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 Companys and Alvogens collaboration to develop and commercialize PF708 (teriparatide) (the Product), a therapeutic equivalent candidate
to Eli Lilly & Companys 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 Womens Health, in MENA by SAJA, a Tamer Group company, and in ROW by Alvogens 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 Companys Quarterly Report on
Form 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 to
Rule 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.