Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

This new rule is interesting.

https://www.dea.gov/sites/default/files/2023-11/Quota-Shortages%20Letter.pdf




How should we interpret this new rule in the context of our supply agreement with Dexcel to sell Adderall in Israel and Palestinian Authority Territory. Let's say hypothetically when we do our new quarterly quota report to DEA it says we sent 25% of our quota to Israel. Does that mean they will grant us "replacement" quota for U.S. distribution to "Americans"?


https://contracts.justia.com/companies/elite-pharmaceuticals-inc-1799/contract/245031/

2 Grant of Exclusive Rights

2.1 Subject to Dexcel fulfilling its obligations in accordance with the terms and conditions of this Agreement, Elite hereby grants to Dexcel the exclusive right, for and during the Term, to (a) use Elite’s approved Registration File and (b) to allow Dexcel to refer to Elite’s ANDA for the Product to enable Dexcel to obtain one Marketing Authorization for each strength of the Product in the Territory and to import into, market, sell and distribute the Product in the Territory.

2.2 During the Term of the Agreement and subject to the terms and conditions of this Agreement, Dexcel may designate the following sub-distributors; provided further that Dexcel may designate other sub-distributors in the Territory with the prior written consent of Elite (not to be unreasonably withheld):

a. Within Israel and Israeli-controlled areas: Chemipal Ltd., 44 Giborei Israel Street, Poleg Industrial Zone, Netanya ###-###-####, Israel;

b. In the areas under Palestinian Authority control: The Al-Ram Drugstore, Qalonia St., Jerusalem