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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, DC 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B><FONT
STYLE="white-space:nowrap">FORM&nbsp;8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>of the Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): February&nbsp;8, 2019 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>Recro Pharma, Inc. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Pennsylvania</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">001-36329</FONT></B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">26-1523233</FONT></B></TD></TR>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction of</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>incorporation or organization)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(I.R.S. Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
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<TD VALIGN="top" COLSPAN="3" ALIGN="center"><B>490 Lapp Road, Malvern, Pennsylvania</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>19355</B></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:8pt">
<TD VALIGN="top" COLSPAN="3" ALIGN="center"><B>(Address of principal executive offices)</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>(Zip Code)</B></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Registrant&#146;s telephone number, including area
<FONT STYLE="white-space:nowrap">code:&nbsp;(484)&nbsp;395-2470</FONT> </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Not Applicable </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or former address, if changed since last report) </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below if the <FONT STYLE="white-space:nowrap">Form&nbsp;8-K&nbsp;filing</FONT> is intended to simultaneously satisfy the filing
obligation of the registrant under any of the following provisions (see General Instruction A.2. below): </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to <FONT STYLE="white-space:nowrap">Rule&nbsp;14a-12&nbsp;under</FONT> the
Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement&nbsp;communications</FONT> pursuant to <FONT
STYLE="white-space:nowrap">Rule&nbsp;14d-2(b)&nbsp;under</FONT> the Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.14d-2(b))</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">&#9744;</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement&nbsp;communications</FONT> pursuant to <FONT
STYLE="white-space:nowrap">Rule&nbsp;13e-4(c)&nbsp;under</FONT> the Exchange Act (17 <FONT STYLE="white-space:nowrap">CFR&nbsp;240.13e-4(c))</FONT> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this
chapter) or <FONT STYLE="white-space:nowrap">Rule&nbsp;12b-2&nbsp;of</FONT> the Securities Exchange Act of <FONT STYLE="white-space:nowrap">1934&nbsp;(&#167;240.12b-2&nbsp;of</FONT> this chapter). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right">Emerging growth company&nbsp;&nbsp;&#9746; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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&nbsp;13(a) of the Exchange
Act.&nbsp;&nbsp;&#9746; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>
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<TD WIDTH="12%" VALIGN="top" ALIGN="left"><B>Item&nbsp;1.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Entry Into a Material Definitive Agreement. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On February&nbsp;8, 2019, Recro Pharma, Inc., through its wholly-owned subsidiary, Recro Gainesville LLC (collectively, the &#147;<U>Company</U>&#148;) entered
into a new Manufacturing and Supply Agreement (the &#147;<U>Agreement</U>&#148;) with Novartis Pharma AG (&#147;<U>Novartis</U>&#148;), effective as of January&nbsp;1, 2019, pursuant to which the Company will continue to be the exclusive global
supplier to Novartis of Ritalin LA and Focalin XR capsules (together, the &#147;<U>Products</U>&#148;) through 2023. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company and Novartis were
previously parties to two separate manufacturing and supply agreements, one for the exclusive supply of Ritalin LA capsules and one for the exclusive supply of Focalin XR capsules (the &#147;<U>Prior Agreements</U>&#148;), which were set to expire
in late 2019 and <FONT STYLE="white-space:nowrap">mid-2020,</FONT> respectively. The Agreement terminates and replaces the Prior Agreements. Under the terms of the Agreement, subject to exceptions for the Company&#146;s failure to timely supply
Novartis&#146; requirements and bankruptcy, the Company will produce and supply the Products exclusively for, and to, Novartis, and Novartis will exclusively purchase its requirements for the Products from the Company, until December&nbsp;31, 2023.
Pursuant to the terms of the Agreement, the Company has granted Novartis a worldwide, exclusive, royalty-free sublicensable license to the intellectual property owned and controlled by the Company relating to the Products. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Agreement expires December&nbsp;31, 2023 (the &#147;<U>Initial Term</U>&#148;) and will renew automatically thereafter for successive <FONT
STYLE="white-space:nowrap">one-year</FONT> periods unless terminated by either party at least twenty-four (24)&nbsp;months prior to the end of the Initial Term or any subsequent <FONT STYLE="white-space:nowrap">one-year</FONT> term after the Initial
Term. Novartis may terminate the Agreement immediately if (i)&nbsp;any governmental regulatory authority prevents Novartis from supplying the active pharmaceutical ingredients in the Products and/or exporting, purchasing or selling the Products in
its bulk or packaged form; (ii)&nbsp;any Product or pharmaceutical product contained therein cannot be reasonably commercialized for medical, scientific or legal reasons; or (iii)&nbsp;the Company fails to comply with certain health, safety and
environmental protection requirements. After the Initial Term, Novartis may terminate the Agreement upon 12 months&#146; written notice in the event of any sale or divestment by the Company of its business or assets relating to the Products. Either
party may terminate the Agreement for material, uncured breaches or in the event of the other party&#146;s bankruptcy. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Agreement also contains
customary representations, warranties, mutual indemnities, limitations of liability and confidentiality provisions. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The foregoing description of the
Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which will be filed with the Company&#146;s Quarterly Report on Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarter
ending March&nbsp;31, 2019, which is incorporated herein by reference. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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,
thereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TD VALIGN="top" COLSPAN="3">Recro Pharma, Inc.</TD></TR>
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<TD HEIGHT="16" COLSPAN="2"></TD></TR>
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<TD VALIGN="top">By:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Gerri A. Henwood</P></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Name:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Gerri A. Henwood</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Title:</TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Chief Executive Officer</TD></TR>
</TABLE></DIV> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Date: February&nbsp;14, 2019 </P>
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{"company-data": {"conformed-name": "Recro Pharma, Inc.", "cik": "0001588972", "assigned-sic": "2834", "irs-number": "261523233", "state-of-incorporation": "PA", "fiscal-year-end": "1231"}, "filing-values": {"form-type": "8-K", "act": "34", "file-number": "001-36329", "film-number": "19607760"}, "business-address": {"street1": "490 LAPP ROAD", "city": "MALVERN", "state": "PA", "zip": "19355", "phone": "(484) 395-2400"}, "mail-address": {"street1": "490 LAPP ROAD", "city": "MALVERN", "state": "PA", "zip": "19355"}}
Form 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): February 8, 2019
Recro Pharma, Inc.
(Exact name of registrant as specified in its charter)
Pennsylvania
001-36329
26-1523233
(State or other jurisdiction of
incorporation or organization)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
490 Lapp Road, Malvern, Pennsylvania
19355
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area
code: (484) 395-2470
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))
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 1.01
Entry Into a Material Definitive Agreement.
On February 8, 2019, Recro Pharma, Inc., through its wholly-owned subsidiary, Recro Gainesville LLC (collectively, the "
Company
") entered
into a new Manufacturing and Supply Agreement (the "
Agreement
") with Novartis Pharma AG ("
Novartis
"), effective as of January 1, 2019, pursuant to which the Company will continue to be the exclusive global
supplier to Novartis of Ritalin LA and Focalin XR capsules (together, the "
Products
") through 2023.
The Company and Novartis were
previously parties to two separate manufacturing and supply agreements, one for the exclusive supply of Ritalin LA capsules and one for the exclusive supply of Focalin XR capsules (the "
Prior Agreements
"), which were set to expire
in late 2019 and
mid-2020,
respectively. The Agreement terminates and replaces the Prior Agreements. Under the terms of the Agreement, subject to exceptions for the Company's failure to timely supply
Novartis' requirements and bankruptcy, the Company will produce and supply the Products exclusively for, and to, Novartis, and Novartis will exclusively purchase its requirements for the Products from the Company, until December 31, 2023.
Pursuant to the terms of the Agreement, the Company has granted Novartis a worldwide, exclusive, royalty-free sublicensable license to the intellectual property owned and controlled by the Company relating to the Products.
The Agreement expires December 31, 2023 (the "
Initial Term
") and will renew automatically thereafter for successive
one-year
periods unless terminated by either party at least twenty-four (24) months prior to the end of the Initial Term or any subsequent
one-year
term after the Initial
Term. Novartis may terminate the Agreement immediately if (i) any governmental regulatory authority prevents Novartis from supplying the active pharmaceutical ingredients in the Products and/or exporting, purchasing or selling the Products in
its bulk or packaged form; (ii) any Product or pharmaceutical product contained therein cannot be reasonably commercialized for medical, scientific or legal reasons; or (iii) the Company fails to comply with certain health, safety and
environmental protection requirements. After the Initial Term, Novartis may terminate the Agreement upon 12 months' written notice in the event of any sale or divestment by the Company of its business or assets relating to the Products. Either
party may terminate the Agreement for material, uncured breaches or in the event of the other party's bankruptcy.
The Agreement also contains
customary representations, warranties, mutual indemnities, limitations of liability and confidentiality provisions.
The foregoing description of the
Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which will be filed with the Company's Quarterly Report on Form
10-Q
for the quarter
ending March 31, 2019, which is incorporated herein by reference.
-2-
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,
thereunto duly authorized.
Recro Pharma, Inc.
By:
/s/ Gerri A. Henwood
Name:
Gerri A. Henwood
Title:
Chief Executive Officer
Date: February 14, 2019
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