. Except as expressly stated
herein, nothing in this Agreement shall be construed as:
(a) A warranty or representation by JJCC as to the validity or
scope of any of the JJCC IP Rights;
(b) A warranty or representation by JJCC that anything made, used,
sold, offered for sale, or imported under the licenses provided herein is or
will be free from infringement of patents of third parties;
(c) An obligation on the part of either party to bring or
prosecute actions or suits against third parties for infringement of any of the
JJCC IP Rights;
(d) Conferring on either party a right to use in advertising,
publicity, or otherwise the name or any trademark, service xxxx, or trade name
of the other party or its Affiliates;
(e) Granting by implication, estoppel, or otherwise, any licenses
or rights under patents or other intellectual property of JJCC or an Affiliate
of JJCC other than that included in the JJCC IP Rights;
(f) A representation or warranty that the Diaper Dermatitis
Product, the Sebderm Product, or other Licensed Product will be approved for
marketing by the United States Food and Drug Administration and successor bodies
or corresponding foreign administrative bodies; or
(g) A representation or warranty with respect to the use, sale, or
other disposition by Barrier or its sublicensees, Affiliates, vendees, or other
transferees of products incorporating or making use of inventions licensed under
this Agreement.
ARTICLE 11
TERM AND TERMINATION
11.1 Term. This Agreement shall commence as of the Execution Date and,
unless otherwise terminated in accordance with any of the provisions of this
Article or Article 6 shall remain in force on a country-by-country basis and a
Licensed Product-by-Licensed Product basis, until the longer of (a) ten (10)
years or (b) the last to expire of the patents included within the JJCC Patent
Rights for such Licensed Product in such country.
11.2 Termination for Breach.
(a) Upon any breach of, or default under, any material provision
of this Agreement by Barrier with respect to a `683 Product, JJCC may terminate
this Agreement with respect to the `683 Patent Rights and the JJCC Know-How
relating to the Sebderm Product by giving ninety (90) days written notice to
Barrier. Said notice shall become effective at the end of such period, unless
during said period Barrier shall cure such breach or default.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
(b) Upon any breach of, or default under, any material provision
of this Agreement by JJCC with respect to a `683 Product, Barrier may terminate
JJCC's rights under Section 5 with respect to such `683 Product by giving ninety
(90) days written notice to JJCC. Said notice shall become effective at the end
of such period, unless during said period, JJCC shall cure such breach or
default.
(c) Upon any breach of, or default under, any material provision
of this Agreement by Barrier with respect to a `932 Product, JJCC may terminate
this Agreement with respect to the `932 Patent Rights and the JJCC Know-How
relating to the Diaper Dermatitis Product by giving ninety (90) days written
notice to Barrier. Said notice shall become effective at the end of such period,
unless during said period Barrier shall cure such breach or default.
(d) Upon any breach of, or default under, any material provision
of this Agreement by JJCC with respect to a `932 Product, Barrier may terminate
JJCC's rights under Section 5 with respect to such `932 Product by giving ninety
(90) days written notice to JJCC. Said notice shall become effective at the end
of such period unless during said period, JJCC shall cure such breach or
default.
(e) The rights of the non-breaching party set forth in this
Section 11.2 shall be in addition to, and not in lieu of, any other remedies to
which the non-breaching party may be entitled at law or equity.
11.3 Barrier's Right to Terminate with Sixty (60) Days Notice.
(a) Barrier shall have the right to terminate this Agreement with
respect to the `683 Patent Rights (and all related JJCC Know-How) upon sixty
(60) days written notice to JJCC.
(b) Barrier shall have the right to terminate this Agreement with
respect to the `932 Patent Rights (and all related JJCC Know-How) upon sixty
(60) days written notice to JJCC.
11.4 Certain Termination for Bankruptcy.
(a) At any time prior to the earlier of Barrier's initial public
offering or the third anniversary of the Execution Date, this Agreement may be
terminated upon fifteen (15) days written notice by either party with respect to
all Licensed Products (other than any Licensed Product with respect to which
either (i) JJCC has failed to send a Section 5.1 Reply or (ii) the appropriate
Section 5.1 J&J Party and Barrier have not entered into a Commercialization
Agreement within the Section 5.1 Negotiation Period): (i) in the event that the
other party hereto shall (1) apply for or consent to the appointment of, or the
taking of possession by, a receiver, custodian, trustee or liquidator of itself
or of all or a substantial part of its property, (2) make a general assignment
for the benefit of its creditors, (3) commence a voluntary case under the United
States Bankruptcy Code, as now or hereafter in effect (the "Bankruptcy Code"),
(4) file a petition seeking to take advantage of any law (the "Bankruptcy Laws")
relating to bankruptcy, insolvency, reorganization, winding-up, or composition
or readjustment of debts, (5) fail to
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
controvert in a timely and appropriate manner, or acquiesce in writing to, any
petition filed against it in any involuntary case under the Bankruptcy Code, or
(6) take any corporate action for the purpose of effecting any of the foregoing;
or (ii) if a proceeding or case shall be commenced against the other party
hereto in any court of competent jurisdiction, seeking (1) its liquidation,
reorganization, dissolution or winding-up, or the composition or readjustment of
its debts, (2) the appointment of a trustee, receiver, custodian, liquidator or
the like of the party or of all or any substantial part of its assets, or (3)
similar relief under any Bankruptcy Laws, or an order, judgment or decree
approving any of the foregoing shall be entered and continue unstayed for a
period of sixty (60) days; or an order for relief against the other party hereto
shall be entered in an involuntary case under the Bankruptcy Code.
(b) For clarity, after the third anniversary of the Execution
Date, or if earlier, after Barrier's initial public offering, neither party
shall have the right to terminate this Agreement pursuant to Section 11.4(a).
11.5 JJCC's Right to Terminate Prior to Closings.
(a) If Barrier has not satisfied all of the conditions of the
capital financing transactions set forth in Section 13.15 by September 30, 2002
(the "Closing Date"), JJCC shall have the right to terminate this Agreement upon
written notice to Barrier, provided, however, that the Closing Date shall be
extended as necessary, but in no event past December 31, 2002, in the event the
failure to satisfy such conditions is not primarily attributable to any act or
omission of Barrier.
(b) If, subsequent to the Initial Closing (as defined in the
Series B Securities Acquisition Agreement dated as of May 6, 2002) and prior to
November 15, 2003, Barrier has not completed and closed a capital financing
transaction in one or more closings in which the aggregate cash proceeds
received by Barrier equal or exceed thirteen million dollars ($13,000,000) and
pursuant to which Barrier will issue fully paid and non-assessable shares of
Series B Convertible Preferred Stock in accordance with the terms set forth in
the Company's Amended Certificate of Incorporation in substantially the form
attached to the Securities Acquisition Agreement as Exhibit B, JJCC shall have
the right to terminate this Agreement upon written notice to Barrier; provided
however, that in the event that JJCC exercises its right to terminate under this
Section 11.5(b), each share of preferred stock of Barrier then owned by JJCC and
its Affiliates shall be automatically converted into one share of common stock
of Barrier.
11.6 Effect of Termination and Expiration.
(a) Following termination of this Agreement by (i) JJCC pursuant
to Sections 11.2, 11.4 or 11.5 or (ii) Barrier pursuant to Sections 11.4:
(i) all licenses granted hereunder shall terminate; and
(ii) Barrier shall have the right to sell off, over the six
(6) months immediately following such termination, any Licensed Products in its
inventory;
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
(iii) Barrier shall promptly return to JJCC all JJCC Tangible
Property;
(iv) Barrier shall assign NDA No. [**] and IND Nos. [**] and
[**] to JJCC; and
(v) Barrier shall promptly return or have returned control
of the prosecution of any JJCC Patent Rights it is prosecuting or having
prosecuted pursuant to Section 8.3.
(b) Following termination of this Agreement by JJCC pursuant to
Section 6.2 or by Barrier pursuant to Section 11.3(a):
(i) the licenses granted pursuant to Section 2.1, Section
2.5(a), and Section 3.1 (to the extent such JJCC Know-How relates to `683 Patent
Rights) shall terminate; and
(ii) Barrier shall have the right to sell off, over the six
(6) months immediately following such termination, any `683 Products in its
inventory. and
(iii) Barrier shall promptly return to JJCC all JJCC Tangible
Property;
(iv) Barrier shall assign IND No. [**] to JJCC; and
(v) Barrier shall promptly return or have returned control
of the prosecution of any JJCC Patent Rights it is prosecuting or having
prosecuted pursuant to Section 8.3.
(c) Following termination of this Agreement by JJCC pursuant to
Section 6.3 or by Barrier pursuant to Section 11.3(b):
(i) the licenses granted pursuant to Section 2.3, Section
2.5(b), and Section 3.1 (to the extent such JJCC Know-How relates to `932 Patent
Rights) shall terminate; and
(ii) Barrier shall have the right to sell off, over the six
(6) months immediately following such termination, any `932 Products in its
inventory; and
(iii) Barrier shall promptly return to JJCC all JJCC Tangible
Property;
(iv) Barrier shall assign NDA No. [**] and IND No. [**] to
JJCC; and
(v) Barrier shall promptly return or have returned control
of the prosecution of any JJCC Patent Rights it is prosecuting or having
prosecuted pursuant to Section 8.3.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
(d) Existing Sublicenses. Upon termination of this Agreement for
any reason, Barrier agrees that it will assign to JJCC all sublicense agreements
entered into by Barrier and its sublicensees and JJCC agrees to assume such
assigned sublicenses, as long as the sublicensees are not in default. If a
sublicensee is in default then JJCC in its sole discretion may assume the
defaulting sublicensee's sublicense. JJCC will not be bound by duties or
obligations contained in any such assigned sublicense that are not contained in
this Agreement, nor will JJCC be bound by duties or obligations extending beyond
this Agreement.
11.7 Expiration. Following expiration of this Agreement pursuant to
Section 11.1, Barrier shall have a fully paid-up, royalty-free license to the
JJCC IP Rights applicable to such Licensed Product in such country.
11.8 Survival. Expiration or termination of this Agreement for any reason
shall not release either party hereto from any liability which at such time has
already accrued or which thereafter accrues from a breach or default prior to
such expiration or termination, nor affect in any way the survival of any other
right, duty or obligation of either party hereto which is expressly stated
elsewhere in this Agreement to survive such expiration or termination.
ARTICLE 12
INDEMNIFICATION
12.1 Indemnity by Barrier. Barrier shall defend, indemnify and hold JJCC,
its directors, officers and employees, harmless from and against any and all
third party claims, suits, actions, or demands for liability, and any associated
damages, losses, costs and expenses (including the reasonable costs and expenses
of attorneys and other professionals) payable to third parties to the extent
arising out of or resulting from the manufacture, use, handling, storage, sale,
or other disposition of a Licensed Product by Barrier or its sublicensees or
Affiliates.
12.2 Mutual Indemnity. Notwithstanding Section 12.1, each party
("Indemnifying Party") shall defend, indemnify and hold the other party and its
directors, officers and employees harmless from and against any and all third
party claims, suits, actions, or demands for liability, and any associated
damages, losses, costs and expenses (including the reasonable costs and expenses
of attorneys and other professionals) payable to third parties to the extent
arising out of or resulting from the (i) negligence or willful misconduct of the
Indemnifying Party, (ii) the inaccuracy of any representation, or (iii) the
breach by the Indemnifying Party of any warranty, covenant or agreement
contained in this Agreement.
12.3 Conditions of Indemnification. In the event that any party hereunder
seeks indemnification under this Article 12, such party shall: (a) promptly
inform the Indemnifying party of any claim, suit or demand threatened or filed,
(b) permit the Indemnifying party to assume direction and control of the defense
of claims resulting therefrom (including the right to settle such claims at the
sole discretion of the Indemnifying party), and (c) cooperate as requested (at
the expense of the Indemnifying party) in the defense of such claims. The
Indemnifying party shall obtain the written consent of the indemnified party
(which consent shall not be unreasonably withheld) prior to ceasing to defend,
settling or otherwise disposing of any claim subject to indemnification if, or
as a result thereof, the indemnified party would become
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
subject to injunctive or other equitable relief or the business of the
indemnified party would be adversely affected in any manner.
12.4 Limits of Indemnity. An indemnifying party's (including
sublicensee's and Affiliate's) obligations under this Article 12 shall not
extend to any claims, suits or demands for liability, damages, losses, costs and
expenses to the extent that such arise from the indemnified party's failure to
comply with the terms and conditions of this Agreement or arise from the
negligence or willful misconduct of the indemnified party, its agents or
employees.
12.5 Insurance. Barrier hereby agrees that prior to the earlier of (i)
the first commencement of clinical trials for a Licensed Product or (ii) the
commercialization of a Licensed Product, it shall obtain and thereafter maintain
in full force and effect general liability and product liability insurance
(which includes clinical trials) with a commercial insurance carrier, which
policy shall have individual limits of Ten Million Dollars ($10,000,000) per
occurrence and an aggregate limit of Ten Million Dollars ($10,000,000). JJCC
shall be named as an additional insured in such insurance policy. Barrier, upon
request, agrees to provide JJCC with a certificate of insurance evidencing its
retention of such insurance coverage and any updates thereto. This insurance
shall remain in effect until five (5) years from the termination of Barrier's
development and/or sale of all Licensed Products.
12.6 Survival of Indemnification Terms. The rights and obligations of
Sections 12.1, 12.2, 12.3, 12.4, and 12.5 shall survive termination or
expiration of this Agreement.
ARTICLE 13
MISCELLANEOUS
13.1 Arbitration. Subject to Section 13.2 below:
(a) Except as set forth in Section 13.1(j) below, any dispute,
claim or controversy arising from or related in any way to this Agreement or the
interpretation, application, breach, termination or validity thereof, including
any claim of inducement of this Agreement by fraud or otherwise, will be
submitted for resolution to binding arbitration pursuant to the rules then
pertaining of the CPR Institute for Dispute Resolution for Non-Administered
Arbitration (available at xxx.xxxxxx.xxx/xxx-xxxxx.xxx), or successor ("CPR"),
except where those rules conflict with these provisions, in which case these
provisions control. The arbitration will be held in New Brunswick, New Jersey.
(b) The panel shall consist of three arbitrators chosen from the
CPR Panels of Distinguished Neutrals (or, by agreement, from another provider of
arbitrators) each of whom is a lawyer with at least fifteen (15) years
experience with a law firm or corporate law department of over twenty-five (25)
lawyers or who was a judge of a court of general jurisdiction. In the event the
aggregate damages sought by the claimant are stated to be less than $5 million,
and the aggregate damages sought by the counter claimant are stated to be less
than $5 million, and neither side seeks equitable relief, then a single
arbitrator shall be chosen, having the same qualifications and experience
specified above. Each arbitrator shall be neutral, independent,
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
disinterested, impartial and shall abide by The CPR-Georgetown Commission
Proposed Model Rule for the Lawyer as Neutral available at
xxx.xxxxxx.xxx/xxx-xxxxxx.xxxx.
(c) The parties agree to cooperate (1) to attempt to select the
arbitrator(s) by agreement within forty-five (45) days of initiation of the
arbitration, including jointly interviewing the final candidates, (2) to meet
with the arbitrator(s) within forty-five (45) days of selection and (3) to agree
at that meeting or before upon procedures for discovery and as to the conduct of
the hearing which will result in the hearing being concluded within no more than
nine (9) months after selection of the arbitrator(s) and in the award being
rendered within sixty (60) days of the conclusion of the hearings, or of any
post-hearing briefing, which briefing will be completed by both sides within
forty-five (45) days after the conclusion of the hearings.
(d) In the event the parties cannot agree upon selection of the
arbitrator(s), the CPR will select arbitrator(s) as follows: CPR shall provide
the parties with a list of no less than twenty-five (25) proposed arbitrators
(fifteen (15) if a single arbitrator is to be selected) having the credentials
referenced above. Within twenty-five (25) days of receiving such list, the
parties shall rank at least sixty-five percent (65%) of the proposed arbitrators
on the initial CPR list, after exercising cause challenges. The parties may then
interview the five candidates (three if a single arbitrator is to be selected)
with the highest combined rankings for no more than one hour each and, following
the interviews, may exercise one peremptory challenge each. The panel will
consist of the remaining three candidates (or one, if one arbitrator is to be
selected) with the highest combined rankings. In the event these procedures fail
to result in selection of the required number of arbitrators, CPR shall select
the appropriate number of arbitrators from among the members of the various CPR
Panels of Distinguished Neutrals, allowing each side challenges for cause and
three peremptory challenges each.
(e) In the event the parties cannot agree upon procedures for
discovery and conduct of the hearing meeting the schedule set forth in paragraph
(c) above, then the arbitrator(s) shall set dates for the hearing, any
post-hearing briefing, and the issuance of the award in accord with the
paragraph (c) schedule. The arbitrator(s) shall provide for discovery according
to those time limits, giving recognition to the understanding of the parties
that they contemplate reasonable discovery, including document demands and
depositions, but that such discovery be limited so that the paragraph (c)
schedule may be met without difficulty. In no event will the arbitrator(s),
absent agreement of the parties, allow more than a total of ten days for the
hearing or permit either side to obtain more than a total of forty (40) hours of
deposition testimony from all witnesses, including both fact and expert
witnesses, or serve more than twenty (20) individual requests for documents,
including subparts, or twenty (20) individual requests for admission or
interrogatories, including subparts. Multiple hearing days will be scheduled
consecutively to the greatest extent possible.
(f) The arbitrator(s) must render their award by application of
the substantive law of New York and are not free to apply "amiable compositeur"
or "natural justice and equity," but shall apply, with respect to issues of
patent law, U.S. federal law or other national law to the extent applicable. The
arbitrator(s) shall render a written opinion setting forth findings of fact and
conclusions of law with the reasons therefor stated. A transcript of the
evidence adduced at the hearing shall be made and shall, upon request, be made
available to either party.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
The arbitrator(s) shall have power to exclude evidence on grounds of hearsay,
prejudice beyond its probative value, redundancy, or irrelevance and no award
shall be overturned by reason of such ruling on evidence. To the extent
possible, the arbitration hearings and award will be maintained in confidence.
(g) In the event the panel's award exceeds $5 million in monetary
damages or includes or consists of equitable relief, or rejects a claim in
excess of that amount or for that relief, then the losing party may obtain
review of the arbitrators' award or decision by a single appellate arbitrator
(the "Appeal Arbitrator") selected from the CPR Panels of Distinguished Neutrals
by agreement or, failing agreement within seven working days, pursuant to the
selection procedures specified in paragraph (d) above. If CPR cannot provide
such services, the parties will together select another provider of arbitration
services that can. No Appeal Arbitrator shall be selected unless he or she can
commit to rendering a decision within forty-five (45) days following oral
argument as provided in this paragraph. Any such review must be initiated within
thirty (30) days following the rendering of the award referenced in (f) above.
(h) The Appeal Arbitrator will make the same review of the
arbitration panel's ruling and its bases that the U.S. Court of Appeals of the
Third Circuit would make of findings of fact and conclusions of law rendered by
a district court after a bench trial and then modify, vacate or affirm the
arbitration panel's award or decision accordingly, or remand to the panel for
further proceedings. The Appeal Arbitrator will consider only the arbitration
panel's findings of fact and conclusions of law, pertinent portions of the
hearing transcript and evidentiary record as submitted by the parties, opening
and reply briefs of the party pursuing the review, and the answering brief of
the opposing party, plus a total of no more than four (4) hours of oral argument
evenly divided between the parties. The party seeking review must submit its
opening brief and any reply brief within seventy-five (75) and one hundred
thirty (130) days, respectively, following the date of the award under review,
whereas the opposing party must submit its responsive brief within one hundred
ten (110) days of that date. Oral argument shall take place within five (5)
months after the date of the award under review, and the Appeal Arbitrator shall
render a decision within forty-five (45) days following oral argument. That
decision will be final and not subject to further review, except pursuant to the
Federal Arbitration Act.
(i) The parties consent to the jurisdiction of the Federal
District Court for the district in which the arbitration is held for the
enforcement of these provisions and the entry of judgment on any award rendered
hereunder (including after review by the Appeal Arbitrator where such an appeal
is pursued). Should such court for any reason lack jurisdiction, any court with
jurisdiction shall act in the same fashion.
(j) Each party has the right before or, if the arbitrator(s)
cannot hear the matter within an acceptable period, during the arbitration to
seek and obtain from the appropriate court provisional remedies such as
attachment, preliminary injunction, replevin, etc. to avoid irreparable harm,
maintain the status quo, or preserve the subject matter of the arbitration.
(k) EACH PARTY HERETO WAIVES ITS RIGHTS TO TRIAL OF ANY ISSUE BY
JURY.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
(l) EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY OR
MULTIPLIED DAMAGES FROM THE OTHER.
(m) EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES
FROM THE OTHER, SUBJECT TO INDEMNIFICATION OBLIGATIONS OF EACH PARTY.
(n) EACH PARTY HERETO WAIVES ANY CLAIM FOR ATTORNEYS' FEES AND
COSTS AND PREJUDGMENT INTEREST FROM THE OTHER.
13.2 Mediation.
(a) Except as provided in Section 13.2(f), any dispute,
controversy or claim arising out of or related to this agreement, or the
interpretation, application, breach, termination or validity thereof, including
any claim of inducement by fraud or otherwise, which claim would, but for this
provision, be submitted to arbitration shall, before submission to arbitration,
first be mediated through non-binding mediation in accordance with The CPR
Mediation Procedure then in effect of the CPR Institute for Dispute Resolution
(CPR) available at xxx.xxxxxx.xxx/x_xxxxxx.xxx, except where that procedure
conflicts with these provisions, in which case these provisions control. The
mediation shall be conducted in New Brunswick, New Jersey and shall be attended
by a senior executive with authority to resolve the dispute from each of the
operating companies that are parties.
(b) The mediator shall be neutral, independent, disinterested and
shall be selected from a professional mediation firm such as ADR Associates or
JAMS/ENDISPUTE or CPR.
(c) The parties shall promptly confer in an effort to select a
mediator by agreement. In the absence of such an agreement within ten (10) days
of initiation of the mediation, the mediator shall be selected by CPR as
follows: CPR shall provide the parties with a list of at least fifteen (15)
names from the CPR Panels of Distinguished Neutrals. Each party shall exercise
challenges for cause, two peremptory challenges, and rank the remaining
candidates within five (5) working days of receiving the CPR list. The parties
may together interview the three (3) top-ranked candidates for no more than one
hour each and, after the interviews, may each exercise one peremptory challenge.
The mediator shall be the remaining candidate with the highest aggregate
ranking.
(d) The mediator shall confer with the parties to design
procedures to conclude the mediation within no more than forty-five (45) days
after initiation. Under no circumstances may the commencement of arbitration
under Section 13.1 above be delayed more than forty-five (45) days by the
mediation process specified herein absent contrary agreement of the parties.
(e) Each party agrees not to intentionally use the period or
pendency of the mediation to disadvantage the other party procedurally or
otherwise. No statements made by
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separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
either side during the mediation may be used by the other or referred to during
any subsequent proceedings.
(f) Each party has the right to pursue provisional relief from any
court, such as attachment, preliminary injunction, replevin, etc., to avoid
irreparable harm, maintain the status quo, or preserve the subject matter of the
arbitration, even though mediation has not been commenced or completed.
13.3 Force Majeure. Any delays in or failures of performance by a party
under this Agreement shall not be considered a breach of this Agreement if and
to the extent caused by occurrences beyond the reasonable control of the party
affected, including but not limited to: acts of God; acts, regulations, or laws
or other actions of any government; strikes or other concerted acts of workers;
fires; floods; explosions; riots; wars; rebellions; terrorist attacks and
sabotage; and any time for performance hereunder shall be extended by the actual
time of delay caused by such occurrence.
13.4 Assignment. This Agreement, or any of the rights and obligations
created herein, shall not be assigned or transferred, in whole or in part, by
either party hereto without the prior written consent of the other party;
provided, however, that Barrier and JJCC each shall have the right to assign
this Agreement or a portion hereof to any successor of all or substantially all
of its business to which this Agreement or such portion hereof relates without
written consent. JJCC and Barrier shall each shall have the right to assign this
Agreement or a portion hereof to an Affiliate without prior written consent. Any
attempted assignment or transfer of such rights or obligations without such
consent, except as provided herein, shall be void.
13.5 No Third Party Beneficiaries. This Agreement shall not confer any
rights or remedies upon any person other than Barrier and JJCC and their
respective Affiliates, successors and permitted assigns and sublicensees.
13.6 Waiver. The waiver by a party, whether express or implied, of any
provisions of this Agreement, or of any breach or default of a party, shall not
be construed to be a continuing waiver of such provision, or of any succeeding
breach or default, or a waiver of any other provisions of this Agreement.
13.7 Governing Law. All matters affecting the interpretation, validity,
and performance of this Agreement shall be governed by the laws of the State of
New York, USA, without regard to its choice or conflict of law principles.
13.8 Unenforceable Provisions. Any provision hereof which is prohibited
or unenforceable in any jurisdiction shall, as to such jurisdiction, be
ineffective only to the extent of such prohibition or unenforceability without
invalidating the remaining provisions hereof or affecting the validity or
enforceability of such provision in any other jurisdiction. The parties shall
replace such ineffective provision for such jurisdiction with a valid and
enforceable provision which most closely approaches the idea, intent, purpose
and practical economic benefit of this Agreement, and in particular, the
provision to be replaced. If, after taking into account such ineffective
provision, the parties are unable to realize the practical economic benefit
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
contemplated on the Execution Date, the parties shall negotiate in good faith to
amend this Agreement to reestablish the practical economic benefit provided the
parties on the Execution Date.
13.9 Relationship Between the Parties. JJCC and Barrier are independent
contractors and shall not be deemed to be partners, joint venturers or each
other's agents, and neither shall have the right to act on behalf of the other
except as expressly provided hereunder or otherwise expressly agreed to in
writing.
13.10 Entire Agreement. It is the mutual desire and intent of the parties
to provide certainty as to their future rights and remedies against each other
by defining the extent of their mutual undertakings as provided herein. The
parties have in this Agreement and the Securities Acquisition Agreement
incorporated all representations, warranties, covenants, commitments and
understandings on which they have relied in entering into this Agreement and,
except as provided for herein, neither party has made any covenant or other
commitment to the other concerning its future action. Accordingly, this
Agreement and the Securities Acquisition Agreement, and their attached schedules
(i) constitute the entire agreement and understanding between the parties with
respect to the matters contained herein, and there are no promises,
representations, conditions, provisions or terms related thereto other than
those set forth in this Agreement and the Securities Acquisition Agreement, and
(ii) supersede all previous understandings, agreements and representations
between the parties, written or oral relating to the subject matter hereof. The
parties hereto may from time to time during the continuance of this Agreement
modify, vary or alter any of the provisions of this Agreement, but only by
written agreement of all parties hereto.
13.11 Notices. All communications, reports, payments, and notices required
by this Agreement shall be addressed to the parties at their respective
addresses set forth below or to such other address as requested by a party by
notice in writing to the other party.
If to Barrier: Barrier Therapeutics, Inc.
Attention: President
0 Xxxxxx Xxxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000
With a copy to:
Xxxxxx, Xxxxx & Bockius LLP
Attention: Xxxxxx X. Xxxxx, Esq.
000 Xxxxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
If to JJCC: Xxxxxxx & Xxxxxxx Consumer Companies, Inc.
Attention: Vice-President Research and Development
000 Xxxxxxxxx Xxxx
Xxxxxxxx, Xxx Xxxxxx 00000
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
With a copy to:
Chief Patent Counsel
Xxxxxxx & Xxxxxxx
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, Xxx Xxxxxx 00000
All such notices, reports, payments, and communications shall be made by
first class mail, postage prepaid, return receipt requested or overnight
delivery and shall be considered made as of the date of receipt.
13.12 Recordation of this Agreement. It is understood and acknowledged by
both parties to this Agreement that certain Foreign Countries may require that
this Agreement be recorded or approved in such countries. Accordingly, at its
sole expense, Barrier or its sublicensees or Affiliates shall, if required by
applicable law, promptly cause this Agreement to be recorded and, if required by
applicable law, use commercially reasonable efforts to have this Agreement
approved in any such Foreign Country in which Barrier or its sublicensees or
Affiliates market Licensed Products pursuant to this Agreement.
13.13 Headings. All headings in this Agreement are for convenience only
and shall not affect the meaning of any provision hereof.
13.14 Advice of Counsel. JJCC and Barrier have each consulted counsel of
their choice regarding this Agreement, and each acknowledges and agrees that
this Agreement shall not be deemed to have been drafted by one party or another
and will be construed accordingly.
13.15 Condition on Closing of Series B. The rights and obligations of the
parties under Article 2 and Article 3, including without limitation, the license
grants of JJCC IP Rights to Barrier and the transfer of JJCC Tangible Property,
shall be subject to the satisfaction, on or prior to the Closing Date of
completing and closing a capital financing transaction in one or more closings
in which (i) the aggregate cash proceeds received by Barrier equal or exceed
twenty-three million dollars ($23,000,000) and (ii) Barrier obtains firm
commitments for at least an additional twenty-three million dollars
($23,000,000), which commitments are not subject to any milestones or conditions
precedent (for purposes of both (i) and (ii) above, excluding any investments
made by JJCC or Xxxxxxx & Xxxxxxx Development Corporation or any other Affiliate
of JJCC) and pursuant to which Barrier will issue fully paid and non-assessable
shares of Series B Convertible Preferred Stock in accordance with the terms set
forth in the Amended and Restated Certificate of Incorporation in substantially
the form attached to the Securities Acquisition Agreement as Exhibit B.
13.16 Public Announcements. Neither party will make any public
announcement which either (i) names or otherwise identifies the other party, its
Affiliates, or their products or (ii) relates to the Diaper Dermatitis Product
without first giving the other party at least three (3) business days to review
and comment on such public announcement. In addition, subject to any
Commercialization Agreements that are entered into between Barrier and JJCC
and/or an Affiliate of JJCC, until the earlier of Barrier's initial public
offering or the fifth anniversary of
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separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
the Execution Date, neither party will make any public announcement regarding
Licensed Products (other than the Diaper Dermatitis Product and any Licensed
Product for which JJCC has received all notices required to be delivered
pursuant to Section 5) without giving the other party at least three (3)
business days to review, comment on and approve such public announcement, which
approval shall not be unreasonably withheld or delayed.
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** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
IN WITNESS WHEREOF, and intending to be legally bound, the parties hereto
have caused this Agreement to be executed by their duly authorized
representatives as of the Execution Date.
XXXXXXX & XXXXXXX CONSUMER
COMPANIES, INC.
By: /s/ J. Xxxx Xxxxxxxx
--------------------------------
Name: J. Xxxx Xxxxxxxx
Title: Exec. Vice-President RD&E
Date: May 6, 2002
BARRIER THERAPEUTICS, INC.
By: /s/ Geert Cauwenbergh
-------------------------------
Name: Geert Cauwenbergh
Title: President and CEO
Date: May 6, 2002
SIGNATURE PAGE TO INTELLECTUAL PROPERTY
TRANSFER AND LICENSE AGREEMENT
** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
SCHEDULE 1.1
`683 PATENT RIGHTS
(1) U.S. Patent No. 6,238,683
(2) U.S. Patent Application No. 09/562,371
(3) Argentinean Patent Application No. P990106172
(4) Australian Patent Application No. 18412/00
(5) Brazilian Patent Application No. PI9907666-7
(6) Canadian Patent Application No. 2,319,515
(7) Canadian Patent Application No. 2,345,501
(8) Chinese Patent Application No. 99803656.0
(9) European Patent Application No. 99961929.9
(10) European Patent Application No. 01303901.1
(11) Indian Patent Application No. IN/PCT/2000/00181
(12) Japanese Patent Application No. 586367/00
(13) Korean Patent Application No. 00-0000-0000000
(14) Mexican Patent Application No. 007720
(15) Thailand Patent Application No. 054263
(16) Taiwanese Patent Application No. 88121127
** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
SCHEDULE 1.3
`932 PATENT RIGHTS
(1) U.S. Patent No. 4,911,932
(2) Australian Patent No. 569,602
(3) Canadian Patent No. 1,250,522
(4) European Patent No. 149,561
(5) Greek Patent No. 850,123
(6) Guatemalan Patent No. 4180
(7) Irish Patent No. 58,380
(8) Japanese Patent No. 1,953,017
(9) Korean Patent No. 28,024
(10) Mexican Patent No. 163,628
(11) Portugal Patent No. 79,838
(12) South African Patent No. 85/0400
(13) Singapore Patent No. 8990664.8
(14) Zimbabwe Patent No. 11/85
** Certain information in these exhibits has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
SCHEDULE 1.19
JJCC Related Property
1. IND [**] relating to the Sebderm Product
2. NDA [**], and copies of all regulatory filings cross-referenced therein
as of the Execution Date, relating to the Diaper Dermatitis Product
3. IND [**] relating to the Diaper Dermatitis Product
4. Pursuant to and as set forth in Section 5.5 of the Agreement, copies of
all formulation and manufacturing procedures, and any analytical methods that
have been developed that are necessary for Barrier to manufacture such products
itself, or through a third party.
