Exhibit 10.19

 

Execution Copy

 

CONFIDENTIAL TREATMENT REQUESTED

 

The confidential portions of this exhibit have been delivered separately to the
Securities and Exchange Commission pursuant to a confidential application for
confidential treatment in accordance with Rule 24b-2 under the Securities
Exchange Act of 1934, as amended.

 

REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN [***].

 

LICENSE AGREEMENT

 

THIS LICENSE AGREEMENT (this “Agreement”), is made as of February 21, 2017 (the
“Effective Date”), by and among Eyegate Pharmaceuticals, Inc., a corporation
organized under the laws of Delaware (“Eyegate Pharmaceuticals”), EyeGate Pharma
S.A.S., a French corporation and wholly owned subsidiary of Eyegate
Pharmaceuticals (“EyeGate Pharma” and, collectively with Eyegate
Pharmaceuticals, “Eyegate”) and Valeant Pharmaceuticals Ireland, a company duly
formed and validly existing under the laws of the Republic of Ireland
(“Valeant”).

 

WHEREAS, Eyegate has developed the drug EGP-437 (together with any improvements
or enhancements thereto, “EGP-437”), which incorporates a reformulated topically
active corticosteroid, dexamethasone phosphate, for delivery into the ocular
tissues through Eyegate’s proprietary innovative drug delivery system, the
EyeGate® II Delivery System (together with any improvements or enhancements
thereto, the “EyeGate® II Delivery System,” and, together with EGP-437 and any
improvements or enhancements thereto, the “Product”); and

 

WHEREAS, Valeant desires to acquire (i) the exclusive right to Manufacture,
sell, distribute, Commercialize and otherwise Exploit the Product in the
Territory in the Field, (ii) the exclusive right to Develop the Product in the
Territory in the Field, other than for the United States, and (iii) a
non-exclusive license to Develop the Product in the Field for the United States,
in each case under the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants and
agreements contained herein, the parties hereto, intending to be legally bound
hereby, do agree as follows:

 

ARTICLE 1
DEFINITIONS

 

1.1           Definitions. For purposes of this Agreement, the following terms,
whether in the singular or the plural, shall have the meanings designated to
them under this Article 1, unless otherwise specifically indicated:

 

(a)          “Act” shall mean the Federal Food, Drug and Cosmetic Act, as
amended, and the regulations promulgated thereunder from time to time.

 

 

 

 

(b)          “Affiliate” shall mean, as to any Person, any other Person which,
directly or indirectly, controls, is controlled by, or is under common control
with, such Person. For the purpose of this definition, “control”, “controlled
by” or “under common control with” means the possession of the power to direct
or cause the direction of management and policies of such Person, whether
through direct or indirect ownership of voting securities or otherwise.

 

(c)          “[***] Sales-Based Milestone Payment” shall mean each of the
following payments:

 

(i)a $[***] payment in respect of the first Calendar Year in which [***] in the
Territory earned during such Calendar Year equal or exceed $[***]; and

 

(ii)a $[***] payment in respect of the first Calendar Year in which [***] in the
Territory earned during such Calendar Year equal or exceed $[***]; and

 

For the avoidance of doubt, an [***] Sales-Based Milestone Payment with respect
to a level of [***] shall be payable only once with respect to such level of
[***] achieved solely during the applicable Calendar Year; provided that one or
more additional [***] Sales-Based Milestone Payments may be payable in respect
of a Calendar Year where more than one level of [***] triggering an [***]
Sales-Based Milestone Payment is reached solely during such Calendar Year.
Appendix D sets out an example with respect to the payment of [***] Sales-Based
Milestone Payments.

 

(d)          “Applicable Laws” shall mean all applicable federal, state, local
or foreign laws, statutes or ordinances, common law, or any rules, regulations,
standards, judgments, orders, writs, injunctions, decrees, arbitration awards
and agency requirements, including without limitation the Act.

 

(e)          “Audited Party” shall have the meaning set forth in Section 8.2(a).

 

(f)          “Auditing Party” shall have the meaning set forth in
Section 8.2(a).

 

(g)          “Authorized Generic” shall mean the Product comprised of drug and
device in released, finished form that is: (i) packaged and sold without the
Product Trademark or a Valeant Trademark, (ii) Manufactured, sold, distributed
or Commercialized pursuant to a Marketing Authorization with the consent of
Valeant and (iii) intended to be dispensed as if the Product were a Generic
Substitute.

 

(h)          “Business Day” shall mean any day except Saturday, Sunday or any
other day on which banks in the State of New York or Ireland are closed for
business.

 

(i)           “Calendar Quarter” shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September 30 and
December 31; provided, however, that (i) the first Calendar Quarter of the Term
shall extend from the Effective Date until March 31, 2017; and (ii) the last
Calendar Quarter of the Term shall end upon the termination of this Agreement.

 

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(j)          “Calendar Year” shall mean the respective periods of twelve (12)
consecutive calendar months ending on December 31; provided, however, that (i)
the first Calendar Year of the Term shall extend from the Effective Date until
December 31, 2017; and (ii) the last Calendar Year of the Term shall end upon
the termination of this Agreement.

 

(k)          “Collaboration Results” shall mean all know-how (whether or not
patentable) conceived or reduced to practice by or for either Party or any of
its Affiliates in the course of performing the activities under this Agreement.

 

(l)          “Commercialize,” “Commercializing,” “Commercialization” or
“Commercialized” means all activities directed to the Promotion, selling or
offering for sale of the Product, including planning, market research,
pre-marketing activities, Promoting, importing, exporting, and distributing. For
clarity, “Commercialization” shall not include any activities related to
Manufacturing or Development of the Product.

 

(m)          “Commercially Reasonable Efforts” shall mean the efforts and
resources normally used by a Party for a pharmaceutical product of its own
discovery with a similar market potential at a similar stage in its development
or commercialization, taking into account the competitiveness of the
marketplace, such Party’s proprietary position with respect to such product,
applicable regulatory circumstances, the profitability to such Party of such
product, the likelihood of success of commercialization, and other relevant
factors.

 

(n)          “Competitive Product” shall mean [***].

 

(o)          “Confidential Information” shall have the meaning set forth in
Section 13.1.

 

(p)          “Contract” shall mean any agreement, contract, license, lease,
commitment, arrangement or understanding, written or oral, including any sales
order and purchase order currently outstanding that is legally binding and
enforceable against the parties thereto.

 

(q)          “Controlled” shall mean possession by a Party of the right to grant
to the other Party a license, sublicense or other right to use, of the scope
provided for in this Agreement, under intangible or intellectual property rights
(including patent rights, design rights, copyrights, know-how, trade secrets,
data and rights to access or cross-reference regulatory filings) without
violating the terms of any agreement or other arrangement with any Third Party
existing at the time such Party would be first required hereunder to grant the
other Party such license, sublicense or other right.

 

(r)           “Cover,” “Covered,” and “Covering” shall mean, with respect to an
invention, product, or process, in the absence of a license granted to a Valid
Claim included in the applicable Patent, the Development, Manufacture,
Commercialization or Exploitation of such invention, product, or process (as
applicable) would infringe such Valid Claim (or, in the case of a Valid Claim
that has not yet issued, would infringe such Valid Claim if it were to issue).

 

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(s)          “[***] Sales-Based Milestone Payment” shall mean each of the
following payments:

 

(i)          a $[***] payment in respect of the first Calendar Year in which
[***] in the Territory earned from the date of this Agreement equal or exceed
$[***]; and

 

(ii)         a $[***] payment in respect of the first Calendar Year in which
[***] in the Territory earned from the date of this Agreement equal or exceed
$[***].

 

For the avoidance of doubt, a [***] Sales-Based Milestone Payment with respect
to a level of [***] shall be payable only once with respect to such level of
[***]; provided that one or more additional [***] Sales-Based Milestone Payments
may be payable in respect of a Calendar Year where more than one level of [***]
triggering a [***] Sales-Based Milestone Payment is reached. Appendix D sets out
an example with respect to the payment of [***] Sales-Based Milestone Payments.

 

(t)           “Develop,” “Development,” and “Developing” means those research
and development activities, including research, pre-clinical and other
non-clinical activities, test method development and stability testing,
toxicology, formulation development, clinical trials, and regulatory activities
that are necessary or useful to permit the marketing and sale of a product,
including all research and other activities conducted to obtain any Marketing
Authorizations. For clarity, “Development” shall not include any activities
related to Manufacturing or Commercialization of a Product.

 

(u)          “Development Milestone” shall have the meaning set forth in
Section 7.1(b).

 

(v)          “Development Milestone Payment” shall have the meaning set forth in
Section 7.1(b).

 

(w)          “Disclosing Party” shall have the meaning set forth in
Section 13.1.

 

(x)          “Effective Date” shall have the meaning set forth in the Preamble.

 

(y)          “EGP-437” shall have the meaning set forth in the Recitals.

 

(z)          “Exploit” or “Exploitation” means to import, export, use, sell, or
offer for sale (and, for clarity, shall not include make or have made).

 

(aa)         “Eyegate” shall have the meaning set forth in the Preamble.

 

(bb)         “EyeGate® II Delivery System” shall have the meaning set forth in
the Recitals.

 

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(cc)         “Eyegate Patents” shall have the meaning set forth in
Section 1.1(iii).

 

(dd)         “EyeGate Pharma” shall have the meaning set forth in the Preamble.

 

(ee)         “Eyegate Pharmaceuticals” shall have the meaning set forth in the
Preamble.

 

(ff)          “FDA” shall mean the United States Food and Drug Administration,
or any successor entity thereto.

 

(gg)         “Field” shall mean the ocular iontophoretic treatment for
post-operative ocular inflammation and pain in ocular surgery patients.

 

(hh)         “Force Majeure Event” shall have the meaning set forth in
Section 16.1.

 

(ii)          “GAAP” shall mean U.S. generally accepting accounting principles.

 

(jj)          “Generic Substitute” shall mean, with respect to any particular
country in the Territory, the marketing and sale in such country of a
Substitutable Product, which is marketed and sold without any trademark or under
any trademark other than the Product Trademark or any Valeant Trademark.

 

(kk)         “Indemnitee” shall have the meaning set forth in Section 15.3.

 

(ll)          “Indemnitor” shall have the meaning set forth in Section 15.3.

 

(mm)       “Joint Inventions” shall have the meaning set forth in Section 11.3.

 

(nn)         “Joint Patents” means any Patents arising or resulting from Joint
Inventions.

 

(oo)         “JSC” shall have the meaning set forth in Section 3.1.

 

(pp)         “License Fees and Milestone Payments” shall mean the payments to be
made by Valeant pursuant to Sections 7.1 and 7.2.

 

(qq)         “Litigating Party” shall have the meaning set forth in
Section 11.7(g).

 

(rr)          “Losses” shall have the meaning set forth in Section 15.1.

 

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(ss)         “Manufacturing,” “Manufacture” or “Manufactured” means all
activities related to the production, manufacture, processing, filling,
finishing, packaging, labeling, and shipping and holding (prior to distribution)
of the Product or any intermediate or component thereof, including process
development, process qualification and validation, scale-up, commercial
manufacture and analytic development, product characterization, stability
testing, quality assurance and quality control. For clarity, “Manufacturing”
shall not include any activities related to Commercialization or Development of
a Product.

 

(tt)         “Marketing Authorization” shall mean, with respect to any country,
the regulatory authorization required to market and sell the Product for use in
the Field in that country as granted by the relevant Regulatory Authority.

 

(uu)         “Members” shall have the meaning set forth in Section 3.2(a).

 

(vv)         “Net Sales” shall mean, for a particular period, in a particular
country in the Territory, the gross amount invoiced by or on behalf of Valeant
or its Affiliates or distributors for sale of the Product in the Field for such
period in such country, less the following deductions [***]. To the extent any
such deductions apply to the Product as well as any other products of Valeant or
its Affiliates, such deductions shall be fairly and equitably allocated to the
Product and such other products of Valeant or its Affiliates, such that the
Product does not bear a disproportionate portion of such deductions. Any of the
deductions listed above that involves payment by Valeant or its Affiliates or
distributors shall be taken as a deduction in the Calendar Quarter in which the
payment is accrued by such entity.  To the extent accrued deductions are
subsequently reduced or increased, adjustments will be made to that Calendar
Quarter.  The transfer of Product by Valeant to an Affiliate or a distributor
will not be deemed a sale, except in the case of an Affiliate or distributor
whose primary business is wholesale distribution of pharmaceutical products, in
which case the per unit sales price of Product sold to such Affiliate or
distributor shall be deemed to be the average sales price per unit of the
Product sold by the applicable Party, its Affiliates or distributors to Third
Parties in arm’s length transactions during the Calendar Quarter in which the
sale took place.

 

(ww)        “New York Court” shall have the meaning set forth in
Section 16.7(c).

 

(xx)         “Non-Field Rights” shall have the meaning set forth in Section 2.4.

 

(yy)         “Non-Litigating Party” shall have the meaning set forth in
Section 11.7(g).

 

(zz)         “Party” shall mean either Valeant or Eyegate.

 

(aaa)        “Patents” shall mean patents and patent applications and all
substitutions, divisions, continuations, continuations-in-part, any patent
issued with respect to any such patent applications, any reissue, reexamination,
utility models or designs, renewal or extension (including any supplementary
protection certificate) of any such patent, and any confirmation patent or
registration patent or patent of addition based on any such patent, and all
counterparts thereof in any country.

 

(bbb)        “Person” shall mean any individual, corporation, partnership
(whether general, limited or limited liability), association, joint venture,
limited liability company, unlimited liability company, joint stock company,
unincorporated organization, trust or other legal entity or organization, having
legal personality, or the right to sue in its own name.

 

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(ccc)        “Product” shall have the meaning set forth in the Recitals and for
the sake of clarification shall mean a combination of products for use in the
Field that are comprised of a drug (including EGP-437) and a device (including
the Eyegate® II Delivery System), which shall include (i) the Authorized Generic
of such Product, (ii) any improvements or enhancements to the Product, including
such improvements or enhancements to its components, namely, EGP-437 and the
Eyegate® II Delivery System resulting from the Development activities conducted
by either party hereunder, and (iii) the components of such combination product,
namely EGP-437 and the Eyegate® II Delivery System.

 

(ddd)        “Product Contracts” shall have the meaning set forth in
Section 9.2(k).

 

(eee)        “Product IP” shall mean, collectively, the Product Know-How, the
Product Patents, the Product Trademarks, the Marketing Authorizations and all
other intellectual property rights of any nature whatsoever (including rights to
patents, patent applications, supplementary protection certificates, registered
designs, copyright, trademarks, know-how, confidential information and trade
secrets, including the right to modify, transfer and license such rights) owned
or licensed or otherwise Controlled by Eyegate or any of its Affiliates and that
(i) is related to the Product or the Manufacture, sale, distribution or
Commercialization of the Product or (ii) is necessary or useful to its
Development, Manufacture, sale, distribution, Commercialization, Exploitation or
other use, and, for greater certainty, shall include any such intellectual
property rights arising or otherwise resulting from the Development activities
conducted by or on behalf of Eyegate pursuant to the terms of this Agreement.

 

(fff)        “Product Know-How” shall mean any information, know-how, trade
secrets, inventions (whether patentable or not), data and result that is
Controlled by Eyegate or any of its Affiliates on the Effective Date or at any
time during the Term and that (i) is related to the Product or the Manufacture,
sale, distribution or Commercialization of the Product or (ii) is necessary or
useful to its Development, Manufacture, sale, distribution, Commercialization,
Exploitation or other use and, for greater certainty, shall include any
information, know-how, trade secrets, inventions (whether patentable or not),
data and result arising or otherwise resulting from the Development activities
conducted by or on behalf of Eyegate pursuant to the terms of this Agreement.

 

(ggg)        “Product Patents” shall mean all United States and international
Patents that at any time during the Term of this Agreement are owned by Eyegate
or an Affiliate of Eyegate or to which Eyegate or an Affiliate of Eyegate has
the right to grant licenses in the Field (“Eyegate Patents”), the claims of
which may be infringed, absent a license, by the Manufacture, Commercialization,
distribution, use, sale, offer for sale or importation of the Product in the
Field, including, but not limited to, the Patents set out in Schedule 9.2(c)
hereto, which may be updated from time to time to include further inventions
related to the Product.

 

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(hhh)       “Prosecution and Maintenance” or “Prosecute and Maintain” shall mean
(i) with regard to a particular Product Patent, the preparation, filing,
prosecution and maintenance of such Product Patent, as well as reexaminations,
reissues, requests for patent term extensions and the like with respect to such
Product Patent, together with the defense of oppositions, inter partes reviews
and other similar proceedings with respect to such Product Patent, or (ii) with
regard to a particular Product Trademark, the preparation, filing, prosecution,
maintenance and renewal of such Product Trademark, together with the defense of
oppositions and similar proceedings with respect to such Product Trademark.

 

(iii)         “Product Trademark” shall mean the trademark “EYEGATE” including
United States Patent and Trademark Office Trademark Registration No. 2,934,679,
and any such names, trademarks, trade names, trade dress or logos used with
respect to the Product during the Term of this Agreement and which are owned or
licensed or otherwise Controlled by Eyegate or any of its Affiliates.

 

(jjj)         “Promote,” “Promotional,” “Promotion,” “Promoting” and “Promoted”
mean those activities normally undertaken by a company to encourage sales or
appropriate use of the Product, including details, product sampling, detail
aids, coupons, discount cards, journal advertising, direct mail programs,
direct-to-consumer advertising, convention exhibits and other forms of
marketing, advertising, public relations or promotion.

 

(kkk)       “Recalls” shall have the meaning set forth in Section 12.4.

 

(lll)          “Receiving Party” shall have the meaning set forth in Section
13.1.

 

(mmm)     “Recoverable Amounts” shall have the meaning set forth in Section
11.7(e).

 

(nnn)        “Reduced Royalty” shall have the meaning set forth in Section 7.4.

 

(ooo)        “Regulatory Authority(ies)” shall mean any regulatory authority,
agency, department, bureau, or other governmental entity, including the FDA and
corresponding foreign authorities, which is responsible for issuing approvals,
licenses, registrations, clearances, or authorizations necessary for the
Development, registration, Manufacture, testing, formulation, assembly,
packaging, labelling, use, receipt, shipment, storage, import, export,
transport, Commercialization, Promotion, marketing, distribution or sale of the
Product in a country.

 

(ppp)        “Regulatory Exclusivity” shall mean any rights or protections which
are recognized, afforded or granted by the FDA or any other Regulatory Authority
in any country or region of the Territory, in association with the Marketing
Authorization of the Product, providing the Product: (a) a period of marketing
exclusivity, during which a Regulatory Authority recognizing, affording or
granting such marketing exclusivity shall refrain from either reviewing or
approving a marketing authorization application or similar regulatory
submission, submitted by a Third Party seeking to market a Competitive Product,
or (b) a period of data exclusivity, during which a Third Party seeking to
market a Competitive Product is precluded from either referencing or relying
upon, without an express right of reference from the dossier holder, the
Product’s clinical dossier or relying on previous Regulatory Authority findings
of safety or effectiveness with respect to such Product to support the
submission, review or approval of a marketing authorization application or
similar regulatory submission before the applicable Regulatory Authority.

 

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(qqq)      “Right of Last Refusal” shall have the meaning set forth in Section
2.4.

 

(rrr)        “Royalties” shall have the meaning set forth in Section 7.3.

 

(sss)        “Sublicensee(s)” shall mean a sub-licensee in respect of the rights
and licenses granted hereunder, appointed in accordance with the terms and
conditions of this Agreement.

 

(ttt)        “Substitutable Product” shall mean a product comprised of a drug
and device, wherein said drug with respect to which there has been made an
authorized claim of A-rated therapeutically equivalent or otherwise
therapeutically equivalent, as defined in the Orange Book, with respect to the
United States, or the foreign equivalent thereof in the relevant country in the
Territory (outside the United States), or similar determination of
interchangeability with EGP-437, permitting the pharmacy to switch such product
with EGP-437 for use in the Field together and in combination with an approved
or cleared device that is substantially comparable to the EyeGate® II Delivery
System, which determination has been made by the appropriate Regulatory
Authority or by Applicable Laws, or other claim of substitutability with the
Product for use in the Field in the relevant country in the Territory for the
purpose of payor reimbursement, which has been established by a grant of the
competent Regulatory Authority or by Applicable Laws.

 

(uuu)        “Term” shall have the meaning set forth in Section 14.2.

 

(vvv)        “Territory” shall mean the entire world.

 

(www)      “Third Party” shall mean any Person other than Eyegate or Valeant or
their respective Affiliates.

 

(xxx)        “Third Party Licenses” shall have the meaning set forth in Section
11.7(e).

 

(yyy)        “Transaction Protocol” shall mean that certain Transaction Protocol
(License Agreement), by and between Optis B.V., Optis Franca SA (n/k/a EyeGate
Pharma) and Mrs. Francine Behar-Cohen, dated as of July 23, 1999.

 

(zzz)         “United States” or “U.S.” shall mean the United States of America
and its territories and possessions, including the District of Columbia and
Puerto Rico.

 

(aaaa)      “University of Miami License Agreement” shall mean that certain
Amended and Restated License Agreement, by and between University of Miami and
EyeGate Pharma (f/k/a Optis France SA), dated as of December 16, 2005, as
amended.

 

(bbbb)      “U.S. Development Plan” shall have the meaning set forth in
Section 4.3.

 

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(cccc)       “U.S. Marketing Authorization” shall mean the New Drug application
(NDA) for the Product that is a combination product of EGP-437 and the EyeGate®
II Delivery System, together with any other Marketing Authorizations required to
market and sell the Product in the Field in the United States.

 

(dddd)      “Uveitis License Agreement” shall have the meaning set forth in
Section 2.4.

 

(eeee)       “Valeant” shall have the meaning set forth in the Preamble.

 

(ffff)        “Valeant Stock” shall have the meaning set forth in
Section 14.11(c).

 

(gggg)      “Valeant Trademark” shall mean one or more trademarks owned or
otherwise controlled by Valeant and used in connection with the Product.

 

(hhhh)      “Valid Claim” shall mean (a) a claim of an issued and unexpired
Patent that (i) has not been rejected, revoked or held to be invalid or
unenforceable by a court or other authority of competent jurisdiction, from
which no appeal can be taken or (ii) has not been finally abandoned, disclaimed
or admitted to be invalid or unenforceable through reissue or disclaimer; or (b)
a claim included in a pending patent application of a Patent that (i) has not
been pending for more than five (5) years from the effective date of filing such
Patent application or (ii) has not been finally determined to be unallowable by
the applicable court or other authority of competent jurisdiction (from which no
appeal is or can be taken).

 

(iiii)         “Western Europe” shall mean the countries set out on
Schedule 1.1(iiii) hereto.

 

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ARTICLE 2
LICENSE GRANT TO VALEANT; RESPONSIBILITIES

 

2.1           License Grant to Valeant. Subject to the terms and conditions of
this Agreement, Eyegate hereby grants to Valeant and its Affiliates during the
Term:

 

(a)          an exclusive (even as to Eyegate and its Affiliates) license,
including the right to grant sublicenses (in accordance with Section 2.3), under
the Product IP for Valeant and its Affiliates to Manufacture, have Manufactured,
use, sell, offer for sale, import, distribute, Commercialize and otherwise
Exploit the Product in the Field in the Territory;

 

(b)          an exclusive (even as to Eyegate and its Affiliates) license,
including the right to grant sublicenses (in accordance with Section 2.3), under
the Product IP for Valeant and its Affiliates to Develop the Product in the
Field in the Territory outside the United States; and

 

(c)          a sole license (being exclusive except as to Eyegate and its
Affiliates), including the right to grant sublicenses (in accordance with
Section 2.3), under the Product IP for Valeant and its Affiliates to Develop the
Product in the Field in the United States,

 

and Valeant, on behalf of itself and its Affiliates, hereby accepts such rights
and licenses to carry out such activities under the terms and conditions set
forth in this Agreement.

 

2.2           Limited Scope. Notwithstanding the foregoing, Eyegate shall retain
all rights to the Product as necessary to exercise its rights and perform its
obligations to the extent expressly set forth in, and subject to, this
Agreement. For the avoidance of doubt and without limiting any other rights
retained by Eyegate hereunder, Eyegate retains all rights not expressly granted
to Valeant under this Agreement, and the rights and obligations of the Parties
under this Agreement shall be limited to only the Product and shall not include
any rights or obligations with respect to any other product of Eyegate.

 

2.3           Sublicensing. Valeant shall have the right to grant sublicenses of
the licenses granted pursuant to Section 2.1 to Third Parties. For clarity,
granting a sublicense shall not relieve Valeant of any of its obligations
hereunder. Each sublicense granted hereunder shall be subject to the terms of
this Agreement.

 

2.4           Right of Last Refusal for Use Outside the Field. Subject to the
rights set out in the License Agreement dated July 9, 2015 (as may be amended
from time to time) between Valeant and Eyegate (the “Uveitis License
Agreement”), Eyegate hereby grants Valeant a right of last refusal (the “Right
of Last Refusal”) to obtain rights to Manufacture, have Manufactured, use, sell,
offer for sale, import, distribute, Commercialize and otherwise Exploit the
Product outside the Field in the Territory (the “Non-Field Rights”), on the
following terms (which such Right of Last Refusal shall be read in conjunction
with the right of first refusal set out in the Uveitis License Agreement):

 

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(a)          During the Term, Eyegate shall be free to do further research on
the Product in all fields (subject to the limitations set forth in this
Agreement with respect to the Field and subject to the limitations set forth in
the Uveitis License Agreement) and enter into discussions with Third Parties for
the Product outside the Field. Prior to entering into material discussions with
any Third Party regarding a possible agreement for Non-Field Rights, Eyegate
will provide written notice to Valeant. Valeant shall have [***] from such
notification to provide written notice of its interest in negotiating for such
rights and shall have [***] days from such notification to negotiate in good
faith and enter into an agreement for such Non-Field Rights on mutually
acceptable terms. In the event that Valeant provides notice of its interest in
such Non-Field Rights and the Parties negotiate reasonably and in good faith,
but the Parties are unable to agree upon mutually acceptable terms, then and
only then, in the event that Eyegate or any of its Affiliates proposes to grant,
sell, assign or otherwise transfer all or any portion of the same Non-Field
Rights to a Third Party, Eyegate acknowledges and agrees that prior to entering
into any binding agreement for the grant of the same Non-Field Rights with any
Third Party, Eyegate will notify Valeant and provide to Valeant a copy of the
fully negotiated final draft of such proposed agreement with such Third Party
and offer to Valeant the opportunity to enter into an agreement with Eyegate (or
any of its Affiliates) for substantially the same rights and on substantially
the same or equivalent terms as set forth in such draft.

 

(b)          Provided that Valeant has timely complied with all the terms set
forth in Section 2.4(a), Valeant shall have [***] from the date Eyegate notifies
Valeant of its intent to enter into any binding proposed agreement as set forth
in Section 2.4(a), to provide Eyegate written notice of its decision with
respect to the exercise of its Right of Last Refusal. If Valeant exercises its
Right of Last Refusal within such [***] period, Valeant and Eyegate shall
negotiate, in good faith and acting reasonably, enter into an agreement for
substantially the same rights and on substantially the same or equivalent terms
as set forth in the draft agreement provided to Valeant pursuant to the terms of
Section 2.4(a). If and only if Valeant fails to exercise its Right of Last
Refusal within such [***] period, Eyegate will be free to enter into such
agreement with such Third Party; it being understood and acknowledged by Eyegate
that any material modification of the terms of such proposed agreement with the
Third Party after it had been declined by Valeant shall reinstate Eyegate’s
obligations under this Section 2.4. If Eyegate or any of its Affiliates fails to
enter into such agreement with such Third Party within [***], Valeant’s Right of
Last Refusal shall be reinstated.

 

(c)          Each subsequent time that Eyegate proposes to grant, sell assign,
or otherwise transfer all or any portion of the Non-Field Rights to a Third
Party, Valeant’s Right of Last Refusal shall be reinstated and both Parties
shall comply with the requirements set forth in Sections 2.4(a) and 2.4(b).

 

(d)          For greater certainty, for the purposes of this Section 2.4,
“Non-Field Rights” shall include the right to Manufacture, have Manufactured,
use, sell, offer for sale, import, distribute, Commercialize and otherwise
Exploit the Eyegate® II Delivery System alone or in conjunction with another
drug or pharmaceutical product outside the Field in the Territory.

 

2.5           Competitive Products. [***], neither Party shall, nor shall it
permit its Affiliates to, directly or indirectly (including by means of
license), Develop, make or have made, promote, market, sell or distribute in the
Territory any Competitive Product, except pursuant to the terms of this
Agreement; provided, however, that, [***], then Valeant (and its then
Affiliates) shall be permitted to continue to make or have made, promote,
market, sell or distribute such Competitive Product in the Territory and such
making or having made, promotion, marketing, sale or distribution shall not be
considered a breach of the terms of this Section 2.5. Notwithstanding anything
herein to the contrary, nothing shall prevent Valeant or its Affiliates from
Developing, making or having made, promoting, marketing, selling or distributing
an Authorized Generic in the Field in the Territory.

 

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2.6           Assistance of Eyegate. Valeant shall have the right from time to
time during the Term to request the assistance of Eyegate in relation to
technical services that assist Valeant in the Manufacturing of the Product,
including the components of the Product, EGP-437 and the EyeGate® II Delivery
System.

 

2.7           Limitations on Valeant’s License. Notwithstanding the license
granted to Valeant by Eyegate pursuant to Section 2.1 of this Agreement, subject
to Section 2.4 and subject to the terms of and rights granted under the Uveitis
License Agreement, Valeant hereby covenants and agrees not to promote, sell or
distribute, anywhere in the Territory, without the prior written consent of
Eyegate, any components of the Eyegate® II Delivery System other than for use in
connection with EGP-437 in the Field.

 

ARTICLE 3
Joint Steering Committee

 

3.1           Joint Steering Committee. On or within thirty (30) days after the
Effective Date, the Parties shall establish a Joint Steering Committee (“JSC”)
to serve as a forum for the discussion and exchange of information and
coordination of activities between the Parties solely with respect to the
Product. In particular, the JSC shall be responsible for:

 

(a)          discussing and monitoring Development and Commercialization
activities in relation to the Product, or to any improvement or further
Development thereof that the Parties may agree to undertake subject to the terms
and conditions of this Agreement, including discussing and coordinating clinical
studies, including stability studies or other Development work required to
obtain any Marketing Authorizations or for marketing purposes;

 

(b)          facilitating the exchange of information between the Parties under
this Agreement regarding the implementation of Development activities;

 

(c)          discussing and reviewing sales forecasts, trademark usage,
marketing strategies and plans to seek and obtain Marketing Authorizations;

 

(d)          monitoring the progress and results of Valeant’s Manufacturing,
sale, distribution, Commercialization and Exploitation of the Product in the
Field in the Territory;

 

(e)          reviewing and discussing the strategy for obtaining, maintaining
and enforcing Product IP protection for the Product in the Territory;

 

(f)          resolving any disputes with respect to audits conducted by the
Parties under this Agreement;

 

(g)          approving the U.S. Development Plan; and

 

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(h)          such other functions as may be mutually agreed upon by the Parties
from time to time.

 

3.2           Membership and Governance of the JSC.

 

(a)          The JSC shall be comprised of four (4) members (the “Members”),
with Eyegate appointing two (2) Members and Valeant appointing two (2) Members
as their respective representatives on the JSC. The some or all of the members
of the JSC may be the same as the members of the joint steering committee under
the Uveitis License Agreement. The initial Members of the JSC shall be notified
by each Party to the other Party in writing on the Effective Date or as soon as
reasonably possible thereafter.

 

(b)          Each Party shall be entitled to remove any Member appointed by it
and to appoint any person to fill the vacancy arising from the removal or
retirement of such Member. Each Party shall give the other Party prior written
notice of any changes in the identity of its Members. The Parties shall ensure
that all of their appointed Members are of a suitable level of expertise,
seniority and decision-making authority to deal with the issues that may arise
in connection with matters to be considered by the JSC.

 

(c)          The JSC shall exercise its authority in good faith and in
accordance with the terms of this Agreement. The JSC shall have no authority to
bind the Parties unless the Parties expressly delegate matters to the JSC or
ratify the decision of the JSC.

 

(d)          From time to time, the JSC may establish one or more subcommittees
to oversee particular projects or activities related to this Agreement, and such
subcommittees will be constituted as the JSC agrees. The Parties may replace
their respective subcommittee representatives at any time, with prior written
notice to the other Party. Any such subcommittee shall be run on the same basis
as the JSC (i.e., including, without limitation, an agreed equal amount of
representatives appointed by each Party) except that any issue within the
purview of such a subcommittee that is not settled or determined by the
applicable subcommittee shall be submitted to the JSC for resolution. The
chairperson of each subcommittee shall report on subcommittee efforts at each
JSC meeting, and either Party may invite its own representatives on such
subcommittee to also report on such efforts.

 

3.3           Meetings of the JSC.

 

(a)          At least twenty-one (21) days prior to each regularly scheduled
meeting of the JSC, written notice shall be given to each Member by the Party
convening the meeting and at least fourteen (14) days prior to each such
meeting, each Party shall provide to the other all written information expected
to be disclosed at such meeting. In addition, special meetings of the JSC may be
called on such shorter notice period as may be agreed between the Parties.

 

(b)          Valeant shall designate a Valeant Member as the chairperson of the
JSC. The chairperson of the JSC shall set meeting agendas for the JSC, which
shall include any matter that either Party requests to be included. Such agendas
shall be circulated to all Members at least seven (7) business days prior to the
date of the relevant meeting. The JSC chairperson shall be responsible for
recording, preparing and (within ten (10) business days) issuing draft minutes
of the JSC meetings, which draft minutes shall be reviewed, modified and
approved in writing by the Members.

 

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(c)          The JSC shall have its first meeting within forty-five (45) days
after the Effective Date, and thereafter shall hold meetings at least
semiannually or as frequently as otherwise agreed by the Parties, by telephone
or video conference. In the event that the Parties agree to hold face-to-face
meetings, the venue for the meeting of the JSC shall alternate between the U.S.
headquarters of Eyegate and Valeant, unless the Parties mutually agree
otherwise. Each Party shall bear its own costs for its Members to attend JSC
meetings and, as applicable, for its obligations to host such meetings. If
agreed to by both Parties, meetings of the JSC may be held jointly with meetings
of the joint steering committee established under the Uveitis License Agreement.

 

3.4           Limited Purpose. The JSC shall have only the purpose as is
specifically granted to it in this Article 3, and such powers shall be subject
to the terms and conditions set forth herein. Each Party shall retain the
rights, powers and discretion over the matters allocated to such Party herein,
and no such rights, powers, or discretion shall be delegated to or vested in the
JSC. The JSC shall not have the authority to: (i) modify or amend the terms and
conditions of this Agreement; (ii) waive either Party’s compliance with the
terms and conditions of under this Agreement; or (iii) determine any such issue
in a manner that would conflict with the express terms and conditions of this
Agreement. Without limiting the foregoing, (a) Valeant will make the final
determination with respect to the Manufacture, sale, distribution,
Commercialization or Exploitation of the Product in the Field in the Territory
and with respect to the Development of the Product in the Field in the Territory
outside of the United States, and (b) Eyegate will make the final determination
with respect to the Development of the Product in the Development Field for the
United States (except as otherwise set forth herein). Notwithstanding the
foregoing, following the approval of the U.S. Marketing Authorization, if
Valeant conducts its own Development of the Product in the Field in the United
States, Valeant will make the final determination with respect to such
Development.

 

ARTICLE 4
Development

 

4.1           Eyegate and Valeant Development Representatives. Promptly (and no
later than thirty (30) days) after the Effective Date, each Party shall
designate in writing a representative of such Party that shall have the
responsibility of communicating with the other Party’s personnel regarding
Development of the Product in the Field for the United States under this
Agreement (including the provision of such individual’s name, job title, fax and
phone number). Each Party may change such representative from time to time by
written notice to the other Party containing the name and contact information
for the new representative.

 

4.2           Eyegate’s Obligation to Develop the Product. Eyegate shall use
Commercially Reasonable Efforts to (i) Develop the Product in the Field for the
United States, and (ii) obtain the Marketing Authorizations in the Field in the
United States, including the U.S. Marketing Authorization.

 

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4.3           U.S. Development Plan. The Development activities with respect to
the Product in the Field for the United States conducted in connection with this
Agreement shall occur pursuant to a Development plan proposed by Eyegate and
agreed upon by the JSC (the “U.S. Development Plan”). Eyegate shall propose the
initial U.S. Development Plan to the JSC within sixty (60) days after the
Effective Date, and the JSC shall discuss any amendments thereto and approve the
initial U.S. Development Plan within ninety (90) days after the Effective Date.
Prior to submission to the JSC, Eyegate shall provide a draft of the U.S.
Development Plan for Valeant’s review and comment and Eyegate shall use good
faith efforts to include Valeant’s comments in such U.S. Development Plan. On at
least an annual basis, Eyegate shall review, update and decide whether to amend
the then-current U.S. Development Plan to reflect any changes, reprioritizations
of, or additions thereto. Any changes to the U.S. Development Plan shall require
approval by the JSC and once approved by the JSC, such updated or amended U.S.
Development Plan shall become effective and supersede the prior U.S. Development
Plan. The U.S. Development Plan shall include:

 

(a)          a reasonably detailed written plan of Development activities in the
Field for the United States for the period of time during which Development
activities will be conducted, including any related target timelines;

 

(b)          plans and timelines for preparing any and all materials that are
necessary for any required or useful approvals or authorizations to
Commercialize the Product in the Field for the United States, including the U.S.
Marketing Authorization; and

 

(c)          a detailed budget, setting forth the level of spending with respect
to the Development activities in the Field for the United States for the period
of time during which Development activities will be conducted.

 

In addition, Valeant shall have the right to review and approval (such approval
not to be unreasonably withheld) any and all protocols, Phase 3 clinical plans
and regulatory plans prepared by Eyegate, as well as any other Development or
regulatory document that may reasonably impact the commercial viability of the
Product.

 

4.4           Updates on Product Development Progress. At least once every
Calendar Quarter, both Parties shall provide each other with a summary of the
activities conducted during the preceding Calendar Quarter with respect to the
Development of the Product. In addition, at least once per year, Eyegate shall
prepare and provide a copy of a detailed report describing the progress made in
implementing the U.S. Development Plan. Each report shall include with respect
to the applicable one (1) year period a description of the Development
activities conducted both within and outside the United States with respect to
the Product, as well as any proposed amendments or revisions to any development
plan. Both Parties shall also provide each other with regular telephonic updates
on the progress made in implementing the development plans and other information
as may be reasonably requested.

 

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4.5           Development Costs.

 

(a)          Eyegate shall be responsible for one hundred percent (100%) of all
Development costs incurred by or on behalf of Eyegate or any of its Affiliates
with respect to any Development of the Product (i) in the Field for the United
States, and (ii) subject to the terms of the Uveitis License Agreement, outside
of the Field. To the extent the applicable Regulatory Authority requires a
post-marketing study or some other post-approval Development work in connection
with the grant of a Marketing Authorization in the United States, the Parties
shall meet to negotiate a development plan for such additional studies and shall
agree to split the costs associated with such Development work.

 

(b)          Valeant shall be responsible for one hundred percent (100%) of all
Development costs with respect to any Development of the Product in the Field
for countries other than the United States.

 

(c)          Within thirty (30) days of the end of each Calendar Quarter,
Eyegate will submit to Valeant a report detailing Eyegate’s and its Affiliates’
Development costs incurred during such Calendar Quarter for the Development of
the Product in the Field for the United States, including copies of invoices and
any other supporting evidence necessary to substantiate such Development costs.

 

4.6           Development Records. Eyegate shall maintain current and accurate
records of all work conducted by it under the U.S. Development Plan and all
data, know-how and other results invented in connection with, generated by or
that results from the conduct of such Development activities (which records
shall include, as applicable, books, records, reports, research notes, charts,
graphs, comments, computations, analyses, recordings, photographs, computer
programs and documentation thereof (e.g., samples of materials and other graphic
or written data generated in connection with the Development activities)). Such
records shall properly reflect all work done and results achieved in the
performance of the Development activities in sufficient detail and in good
scientific manner appropriate for regulatory and patent purposes. All such
records shall be retained by Eyegate until the later of (a) three (3) years
after the end of the Calendar Year in respect of which payment such work is
conducted and (b) the period of time required by Applicable Law.

 

4.7           Valeant’s Development Rights and Obligations.

 

(a)          Valeant and its Affiliates shall have the exclusive (even as to
Eyegate and its Affiliates) right to Develop the Product in the Field for
countries outside of the United States, , in accordance with the terms of this
Agreement, and Valeant shall be responsible for all costs associated with such
Development; provided that Valeant and/or its Affiliates must provide Eyegate
with prior written notice prior to commencing the Development of the Product in
the Field in each country or territory outside of the United States. Following
the receipt of the U.S. Marketing Authorization, Valeant and its Affiliates
shall also have the right to Develop the Product in the Field for the United
States and Valeant shall be responsible for its own costs of any such
Development.

 

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ARTICLE 5
Commercialization AND MANUFACTURING

 

5.1           Commercialization Generally. Valeant and its Affiliates shall have
the exclusive (even as to Eyegate and its Affiliates) right to Commercialize the
Product in the Field in the Territory and to establish the strategy, including
the price and sales strategy, for the Commercialization of the Product in the
Field in the Territory. Valeant and its Affiliates shall be responsible for
establishing and approving (in its sole discretion) the form, content and terms
and conditions of contracts and other arrangements regarding the sale of the
Product in the Field in the Territory, including contracts with wholesalers,
other distributors, and retailers (as applicable). Notwithstanding anything
herein to the contrary, Valeant shall be solely responsible for determining the
prices of the Product in the Field in the Territory.

 

5.2           Reimbursement for Medical Procedures. Before submitting any
request, application or information to a governmental entity for the purpose of
obtaining, maintaining or changing a Healthcare Common Procedure Coding System
(HCPCS) code (J-Code) or Current Procedural Terminology (CPT) code for the
Product or for the medical procedures involving the Product, Valeant shall
submit such proposed request, application or information to Eyegate for prior
written approval, which approval shall not be unreasonably withheld or delayed.
Valeant shall not make any material changes to such request, application or
information after it has been approved by Eyegate without the prior written
consent of Eyegate, except to the extent such changes are required by applicable
laws or regulations. Valeant shall promptly notify Eyegate of all changes made
to any such request, application or information that has been previously
approved by Eyegate and shall consult with Eyegate with respect to any changes
required by applicable laws or regulations.

 

5.3           Promotion Rights and Responsibilities. Notwithstanding anything
herein to the contrary, during the Term, subject to, and in accordance with, the
terms and conditions of this Agreement, Valeant and its Affiliates shall have
the exclusive right to Promote the Product under the Product Trademarks or the
Valeant Trademarks throughout the Territory in the Field; provided that,
notwithstanding this exclusive right, during the Term of this Agreement, Eyegate
shall have the non-exclusive right, at its own expense, to publish journal
articles and make presentations relating to or mentioning the Product in the
Field with the prior written consent of Valeant, such consent not to be
unreasonably withheld, provided that Valeant is provided with a copy of such
journal articles and presentations a reasonable amount of time in advance of
such publication or presentation and Eyegate uses good faith efforts to include
in such articles or presentations the comments of Valeant thereon. For the sake
of clarity but subject to the terms of the Uveitis License Agreement, Eyegate
shall be free to publish journal articles and make presentations concerning
Eyegate’s technology relating to iontophoresis or any products outside the Field
without the need of Valeant’s consent.

 

5.4           Manufacturing Rights.

 

(a)          Valeant shall have the exclusive right to Manufacture or have
Manufactured the Product (including its components) for use in the Field in the
Territory and for establishing the strategy for the Manufacture of the Product,
including as to whether to Manufacture the Product (and its components) through
its Affiliates or Third Parties and to select any such Third Party manufacturers
and suppliers. Valeant and its Affiliates shall be responsible for establishing
and approving (in its sole discretion) the form, content and terms and
conditions of contracts and other arrangements regarding the Manufacture of the
Product in the Field in the Territory, including contracts with Third Party
suppliers of the Product or components of the Product and Third Party packagers.
On request by Valeant, Eyegate shall facilitate introductions with its Third
Party suppliers and manufacturers of the Product and its components to enable
Valeant to purchase Product directly from such third party suppliers.

 

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(b)          In the event that Valeant is manufacturing the Product, either
itself or through an Affiliate or Third Party, and Eyegate wishes to obtain
supply of Product from such source, whether for Development purposes or for use
outside of the Field, the Parties shall meet to discuss the appropriate strategy
of providing supply of Product to Eyegate, which may include (i) if Valeant or
its Affiliate is manufacturing the Product, the good faith negotiation of a
supply agreement, on mutually agreeable terms (including provisions relating to
priority of supply in supply shortage situations), pursuant to which Valeant or
its Affiliates supplies Product to Eyegate at a purchase price of [***] or some
other mutually agreeable purchase price, or (ii) if Valeant (or its Affiliate)
obtains supply of Product from a Third Party manufacturer, (A) the negotiation
of a supply agreement between Valeant (or its Affiliate) and Eyegate, pursuant
to which Valeant (or it Affiliate) supplies Product to Eyegate on the same terms
as Valeant (or its Affiliate) receives supply from the Third Party manufacturer,
with such mutually agreeable adjustments as may be agreed to between the Parties
(including with respect to purchase price and priority in supply shortage
situations), (B) facilitation of introductions to such Third Party manufacturer
for the purposes of permitting Eyegate to obtain direct supply from such
manufacturer, or (C) the assignment to Eyegate of the supply arrangements with
such Third Party manufacturer and the concurrent negotiation of a supply
agreement between Eyegate and Valeant (or its Affiliate) pursuant to which
Eyegate supplies Product to Valeant (or its Affiliates) on the same terms as
Eyegate receives supply from the Third Party manufacturer, with such mutually
agreeable adjustments as may be agreed to between the Parties (including with
respect to purchase price and priority in supply shortage situations). If both
Parties act reasonably and in good faith in determining an appropriate supply
strategy and, if agreed, in negotiating a supply agreement between the Parties,
the obligations of the Parties under this Section 5.4(b) shall have been
satisfied.

 

 

ARTICLE 6
Regulatory

 

6.1           Marketing Authorizations.

 

(a)          United States. Eyegate shall use Commercially Reasonable Efforts to
seek and obtain the U.S. Marketing Authorization for the Product in the Field,
with Valeant’s assistance, support and cooperation; provided, however, that,
except as set forth in Section 4.7, Eyegate shall be responsible for one hundred
percent (100%) of all costs with respect to seeking and obtaining such U.S.
Marketing Authorization. Valeant and Eyegate shall mutually agree on a strategy
and plan to obtain the U.S. Marketing Authorization. Upon obtaining such U.S.
Marketing Authorization for the Product, Eyegate shall, as promptly as
practicable, transfer such U.S. Marketing Authorization, together with the
regulatory dossier associated with such U.S. Marketing Authorization, to Valeant
(or its designee), at Valeant’s cost and with Valeant’s assistance, support and
cooperation. Upon the transfer of such U.S. Marketing Authorization and its
regulatory dossier, Eyegate shall retain a right of reference to such U.S.
Marketing Authorization and its regulatory dossier for the purposes of the
products outside of the Field. Following such transfer, during the Term of this
Agreement, Valeant shall maintain such U.S. Marketing Authorization, at
Valeant’s cost. If Valeant fails to maintain such U.S. Marketing Authorization
for the Product or makes the decision to no longer maintain such U.S. Marketing
Authorization, on Eyegate’s request, Valeant shall promptly transfer such U.S.
Marketing Authorization to Eyegate (or its designee), at Eyegate’s cost.

 

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(b)          Outside the United States. Valeant shall have the exclusive right
to seek, obtain and maintain Marketing Authorizations for the Product in the
Field in the Territory outside of the United States, at its own cost and in its
sole discretion, provided that Valeant and/or its Affiliates must provide
Eyegate with prior written notice prior to applying for any Marketing
Authorizations for the Product in the Field in any country or territory outside
of the United States. Following the transfer of the U.S. Marketing
Authorization, Valeant shall also have the right to seek, obtain and maintain
Marketing Authorizations for the Product in the Field in the Territory for the
United States.

 

(c)          Notwithstanding anything herein to the contrary, Eyegate shall not,
and shall not permit its Affiliates or representatives, to seek, apply for or
obtain either a Premarket Approval (PMA), a Premarket Notification 510(k) or a
CE mark for the EyeGate® II Delivery System alone (i.e., on a stand-alone
basis), unless either (i) such PMA, Premarket Notification 510(k) or CE mark is
applied for in conjunction with a drug product or (ii) Valeant has given its
prior written consent (which may be withheld in its sole discretion).

 

6.2           Communications with Regulatory Authorities.

 

(a)          United States. As between the Parties, subject to the terms of this
Section 6.2(a), in connection with seeking and obtaining the Marketing
Authorizations for the Product in the Field for the United States, Eyegate shall
have the sole responsibility and authority to communicate with any applicable
Regulatory Authorities prior to obtaining such Marketing Authorizations. Without
limiting the provisions of this Article 6, Eyegate shall promptly provide
Valeant with copies of all written and electronic communications received by
Eyegate or its Affiliates from, or forwarded by Eyegate or its Affiliates to,
any applicable Regulatory Authorities with respect to obtaining such Marketing
Authorizations for the Product in the Field in the United States. With respect
to such written and electronic communications forwarded by Eyegate or its
Affiliates to any Regulatory Authorities, prior to submission to the applicable
Regulatory Authority, Eyegate shall provide Valeant with copies thereof so that
Valeant may review and comment on such communications and have a reasonable
opportunity to influence the substance of such submissions. Eyegate agrees to
consider all such comments in good faith, taking into account the best interest
of the Development of the Product in the Field on a global basis. Following the
transfer to Valeant (or its designee) of a Marketing Authorization for the
Product in the Field in the United States, Valeant shall have the sole
responsibility and authority to communicate with any applicable Regulatory
Authorities in the United States in connection with the Product in the Field in
the United States or the Marketing Authorizations for the United States.
Following the transfer of the Marketing Authorization, Valeant shall consult
with Eyegate with respect to, or provide Eyegate a right of review of or copies
of, any correspondence with such Regulatory Authorities regarding the Marketing
Authorizations in the United States.

 

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(b)          Outside the United States. Valeant shall have the sole
responsibility and authority to communicate with any applicable Regulatory
Authorities outside the United States in connection with the Product in the
Field outside of the United States or the Marketing Authorizations for countries
outside the United States, including with respect to the application for such
Marketing Authorizations. Valeant shall provide Eyegate a right of review of or
copies of, any correspondence with such Regulatory Authorities regarding the
Marketing Authorizations outside of the United States.

 

(c)          General. During the Term of this Agreement, each Party shall send
the other Party, promptly upon receipt, copies of any correspondence or other
materials received by such Party from a Regulatory Authority relating to the
Product in the Territory. In addition, during the Term of this Agreement, each
Party shall send the other Party, promptly upon submission, copies of any
correspondence, submissions or filings made by such Party to a Regulatory
Authority relating to the Product in the Territory. Promptly upon receipt of
notification from the Regulatory Authority, a Party shall notify the other Party
of any audit or inspection being conducted by a Regulatory Authority respecting
or relating to the Product. If permitted by Applicable Law, the other Party
shall be entitled to attend on such audit or inspection. Following such
inspection or audit, the Party shall provide the other Party, promptly upon
receipt, a copy of any report, findings or other results received from such
Regulatory Authority with respect to such audit or inspection.

 

 

ARTICLE 7
Compensation for Product

 

7.1           License Fees and Milestone Payments Related to Signing and
Development and Regulatory Milestones. In consideration for the license granted
to Valeant and its Affiliates hereunder, and in addition to any other payments
provided for in this Agreement, Valeant shall pay to Eyegate Pharmaceuticals the
following non-refundable and non-deductible license fees and milestone payments:

 

(a)          an initial license fee in the amount of four million dollars
($4,000,000), due and payable on the Effective Date;

 

(b)          milestone payments in the aggregate amount of up to [***] ([***])
(each a “Development Milestone Payment”), payable upon the achievement by
Eyegate of the milestone events as specified in Appendix B to this Agreement
(each, a “Development Milestone”); and

 

(c)          a milestone payment in the amount of [***] ([***]), due and payable
within fifteen (15) calendar days after [***].

 

7.2           Milestone Payments Related to Sales Milestones. In consideration
for the license granted to Valeant and its Affiliates hereunder, and in addition
to any other payments provided for in this Agreement, not later than [***],
Valeant shall provide to Eyegate Pharmaceuticals a report setting out [***] and
Valeant shall pay to Eyegate Pharmaceuticals any [***] Sales-Based Milestone
Payments or [***] Sales-Based Milestone Payments payable with respect to such
Calendar Year not later than [***]. Following the payment by Valeant of both
Sales-Based Milestone Payments and both [***] Sales-Based Milestone Payments,
Valeant’s obligation under this Section 7.2 to provide annual reports to Eyegate
shall cease.

 

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7.3           Royalties. In consideration for the license granted to Valeant and
its Affiliates hereunder, for each [***] during the Term, not later than [***]
in the Term, Valeant shall provide to Eyegate Pharmaceuticals a report setting
out [***] and a calculation of the royalties payable hereunder (the “Royalties”)
for such [***], in each case, on a country by country basis for each country in
the Territory in which the Product is sold and for which Royalties are payable.
Valeant shall pay to Eyegate Pharmaceuticals Royalties as follows: (i) for the
first [***] ([***]) in [***] of the Product in the Territory in the Field, an
amount equal to [***] ([***]) of such [***] of the Product in the Field in the
Territory and (ii) for [***] of the Product in the Territory in the Field
exceeding [***] ([***]), an amount equal to [***] of the Product in the Field in
the Territory. Royalties payable with respect to a [***] shall be payable by
Valeant not later than [***]. The Royalties payable pursuant to this Section 7.3
shall be subject to reduction as set forth in Section 7.4.

 

7.4           Reduction in Royalty Rate. Notwithstanding Section 7.3, on a
country-by country basis, the Royalties payable pursuant to Section 7.3 shall be
reduced to [***] from and after the date on which (a) [***] or (b) [***];
provided, however, that in the case of clause (a), such Royalties shall only be
reduced to [***] in such country if (i) [***] (“Reduced Royalty”), (ii) [***]
and (iii) [***]; provided further that, once the condition in either clause (i)
or (ii) ceases to be satisfied, the Royalty shall be further reduced to [***]
for such country. Once a Royalty payable in a country has been reduced pursuant
to this Section 7.4, such Royalty shall not be subsequently increased, even if
the conditions in clauses (a) and (b) in the immediately preceding sentence
cease to be applicable in such country; provided that, in the event that,
subsequent to such Royalty reduction, either (x) [***], (y) [***], or (z) [***],
then, following receipt by Valeant of written notice from Eyegate of the
existence of such condition, the Royalty shall be reverted back to the
applicable level (pursuant to the terms of Sections 7.3 and 7.4), until such
time as the conditions in (x), (y) or (z) cease to be satisfied, at which time
the Royalty shall be reduced to the prior level. Following the reduction of the
Royalty to [***] in any country in the Territory, Valeant’s obligation under
Section 7.3 to provide [***] Royalty reports to Eyegate shall cease with respect
to such country. In addition, following the reduction of the Royalty in a
country pursuant to this Section 7.4 (whether to [***] or [***]), such Net Sales
in such country shall not be counted in determining the aggregate annual Net
Sales under Section 7.3 for the purposes of determining whether the amount of
the Royalty payable shall be [***] or [***].

 

7.5           Payments. All payments to be made pursuant to this Article 7 shall
be made in U.S. dollars by wire transfer no later than the applicable payment
due date. Such payments shall be made to the designated account of Eyegate
Pharmaceuticals in accordance with wiring instructions to be provided. Payments
are to be wired to the account specified in Appendix A to this Agreement, which
may be changed by Eyegate Pharmaceuticals from time to time by written notice to
Valeant. Any payments due under this Agreement which are not paid by the date
such payments are due under this Agreement shall bear interest to the extent
permitted by applicable law at the lower of (i) [***], or (ii) the maximum rate
permitted by law; in each case calculated on the number of days such payment is
delinquent.

 

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7.6           Conversion of Foreign Currencies. To the extent that Net Sales are
accrued in currencies other than United States dollars, such Net Sales shall be
converted to United States dollars using the applicable monthly exchange rate
for converting such local currency to Unites States dollars in accordance with
Valeant’s worldwide accounting systems and policies.

 

7.7           Collection Actions. In the event of any legal action to collect
unpaid amounts due under this Article 7, the losing Party shall be reimburse the
winning Party for all attorneys’ fees and reasonable costs incurred in such
action.

 

7.8           Taxes. Valeant may withhold the appropriate tax from any payment
to be made to Eyegate Pharmaceuticals under this Agreement provided that such
withholding is required by Applicable Laws and Valeant submits the amounts
withheld to the applicable tax authorities. In such event, Valeant shall furnish
Eyegate Pharmaceuticals with proof of payment of such tax together with official
or other appropriate evidence issued by the applicable government authority. The
Parties will cooperate to enable payments under this Agreement to be exempt from
withholding tax, or to be paid subject to the reduced rate of withholding tax
provided by an applicable double tax treaty in force at the relevant time.
Without limiting the foregoing, the Parties agree to cooperate and produce on a
timely basis complete and accurate tax forms or reports, including, but not
limited to, an IRS Form W-8BEN or W-8ECI, an IRS Form W-9, and/or a certificate
of residency, as applicable, reasonably requested by the other Party in
connection with any payment under this Agreement. Each Party further agrees to
provide reasonable cooperation to the other Party, at the other Party’s expense,
in connection with any official or unofficial tax audit or contest relating to
payments made under this Agreement. All sums payable under this Agreement are
exclusive of value added tax or other similar applicable taxes or duties which
shall be payable by the paying Party at the appropriate rate prescribed by law
from time to time.

 

ARTICLE 8
Recordkeeping; Audits

 

8.1           Records. Valeant shall maintain complete and accurate records in
reasonably sufficient detail of Net Sales, License Fees, Development Milestone
Payments, [***] Sales-Based Milestone Payments, [***] Sales-Based Milestones
Payments and the Royalties and all other amounts due from it to Eyegate under
this Agreement, for a period of at least two (2) years after the end of the
Calendar Year in respect of which payment is to be made hereunder, and during
the Term of this Agreement, Valeant shall maintain accurate data collection and
reporting systems for the foregoing. Eyegate shall maintain, for a period of at
least two (2) years after the end of the Calendar Year in respect of which
payment is to be made hereunder, complete and accurate records in reasonably
sufficient detail of all proceeds received by Eyegate and its Affiliates in
respect of the Product and all Development costs incurred pursuant to the terms
of this Agreement, and during the Term of this Agreement, Eyegate shall maintain
accurate data collection and reporting systems for the foregoing.

 

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8.2           Audits.

 

(a)          During the Term and for a period of two (2) years thereafter, upon
the reasonable request of a Party hereunder (the “Auditing Party”) and no more
than once per year during the Term, the Auditing Party shall have the right to
engage an independent, certified public accountant(s), reasonably acceptable to
the other Party (the “Audited Party”), to perform an audit of the Audited
Party’s books and records and those of its Affiliates for the preceding two (2)
year period as may be necessary to confirm any amounts paid or payable under
this Agreement for such period.

 

(b)          Such audits shall be conducted during normal business hours upon
reasonable prior written notice from the Auditing Party in such a manner as to
not unnecessarily interfere with the Audited Party’s or its Affiliate’s normal
business activities. The accountants shall report its conclusions and
calculation to both Parties; provided, however, that in no event shall the
accountants disclose information except to the extent necessary to verify the
accuracy of the payments due under this Agreement, and at the request of either
Party such accountants shall execute appropriate non-disclosure agreements with
such Party.

 

(c)          If an audit hereunder reveals an underpayment by Valeant to
Eyegate, Valeant shall promptly make up such underpayment. If an audit hereunder
reveals an overpayment by Valeant to Eyegate, Eyegate shall promptly refund
Valeant for the amount of such overpayment.  The Auditing Party shall bear the
full cost of such audit under this Section 8.2, unless such audit, in the case
of an audit initiated by Eyegate, discloses an underpayment to Eyegate of
License Fees, Development Milestone Payments, [***] Sales-Based Milestone
Payments, [***] Sales-Based Milestones Payments or Royalties of more than [***]
of the amount owed during the period being audited, in which case Valeant shall
bear the full cost of such audit, and, in the case of an audit initiated by
Valeant, discloses an overpayment by Valeant of more than [***] of the amount
owed during the period being audited, in which case Eyegate shall bear the full
cost of such audit.

 

8.3           Payments. All payments to be made pursuant to this Article 8 shall
be made by wire transfer in U.S. dollars no later than the applicable payment
due date. Such payments shall be made to the designated account of Eyegate or
Valeant, as the case may be, in accordance with wiring instructions to be
provided.

 

ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS

 

9.1           Representations, Warranties and Covenants of Valeant. Valeant
represents, warrants and covenants to Eyegate as follows:

 

(a)           (i) Valeant is duly organized, validly existing, and in good
standing under the laws of the jurisdiction in which it is incorporated; and
(ii) that Valeant has the requisite legal and company authority to enter into
this Agreement and that it is not bound by any other agreement, obligation or
restriction, and shall not assume any other obligation or restriction or enter
into any other agreement, which would interfere in any material respect or
conflict with its obligations under this Agreement.

 

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(b)           Valeant is, and covenants that it shall continue to be, in
compliance with all requirements of Applicable Laws relevant to its obligations
and activities as set forth in this Agreement.

 

(c)          Assuming the due authorization, execution and delivery by Eyegate,
this Agreement is a legally valid and binding obligation of Valeant, enforceable
against Valeant in accordance with its terms (except in all cases as such
enforceability may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium, or similar laws affecting the enforcement of
creditors’ rights generally and except that the availability of the equitable
remedy of specific performance or injunctive relief is subject to the discretion
of the court or other tribunal before which any proceeding may be brought).

 

9.2           Representations, Warranties and Covenants of Eyegate. Eyegate
Pharmaceuticals and EyeGate Pharma each represent, warrant and covenant to
Valeant, as follows:

 

(a)           (i)  Each of Eyegate Pharmaceuticals and EyeGate Pharma is duly
organized, validly existing, and in good standing under the laws of the
jurisdiction in which it is organized; and (ii)  each of Eyegate Pharmaceuticals
and EyeGate Pharma has the requisite legal and company authority to enter into
this Agreement and that it is not bound by any other agreement, obligation or
restriction, and shall not assume any other obligation or restriction or enter
into any other agreement, which would interfere in any material respect or
conflict with its obligations under this Agreement.

 

(b)          Eyegate owns or Controls intellectual property rights pertaining to
the Product, Product Know-How and other Product IP, necessary to grant the
license to Valeant and its Affiliates hereunder and to perform its obligations
hereunder. Eyegate has not received any written notice from any Third Party
which expressly alleges that the use or sale of the Product would infringe,
misappropriate or otherwise violate a composition of matter or method of use
claim of an issued U.S., European or other Patent of such Third Party or any
other intellectual property rights of a Third Party and the Manufacture,
Commercialization, Development, Exploitation, use or sale of the Product will
not infringe, misappropriate or otherwise violate a composition of matter or
method of use claim of an issued U.S., European or other Patent of such Third
Party or any other intellectual property rights of a Third Party. There are no
pending, or to the best of Eyegate’s knowledge, threatened interferences and
oppositions with respect to the Product Patents, and there is no pending, or to
the best of Eyegate’s knowledge, threatened litigation challenging the validity
or enforceability of the Product Patents. The Product Patents are, or upon
issuance will be, valid and enforceable. To the best of Eyegate’s knowledge, no
Third Party is infringing or misappropriating the Product Patents, Product
Know-How and other Product IP.

 

(c)          Schedule 9.2(c) contains a complete and correct list of all Patents
Controlled by Eyegate relating to the Product.

 

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(d)          Eyegate and its Affiliates have taken reasonable steps to protect
and preserve the confidentiality of all material confidential Product IP. All
current and former employees, consultants, and contractors of Eyegate and its
Affiliates who are or have been involved in Developing the Product have executed
and delivered and, to the best of knowledge of Eyegate, are in material
compliance with, agreements regarding the protection of Product IP and providing
written assignments of all Product IP (other than moral rights) conceived or
developed by such employees, consultants or contractors in connection with their
services for Eyegate or any of its Affiliates. No current or former employee,
consultant or contractor has any right, claim to or interest in any of the
Product IP (other than moral rights).

 

(e)          Eyegate is, and covenants that it shall continue to be, in
compliance in all material respects with all requirements of Applicable Laws
relevant to its obligations and activities as set forth in this Agreement.

 

(f)          All Development activities conducted by or on behalf of Eyegate and
its Affiliates with respect to each of the Product, EGP-437 and the EyeGate® II
Delivery System, including all pre-clinical and clinical investigations, have
been and are being conducted in compliance in all material respects with all
Applicable Laws. To the best of Eyegate’s knowledge, no event has occurred and
no circumstances exist that may result in a violation of, conflict with, or
failure on the part of Eyegate and its Affiliates to comply with Applicable Laws
in connection with the Product or its Development. Neither Eyegate nor any of
its Affiliates has received any written notification, correspondence or any
other written communication from any Regulatory Authority, including the FDA,
alleging any potential or actual material non-compliance by Eyegate or any of
its Affiliates under Applicable Law relating to the Product.

 

(g)          As of the Effective Date, the Product IP is free and clear of
liens, charges and encumbrances.

 

(h)          Assuming the due authorization, execution and delivery by Valeant,
this Agreement is a legally valid and binding obligation of Eyegate, enforceable
against Valeant in accordance with its terms (except in all cases as such
enforceability may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium, or similar laws affecting the enforcement of
creditors’ rights generally and except that the availability of the equitable
remedy of specific performance or injunctive relief is subject to the discretion
of the court or other tribunal before which any proceeding may be brought).

 

(i)          Eyegate shall promptly provide Valeant with copies of all written
notices and other material written communications from the FDA and/or any other
Regulatory Authorities or regulatory agencies that relate to or reasonably
impact the Product in the Field, EGP-437 or the EyeGate® II Delivery System or
that may affect Valeant’s ability or right to Manufacture, sell, distribute,
Commercialize and otherwise Exploit the Product as contemplated by this
Agreement. Eyegate covenants to disclose to Valeant any Product-related
information that comes into the possession or Control of Eyegate or its
Affiliates during the Term of this Agreement that is necessary or useful for
Valeant to exercise its rights or perform its obligations under this Agreement
in relation to the Product.

 

(j)          Eyegate has not granted to any Person any license, sublicense or
other rights, entered into any agreement or understanding or undertaken any
obligation that in any way conflicts or is inconsistent with this Agreement or
the rights and licenses granted to Valeant and its Affiliates under this
Agreement. None of Eyegate Pharmaceuticals, EyeGate Pharma or any of their
respective Affiliates shall grant to any Person any license, sublicense or other
rights, enter into any agreement or understanding or undertake any obligation
that in any way conflicts or is inconsistent with this Agreement or the rights
and licenses hereunder.

 

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(k)          Schedule 9.2(k) hereto sets out all Contracts relating to the
Product, EGP-437 or the EyeGate® II Delivery System or their Development (the
“Product Contracts”), accurate and complete copies of which have been delivered
to Valeant by Eyegate. Each of the Product Contracts are in full force and
effect and enforceable in accordance with their terms against Eyegate and, to
the best knowledge of Eyegate, against the other parties thereto (except in all
cases as such enforceability may be limited by applicable bankruptcy,
insolvency, reorganization, moratorium, or similar laws affecting the
enforcement of creditors’ rights generally and except that the availability of
the equitable remedy of specific performance or injunctive relief is subject to
the discretion of the court or other tribunal before which any proceeding may be
brought).  None of Eyegate Pharmaceuticals, EyeGate Pharma or any of their
Affiliates is in default under any of the Product Contracts, and there has not
occurred any event that, with the lapse of time or the giving of notice or both,
would constitute such a default. No counterparty to any Product Contract has
cancelled or otherwise terminated or, to the best of Eyegate’s knowledge,
threatened to cancel or otherwise terminate the applicable Product Contract.

 

(l)          As of the Effective Date, Eyegate has disclosed or made available
to Valeant (a) all material scientific and technical information known to it or
its Affiliates relating to (i) the safety and efficacy of the Product and (ii)
the drug quality, including, stability, variability, and impurities of the
Product and (b) all material regulatory materials submitted to or filed with any
Regulatory Authority by or on behalf of Eyegate or any of its Affiliates and the
status of all material discussions with Regulatory Authorities in respect of the
Product (if any). All such scientific and technical information and regulatory
materials are accurate and materially complete. To the best of Eyegate’s
knowledge, no data generated by Eyegate or any of its Affiliates with respect to
the Product is the subject of any regulatory or other action, either pending or
threatened, by any Regulatory Authority relating to the truthfulness of such
data or the scientific adequacy of such data for its intended purpose. Neither
Eyegate nor any of its Affiliates has applied for or obtained a Premarket
Approval (PMA) or a Premarket Notification 510(k) for the EyeGate® II Delivery
System.

 

(m)          There is no action, suit or other proceeding pending or, to the
best of Eyegate’s knowledge, threatened anywhere in the Territory (i) relating
to or involving the Product, EGP-437 or the EyeGate® II Delivery System or (ii)
that could prevent, enjoin or delay the transactions or activities contemplated
by this Agreement. There is no order, injunction, judgment or decree of a
Regulatory Authority relating to or involving the Product, EGP-437 or the
EyeGate® II Delivery System.

 

(n)           To the best of Eyegate’s knowledge, there is no information, and
no event or circumstance has occurred, that would reasonably be expected to lead
to the denial of any application for Marketing Authorization in the Territory.
Eyegate is not aware of any safety issues relating to the Product, EGP-437 or
the EyeGate® II Delivery System.

 

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(o)          Other than as disclosed in Schedule 9.2(o) hereto, none of the
Product IP owned by Eyegate or its Affiliates was developed by or on behalf of,
or using grants or any other subsidies of, any Regulatory Authority or other
governmental entity or any university, and no government funding, facilities,
faculty, employees or students of a university, college, other educational
institution or research center.

 

9.3          Disclaimer.

 

(a)          EXCEPT AS EXPRESSLY SET FORTH HEREIN, ALL OTHER WARRANTIES,
CONDITIONS AND REPRESENTATIONS, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE,
INCLUDING WITHOUT LIMITATION ANY WARRANTY AS TO THE QUALITY OR FITNESS FOR ANY
PARTICULAR PURPOSE OR OF NON-INFRINGEMENT, ARE HEREBY EXCLUDED AND DISCLAIMED BY
EACH PARTY AND THEIR RESPECTIVE AFFILIATES.

 

(b)          Nothing in this Agreement shall be deemed to authorize either Party
or its respective Affiliates to act for, represent or bind the other Party or
any of its Affiliates other than as specifically provided in this Agreement.

 

ARTICLE 10
STATUS OF THE PARTIES

 

10.1        No Joint Venture or Partnership. Nothing contained in this Agreement
shall be construed as creating an employee-employer relationship or a
principal-agent relationship or making the parties joint venturers or partners
or, except as otherwise expressly provided herein (if at all), as granting to
either Party the authority to bind or enter into any contracts or incur any
obligations in the name of or on the account of the other Party or to make any
guarantees or warranties on behalf of the other Party.

 

ARTICLE 11
TRADEMARKS; INTELLECTUAL PROPERTY RIGHTS

 

11.1        Product Trademarks.

 

(a)          Valeant shall have the obligation to use the Product Trademark in
connection with the Manufacture, Commercialization, sale, distribution or other
Exploitation of the Product in the Field in the Territory; provided that Valeant
shall also have the right (but not the obligation) to select, register, maintain
and use a Valeant Trademark in conjunction with such Product Trademark in
connection with the Manufacture, Commercialization, sale, distribution or other
Exploitation of the Product in the Field in the Territory, including in relation
to the combination Product or EGP-437, but not in relation to the EyeGate® II
Delivery System itself. Other than as permitted under the Uveitis License
Agreement, Valeant shall not use the Product Trademarks for any purpose other
than for the use expressly authorized under this Agreement, and during the Term
shall not register, challenge, oppose or use a trademark, trade dress or trade
name that is the same as, confusingly similar to, or a derivative of or
combination with, any Product Trademark. Valeant acknowledges and agrees that,
as between the Parties, Eyegate shall retain all right, title and interest in
and to the Product Trademarks except for the rights expressly granted to Valeant
herein, and all use of such Product Trademarks and goodwill associated therewith
shall inure exclusively to the benefit of Eyegate.

 

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(b)          If, with respect to a particular country in the Territory, (i) the
Product Trademark cannot, under Applicable Laws, be used for the Manufacture
sale, distribution, Commercialization and Exploitation of the Product in such
country, (ii) Eyegate is unable to maintain registration of the Product
Trademark in any particular country or such mark is otherwise unavailable or
(iii) it is commercially unreasonable to use the Product Trademark for the
Manufacture sale, distribution, Commercialization and Exploitation of the
Product in such country, then, notwithstanding Section 11.1(a), Valeant shall
not be obligated to use the Product Trademark and shall have the right, but not
the obligation, to select, register and maintain, during the Term of this
Agreement, a Valeant Trademark for use for the Manufacture, sale, distribution,
Commercialization and Exploitation of the Product in such country (including in
relation to the EyeGate® II Delivery System), at its own expense.

 

(c)          Each of the Parties shall use the Product Trademark in accordance
with sound trademark and trade name usage principles, in accordance with any
Eyegate trademark usage guidelines (as provided to Valeant from time to time)
and in accordance with all Applicable Laws as reasonably necessary to maintain
the validity and enforceability of the Product Trademark.

 

11.2        Ownership of Collaboration Results. Except to the extent separately
and expressly agreed between the Parties and subject to the terms hereof,
including the licenses and other rights granted hereunder, the entire right,
title and interest in and to all Collaboration Results (including all Patents
and other intellectual property rights relating thereto) shall be owned solely
by the Party that invented, created or developed such Collaboration Results,
without any obligation to reimburse the other Party except for what is expressly
provided hereunder. However, Eyegate shall have a non-exclusive perpetual fully
paid up royalty free license to practice or use any and all Valeant
Collaboration Results solely in connection with the Product outside the Field
and solely to the extent necessary or useful for the development, manufacture
and/or commercialization of the Product outside the Field.

 

11.3        Joint Inventions. Any intellectual property arising or resulting
from the inventive work by one or more employees of Eyegate and of Valeant, as
to which such employees would be joint inventors under the patent laws of the
United States (“Joint Inventions”), shall be jointly owned by the Parties (each
Party having an undivided interest therein and the right to use without
accounting to the other), and all of Eyegate’s rights and interests therein
shall be subject to the License if and to the extent that such intellectual
property is useful or necessary for the exercise of the License. The laws of the
United States with respect to joint ownership of inventions shall be applied in
all jurisdictions of the world to the Parties’ joint ownership interests.

 

11.4        Patent Marking. Valeant shall mark the Product (or packaging
thereof) with the applicable patent and patent application numbers in accordance
with all applicable laws and regulations.

 

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11.5        Patent Term Extensions. Eyegate will, after discussing its strategy
with Valeant and reasonably considering Valeant’s comments, in each country in
the Territory, determine for which, if any, of the Patents within the Eyegate
Patents and Eyegate’s Collaboration Results, and Joint Patents, Eyegate will
apply to extend the patent term with respect to the Product, as provided for in
patent term extension laws or regulations in the Territory similar to the Patent
Term Restoration Act or other similar laws and regulations affording an
extension or restoration of patent terms in the United States, which similar
laws and regulations shall include without limitation any Supplementary
Protection Certificates. Eyegate shall act with reasonable promptness in light
of the development stage of the Product to apply for any such extension. Valeant
shall not make any submissions, filings or other communications with any
governmental agency with respect to patent term restoration (or other similar
grant of a monopoly right with respect to the Product) for any Patents within
the Eyegate Patents or Eyegate’s Collaboration Results or Joint Patents in the
Territory without Eyegate’s express consent. Valeant will cooperate fully with
Eyegate in making such filings at Eyegate’s sole expense which may include
without limitation, making available regulatory data and information.

 

11.6        Prosecution and Maintenance of Product IP. Eyegate shall be
obligated to Prosecute and Maintain Product Patents and Product Trademarks at
its sole expense; provided, however, that Eyegate shall provide Valeant with
copies of all correspondence regarding the prosecution of Product Patents with
sufficient time for Valeant to comment, and to the extent possible, at least
forty-five (45) days prior to any response being due to the applicable patent
office, and Eyegate will consider in good faith reasonable comments provided by
Valeant. Eyegate shall keep Valeant informed as to material developments with
respect to the Prosecution and Maintenance of Product Patents and Product
Trademarks, including by promptly providing to Valeant copies of any substantive
documents that Eyegate receives from any patent office (including notice of
reissues, reexaminations, oppositions or requests for patent term extensions),
and by providing Valeant the opportunity to have reasonable input into the
strategic aspects of such Prosecution and Maintenance. If Eyegate elects not to
Prosecute and Maintain Patents covering any Product Patent(s) or Product
Trademark(s) in any country, then Eyegate shall provide at least sixty (60)
days’ prior written notice to Valeant. Thereafter, upon Valeant’s request,
Eyegate shall and hereby does assign all of its right, title and interest in and
to such Product Patent(s) and/or Product Trademark(s), and Valeant shall have
the right, but not the obligation, to pursue, at its sole expense and in its
sole discretion, the Prosecution and Maintenance of such Product Patent(s)
and/or Product Trademark(s) in such country.

 

11.7        Protection of Product IP.

 

(a)          Each Party shall notify the other Party promptly upon becoming
aware that there exists an actual or potential infringement or misappropriation
by Third Parties in the Territory of the Product IP in the Field, or that the
Product or any intellectual property rights Covering the Product, might or
actually infringe or misappropriate, or are dependent upon a Third Party
intellectual property right in the Territory. The Parties shall meet to discuss
and agree a joint strategy for prosecuting such infringement, including
decisions on which Party will control resulting actions, assistance from the
other Party and sharing of costs and revenues from such litigation. If the
Parties fail to agree on the terms of such joint action within thirty (30) days
from such notification, then Sections 11.7(b) and (c) shall apply.

 

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(b)          Valeant shall have the first opportunity, but not the obligation,
to bring any suit or action for infringement of any Product IP. Any infringement
action brought by Valeant shall be solely at Valeant’s expense. If requested,
Eyegate shall provide reasonable assistance in the prosecution of such suit or
action at Valeant’s expense, and Eyegate shall have the right, but not the
obligation, at its expense to join as a party in any infringement action brought
by Valeant; provided, however, that Eyegate agrees to be joined as a party
plaintiff if Valeant finds it legally necessary to join Eyegate. Eyegate shall
execute all such papers necessary and perform such other acts as may reasonably
be required by Valeant in connection with the filing or prosecution of the
infringement suit or action at Valeant’s expense. Valeant shall have control
over such suit or action; provided that Valeant consults with Eyegate with
respect to any such suit or action; provided, further, that Valeant may not
settle or compromise such suit or action without the prior written consent of
Eyegate, which consent shall not be unreasonably withheld, conditioned or
delayed. In the event that monetary damages are awarded or obtained by Valeant
whether by judgment, award, decree, settlement or otherwise, as a result of any
infringement action brought by Valeant, the money actually received shall be
retained by Valeant and considered as Net Sales (solely for the purposes of
calculating Net Sales and not for the purposes of calculating the [***]
Sales-Based Milestone Payments or [***] Sales-Based Milestone Payments), after
first deducting the expenses incurred by Valeant in filing, prosecuting,
maintaining and enforcing such suit or action, with an obligation on part of
Valeant to pay Royalties to Eyegate, as set out in Article 7, in relation to any
remaining balance.

 

(c)          In the event that (i) Valeant fails to commence an infringement
suit or take appropriate action for Product IP as set forth in Section 11.7(b),
within the earlier of (A) ninety (90) days after Eyegate’s written request for
Valeant to initiate such action or (B) forty-five (45) days prior to the expiry
of any applicable statute of limitation, or (ii) Valeant notifies Eyegate in
writing of its decision not to take such action, Eyegate shall have the right,
but not the obligation to bring an appropriate suit or action against the Third
Party infringer within the relevant jurisdiction at Eyegate’s expense. Valeant
shall have the right, but not the obligation, at its cost to join as a party;
provided, however, that Valeant agrees to be joined as a party plaintiff if
Eyegate finds it legally necessary to join Valeant. Valeant shall execute all
such papers necessary and perform such other acts as may reasonably be required
by Eyegate in connection with the filing or prosecution of the infringement suit
or action at Eyegate’s expense. In the event that monetary damages are awarded
or obtained by Eyegate, whether by judgment, award, decree, settlement or
otherwise, as a result of any infringement action brought by Eyegate, the money
actually received shall be split equally between the Parties, after first
deducting the expenses incurred by Eyegate in filing, prosecuting, maintaining
and enforcing such suit or action.

 

(d)          In the event that a Third Party commences or threatens to commence
any suit or action against a Party, alleging infringement of such Third Party’s
intellectual property rights by the Development, Manufacture, having
Manufactured, use, marketing, Promotion, distribution, Commercialization, sale,
offer to sell, having sold, export or import of the Products by Valeant, its
Affiliates or its Sublicensees or Eyegate, its Affiliates or its Sublicensees,
the Party against whom such proceedings is threatened or commenced shall give
prompt notice to the other Party. Subject to the terms and conditions of Article
15, each Party shall be responsible for defense of all such claims against such
Party; provided that Eyegate may not settle or compromise any such claim without
the prior written consent of Valeant, which consent shall not be unreasonably
withheld or delayed.

 

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(e)          Subject to Section 11.7(f) below, in the event that, in order for
Valeant to perform its obligations or exercise its rights under this Agreement,
including to Manufacture, Commercialize and Exploit the Product in the
Territory, Valeant, any of its Affiliates or any of its Sublicensees are
required to obtain one or more licenses under patents or other intellectual
property rights of Third Parties that, in the absence of such license(s), would
be infringed by Valeant’s (or its Affiliates’ or Sublicensees’) performance
hereunder ( “Third Party Licenses”), after taking into account any set-off or
credit required under the Uveitis License Agreement with respect to the payments
due thereunder, [***] of all amounts actually paid under such Third Party
Licenses by Valeant, its Affiliates and Sublicensees (“Recoverable Amounts”)
shall be creditable against the License Fees and Milestone Payments and
Royalties due to Eyegate by Valeant hereunder, and Valeant shall thus be
entitled to withhold such amounts from future payment obligations that otherwise
would have been due to Eyegate. Valeant shall consult with Eyegate prior to
entering into any agreements on Third Party Licenses and provide Eyegate with a
reasonable opportunity to provide its views on the need or benefit to obtain
such license agreement and the financial and other terms thereof.
Notwithstanding anything in this Section 11.7(e), Eyegate shall have the
obligation to pay 100% of any and all royalties due on existing licenses from
Third Parties to which Eyegate (or its Affiliates) is a party as of the date
hereof, including any such licenses set out under Schedule 9.2(k).

 

(f)          Notwithstanding Section 11.7(e) above, in the event that the
requirement to obtain one or more Third Party Licenses constitutes a breach by
Eyegate of one or more of its representations, warranties or other obligations
under this Agreement, after taking into account any set-off or credit required
under the Uveitis License Agreement with respect to the payments due thereunder,
[***] of all Recoverable Amounts shall be creditable against the License Fees
and Milestone Payments and Royalties due to Eyegate by Valeant hereunder and
Valeant shall thus be entitled to withhold such amounts from future payment
obligations that otherwise would have been due to Eyegate; provided that, in the
case of the Royalties, (i) the Royalties may only be reduced with respect to the
country in which such Third Party License applies and (ii) the Royalty rate then
payable shall be reduced by no more than [***] of the then current Royalty rate
as a result of the deduction of the Recoverable Amounts.

 

(g)          The Parties shall reasonably cooperate with each other with respect
to any litigation, action, suit, claim or proceeding under this Section 11.7.
The Party prosecuting or controlling the defence of any proceeding under this
Section 11.7 shall be referred to in this context as the “Litigating Party”. The
other Party in this context shall be referred to as the “Non-Litigating Party”.
In respect of any action commenced under Section 11.7(b) or (c), if the
Litigating Party is unable to initiate or prosecute such action solely in its
own name or it is otherwise advisable to obtain an effective remedy, the other
Party will join such action voluntarily and will execute and cause its
Affiliates and Sublicensees to execute all documents necessary for the enforcing
Party to initiate litigation to prosecute and maintain such action.

 

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ARTICLE 12
ADVERSE EVENT REPORTING, MEDICAL INFORMATION AND REGULATORY MATTERS; RECALLS

 

12.1        Prompt Notification. Each Party shall notify the other Party of any
adverse event reports or complaints associated with the use of the Product that
comes to such Party’s attention, but in no event more than two (2) calendar
days, in the event such reports or complaints come to such Party’s attention on
any day other than a Friday, or three calendar days, in the event such reports
or complaints come to such Party’s attention on a Friday, after receiving such
information, as necessary to enable each Party to comply with all Applicable
laws, each Party’s internal policies regarding the recording and reporting of
such events and complaints and its obligations to third parties. Without
limiting the foregoing, each Party shall provide a copy to the other Party of
any information that such Party obtains or receives concerning the Product or
package complaint. Additionally, Eyegate shall transfer all requests it receives
for medical information relating to the Product to Valeant.

 

12.2        Valeant Reporting Responsibilities.

 

(a)          Valeant shall be solely responsible, at its sole expense, for
recording, evaluating, summarizing and reviewing all adverse drug experiences
and complaints associated with the Product in the Field in the Territory, and
timely reporting all such information to the FDA and any other applicable
professional or Regulatory Authority in accordance with Applicable Laws,
including without limitation those that apply to the promotion and marketing of
the Product in the Field in the Territory. Valeant shall respond to all requests
for medical information relating to the Product in the Field in the Territory
received by Valeant. In addition, Valeant shall be responsible for all other
reporting requirements under Applicable Laws arising from its Manufacture, sale,
distribution, Commercialization and Exploitation of the Product in the Field in
the Territory. Eyegate shall provide Valeant with all information, assistance
and cooperation reasonably requested by Valeant in undertaking such reporting.

 

(b)          Subject to the terms of the Uveitis License Agreement, Eyegate
shall be solely responsible, at its sole expense, for recording, evaluating,
summarizing and reviewing all adverse drug experiences and complaints associated
with the Product outside the Field in the Territory, and timely reporting all
such information to the FDA and any other applicable professional or Regulatory
Authority in accordance with Applicable Laws, including without limitation those
that apply to the promotion and marketing of the Product in the Field in the
Territory. Subject to the terms of the Uveitis License Agreement, Eyegate shall
respond to all requests for medical information relating to the Product outside
the Field in the Territory received by Eyegate. In addition, subject to the
terms of the Uveitis License Agreement, Eyegate shall be responsible for all
other reporting requirements under Applicable Laws arising from its Manufacture,
sale, distribution, Commercialization and Exploitation of the Product outside
the Field in the Territory. Valeant shall provide Eyegate with all information,
assistance and cooperation reasonably requested by Eyegate in undertaking such
reporting.

 

12.3        Pharmacovigilance Agreement. The Parties will, promptly after the
Effective Date, enter into a pharmacovigilance agreement (or an amendment to any
existing pharmacovigilance agreement entered into by the Parties with respect to
the Uveitis License Agreement) that will govern the Parties’ obligations under
Sections 12.1 and 12.2 in further detail, and that will cover other matters
typically contained in similar agreements for products of a similar nature.

 

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12.4        Recalls. The Parties shall immediately contact each other in the
event that either Party has reason to believe that the recall of the Product,
EGP-437 or the EyeGate® II Delivery System may be necessary. The Parties shall
fully cooperate and shall resolve any issues with respect to all recalls, field
corrections and market withdrawals (“Recalls”) of Product, EGP-437 or the
EyeGate® II Delivery System including the necessity of declaring the Recall, the
manner in which the Recall should be conducted and the duration of the Recall.
Valeant shall be responsible for the administration of the Recall and for all
costs and expenses of any such Recalls with respect to the Product in the Field;
provided that (i) if such Recall is the result solely of (A) the failure by
Eyegate or its Affiliates or representatives to comply with any Applicable Law
or (B) the negligent or willful act or omission of Eyegate or its Affiliates or
representatives, in which case the costs and expenses of such Recall shall be
paid by Eyegate, and (ii) if such Recall is the result of the negligent or
willful act or omission of both Eyegate and Valeant, the Parties shall share the
costs and expenses of such Recall in proportion to their relative fault. Subject
to the terms of the Uveitis License Agreement, Eyegate shall be responsible for
the administration of the Recall and for all costs and expenses of any such
Recalls with respect to the Product outside the Field.

 

ARTICLE 13
CONFIDENTIALITY; PUBLIC STATEMENTS

 

13.1        Confidential Information. Each Party acknowledges and agrees that it
shall have access to, or receive, the Confidential Information of the other
Party in the course of performance of the services required under this
Agreement. For the purposes of this Agreement, the “Confidential Information”
shall mean any information (whether oral or written or otherwise in tangible or
intangible form) received pursuant to this Agreement by one Party or any
Affiliate thereof (“Receiving Party”) from or on behalf of the other Party or
any Affiliate thereof (“Disclosing Party”), whether or not developed by the
Disclosing Party, including but not limited to, any and all information which
relates in any way to any ideas, designs, methods, discoveries, improvements,
documents or other results of the Parties’ activities to be conducted hereunder,
trade secrets, proprietary rights, business affairs, marketing strategies or
information, customer information or employee information, and without limiting
the foregoing, in the case of Eyegate, proprietary or confidential information
relating to the Product or the Product IP, and in the case of Valeant, certain
proprietary or confidential information or know-how with respect to Valeant’s
performance of its obligations hereunder. Confidential Information of the
Disclosing Party shall not be subject to the obligations set forth in
Section 13.2 to the extent that such information:

 

(a)          is, at the time of disclosure, in the public knowledge;

 

(b)          becomes part of the public knowledge after disclosure, by
publication or otherwise, except by breach of this Agreement by the Receiving
Party or other obligation of confidentiality owed to the Disclosing Party;

 

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(c)          is demonstrably in the Receiving Party’s possession at the time of
disclosure and which was not acquired, directly or indirectly, from the
Disclosing Party or any Third Party which was, at the time of such acquisition,
subject to an obligation of confidentiality owed to the Disclosing Party;

 

(d)          is received by the Receiving Party from third parties, provided
such information was not obtained, directly or indirectly, from the Disclosing
Party or any Third Party which was, at the time such information was obtained,
subject to an obligation of confidentiality owed to the Disclosing Party; or

 

(e)          was independently developed by the Receiving Party, without use of
or access to the information provided by the Disclosing Party (as demonstrated
by competent proof).

 

13.2        Confidentiality Obligations. Each Party acknowledges and agrees that
the Confidential Information of the Disclosing Party constitutes valuable
information and in certain instances trade secrets of the Disclosing Party. Each
Receiving Party shall keep all Confidential Information of the Disclosing Party
in confidence and shall not, at any time during or after the Term of this
Agreement, without the Disclosing Party’s prior written consent, disclose or
otherwise make available, directly or indirectly, any item of the Disclosing
Party’s Confidential Information to anyone other than the Receiving Party’s
employees, licensors, distributors, manufacturers, Affiliates and
representatives who need to know the same in the performance of such Party’s
obligations hereunder and who are bound by obligations of confidentiality,
except, however, to the extent otherwise required by Applicable Laws or rules of
a securities exchange, or to the extent necessary for such Party to confer with
its legal, accounting or other advisors (in which case such disclosure shall be
made under confidentiality). Each Receiving Party, its employees and
representatives, shall use the Confidential Information of the Disclosing Party
only in connection with the performance of the Receiving Party’s obligations or
exercising the Receiving Party’s rights hereunder and for no other purpose. Each
Receiving Party shall inform its employees and representatives of the trade
secret, proprietary and confidential nature of the Confidential Information of
the Disclosing Party and their obligation to use the Confidential Information
only for such purposes as is entitled to use it hereunder.

 

13.3        Return of Confidential Information. Upon termination of this
Agreement, the Receiving Party agrees to promptly, and in any event not more
than thirty (30) days following such termination, return to the Disclosing Party
any and all of its Confidential Information; provided that the Receiving Party
shall be entitled to retain one copy solely for archival purposes, provided that
such Confidential Information continues to be subject to the confidentiality
restrictions under this Agreement as long as so retained and such Confidential
Information is not accessed by anyone other than the Receiving Party’s systems
backup personnel or its legal and regulatory compliance personnel.

 

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13.4        Public Statements. Each Party hereto agrees not to issue, and shall
cause its Affiliates, representatives and agents not to issue, any press release
or other public statement disclosing the existence of, or relating to this
Agreement, including without limitation its terms and substance, without the
prior written consent of the other Party; provided, however, that neither Party
shall be prevented from complying with any duty of disclosure it may have under
Applicable Laws, including applicable federal securities regulations, in which
case the affected Party shall use reasonable efforts to notify the other Party
in advance of such disclosure and take reasonable steps to limit or avoid such
disclosure where available under Applicable Laws. Valeant and Eyegate shall
issue a joint press release concerning this Agreement, to be issued on or about
the Effective Date, as set forth in Appendix C attached hereto. In addition,
each Party may disclose the terms of this Agreement (i) in confidence on terms
no less restrictive than those contained herein to the extent required in
connection with a bona fide Third Party acquisition or financing; (ii) as
advisable or required in connection with any government or regulatory filings,
including without limitation filings with the FDA, provided that the filing
party consults in advance of such disclosure in good faith with the Party whose
Confidential Information is to be disclosed with respect to the specific
disclosure and seeks confidential treatment to the extent reasonably
practicable; and (iii) as required to be disclosed in such Party’s financial
statements as reasonably required or recommended by such Party’s independent
auditor.

 

ARTICLE 14
TERM; TERMINATION

 

14.1        Effective Time. This Agreement shall become effective on the
Effective Date.

 

14.2        Term of this Agreement. The term of this Agreement shall commence as
of the Effective Date, and shall continue until terminated as set forth in this
Article 14 (the “Term”).

 

14.3        Voluntary Termination by Valeant upon Notice. Valeant may terminate
this Agreement at any time by providing ninety (90) days’ prior written notice
to Eyegate.

 

14.4        Termination by Eyegate for Cessation of U.S. Commercialization. If,
following the commercial launch of the Product in the Field in the Territory,
Valeant or its Affiliates or Sublicensees cease selling and distributing the
Product in the United States in the Field for a period of at least [***],
provided that such failure to sell or distribute does not result or arise
(a) from the breach by Eyegate of any representation, warranty, covenant or
agreement in this Agreement or other negligent or willful act or omission of
Eyegate, (b) from a Force Majeure Event, or (c) from a recall or market
suspension of the Product or any other event or a cause beyond Valeant’s
reasonable control (including a supply failure or supply shortage), then Eyegate
shall have the right to terminate this Agreement upon [***] prior written notice
to Valeant, provided that Valeant (or its Affiliate or Sublicensee) does not
recommence selling or distributing the Product in the Field in the United States
during such [***] notice period and is continuing to so sell and distribute upon
the termination of such [***] notice period.

 

14.5        Termination for Breach. Either Party shall have the right to
terminate this Agreement upon the material breach of any of the terms and
conditions of this Agreement by the other Party, if such breach is not cured
within [***] after the breaching Party’s receipt of written notice from the
other Party specifying the nature of such breach in reasonable detail.

 

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14.6        Termination for Infringement or Violation of Law. Valeant shall have
the right to terminate this Agreement immediately upon a determination by a
court of competent jurisdiction that Valeant’s Manufacture, sale, distribution,
Commercialization or Exploitation of the Product in accordance with the terms
hereof results in a violation or infringement upon any trademark, tradename,
copyright, Patent, trade secret or other rights held by any Person or a
violation of Applicable Law.

 

14.7        Bankruptcy; Insolvency. Either Party may terminate this Agreement
upon the occurrence of either of the following:

 

(a)          The entry of a decree or order for relief by a court of competent
jurisdiction in respect of the other Party in an involuntary case under the
Federal Bankruptcy Code, as now constituted or hereafter amended, or any other
applicable federal, state or foreign insolvency or other similar law and the
continuance of any such decree or order that is unstayed and in effect for a
period of [***]; or

 

(b)          The filing by the other Party of a petition for relief under the
Federal Bankruptcy Code, as now constituted or hereafter amended, or any other
applicable federal, state or foreign insolvency or similar law.

 

14.8        Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by Eyegate are, and will otherwise be deemed to be,
for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights
to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code. The Parties agree that Valeant as licensee of such rights under this
Agreement, will retain and may fully exercise all of its rights and elections
under the U.S. Bankruptcy Code including, without limitation, Valeant’s right to
retain all licenses granted herein, subject to payments when due to Eyegate of
all applicable License Fees and Milestone Payments and Royalties. The Parties
further agree that, in the event of the commencement of a bankruptcy proceeding
by or against Eyegate under the U.S. Bankruptcy Code, Valeant will be entitled
to a complete duplicate of (or complete access to, as appropriate) the Product
IP and all embodiments of such Product IP, and same, if not already in its
possession, will be promptly delivered to Valeant (a) upon any such commencement
of a bankruptcy proceeding upon its written request therefor, unless Eyegate
elects to continue to perform all of its obligations under this Agreement, or
(b) if not delivered under (a) above, following the rejection of this Agreement
by or on behalf of Eyegate upon written request therefor by Valeant.

 

14.9        Mutual Termination. The Parties may terminate this Agreement on
mutually agreeable terms, as set out in a mutual termination agreement,
including pursuant to Section 4.2 of this Agreement.

 

14.10      Consequences of Termination.

 

(a)          The termination of this Agreement shall not affect any rights or
obligations of the Parties under this Agreement which by their terms are
intended to survive such termination, including, without limitation,
Section 11.1, this Section 14.10 and Articles 1, 7–8 (to the extent necessary to
complete payment obligations accruing during the Term, or to exercise a Party’s
audit rights as provided therein), 12, 13, 15 (as to activities conducted during
the Term) and 16 hereto, which shall survive termination of this Agreement for
as long as necessary to permit their full discharge. In addition, the
termination of this Agreement shall not affect any rights or obligations of the
Parties arising in any way out of this Agreement which are accrued prior to the
date of termination.

 

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(b)          Upon termination of this Agreement for any reason, Valeant shall
pay to Eyegate all earned, but unpaid Development Milestone Payments, [***]
Sales-Based Milestone Payments and [***] Sales-Based Milestones Payments. In
addition, upon termination of this Agreement by Valeant pursuant to Section 14.3
or by Eyegate pursuant to Section 14.5, to the extent that Eyegate has engaged
in Development work but has not yet achieved the then next Development
Milestone, then Valeant shall reimburse Eyegate for [***] of any reasonable,
documented out-of-pocket costs incurred by Eyegate in connection with such
Development work up to the amount of the then next Development Milestone
Payment.

 

(c)          Upon termination of this Agreement for any reason (other than by
Valeant pursuant to Section 14.5), Valeant shall retain all inventory of Product
then in its possession (the “Valeant Stock”) for a “sell-off” period not to
exceed [***] from the date of such termination during which Valeant and its
Affiliates shall have the right to sell, distribute and Commercialize the
Valeant Stock subject to the terms of this Agreement, including, but not limited
to, the rendering of reports and making of payments required under this
Agreement, and, for the avoidance of doubt, the licenses granted by Eyegate to
Valeant pursuant to Section 2.1, including, but not limited to, the right to use
all Product IP, shall continue until the end of such [***] “sell-off” period
with respect to the Valeant Stock. During the [***] “sell-off” period, Valeant
shall fully cooperate and coordinate with EyeGate or its designee to ensure an
orderly and seamless transfer of manufacturing marketing responsibilities.
Following the expiration of this [***] “sell off” period, Valeant shall, with
the assistance and cooperation of Eyegate, transfer to Eyegate (or its designee)
any Marketing Authorizations held by Valeant or its Affiliates in the Territory,
at Eyegate’s cost and Eyegate shall have an exclusive perpetual fully paid up
royalty free license to any Collaboration Results for use in any product in any
field.

 

(d)          Except as expressly set out herein, the license granted to Valeant
hereunder shall not survive the termination of this Agreement; provided that, in
the event of termination by Valeant pursuant to Section 14.5, the licenses and
rights granted to Valeant pursuant to Section 2.1 herein shall become exclusive,
perpetual, fully-paid up licenses and shall survive the termination of this
Agreement. In the event of any such termination, Eyegate shall, upon reasonable
request from Valeant and at Valeant’s costs, cooperate with and assist Valeant
in the transition of the Product and any ongoing Development work from Eyegate
to Valeant (or its designee), including with respect to the transfer of any
Marketing Authorizations for the Product (including any application therefor),
any contracts or agreements required for the Development or Commercialization of
the Product and any ongoing studies or trials and, if required, complete the
submission for the U.S. Marketing Authorization.

 

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ARTICLE 15
INDEMNIFICATION; LIMITATION ON LIABILITY; INSURANCE

 

15.1        Indemnification by Valeant. Valeant shall indemnify, defend and hold
Eyegate and its Affiliates and their respective directors, officers, employees,
agents, successors and assigns harmless from and against any and all losses,
claims, suits, actions, damages, assessments, interest charges, penalties, costs
and expenses (including without limitation reasonable attorneys’ fees)
(hereinafter collectively, the “Losses”), arising out of (a) the breach by
Valeant of any of its obligations, representations, warranties or covenants in
this Agreement, (b) the Manufacture, sale, distribution, Commercialization or
Exploitation of the Product in the Field in the Territory by, or on behalf of,
Valeant or its Affiliates in violation of Applicable Laws or (c) a negligent or
willful act or omission on the part of Valeant or any of its directors,
officers, agents or employees in connection with this Agreement, except, in each
case, to the extent such Losses are covered by Eyegate’s indemnification of
Valeant pursuant to Section 15.2.

 

15.2        Indemnification by Eyegate. Eyegate Pharmaceuticals and Eyegate
Pharma shall, on a joint and several basis, indemnify, defend and hold Valeant
and its Affiliates and their respective directors, officers, employees, agents,
successors and assigns harmless from and against any and all Losses, arising out
of (a) the breach by Eyegate of any of its obligations, representations,
warranties or covenants in this Agreement, (b) a negligent or willful act or
omission on the part of Eyegate or any of its directors, officers, agents or
employees in connection with this Agreement, (c) all liabilities to Third
Parties relating to the Product in the Field arising or incurred on or prior to
the Effective Date, or (d) any violation or infringement upon any trademark,
tradename, copyright, Patent, trade secret or other rights held by any Person in
the manufacture, use, sale, offering for sale, import or promotion of the
Product in the Field in the Territory, except to the extent such Losses are
covered by Valeant’s indemnification of Eyegate pursuant to Section 15.1.

 

15.3        Indemnification Procedures. A Party (the “Indemnitee”) which intends
to claim indemnification under this Article 15 shall promptly notify the other
Party (the “Indemnitor”) in writing of any action, claim or liability in respect
of which the Indemnitee or any of its directors, officers, employees or agents
intend to claim such indemnification, provided that the failure to provide
timely notice to the Indemnitor shall not release the Indemnitor from any
liability to the Indemnitee to the extent the Indemnitor is not prejudiced
thereby. Within fifteen (15) days after such notification is delivered by the
Indemnitee to the Indemnitor, the Indemnitee shall permit, and shall cause its
employees and agents to permit, the Indemnitor to assume the defense of any such
action or claim with qualified counsel at the Indemnitor’s sole cost and
expense, provided, however, that if the Indemnified Party shall have reasonably
concluded that representation of both Indemnitor and Indemnitee by the same
counsel would be inappropriate due to an actual conflict of interests between
them, the Indemnitee shall be able to obtain its own counsel at the expense of
the Indemnitor. If the Indemnitor does not deliver written notice to the
Indemnitee of its intent to assume control of such defense within such
fifteen (15) day period, the Indemnitee may assume such defense with qualified
counsel if its choice at the sole cost of the Indemnitor. If the Indemnitor
assumes such defense hereunder, the Indemnitee may participate in such defense
through counsel of its own selection at the Indemnitee’s sole cost and expense.
Neither party shall settle or consent to entry of judgment of any such claim or
dispute without the other Party’s prior written consent, which consent shall not
be unreasonably withheld, conditioned or delayed; provided that the Indemnitee
shall be deemed to have granted such consent if either (i) such settlement does
not adversely affect the Indemnitee, and does not impose any obligation or
liability on the Indemnitee which cannot be assumed and performed in full by the
Indemnitor, or (ii) such settlement involves only the payment of money by the
Indemnitor or its insurer. The Indemnitor shall not be responsible for any
attorneys’ fees or other costs incurred other than as provided in this
Agreement. The Indemnitee, its employees and agents, shall provide reasonable
and good faith assistance (including but not limited to documents and testimony)
to the Indemnitor and its legal representatives, at the Indemnitor’s expense, in
the investigation and defense of any action, claim or liability covered by this
indemnification.

 

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15.4        LIMITATION ON LIABILITY. NOTWITHSTANDING ANYTHING HEREIN TO THE
CONTRARY, NO PARTY TO THIS AGREEMENT SHALL BE LIABLE TO OR OTHERWISE RESPONSIBLE
TO THE OTHER PARTY OR ANY AFFILIATE OF THE OTHER PARTY FOR LOST REVENUES OR
PROFITS, OR INCIDENTAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR MULTIPLIED DAMAGES
THAT ARISE OUT OF OR RELATE TO THIS AGREEMENT OR THE PERFORMANCE OR BREACH
HEREOF OR THEREOF, EXCEPT (A) IN CONNECTION WITH A BREACH OF ARTICLE 13, (B) FOR
FRAUD, OR (C) TO THE EXTENT THAT SUCH DAMAGES WERE ACTUALLY PAID TO A THIRD
PARTY PURSUANT TO A THIRD PARTY CLAIM.

 

15.5        Insurance. As from the Effective Date, and for a period of five (5)
years after the termination of this Agreement, each Party shall maintain
adequate liability insurance coverage to cover its liabilities related to its
activities and obligations under this Agreement in such amounts and with such
coverage as is customary for similar companies in the pharmaceutical business,
including any legally mandatory insurance (or reasonable self-insurance
sufficient to provide materially the same level of protection).

 

15.6        Relation to Indemnification under Uveitis License Agreement. In
calculating amounts payable to an indemnified Party hereunder, the amount of any
indemnified Losses shall be computed net of any amounts actually recovered by
the indemnified Party under the terms of the Uveitis License Agreement. It is
the intention of the Parties that neither Party shall be entitled to recover for
(nor shall any Party be responsible to indemnify the other for) the same Losses
under both this Agreement and the Uveitis License Agreement.

 

ARTICLE 16
MISCELLANEOUS PROVISIONS

 

16.1        Force Majeure. Failure of either Party hereto to fulfill or perform
its obligations under this Agreement shall not subject such Party to any
liability if such failure is due to an event or a cause beyond its reasonable
control, such as unforeseen nationwide labor conflict, acts of God, fire,
earthquakes, floods, war, mobilization or unforeseen military call-up of a large
magnitude, requisition, confiscation, commandeering, public decrees, riots,
insurrections (a “Force Majeure Event”), provided that the affected Party uses
commercially reasonable efforts to remove such Force Majeure Event and commence
performance hereunder as soon as possible following the removal of such Force
Majeure Event and that the affected Party gives the other Party prompt notice of
the existence of such Force Majeure Event.

 

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16.2        Notices. Unless otherwise specified herein, all notices required or
permitted to be given under this Agreement shall be in writing and shall be
delivered personally, by facsimile transmission or sent by a nationally
recognized overnight courier service, and shall be deemed to have been given
upon receipt. Any such notices shall be addressed to the receiving party at such
party’s address set forth below, or at such other address as may from time to
time be furnished by similar notice by either party:

 

  If to Valeant: [***]     [***]     [***]     [***]     [***]     [***]        
  [***]           [***]     [***]     [***]     [***]           [***]         If
to Eyegate: [***]     [***]     [***]     [***]     [***]           [***]      
    [***]     [***]     [***]     [***]     [***]

 

16.3        Entire Agreement; Modification. This Agreement, including without
limitation all exhibits and attachments hereto, contains the entire Agreement
among the parties hereto with respect to the subject matter hereof and
supersedes all previous agreements, negotiations, commitments and writings among
the parties hereto with respect of the subject matter hereof, and may not be
changed or modified in any manner unless in a written instrument duly approved
by both Parties. Notwithstanding this Section 16.3, the Uveitis License
Agreement shall not be superseded, replaced or amended by this Agreement.

 

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16.4        Severability. If any provision of this Agreement or any other
document delivered under this Agreement is prohibited or unenforceable in any
jurisdiction, it shall be ineffective in such jurisdiction only to the extent of
such prohibition or unenforceability, and such prohibition or unenforceability
shall not invalidate the balance of such provision to the extent it is not
prohibited or enforceable nor the remaining provisions hereof, nor render
unenforceable such provision in any other jurisdiction, unless the effect of
rendering such provision ineffective would be to substantially deviate from the
expectations and intent of the respective parties in entering into this
Agreement. In the event any provisions of this Agreement shall be held to be
invalid, illegal or unenforceable, the parties hereto shall use reasonable best
efforts to substitute a valid, legal and enforceable provision which, insofar as
practical, implements the purposes hereof.

 

16.5        No Waiver; Cumulative Remedies. No failure or delay on the part of
either Party in exercising any right, power or remedy hereunder shall operate as
a waiver thereof; nor shall any single or partial exercise of any such right,
power or remedy preclude any other or further exercise thereof or the exercise
of any other right, power or remedy hereunder. No waiver of any provision hereof
shall be effective unless the same shall be in writing and signed by the Party
giving such waiver. The remedies herein provided are cumulative and not
exclusive of any remedies provided by law.

 

16.6        Headings. All Article and Section headings are for reference
purposes only and shall not in any way affect the meaning or interpretation of
this Agreement.

 

16.7        Governing Law; Arbitration; Mediation.

 

(a)          This Agreement shall be governed, construed and interpreted in
accordance with the laws of the State of New York, without giving effect to
choice of law rules.

 

(b)          If any dispute, controversy or difference arises between the
Parties in connection with or arising out of this Agreement, the Parties shall
first attempt to settle such matter amicably through mutual discussion,
involving, to the extent necessary, senior executives of both Parties. Should
the Parties fail to reach an amicable settlement within sixty (60) days of a
formal written request by one Party to the other for such discussion, said
dispute, controversy or difference shall be submitted to non-binding mediation
in accordance with Section 16.7(c).

 

(c)          With respect to any proceeding, each of the parties irrevocably
(i) agrees and consents to be subject to the exclusive jurisdiction of any
federal or state court in New York, United States of America (any such court,
the “New York Court”) and (ii) waives any objection which it may have at any
time to the laying of venue of any proceeding brought in any such New York Court
and waives any claim that such proceeding has been brought in an inconvenient
forum and further waives the right to object, with respect to such proceeding,
that such court does not have any jurisdiction over such Party. Notwithstanding
the foregoing: (i) each of the parties shall be entitled to seek injunctive
relief and specific performance in any court of competent jurisdiction, and (ii)
if the court adjudicating such proceeding refuses for any reason to exercise
jurisdiction over the dispute, the parties shall be free to bring such
proceeding in any other Court in the State of New York as provided above and, in
the event such other court(s) refuse for any reason to exercise jurisdiction
over the dispute, of the parties shall be free to bring such proceeding in any
other court of competent jurisdiction.

 

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(d)          Notwithstanding the foregoing, neither Valeant nor Eyegate shall be
required to pursue the escalation procedures set forth in this Section 16.7 if
the result of following such escalation provisions set forth would result in the
lapse of the statute of limitations applicable to a claim hereunder.

 

16.8        Counterparts. This Agreement and any amendment or supplement hereto
may be executed in any number of counterparts, each of which shall be deemed an
original, and all of which taken together shall constitute one and the same
instrument. This Agreement shall become binding when any number of counterparts,
individually or taken together, shall bear the signatures of both Parties. This
Agreement may be executed and delivered by facsimile or any other electronic
means, including “.pdf” or “.tiff” files, and any facsimile or other scanned
copy of a signed copy of this Agreement shall constitute an original for all
purposes.

 

16.9        Assignments. No party shall be permitted to assign this Agreement or
any of its rights or obligations under this Agreement, directly or by operation
of law or otherwise, without the other parties’ express, prior written consent,
except that (i) Eyegate may assign or sublicense this Agreement, in whole or in
part, to an Affiliate or to its successor in connection with any merger,
consolidation or sale or other disposal of all or substantially all of its
assets without Valeant’s consent and (ii) Valeant may assign or sublicense this
Agreement, in whole or in part, to an Affiliate or to its successor in
connection with any merger, consolidation or sale or other disposal of all or
substantially all of its assets and/or business to which this License Agreement
relates without Eyegate’s consent; provided that no such assignment shall
relieve the assigning party of any of its obligations under this Agreement. Any
such purported assignment in violation of this Agreement shall be null and void
ab initio.

 

16.10      Costs and Expenses. Except as otherwise specified herein, each Party
shall bear its own expenses with respect to the transactions contemplated by
this Agreement.

 

16.11      Affiliates. Valeant may perform certain of its obligations and
activities hereunder through one or more of its Affiliates, provided that
Valeant shall remain responsible for such Affiliates and for ensuring that such
Affiliates performance such obligations and activities in accordance with the
terms hereof.

 

(Signature Page to Follow)

 

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IN WITNESS WHEREOF, the Parties, by their duly authorized representatives, have
entered into this Agreement effective as of the Effective Date.

 

  Valeant Pharmaceuticals Ireland           By: /s/ Graham Jackson     Name:
Graham Jackson     Title: Director           EYEGATE PHARMACEUTICALS, INC.      
    By: /s/ Stephen From     Name: Stephen From     Title: President & CEO      
    EYEGATE PHARMA S.A.S.           By: /s/ Stephen From     Name: Stephen From
    Title: President

 

[Signature Page to Eyegate License Agreement]

 

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Appendix A: Wire Instructions

 

[***]

 

[***]

 

[***]

[***]

[***]

 

[***]

 

[***]

[***]

[***]

[***]

[***]

[***]

 

[***]

 

[***]

[***]

 

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Appendix B: Schedule of Development-Based Milestone Payments

 

Development Milestone Percentage of
Aggregate
Development
Milestone Payment   [***] [***]   [***] [***]   [***] [***]   [***] [***]  
[***] [***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]   [***]
[***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]  

 

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Appendix C: Joint Press Release

 

See attached.

 

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Appendix D

 

Example of [***] Sales-Based Milestone Payments and [***] Sales-Based Milestone
Payments

 

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

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Schedule 1.1(iiii)

Western European Countries

 

United Kingdom

France

Germany

Spain

Italy

Austria

Belgium

Cyprus

Denmark

Finland

Greece

Iceland

Ireland

Liechtenstein

Luxembourg

Malta

Monaco

Netherlands

Norway

Portugal

Sweden

Switzerland

 

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Schedule 9.2(c)

Product Patents

 

[***] [***] [***] [***] [***] [***] [***] [***]   [***] [***]   [***] [***]  
[***] [***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]   [***]
[***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]  
[***] [***]   [***] [***]   [***] [***]   [***] [***]   [***] [***] [***] [***]

 

[***] [***] [***] [***] [***] [***] [***] [***]   [***] [***]   [***] [***]  
[***] [***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]   [***]
[***] [***] [***]

 

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[***] [***] [***]   [***] [***] [***] [***]   [***] [***]   [***] [***]   [***]
[***]   [***] [***] [***] [***]

 

[***] [***] [***] [***] [***] [***] [***] [***]   [***] [***] [***]   [***]
[***] [***]   [***] [***] [***]   [***] [***] [***]   [***] [***] [***]   [***]
[***] [***] [***] [***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]
  [***] [***]   [***] [***]   [***] [***]   [***] [***] [***]   [***] [***]  
[***] [***] [***]   [***] [***] [***]   [***] [***] [***]   [***] [***] [***]  
[***] [***] [***]   [***] [***] [***]   [***] [***] [***]   [***] [***] [***]  
[***] [***] [***]   [***] [***] [***]   [***] [***] [***] [***]

 

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[***] [***] [***] [***] [***] [***] [***] [***]   [***] [***] [***]   [***]
[***] [***]   [***] [***] [***]   [***] [***]   [***] [***]   [***] [***]  
[***] [***]   [***] [***]   [***] [***]   [***] [***]   [***] [***]   [***]
[***]   [***] [***]   [***] [***] [***] [***]

 

[***] [***] [***] [***] [***] [***] [***] [***]   [***] [***] [***] [***] [***]
  [***] [***] [***] [***] [***]   [***] [***]   [***] [***] [***]   [***] [***]
  [***] [***] [***] [***] [***]

 

[***] [***] [***] [***]

 

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Schedule 9.2(k)

Product Contracts

 

Dalton Chemical Laboratories, Inc. operating as Dalton Pharma Services

·Master Services Agreement, August 25, 2014

 

University of Miami

·December 16, 2005: Amended and Restated Licensing Agreement

 

BEHAR-COHEN

·July 23, 1999: Transaction Protocol

 

TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA

·March 6, 2012: Clinical Trial Agreement

 

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Schedule 9.2(o)

Certain Government Grants and Other Funding

 

[***]

·[***]

·[***]

·[***]

 

[***]

·[***]

 

[***]

·[***]

 

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