BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Files An 8-K Entry into a Material Definitive Agreement
Item1.01.
| Entry into a Material Definitive Agreement |
On December7, 2016, BioDelivery Sciences International, Inc.
(BDSI), Arius Pharmaceuticals Inc. and Arius Pharmaceuticals Two
Inc., each of which is a wholly-owned subsidiary of BDSI (which,
together with the BDSI will be referred to herein as the Company)
entered into an agreement (the Termination Agreement) with Endo
Pharmaceuticals, Inc. (Endo) terminating Endos licensing of
rights for BELBUCA (buprenorphine) buccal film. The closing of
the Termination Agreement, and the formal termination of the
BELBUCA license to Endo and closing of the transactions further
described below to be undertaken in connection therewith (the
Closing), is expected to occur on January6, 2017.
Upon Closing, the Company will purchase from Endo the following
assets (the Assets): (i)current BELBUCA product inventory and
work-in-progress, (ii)material manufacturing contracts related to
BELBUCA, (iii)BELBUCA-related domain names and trademarks
(including the BELBUCA trademark), (iv)BELBUCA-related
manufacturing equipment, and (v)all pre-approval regulatory
submissions, including any Investigational New Drug Applications
and New Drug Applications, regulatory approvals and post-approval
regulatory submissions concerning BELBUCA. The purchase price for
the Assets (the Asset Purchase Price) will be equal to the sum of
(i)the aggregate book value of the portion of the transferred
product inventory forecasted to be used or sold by BDSI, (ii)the
aggregate book value of work-in-progress inventory, and (iii)the
assumption of any assumed liabilities. Upon Closing, BDSI will
accept transfer of the Assets and assume and agree to discharge
when due all applicable liabilities assumed by BDSI, which
consist of post-Closing obligations for liabilities and payments
associated with the Assets, the assumed contracts related to the
Assets and applicable taxes (with the obligation for pre-Closing
and other certain liabilities resulting from the acts or
omissions of Endo being retained by Endo).
The Asset Purchase Price, together with all other payments
(including a non-compete covenant payment) due to Endo under the
Termination Agreement, is of such an amount that will not
materially impact the Companys future cash flows and will be paid
to Endo in four quarterly installments on the last calendar day
of each quarter in 2017. Furthermore, the Company will not be
responsible for future royalties or milestone payments to Endo,
and Endo will not be obligated to any future milestone payments
to the Company. The Termination Agreement contains customary
representations and warranties and mutual releases and
indemnification.
At the Closing, the Company and Endo will enter into a Transition
Services Agreement (the terms and form of which have been
substantially agreed to) which governs the post-Closing rights
and responsibilities of the Company and Endo in connection with
the license termination and the transfer of the Assets to BDSI.
Under this agreement, the Company and Endo agreed to the handling
of transition matters such as managing customer contracts,
BELBUCA price reporting, payments, returns and rebates, and
customer and managed care relations. In connection therewith,
Endo has agreed to provide to the Company an agreed upon number
of work hours to be provided by Endo personnel during the
transition for certain of these transition services and other
assistance with respect to the transition of BELBUCA to the
Company.
The descriptions of the agreements set forth above do not purport
to be complete and are qualified in their entireties by reference
to the complete text of such agreements, which BDSI intends to
file as exhibits to the Companys Annual Report on 10-K for the
year ended December31, 2016.
| Item8.01. | Other Information. |
On December8, 2016, BDSI issued a press release announcing that
the execution of the Termination Agreement. A copy of the press
release is attached as Exhibit99.1 hereto.
| Item9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| 99.1 |
Press release, dated December8, 2016, announcing the Companys execution of the Termination Agreement. |
Cautionary Note Regarding Forward-Looking
Statements
This Current Report on Form 8-K, the press release included
herein, the conference call referenced in such press release, and
any statements of representatives and partners of BioDelivery
Sciences International, Inc. (the Company) related thereto
contain, or may contain, among other things, certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements involve significant risks and uncertainties. Such
statements may include, without limitation, statements with
respect to the Companys plans, objectives, projections,
expectations and intentions and other statements identified by
words such as projects, may, will, could, would, should,
believes, expects, anticipates, estimates, intends, plans,
potential or similar expressions. These statements are based upon
the current beliefs and expectations of the Companys management
and are subject to significant risks and uncertainties, including
those detailed in the Companys filings with the Securities and
Exchange Commission. Actual results (including, without
limitation, the results of the Companys reacquisition of, and
commercialization efforts for BELBUCA as described herein) may
differ significantly from those set forth in the forward-looking
statements. These forward-looking statements involve certain
risks and uncertainties that are subject to change based on
various factors (many of which are beyond the Companys control).
The Company undertakes no obligation to publicly update any
forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
applicable law.
About BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company. The Company develops and commercializes, either on its own or in partnerships with third parties, applications of approved therapeutics to address unmet medical needs using drug delivery technologies. The Company develops pharmaceutical products aimed principally in the areas of pain management and addiction. The Company’s products utilize the BioErodible MucoAdhesive (BEMA) drug delivery technology, a small, erodible polymer film for application to the buccal mucosa (the lining inside the cheek). The Company’s United Sates Food and Drug Administration (FDA) approved product, ONSOLIS (fentanyl buccal soluble film), as well as its approved products BUNAVAIL (buprenorphine and naloxone buccal film) buccal film and BELBUCA (buprenorphine) buccal film, utilize BEMA technology. BioDelivery Sciences International, Inc. (NASDAQ:BDSI) Recent Trading Information
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) closed its last trading session down -0.05 at 1.90 with 2,119,984 shares trading hands.