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Re: WeeZuhl post# 339264

Wednesday, 07/22/2020 9:37:48 AM

Wednesday, July 22, 2020 9:37:48 AM

Post# of 403109

Some of these recent business deals (and not so recent) by Elite and MIKAH have the APPEARANCE OF IMPROPRIETY.






Here is an SEC filing between MIKAH and Dr. Reddy. The details show that MIKAH's agreement with Actavis to distribute trimipramine ended in May 2016. Mikah and Dr. Reddy entered this exclusive rights agreement on May 4, 2017. MIKAH then sold the trimipramine ANDA to Elite two weeks later on May 22, 2017. As I recall, this was billed as a "favor" from Nasrat to Elite. The relationship between Elite and Dr. Reddy ended quickly and abruptly for unknown reasons. It certainly has the APPEARANCE OF IMPROPRIETY.




https://www.sec.gov/Archives/edgar/data/1053369/000114420417032547/v468485_ex10-55.htm

SUPPLY AND DISTRIBUTION AGREEMENT

This SUPPLY AND DISTRIBUTION AGREEMENT (the “Agreement”), dated May 4, 2017 (the “Effective Date”), is by and between Dr. Reddy’s Laboratories Inc., organized and existing under the laws of New Jersey having an office at 107 College Road East, Princeton, New Jersey 08540 ("DRL") and Mikah Pharma, LLC, organized and existing under the laws of the State of Delaware, having an office at 20 Kilmer Drive, Hillsborough, New Jersey 08844 (“Mikah”). DRL and Mikah are each a “Party” and together constitute the “Parties” under this Agreement.

RECITALS

WHEREAS, Mikah owns a certain abbreviated new drug application (“ANDA”) for Product that Actavis LLC has the exclusive rights to market and sell. Due to a potential merger between Actavis LLC (“Actavis”) and Teva Pharmaceutical Industries Ltd., Actavis wishes to terminate the agreement with Mikah under the terms outlined in Attachment 1;

WHEREAS, DRL possesses expertise relating to the marketing, distribution and sale of pharmaceutical products; and

WHEREAS, Mikah and DRL wish to enter into an agreement whereby DRL will have exclusive marketing, distribution and sales rights to Product.

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the sufficiency and satisfaction of which are hereby acknowledged, DRL and Mikah hereby agree as follows:



EXHIBIT A



PRODUCT INFORMATION



Product Batch Size Price Per Bottle without API
Trimipramine 25mg, 30ct bottle {***} See Product pricing given in Attachment 2
Trimipramine 50mg, 30ct bottle {***} See Product pricing given in Attachment 2
Trimipramine 100mg, 30ct bottle {***} See Product pricing given in Attachment 2






Attachment 1

Termination of the Asset Purchase Agreement and Master Supply Agreement dated as of May 25, 2016 by and between Actavis LLC and Mikah Pharma LLC

CONFIDENTIAL




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