SEC Contract Filing

Filing Date: 2021-05-10

Document Content:
<DOCUMENT>
<TYPE>EX-10.1
<SEQUENCE>2
<FILENAME>adms10qq12021ex101.htm
<DESCRIPTION>EX-10.1
<TEXT>
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<title>Document</title></head><body><div id="id798ece4feab4882b263f7e15289718b_1"></div><div style="min-height:58.5pt;width:100%"><div style="margin-bottom:9pt;text-align:right"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Exhibit 10.1</font></div><div><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">&#91;*&#93; &#61; Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) is the type of information that Adamas Pharmaceuticals, Inc. treats as private or confidential.</font></div></div><div style="margin-bottom:6pt;padding-left:72pt;text-align:right;text-indent:36pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Execution Version</font></div><div style="margin-bottom:6pt;text-align:center"><font><br></font></div><div style="margin-bottom:6pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%;text-decoration:underline">Adamas-Zydus Binding Term Sheet</font></div><div style="margin-bottom:6pt"><table style="border-collapse:collapse;display:inline-table;vertical-align:top;width:98.333%"><tr><td style="width:1.0%"></td><td style="width:15.284%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:82.516%"></td><td style="width:0.1%"></td></tr><tr><td colspan="3" style="border-left:1pt solid #000;border-top:1pt solid #000;padding:2px 1pt;text-align:left;vertical-align:top"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:100%">Parties</font></td><td colspan="3" style="border-left:1pt solid #000;border-right:1pt solid #000;border-top:1pt solid #000;padding:2px 1pt;text-align:left;vertical-align:top"><div style="text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:130%">Adamas Pharma, LLC (&#8220;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:130%;text-decoration:underline">Adamas</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:130%">&#8221;) and Zydus Worldwide DMCC and Zydus Pharmaceuticals (USA) Inc. (collectively, &#8220;Zydus&#8221;)</font></div></td></tr><tr><td colspan="3" style="border-left:1pt solid #000;border-top:1pt solid #000;padding:2px 1pt;text-align:left;vertical-align:top"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:100%">Overview</font></td><td colspan="3" style="border-left:1pt solid #000;border-right:1pt solid #000;border-top:1pt solid #000;padding:2px 1pt;text-align:left;vertical-align:top"><div><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">On April 30, 2020, Zydus Worldwide DMCC submitted ANDA No. 214897 for amantadine extended release capsules 68.5 mg and 137 mg to the United States Food and Drug Administration (&#8220;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%;text-decoration:underline">FDA</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">&#8221;) that references Adamas&#8217;s NDA No. 208944 and contains certifications pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) (&#8220;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%;text-decoration:underline">Paragraph IV Certification</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">&#8221;) with respect to U.S. Patent Nos. 8,389,578, 8,741,343, 8,796,337, 8,889,740, 8,895,614, 8,895,615, 8,895,616, 8,895,617, 8,895,618, 9,867,791, 9,867,792, 9,867,793, 9,877,933, and 10,154,971 (&#8220;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%;text-decoration:underline">Zydus&#8217;s Paragraph IV Certifications</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">&#8221;). Since that time, Adamas was issued U.S. Patent No. 10,646,456, which is now listed in the FDA&#8217;s Approved Drug Products with Therapeutic Equivalence Evaluations. Adamas and Zydus have had discussions to resolve Zydus&#8217;s Paragraph IV Certifications, including the negotiation of rights and obligations in connection therewith and certain commercial terms, and each Party has determined that it is in its best interests to execute and be bound by this term sheet in connection therewith (this &#8220;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%;text-decoration:underline">Term Sheet</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">&#8221;). Adamas and Zydus is each referred to as a &#8220;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%;text-decoration:underline">Party</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">&#8221; and, collectively, as the &#822