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<P id=PARA1 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>UNITED STATES<BR>SECURITIES AND EXCHANGE COMMISSION<BR>WASHINGTON, D.C. 20549<BR></B></FONT></P>
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<P id=PARA3 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 12pt; FONT-FAMILY: Times New Roman, Times, serif"><B>FORM 8-K</B></FONT></P>
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<P id=PARA5 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 12pt; FONT-FAMILY: Times New Roman, Times, serif"><B>CURRENT REPORT</B></FONT></P>
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<P id=PARA7 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>Pursuant to Section 13 or 15(d) of the<BR>Securities Exchange Act of 1934</B></FONT></P>
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<P id=PARA9 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>&nbsp;</B></FONT><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"></FONT></P>
<P id=PARA11 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">Date of Report (Date of earliest event reported): May 31, 2016</FONT></P>
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<P id=PARA14 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 12pt; FONT-FAMILY: Times New Roman, Times, serif"><B>Impax Laboratories</B><B>, Inc.</B></FONT></P></TD></TR>
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<P id=PARA18 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>Delaware</B></FONT></P></TD>
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<P id=PARA19 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>001-34263</B></FONT></P></TD>
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<P id=PARA20 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>65-0403311</B></FONT></P></TD></TR>
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<P id=PARA21 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">(State or other jurisdiction</FONT></P>
<P id=PARA22 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">of incorporation)</FONT></P></TD>
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<P id=PARA23 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">(Commission </FONT></P>
<P id=PARA24 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">File Number)</FONT></P></TD>
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<P id=PARA25 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">(IRS Employer </FONT></P>
<P id=PARA26 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">Identification No.)</FONT></P></TD></TR></TABLE>
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<P id=PARA29 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>30831 Huntwood Avenue, Hayward, CA</B></FONT></P></TD>
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<P id=PARA30 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>94544</B></FONT></P></TD></TR>
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<P id=PARA32 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">(Zip Code)</FONT></P></TD></TR></TABLE>
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<P id=PARA35 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">Registrant&#8217;s telephone number, including area code:</FONT></P></TD>
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<P id=PARA36 style="TEXT-ALIGN: left; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>(510) 240-6000</B></FONT></P></TD></TR></TABLE>
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<P id=PARA39 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>Not Applicable</B></FONT></P></TD></TR>
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<P id=PARA40 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">(Former name or former address, if changed&nbsp;since last report)</FONT></P></TD></TR></TABLE>
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<P id=PARA44 style="TEXT-ALIGN: left; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):</FONT></P>
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<P id=PARA96><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</P></FONT></TD></TR></TABLE>
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<P id=PARA98><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</P></FONT></TD></TR></TABLE>
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<P id=PARA58 style="MARGIN-BOTTOM: 0pt; TEXT-ALIGN: left; MARGIN-TOP: 0pt; LINE-HEIGHT: 1.25; MARGIN-RIGHT: 0pt"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</FONT></P></TD></TR></TABLE>
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<P id=PARA99.2 style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&nbsp;</FONT></P>
<P id=PARA60 style="TEXT-ALIGN: left; MARGIN: 0pt; LINE-HEIGHT: 1.25; BACKGROUND-COLOR: #ffffff"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>Item&nbsp;1.01 Entry into a Material Definitive Agreement.</B></FONT></P>
<P id=PARA62 style="MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0pt"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">&nbsp;</FONT></P>
<P id=PARA61 style="TEXT-ALIGN: left; MARGIN: 0pt; LINE-HEIGHT: 1.25; BACKGROUND-COLOR: #ffffff; TEXT-INDENT: 24.5pt"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">On May 31, 2016, Impax Laboratories, Inc. (&#8220;<U>Impax</U>&#8221; or the &#8220;<U>Company</U>&#8221;) entered into the First Amendment (the &#8220;<U>Amendment</U>&#8221;) to the Distribution, License, Development and Supply Agreement dated as of January 31, 2012 (the &#8220;<U>License Agreement</U>&#8221;) between the Company and AstraZeneca UK Limited (&#8220;<U>AstraZeneca</U>&#8221;). Pursuant to the License Agreement, the Company received, among other rights set forth therein, the exclusive rights to distribute and sell certain products containing Zomig<SUP style="vertical-align: baseline; position: relative; bottom:.33em;">&#174;</SUP>&nbsp;(zolmitriptan) in the United States and certain U.S. territories and AstraZeneca retained, among other rights, the right to continue to be the holder of the New Drug Application (&#8220;<U>NDA</U>&#8221;) for such products, including the obligation to complete certain studies related to the products as specified in the License Agreement. Under the terms of the Amendment, under certain conditions and depending on the nature and terms of the study agreed to with the U.S. Food and Drug Administration (the &#8220;<U>FDA</U>&#8221;), Impax agreed to conduct, at its own expense, the juvenile toxicity study and pediatric study required by the FDA under the Pediatric Research Equity Act (&#8220;<U>PREA</U>&#8221;) for approval of the nasal formulation of Zomig<SUP style="vertical-align: baseline; position: relative; bottom:.33em;">&#174;</SUP> for the acute treatment of migraine in pediatric patients ages six through 11 years old, as further described in the study protocol mutually agreed to by the parties (the &#8220;<U>PREA Study</U>&#8221;). In consideration for the Company conducting the PREA Study at its own expense, the Amendment provides for the total royalty payments payable by the Company to AstraZeneca on net sales of Zomig<SUP style="vertical-align: baseline; position: relative; bottom:.33em;">&#174;</SUP> products under the License Agreement to be reduced by certain specified amounts beginning from the quarter ended June 30, 2016 and through the quarter ended December 31, 2020, with such reduced royalty amounts totaling an aggregate amount of $30 million. In the event the royalty reduction amounts exceed the royalty payments payable by the Company to AstraZeneca pursuant to the License Agreement in any given quarter, AstraZeneca will be required to pay the Company an amount equal to the difference between the royalty reduction amount and the royalty payment payable by the Company to AstraZeneca. The Company&#8217;s commitment to perform the PREA Study may be terminated, without penalty, under certain circumstances as set forth in the Amendment.</FONT></P>
<P id=PARA64 style="MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0pt"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">&nbsp;</FONT></P>
<P id=PARA63 style="TEXT-ALIGN: left; MARGIN: 0pt; LINE-HEIGHT: 1.25; BACKGROUND-COLOR: #ffffff; TEXT-INDENT: 24.5pt"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">Under the terms of the Amendment, AstraZeneca will be the regulatory sponsor for the PREA Study and will be responsible, at its sole expense, for the filing of all regulatory documentation related to the PREA Study, including without limitation the supplemental NDA related to the nasal spray formulations of Zomig<SUP style="vertical-align: baseline; position: relative; bottom:.33em;">&#174;</SUP>. AstraZeneca will also be responsible, at its sole expense, for supplying to the Company all Zomig<SUP style="vertical-align: baseline; position: relative; bottom:.33em;">&#174;</SUP> products as well as any control, comparator or placebo compounds, without charge, for use in the PREA Study in accordance with the terms of the Amendment.</FONT></P>
<P id=PARA66 style="MARGIN-BOTTOM: 0pt; MARGIN-TOP: 0pt"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">&nbsp;</FONT></P>
<P id=PARA65 style="TEXT-ALIGN: left; MARGIN: 0pt; LINE-HEIGHT: 1.25; BACKGROUND-COLOR: #ffffff; TEXT-INDENT: 24.5pt"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif">The foregoing is a brief description of the terms and conditions of the Amendment that are material to Impax. This description is not intended to be complete and is qualified in its entirety by reference to the Amendment, which Impax will file with the Securities and Exchange Commission, along with a request for confidential treatment of certain terms of the Amendment, in its quarterly report on Form 10-Q for the second quarter ended June 30, 2016.</FONT></P>
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<P id=PARA69 style="TEXT-ALIGN: left; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>Forward-Looking Statements</B></FONT></P>
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<P id=PARA70 style="TEXT-ALIGN: left; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><I>Certain statements contained herein, regarding matters that are not historical facts, are forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). These include statements regarding management&#8217;s intentions, plans, beliefs, expectations or forecasts for the future. Such forward-looking statements are based on the Company&#8217;s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements. Such risks and uncertainties include, but are not limited to, general economic conditions, our ability to successfully develop and commercialize pharmaceutical products in a timely manner, changes to FDA approval requirements, our ability to successfully conduct clinical trials, our reliance on third parties to conduct clinical trials and testing, our dependence on certain employees, our ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment and </I><I>the </I><I>other risks described in our Annual Report on Form 10-K for the year ended December 31, 2015 and other subsequent filings with the Securities and Exchange Commission. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events or circumstances</I>.</FONT></P>
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<P id=PARA72 style="TEXT-ALIGN: center; MARGIN: 0pt; LINE-HEIGHT: 1.25"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman, Times, serif"><B>SIGNATURES</B></FONT></P>
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<P id=PARA101.2 style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><B>IMPAX LABORATORIES, INC</B>.</FONT></P></TD>
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<P id=PARA101.4 style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Dated: June 2, 2016</FONT></P></TD>
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<P id=PARA101.14 style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">/s/&nbsp;</FONT>Bryan M. Reasons</P></TD>
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<P id=PARA101.18 style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Name:&nbsp; </FONT>Bryan M. Reasons</P></TD>
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<P id=PARA101.22 style="MARGIN-BOTTOM: 0px; MARGIN-TOP: 0px"><FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Title:&nbsp;&nbsp;&nbsp; </FONT>Senior Vice President, Finance and Chief Financial Officer <FONT style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&nbsp;</FONT></P></TD></TR></TABLE>
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ipxl20160601_8k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 31, 2016
Impax Laboratories
, Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-34263
65-0403311
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
30831 Huntwood Avenue, Hayward, CA
94544
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code:
(510) 240-6000
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 of the registrant under any of the following provisions (see General Instruction A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement.
On May 31, 2016, Impax Laboratories, Inc. ("
Impax
" or the "
Company
") entered into the First Amendment (the "
Amendment
") to the Distribution, License, Development and Supply Agreement dated as of January 31, 2012 (the "
License Agreement
") between the Company and AstraZeneca UK Limited ("
AstraZeneca
"). Pursuant to the License Agreement, the Company received, among other rights set forth therein, the exclusive rights to distribute and sell certain products containing Zomig
®
(zolmitriptan) in the United States and certain U.S. territories and AstraZeneca retained, among other rights, the right to continue to be the holder of the New Drug Application ("
NDA
") for such products, including the obligation to complete certain studies related to the products as specified in the License Agreement. Under the terms of the Amendment, under certain conditions and depending on the nature and terms of the study agreed to with the U.S. Food and Drug Administration (the "
FDA
"), Impax agreed to conduct, at its own expense, the juvenile toxicity study and pediatric study required by the FDA under the Pediatric Research Equity Act ("
PREA
") for approval of the nasal formulation of Zomig
®
for the acute treatment of migraine in pediatric patients ages six through 11 years old, as further described in the study protocol mutually agreed to by the parties (the "
PREA Study
"). In consideration for the Company conducting the PREA Study at its own expense, the Amendment provides for the total royalty payments payable by the Company to AstraZeneca on net sales of Zomig
®
products under the License Agreement to be reduced by certain specified amounts beginning from the quarter ended June 30, 2016 and through the quarter ended December 31, 2020, with such reduced royalty amounts totaling an aggregate amount of $30 million. In the event the royalty reduction amounts exceed the royalty payments payable by the Company to AstraZeneca pursuant to the License Agreement in any given quarter, AstraZeneca will be required to pay the Company an amount equal to the difference between the royalty reduction amount and the royalty payment payable by the Company to AstraZeneca. The Company's commitment to perform the PREA Study may be terminated, without penalty, under certain circumstances as set forth in the Amendment.
Under the terms of the Amendment, AstraZeneca will be the regulatory sponsor for the PREA Study and will be responsible, at its sole expense, for the filing of all regulatory documentation related to the PREA Study, including without limitation the supplemental NDA related to the nasal spray formulations of Zomig
®
. AstraZeneca will also be responsible, at its sole expense, for supplying to the Company all Zomig
®
products as well as any control, comparator or placebo compounds, without charge, for use in the PREA Study in accordance with the terms of the Amendment.
The foregoing is a brief description of the terms and conditions of the Amendment that are material to Impax. This description is not intended to be complete and is qualified in its entirety by reference to the Amendment, which Impax will file with the Securities and Exchange Commission, along with a request for confidential treatment of certain terms of the Amendment, in its quarterly report on Form 10-Q for the second quarter ended June 30, 2016.
Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, are forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). These include statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future. Such forward-looking statements are based on the Company's expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements. Such risks and uncertainties include, but are not limited to, general economic conditions, our ability to successfully develop and commercialize pharmaceutical products in a timely manner, changes to FDA approval requirements, our ability to successfully conduct clinical trials, our reliance on third parties to conduct clinical trials and testing, our dependence on certain employees, our ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment and
the
other risks described in our Annual Report on Form 10-K for the year ended December 31, 2015 and other subsequent filings with the Securities and Exchange Commission. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events or circumstances
.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
IMPAX LABORATORIES, INC
.
Dated: June 2, 2016
By:
/s/
Bryan M. Reasons
Name:
Bryan M. Reasons
Title:
Senior Vice President, Finance and Chief Financial Officer