Edge Therapeutics, Inc. (NASDAQ:EDGE) Files An 8-K Entry into a Material Definitive AgreementItem 1.01 – Entry into a Material Definitive Agreement
Concurrent with its entry into the Restated Development Agreement, on June 30, 2017, Edge entered into a Manufacturing and Supply Agreement with Oakwood (the “Supply Agreement”), to which Oakwood will manufacture and supply, and Edge will purchase from Oakwood, EG-1962 in commercial quantities following the commercial launch of the product.
to the Supply Agreement, the price per unit of EG-1962 to be purchased by Edge is based on theexpected commercially usable units per batch. In addition, Edge has agreed to pay Oakwood milestone payments that could total up to an aggregate of $2.25 million upon the achievement of certain development and regulatory milestones.
Edge shall have no minimum order requirement under the Supply Agreement until the third (3rd) year following commercial launch of EG-1962. Beginning in the third year following commercial launch and continuing until the fifth year following commercial launch,Edge shall be required to (x) order, at a minimum, the greater of (a) five (5) batches and (b) fifty percent (50%) of the aggregate vials of EG-1962 purchased by Edge from all sources in such year (such greater amount being the “Minimum Order Commitment”) or (y) pay a catch-up price to Oakwood, as described below.In the event that Edge fails to order the Minimum Order Commitment, Edge shall be required to pay to Oakwood a catch-up price calculated based on the amount of EG-1962 actually ordered by Edge during the applicable time period.
The term of the Supply Agreement shall continue (unless earlier terminated) until three (3) years following commercial launch of EG-1962. Thereafter, the Supply Agreement shall automatically renew for additional two (2)-year periods unless Edge provides notice of non-renewal at least twelve (12) months prior to the end of the then-current term. The Supply Agreement shall also terminate automatically upon the termination of the Restated Development Agreement for any reason. Following the first anniversary of the commercial launch of EG-1962, either party may terminate upon two (2) years written notice. Further, either party may terminate the Supply Agreement upon a material breach by the other party that fails to be cured in the applicable cure period.
Edge may terminate the Supply Agreement immediately upon notice to Oakwood in the event that (a) any regulatory authority requires or causes the withdrawal of EG-1962 from the market or (b) Edge ceases to develop or commercialize EG-1962; provided, that in the latter case of termination prior to completion of the most recent project plan attached to the Restated Development Agreement, Edge must pay to Oakwood a termination fee.
The foregoing description of the Supply Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Supply Agreement, which Edge expects to file as an exhibit to Edge’s Quarterly Report on Form 10-Q for the period ending June 30, 2017.
Item 8.01 – Other Events
On July 6, 2017, Edge issued a press release announcing the entry into the Restated Development Agreement and Supply Agreement with Oakwood. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.
Item 9.01 – Financial Statements and Exhibits
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Exhibit No. |
Description |
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99.1 |
Press Release, dated July 6, 2017 |
Edge Therapeutics, Inc. ExhibitEX-99.1 2 s001773x1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Edge Therapeutics Announces Commercial Supply Agreement for EG-1962 with Oakwood Laboratories BERKELEY HEIGHTS,…To view the full exhibit click here
About Edge Therapeutics, Inc. (NASDAQ:EDGE)
Edge Therapeutics, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize, hospital-based therapies capable of transforming treatment paradigms in the management of life-threatening neurological and other conditions. Edge is evaluating EG-1962, its lead product candidate, in the Phase 3 NEWTON 2 study in adult patients with aneurysmal subarachnoid hemorrhage (aSAH). This study will evaluate EG-1962’s ability to improve patient outcomes versus standard of care oral nimodipine after an aSAH resulting from a ruptured brain aneurysm. Edge’s product candidates utilize Precisa, a platform with a approach that seeks to enable targeted and sustained drug exposure at the site of injury, while potentially avoiding off-target side effects associated with systemic delivery. Edge is also using its Precisa development platform to develop additional product candidates targeting other acute, serious conditions where limited or no current therapies exist.
