8-K: Current report filing
Published on May 15, 2020
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): May 12, 2020
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ITEM 1.01. |
Entry into a Material Definitive Agreement. |
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On May 12, 2020, OPKO Health, Inc. (“OPKO”) entered into an amendment (the “Amendment”) to that certain Development, Commercialization License Agreement, dated December 13, 2014 (the “Original License Agreement”), by and among OPKO, OPKO Ireland Ltd. (“OPKO Ireland”, and together with OPKO, the “Company”), and Pfizer, Inc. (“Pfizer”) for the Company’s long-acting human growth hormone product (hGH-CTP) for the treatment of growth hormone deficiency (GHD) and growth failure in children born small for gestational age (“PSGA”).
Under the terms of the Amendment, effective January 1, 2020, OPKO and Pfizer have agreed to share equally all costs for the remaining development of hGH-CTP for pediatric GHD (“PGHD”), including manufacturing costs and post-marketing studies. In addition, the parties updated and amended the Development Plan and Development Budget under the Original License Agreement. The milestone payments, royalties and profit share provisions under the Original License Agreement remain unchanged.
Pursuant to the Amendment, the parties have also agreed to work together to identify an additional pediatric indication for development other than PGHD on or before December 1, 2020. Development of the additional pediatric indication is subject to subsequent mutual agreement of the parties but, if agreed, all development costs for such indication shall be shared equally by the parties.
In addition, the parties also agreed on a process whereby Pfizer may, based on subsequent feedback from the US Food & Drug Administration, and in its reasonable discretion, submit a supplemental BLA for GHD in adults following receipt of regulatory approval of a biologics license application (BLA) for PGHD.
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.
OPKO Health, Inc. |
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By: |
/s/ Steven D. Rubin |
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Date: May 15, 2020 |
Name: |
Steven D. Rubin |
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Title: |
Executive Vice President - Administration |
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