Item 1.01 Entry into a Material Definitive Agreement
On February 25, 2019, Pfenex Inc. (the “Company”) and Alvogen Ltd., through certain of its subsidiaries, (together, “Alvogen”) entered into agreements (the “Agreements”) expanding the Company’s and Alvogen’s collaboration to develop and commercialize PF708 (teriparatide) (the “Product”), a therapeutic equivalent candidate to Eli Lilly & Company’s Forteo®, to the European Union (EU), to Afghanistan, Algeria, Armenia, Azerbaijan, Bahrain, Chad, Comoros, Cyprus, Djibouti, Egypt, Eritrea, Georgia, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Mali, Mauritania, Morocco, Niger, Oman, Pakistan, Palestine, Qatar, Sahrawi Arab Democratic Republic, Saudi Arabia, Somalia, Sudan, Syria, Tunisia, Turkey, United Arab Emirates and Yemen (collectively, “MENA”) and to all other countries outside of the United States, EU and MENA (other than Mainland China, Hong Kong, Singapore, Malaysia and Thailand) (ROW). The Company and Alvogen previously entered into a Development and License Agreement pursuant to which Alvogen has the exclusive right to commercialize and manufacture the Product in the United States (the “US D&L Agreement”). The Product will be commercialized in Europe and Switzerland by Theramex, a leading global specialty pharmaceutical company dedicated to Women’s Health, in MENA by SAJA, a Tamer Group company, and in ROW by Alvogen’s current and/or future commercialization partners.
In consideration for the licenses and other rights granted in the Agreements, the Company will be eligible to receive additional upfront and milestone payments of $2.5 million and may also be eligible to receive a gross profit split of up to 60% from sales of the Product, depending on geography and cost of goods sold.
Under the terms of the Agreements, Alvogen will be responsible for the local activities through Theramex, SAJA, and its other commercialization partners and for overseeing any clinical development, regulatory, litigation, commercial manufacturing and commercialization.
Unless terminated earlier or extended, the Agreements will continue for a period of ten years following the first commercial sale of the Product in the applicable territory. The Agreements includes customary termination provisions and effects thereof.
In the event of an assignment of either of the Agreements, any entity to whom the Agreements are assigned will be obligated to assume the responsibilities of the assigning party.
On February 25, 2019, the Company and Alvogen agreed to amend the US D&L Agreement, under which Alvogen agreed, among other things, to reimburse Pfenex for certain costs for third party contractors in 2018.
The foregoing summary of the Agreements does not purport to be complete and is qualified in its entirety by reference to the Agreements, which will be filed as exhibits to the Company’s Quarterly Report onForm 10-Q for the period ended March 31, 2019. The Company intends to submit a FOIA Confidential Treatment Request to the Securities and Exchange Commission pursuant toRule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the Agreements. The omitted materials will be included in the request for confidential treatment.
Item 7.01. Regulation FD Disclosure.
On February 28, 2019, the Company issued a press release announcing it entered into the Agreements. A copy of the press release announcing the Agreements is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information referenced under Item 7.01 (including Exhibit 99.1 referenced in Item 9.01 below) of this Current Report 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 it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report. This Current Report shall not be deemed an admission as to the materiality of any information in the Current Report that is required to be disclosed solely by Regulation FD.
