Item 1.01
Entry into a Material Definitive Agreement.
On July 16, 2019, Aridis Pharmaceuticals, Inc. (the “Company”) entered into an Option Agreement for Exclusive Product and Platform Technology License (the “Option Agreement”) with Serum International BV, a company incorporated in the Netherlands (together with its affiliates, “SIBV”).
Pursuant to the Option Agreement, SIBV made a fee payment on July 26, 2019 to the Company in an amount of $5 million (which fee shall be reimbursed to SIBV if for any reason the License Agreement (as defined below) is not executed by August 31, 2019). SIBV is also obligated to pay a $10 million fee to the Company within 5 days of execution of the License Agreement.
Additionally, in connection with the Option Agreement, the Company and SIBV entered into a stock subscription agreement, dated July 19, 2019 (the “Subscription Agreement”). Pursuant to the Subscription Agreement, on July 26, 2019, SIBV purchased 801,820 shares of restricted Company common stock at a purchase price of approximately $12.47 per share, for an aggregate purchase price of $10 million.
Pursuant to the Option Agreement, SIBV received an option to enter into an Exclusive Product and Platform Technology License Agreement (the “License Agreement”) with the Company, which option may be exercised by executing the complete and final License Agreement with the Company. The parties have agreed to use their best commercially reasonable efforts to execute the License Agreement as soon as possible, but not later than August 31, 2019.
As of the effective date of the License Agreement (the “Effective Date”), the Company shall grant to SIBV an exclusive license to make, have made, import, use and have used, and sell and have sold Aridis products related to AR-301, AR-105, and AR-101 (“Aridis Products”) in (a) the country of India, and (b) all other countries of the world except the USA, Canada, EU Territory, UK, China, Australia, New Zealand, and Japan (the “Limited Territory”) for a term of 20 years (the “Term”). The Company shall also grant to SIBV an exclusive license to develop, make, have made, import, use and have used, and sell and have sold, up to five (5) approved Development Products (as such term is defined in the Option Agreement) in all countries of the world except China (the “Worldwide Territory”), during the Term. The Company also agrees to grant the right for SIBV to have the Company perform Candidate Development (as such term is defined in the Option Agreement) for the development of up to five (5) Development Products. The Company shall also grant to SIBV an exclusive license to develop, make, have made, import, use and have used, and sell and have sold the AR-201 product in the Worldwide Territory during the Term.
Additionally, in certain circumstances, SIBV and the Company will agree to commit to negotiate in good faith to extend the rights to be granted in the License Agreement to include an exclusive license to make, have made, import, use and have used, and sell and have sold, certain Aridis Products in the European Union during the Term. Such an obligation upon Aridis to negotiate such rights is preconditioned upon the demonstration of certain milestones by SIBV, including its obtaining, under certain funding programs, sufficient financial support to cover all requisite clinical development and manufacturing development costs, under terms which allow distribution of Aridis Products at commercially reasonable prices and without materially hindering distribution of Aridis Products in any other territories.
The License Agreement will establish manufacturing rights and obligations for the parties. SIBV shall have the rights to manufacture any Aridis Product and any Development Product in the Worldwide Territory for use in the Worldwide Territory. SIBV shall have the right to supply Aridis Products for use by the Company and its sublicensees outside of the Limited Territory, upon the demonstration of SIBV’s ability for manufacturing consistency of Aridis Products in conformance to all regulatory FDA and EMA requirements, at commercially reasonable rates, and at sufficient capacity as specified in a manufacturing agreement that shall be negotiated and executed in good faith. The term of the manufacturing agreement shall be twenty (20) years. If a third party sublicensee of Aridis Products wishes to have Aridis Product manufactured by itself for the territory for which it has a license from the Company, then the Company shall have the right to buy back the manufacturing rights by paying to SIBV $5 million.
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The License Agreement will also establish regulatory rights and obligations for the parties, including, but not limited to, the obligation that the Company and SIBV establish a joint committee under which each party shall share all relevant clinical data and regulatory documentation created by it anywhere in the world.
Commencing upon the Effective Date, SIBV shall make commercially reasonable efforts to obtain all regulatory approvals, to have approved for commercialization and sale, and to commercialize and sell (i) Aridis Products in the Limited Territory, and (ii) Development Products and the AR-201 product in the Worldwide Territory. Upon the achievement of certain milestones, SIBV shall pay to the Company up to $18.5 million in milestone fees related to the Products covered in the License Agreement. SIBV shall also be obligated to pay the Company single digit percentage royalties on net sales of all licensed products, except for Aridis Products in the European Union, should such be authorized at a later date, which require payment of 20% royalties on the net sales of those products.
The foregoing description of the Option Agreement is not intended to be complete and is qualified in its entirety by reference to the Option Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K. The foregoing description of the Subscription Agreement is not intended to be complete and is qualified in its entirety by reference to the Subscription Agreement, a copy of which is filed as Exhibit 10.2 to this Current Report on Form 8-K.
Item 3.02
Unregistered Sales of Equity Securities.
The information included in Item 1.01 of this Form 8-K relating to the Subscription Agreement is hereby incorporated by reference into this Item 3.02.
The sale of securities pursuant to the Subscription Agreement was made pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended.
Item 8.01
Other Events.
On July 30, 2019, the Company issued a press release announcing the Option Agreement and Subscription Agreement . A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01.
Financial Statements and Exhibits
(d) Exhibits.
* Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of making such portions with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
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