Item 1.01 Entry Into a Material Definitive Agreement.
On February 21, 2017, Eyegate Pharmaceuticals, Inc. (the
“Company”) and its wholly owned subsidiary EyeGate Pharma S.A.S. entered into a License Agreement (the “Agreement”)
with Valeant Pharmaceuticals Ireland (“Valeant”), with respect to the development and commercialization of the Company’s
EGP-437 combination product, which delivers the drug EGP-437, a reformulated topically active corticosteroid, dexamethasone phosphate,
into the ocular tissues through the Company’s proprietary iontophoresis drug delivery system, the EyeGate® II Delivery
System (the “Product”). Under the Agreement, the Company granted Valeant (i) an exclusive license to manufacture,
sell, distribute, commercialize and otherwise exploit the Product throughout the world (the “Territory”) for use in
the field of ocular iontophoretic treatment for post-operative ocular inflammation and pain in ocular surgery patients (the “Field”),
(ii) an exclusive license to develop the Product in the Field outside of the United States, and (iii) a license, being exclusive
except as to the Company, to develop the Product in the Field in the United States. The Company also granted Valeant a certain
right of last refusal in the event the Company seeks to manufacture, commercialize or otherwise exploit the Product in the Territory
outside the Field.
The Company will be responsible for conducting development work
supporting regulatory approval of the Product in the United States for the Field, subject to a development plan agreed upon by
a joint steering committee established by the parties to coordinate activities with respect to the rights and obligations set forth
in the Agreement. In connection with such development, the Company will bear the costs of the development work in the United
States and Valeant will bear the costs of any development in the Field outside of the United States. If a regulatory authority
requires a post-marketing study or other post-approval development work in connection with marketing authorization in the United
States, the Company and Valeant will negotiate a development plan and split the costs associated with any such work. For a certain
period of time, neither party will develop, make or have made, promote, market, sell or distribute competitive products in the
Territory, subject to certain exceptions.
The Company will be responsible for filing and obtaining the
marketing authorization from the Food and Drug Administration (the “FDA”) for the Product in the Field in the United
States. Promptly following receipt of such U.S. marketing authorization, the Company shall transfer such marketing authorization
to Valeant and, thereafter, Valeant shall be responsible for all communications with the FDA. Valeant will be responsible,
at its own cost and in its sole discretion, for filing any regulatory applications in countries in the Territory outside of the
United States and will have the exclusive right, at its own cost and in its sole discretion, to commercialize the Product in the
Field throughout the Territory.
Under the Agreement, Valeant will pay the Company an upfront
payment of $4.0 million. The Company is eligible to receive milestone payments totaling up to approximately $99.0 million,
upon and subject to the achievement of certain specified developmental and commercial milestones. In addition, the Company
is eligible to receive royalties based on a specified percent of net sales of the Product in the Territory, subject to adjustment
in certain circumstances.
Either party may terminate the Agreement in its entirety if
the other party materially breaches the Agreement and the breach remains uncured for a defined cure period, and either party may
terminate the Agreement in its entirety upon the bankruptcy of the other party. The Company may terminate the Agreement following
commercial launch of the Product if Valeant ceases selling and distributing the Product in the United States for a defined period
of time, subject to certain limitations. Valeant may terminate the Agreement at any time, on a without cause basis, by providing
90 days written notice, or immediately upon the determination by a court of competent jurisdiction if Valeant’s actions pursuant
to the terms of the Agreement infringe upon the intellectual property rights of a third party or violate applicable law.
The press release dated February 21, 2017 announcing the entry
into the Agreement is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The foregoing description of the Agreement does not purport
to be a complete description of all of the terms of the Agreement, and is qualified in its entirety by reference to the full text
of the Agreement, a copy of which will be filed with the Securities and Exchange Commission (the “Commission”) as an
exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2017 (the “Form 10-Q”).
Certain terms of the Agreement have been omitted from this Current Report on Form 8-K and will be omitted from the version of the
Agreement to be filed as an exhibit to the Form 10-Q pursuant to a Confidential Treatment Request that the Company plans to submit
to the Commission at the time of the filing of the Form 10-Q.