SEC Contract Filing

Filing Date: 2021-02-26

Document Content:
<DOCUMENT>
<TYPE>EX-10.51
<SEQUENCE>2
<FILENAME>tbph-20201231xex10d51.htm
<DESCRIPTION>EX-10.51
<TEXT>
<!--Enhanced HTML document created with Toppan Merrill Bridge 9.9.1.77--><!--Created on: 2/26/2021 09:06:28 PM (UTC)--><!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"><html><head><meta charset="UTF-8"><title></title></head><body><div style="margin-top:30pt;"></div><div style="max-width:100%;padding-left:5.88%;padding-right:5.88%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:right;margin:0pt 0pt 10pt 0pt;"><b style="font-weight:bold;">Exhibit 10.51</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 10pt 0pt;"><b style="font-weight:bold;">DEVELOPMENT AND COMMERCIALIZATION AGREEMENT</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:6pt;text-indent:36pt;margin:0pt 0pt 10pt 0pt;"><font style="font-size:10pt;">This Development and Commercialization Agreement (&quot;Agreement&quot;) dated January 30, 2015 (the &quot;Effective Date&quot;) is made by and between THERAVANCE BIOPHARMA R&amp;D, INC., a Cayman Islands exempted company having its principal office at Ugland House, South Church Street, George Town, Grand Cayman, Cayman Islands E9 KY1-1104 (&quot;THERAVANCE&quot;), and MYLAN IRELAND LIMITED, a limited company organized and existing under the laws of Ireland with its offices at South Bank House, Barrow Street, 6</font><font style="font-size:6.5pt;">th</font><font style="font-size:10pt;"> Floor, Dublin 4, Ireland (&quot;MYLAN&quot;). THERAVANCE and MYLAN may be referred to, individually, as a &quot;Party&quot; or, together, as the &quot;Parties.&quot;</font></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 10pt 0pt;"><b style="font-weight:bold;">RECITALS</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 10pt 0pt;">WHEREAS, THERAVANCE has discovered and is currently developing the proprietary long-acting muscarinic compound identified as TD-4208 for the treatment of respiratory disorders; and</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 10pt 0pt;">WHEREAS, MYLAN and THERAVANCE desire to establish a broad collaboration for the development and commercialization of TD-4208 in a nebulized form, both as a standalone monotherapy and in combination or co-formulation with other chemically distinct and therapeutically active compounds.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 10pt 0pt;">NOW, THEREFORE THERAVANCE and MYLAN, intending to be legally bound, hereby agree as follows:</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 10pt 0pt;"><b style="font-weight:bold;">ARTICLE 1<br>DEFINITIONS</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 10pt 0pt;">For purposes of this Agreement, the following initially capitalized terms, whether used in the singular or plural, shall have the following meanings:</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 10pt 0pt;">Section 1.01 &quot;Adverse Drug Experience&quot; means any of: an &quot;adverse drug experience/reaction,&quot; a &quot;life-threatening adverse drug experience,&quot; a &quot;serious adverse drug experience,&quot; or an &quot;unexpected adverse drug experience,&quot; in each case as defined in the Federal Food Drug and Cosmetic Act, or any comparable experience, response or reaction associated with a pharmaceutical product that is reportable to Governmental Authorities in jurisdictions outside of the United States pursuant to applicable Laws.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 10pt 0pt;">Section 1.02 &quot;Affiliate&quot; of a Person means any other Person, whether de jure or de facto, that directly or indirectly controls, is controlled by, or is under common control with such Person for so long as such control exists, where &quot;control&quot; means the decision-making authority to control the management of such other Person whether by ownership,</p><div style="font-family:'Times New Roman','Times','serif';font-size:12.0pt;margin-bottom:0pt;margin-top:0pt;min-height:1.19em;position:relative;width:100%;"><hr noshade="true" color="#a0a0a0" size="0.75" width="25.0%" style="background-color:#a0a0a0;color:#a0a0a0;height:1px;position:relative;top:0.6em;border:none;margin:0pt;" align="left"></div><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><font style="visibility:hidden;">&#8203;</font></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;">1</p></div></div><hr style="background-color:#000000;clear:both;color:#000000;height:2pt;line-height:0;margin-bottom:30pt;margin-left:5.88%;margin-right:5.88%;margin-top:30pt;page-break-after:always;width:88.24%;border-width:0;"><div style="max-width:100%;padding-left:5.88%;padding-right:5.88%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">contract or otherwise; and, further, where such control shall be presumed to exist where a Person owns more than fifty percent (50%) of the equity