UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01. | Entry into a Material Definitive Agreement. |
On October 28, 2020, Aerie Pharmaceuticals Ireland, Ltd. (“Aerie”), a subsidiary of Aerie Pharmaceuticals, Inc. (the “Company”), entered into a Collaboration and License Agreement (the “Agreement”) with Santen Pharmaceutical Co., Ltd (“Santen”). Pursuant to the Agreement, Aerie granted to Santen the exclusive right to develop, manufacture, market and commercialize Rhopressa® and Rocklatan® (the “Licensed Products”) in Japan, South Korea, Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam and Taiwan (such jurisdictions collectively, the “Territories”). Aerie is the sole manufacturer of the Licensed Products for Santen. Under the Agreement, Aerie granted Santen a first right of negotiation for the rights to the Licensed Products in any Asian countries other than the Territories.
Under the Agreement, Santen must pay Aerie an upfront payment of $50.0 million (“Upfront Payment”) and various development milestones of up to $39.0 million and sales milestones of up to $60.0 million. In addition, Santen will pay Aerie a royalty in excess of 25% of the Licensed Products’ net sales, such consideration consisting of the cost of products supplied to Santen from Aerie and a royalty for Aerie’s intellectual property. Santen will be responsible for sales, marketing and pricing decisions relating to the Licensed Products. Santen is also responsible for all development and commercialization costs and activities related to the Licensed Products in the Territories, except that Aerie shares 50% of the costs related to conducting the first Rhopressa® Phase 3 clinical trial in Japan.
The term of the Agreement continues on a country-by-country basis in the Territory until the later of (i) the expiration of the last to expire valid patent claim covering the Licensed Products and (ii) 12 years from the date of the first commercial sale of each Licensed Product under an NDA approval, marketing authorization or the equivalent. The Agreement may be terminated by either Aerie or Santen upon the other party’s material breach or bankruptcy or insolvency. Aerie may also terminate the Agreement upon a patent challenge by Santen, and Santen may terminate the Agreement in its discretion if, following marketing authorization for Rhopressa® in Japan, Santen reasonably determines that the Licensed Products are not commercially viable in the Territory (effective upon 180 days’ prior written notice). In addition, in the event that patents are issued that may prevent the commercialization of the Licensed Products, Santen would have the right to terminate the Agreement and require Aerie’s repayment of up to approximately 85% of the Upfront Payment, all development milestone payments, and 50% of the development expenses incurred by Santen. In the event of termination, the Licensed Products in the applicable Territories will revert to Aerie.
The above description of the Agreement is a summary only and is subject to, and qualified entirely by, the Agreement, which the Company intends to file as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2020.
| Item 7.01. | Regulation FD Disclosure. |
On October 28, 2020, the Company issued a press release announcing the signing of a collaboration and license agreement with Santen. A copy of this press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.
The information in this Item 7.01 (including Exhibit 99.1) is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 is not intended to, and does not, constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed:
| 99.1 | Press release, dated October 28, 2020. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AERIE PHARMACEUTICALS, INC. | ||||
| Date: October 28, 2020 | By: | /s/ Richard J. Rubino | ||
| Richard J. Rubino | ||||
| Chief Financial Officer | ||||