UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): August 20, 2020
Commission file number 333-184948
PROCESSA PHARMACEUTICALS, INC.
(Exact name of Registrant as Specified in its Charter)
| Delaware | 45-1539785 | |
| (State
or Other Jurisdiction of Incorporation or Organization) |
(I.R.S.
Employer Identification Number) |
| 7380 Coca Cola Drive, Suite 106, Hanover, Maryland 21076 |
| (Address of Principal Executive Offices, Including Zip Code) |
| (443) 776-3133 |
| (Registrant’s Telephone Number, Including Area Code) |
| (Former Name or Former Address, if Changed Since Last Report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act: None.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
| Emerging growth company [ ] |
| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ] |
Item 1.01. Entry into a Material Definitive Agreement.
On August 19, 2020, Processa Pharmaceuticals, Inc. (“Processa”) entered into a License Agreement (the “Yuhan License Agreement”) with Yuhan Corporation (“Yuhan”), pursuant to which Processa acquired an exclusive license to develop, manufacture and commercialize YH12852 globally, excluding South Korea.
As consideration for the Yuhan License Agreement, Yuhan shall receive $2 million of Processa common stock. As additional consideration, Processa will pay Yuhan development and regulatory milestone payments (a portion of which are payable in shares of Processa common stock based on the volume weighted average trading price during the period prior to such achievement and a portion of which are payable in cash) upon the achievement of certain milestones, which primarily consist of dosing a patient in pivotal trails or having a drug indication approved by a regulatory authority in the United States or another country. The amount of such development and regulatory milestone payments is increased if Yuhan invests at least $3.0 million in Processa’s planned underwritten public offering. In addition, Processa must pay Yuhan one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. Processa is also required to split any milestone payments received with Yuhan based on any sub-license agreement it may enter into.
Processa is required to use commercially reasonable efforts, at its sole cost and expense, in conjunction with a joint Processa-Yuhan Board to oversee such commercialization efforts, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) preparing a first draft of the product development plan within 90 days; (ii) requesting an FDA pre-IND meeting for a product within 6 months; (iii) dosing a first patient in a Phase 2A clinical trial with a product within 24 months; and (iv) dosing a first patient with a product in a Phase 2B clinical trial, Phase 3 clinical trial or other pivotal clinical trial with a product within 48 months. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 60-day opportunity to cure such breach (which is shortened to 15 days for a payment breach).
The above summary of the Yuhan License Agreement above is not complete and is subject to the full terms and conditions of such agreement, which is attached hereto as Exhibit 10.1 and incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
On August 20, 2020, Processa issued a press release announcing the entry into the Yuhan Licensing Agreement. The press release is attached hereto as Exhibit 99.1 and incorporated by reference in this Item 7.01.
The information contained in Item 7.01 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
SIGNATURE
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, on August 20, 2020.
| PROCESSA PHARMACEUTICALS, INC. | ||
| Registrant | ||
| By: | /s/ David Young | |
| David Young | ||
| Chief Executive Officer | ||