Current Report Filing (8-k)
December 14 2017 - 5:17PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
December
14, 2017 (December 8, 2017)
BioDelivery Sciences International, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-31361
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35-2089858
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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4131 ParkLake Ave., Suite #225
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Raleigh, NC
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27612
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code:
919-582-9050
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the
Form 8-K
filing is intended to simultaneously satisfy the filing obligation
to the registrant under any of the following provisions:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined
in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☐
If an
emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
Item 1.02
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Termination of a Material Definitive Agreement
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On December 8, 2017, BioDelivery
Sciences International, Inc. (the Company) received the required
90-day
notice from Collegium Pharmaceutical, Inc. (Collegium) regarding termination of the previously announced license
and development agreement between the Company and Collegium for the Companys ONSOLIS
®
(fentanyl buccal soluble film) product (the License Agreement).
The License Agreement was originally executed between the Company and Collegium on May 11, 2016. Under terms of the License Agreement,
Collegium was to be responsible for the manufacturing, distribution, marketing and sales of ONSOLIS
®
in the United States. In return, and also in consideration of the Companys
obligations under the License Agreement, the Company was to receive certain milestone and royalty payments.
Collegiums decision to
terminate the license involved their recent execution of a license agreement to commercialize Nucynta
®
(tapentadol) Immediate Release and
Nucynta
®
ER (tapentadol).
Termination of the License Agreement will be effective
on March 8, 2018 (the Effective Date). There are no early termination penalties incurred by the Company pursuant to the License Agreement.
The Company will be assessing its commercial options for ONSOLIS
®
, but the Company
does not currently believe that the return of ONSOLIS
®
will have a material impact on the Companys business.
Item 8.01
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Other Information
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On December 14, 2017, the Company issued a press release
announcing the termination of the License Agreement, which press release is attached as Exhibit 99.1 hereto.
Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form
8-K,
the press release included herein, and any statements of representatives and partners
of 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 reacquistion of ONSOLIS and any related corporate plans or initiatives as described herein or in the
attached press release) 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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December 14, 2017
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BIODELIVERY SCIENCES INTERNATIONAL, INC.
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By:
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/s/ Ernest R. De Paolantonio
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Name:
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Ernest R. De Paolantonio
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Title:
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Chief Financial Officer, Secretary and Treasurer
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