Opko Health Inc (OPK)

[joe_techi]

CT Order....Based on representations by OPKO Health, Inc. that this information qualifies as confidential commercial or financial information under the Freedom of Information Act, 5 U.S.C. 552(b)(4), the Division of Corporation Finance has determined not to publicly disclose it. Accordingly, excluded information from the following exhibit(s) will not be
released to the public for the time period(s) specified:
Exhibit 10.26 through October 12, 2027

From the 10k
10.26+**
Development and License Agreement by and between EirGen Pharma Limited, a subsidiary of OPKO Health, Inc., and Japan Tobacco Inc., dated October 12, 2017.

PR
OPKO HEALTH ENTERS INTO EXCLUSIVE AGREEMENT WITH JAPAN TOBACCO
12 Oct
OPKO Health Enters into Exclusive Agreement with Japan Tobacco to Develop and Commercialize RAYALDEE® in Japan

OPKO to receive up to $118 million in upfront and milestone payments, plus tiered double-digit royalties on product sales MIAMI, Oct. 12, 2017 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ:OPK) announced that its subsidiary EirGen Pharma has entered into an exclusive agreement with Japan Tobacco Inc. (JT) for the development and commercialization in Japan of RAYALDEE® for the treatment of secondary hyperparathyroidism (SHPT) in non-dialysis and dialysis patients with chronic kidney disease (CKD).

Under the terms of the agreement, JT will make an upfront payment to OPKO of $6 million with another $6 million payment to be made upon initiation of OPKO’s planned phase 2 study of RAYALDEE in U.S. dialysis patients. In addition, OPKO will be eligible to receive up to an additional $31 million in development and regulatory milestones and $75 million in sales based milestones. JT will also pay OPKO tiered, double digit royalties on net product sales. JT will be responsible for all regulatory approvals and commercial activities pertaining to RAYALDEE in Japan. According to JT, an estimated 13.3 million people in Japan have CKD and more than 300,000 are undergoing dialysis, with both patient populations increasing due to the aging population. “JT, together with its subsidiary Torii Pharmaceuticals, has a strong and growing franchise in hemodialysis and renal diseases, which makes JT an ideal partner to bring RAYALDEE to physicians and patients in Japan,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. “We believe JT and Torii’s innovative marketing activities and their established network with Japanese nephrologists will accelerate adoption of RAYALDEE in this key market. We are confident this collaboration will substantially expand access to the important clinical benefits of RAYALDEE for Japanese patients with CKD.” RAYALDEE is an extended-release prohormone of calcitriol, the active form of vitamin D3 that is the first and only such therapy approved by the U.S. Food and Drug Administration (FDA) that both raises serum 25-hydroxyvitamin D and lowers blood levels of intact parathyroid hormone.

http://www.eirgen.com/opko-health-enters-into-exclusive-agreement-with-japan-tobacco/