EYEGATE PHARMACEUTICALS, INC. (NASDAQ:EYEG) Files An 8-K Entry into a Material Definitive Agreement
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 Companys EGP-437
combination product, which delivers the drug EGP-437, a
reformulated topically active corticosteroid, dexamethasone
phosphate, into the ocular tissues through the Companys
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
Valeants actions 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 Exhibit99.1 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
Companys 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 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The Company hereby files the following exhibit:
| 99.1 | Press Release dated February 21, 2017. |
About EYEGATE PHARMACEUTICALS, INC. (NASDAQ:EYEG)
Eyegate Pharmaceuticals, Inc. is a clinical-stage specialty pharmaceutical company. The Company is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye. The Company’s lead product, EGP-437, incorporates a reformulated topically active corticosteroid, dexamethasone phosphate, which is delivered into the ocular tissues through its drug delivery system, the EyeGate II Delivery System. The Company is developing EGP-437 for the treatment of various inflammatory conditions of the eye, including uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea, such as the iris and/or ciliary body, and macular edema, an abnormal thickening of the macula associated with the accumulation of excess fluids in the extracellular space of the neurosensory retina. The EyeGate II Delivery System is designed to deliver optimal quantities of drugs to the anterior or posterior segments of the eye. EYEGATE PHARMACEUTICALS, INC. (NASDAQ:EYEG) Recent Trading Information
EYEGATE PHARMACEUTICALS, INC. (NASDAQ:EYEG) closed its last trading session down -0.03 at 1.63 with 58,813 shares trading hands.