Quarterly Report — Form 10-Q — Sect. 13 / 15(d) – SEA’34 Filing Table of Contents
Document/ExhibitDescriptionPagesSize
1: 10-Q Form 10-Q (09-30-2017) HTML 396K
2: EX-10.1 Amendment No. 1 to Collaboration and License HTML 50K Agreement
3: EX-31.1 Certification of Principal Executive Officer HTML 23K
4: EX-31.2 Certification of Principal Financial Officer HTML 23K
5: EX-32.1 Certification of Principal Executive and Principal HTML 19K
Financial Officers
12: R1 Document and Entity Information Document HTML 37K
13: R2 Consolidated Balance Sheets (Unaudited) HTML 107K
14: R3 Balance Sheet Parenthetical (Parenthetical) HTML 42K
15: R4 Consolidated Statements of Comprehensive Loss HTML 68K
(Unaudited)
16: R5 Statements of Comprehensive Loss Parenthetical HTML 18K
(Parenthetical)
17: R6 Consolidated Statements of Stockholders' Equity HTML 65K
(Unaudited)
18: R7 Consolidated Statements of Cash Flows (Unaudited) HTML 94K
19: R8 Summary of Significant Accounting Policies (Notes) HTML 110K
20: R9 Recent Accounting Pronouncements Level 1 (Notes) HTML 25K
21: R10 Cash and Cash Equivalents and Investments HTML 71K
22: R11 Fair Value Measurements HTML 77K
23: R12 Debt Obligations HTML 27K
24: R13 Arrangements with Symphony Icon Inc HTML 30K
25: R14 Commitments and Contingencies HTML 20K
26: R15 Collaboration and License Agreements HTML 49K
27: R16 Summary of Significant Accounting Policies HTML 103K
(Policies)
28: R17 Summary of Significant Accounting Policies HTML 23K
(Tables)
29: R18 Summary of Significant Accounting Policies Equity HTML 67K
Incentive Awards (Tables)
30: R19 Cash and Cash Equivalents and Investments (Tables) HTML 67K
31: R20 Fair Value Measurements (Tables) HTML 76K
32: R21 Summary of Significant Accounting Policies HTML 25K
(Details)
33: R22 Summary of Significant Accounting Policies HTML 24K
Inventory (Details)
34: R23 Summary of Significant Accounting Policies HTML 36K
Stock-based Compensation Valuation (Details)
35: R24 Summary of Significant Accounting Policies HTML 72K
Stock-based Compensation Summary (Details 1)
36: R25 Summary of Significant Accounting Policies HTML 20K
Stock-based Compensation Summary (Details 2)
37: R26 Recent Accounting Pronouncements (Details) HTML 19K
38: R27 Cash and Cash Equivalents and Investments (Details HTML 40K
1)
39: R28 Cash and Cash Equivalents and Investments (Details HTML 18K
2)
40: R29 Fair Value Measurements (Details 1) HTML 40K
41: R30 Fair Value Measurements (Details 2) HTML 25K
42: R31 Debt Obligations (Details) HTML 44K
43: R32 Arrangements with Symphony Icon Inc (Details) HTML 72K
44: R33 Commitments and Contingencies (Details) HTML 18K
45: R34 Collaboration and License Agreements (Details) HTML 63K
47: XML IDEA XML File -- Filing Summary XML 80K
46: EXCEL IDEA Workbook of Financial Reports XLSX 57K
6: EX-101.INS XBRL Instance -- lxrx-20170930 XML 951K
8: EX-101.CAL XBRL Calculations -- lxrx-20170930_cal XML 122K
9: EX-101.DEF XBRL Definitions -- lxrx-20170930_def XML 461K
10: EX-101.LAB XBRL Labels -- lxrx-20170930_lab XML 1.02M
11: EX-101.PRE XBRL Presentations -- lxrx-20170930_pre XML 552K
7: EX-101.SCH XBRL Schema -- lxrx-20170930 XSD 116K
48: ZIP XBRL Zipped Folder -- 0001062822-17-000054-xbrl Zip 141K
‘EX-10.1’ — Amendment No. 1 to Collaboration and License Agreement
Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.
AMENDMENT NO. 1 TO COLLABORATION AND LICENSE AGREEMENT
This Amendment No. 1 to Collaboration and License Agreement (this “Amendment”), is dated as of July 1st, 2017 (the “Amendment Effective Date”) and is entered
into by and between Lexicon Pharmaceuticals, Inc., a Delaware corporation (“Lexicon”), and SANOFI-AVENTIS DEUTSCHLAND GmbH, a German corporation (assignee of SANOFI, a société anonyme under the laws of France), with its principal place of business at 65926 Frankfurt am Main, Germany (“Sanofi”). Lexicon and Sanofi are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” Capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Agreement.
RECITALS
WHEREAS, Lexicon
and SANOFI entered into a Collaboration and License Agreement, dated as of November 5, 2015 (the “Agreement”), and SANOFI subsequently assigned its rights and obligations thereunder to SANOFI-AVENTIS DEUTSCHLAND GmbH as of December 30, 2015.
WHEREAS, Lexicon and Sanofi have agreed to amend (a) the initial Development Plan with respect to T2DM and certain development milestone payments associated therewith, (b) the definition of European Union and (c) such other terms and conditions of the Agreement as contemplated herein.
NOW, THEREFORE, in consideration of the premises and the mutual covenants and
agreements of the Parties contained in this Amendment, the Parties hereby agree as follows:
1.
Amended Development Plan for T2DM
As of the Amendment Effective Date, the initial Development Plan with respect to T2DM contained in Schedule 3.1.2 to the Agreement shall be replaced by the Development Plan for T2DM attached hereto as Exhibit 3.1.2.
For the avoidance of doubt, it is hereby acknowledged that this Amendment is not subject to
a Lexicon Consent Right pursuant to Section 1.99(iii).
2.
Amendments to Definitions. The Agreement shall be amended as follows, with effect from and after the Amendment Effective Date
2.1
The definition of “306 Study” shall be deleted and replaced with the following:
“Study [**]“
means that certain study described as [**] study in the Development Plan with respect to [**].
“Study [**]” means that certain study described as [**] study in the Development Plan with respect to [**].
2.2
The definition of “311 Study” shall be deleted and replaced with the following:
“Study [**]” means that certain study described as [**] study in the Development Plan with respect to [**].
2.3
The
definition of “T2DM CVOT” shall be deleted and replaced with the following:
“Study [**]” means that certain study described as [**] study in the Development Plan with respect to [**].
2.4
The following new definition shall be added:
“Study [**]” means that certain study described as [**] study in the Development Plan with respect to [**].
2.5
The
definition of “Benefit Data” shall be replaced with the following:
“Benefit Data” shall mean the Study Data from Study [**] or from Study [**].
Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.
2.6
The
definition of “Initial Data” shall be replaced with the following:
“Initial Data” means [**].
2.7
The definition of “European Union” shall be replaced with the following:
“European Union” or “EU” means the economic, scientific and political organization of member states as it may be constituted from time to time, which as of the Execution Date consists of
Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom of Great Britain and Northern Ireland and that certain portion of Cyprus included in such organization. For the avoidance of doubt (including for the purpose of Section 12.3.2(iii)), any country which was a member state of the EU as of the Execution Date (including any Major Market), but which subsequently ceases to be a member state of the EU for any reason, including withdrawal, shall not be considered part of the EU as from the date of its effective withdrawal from the EU.
2.8
A
new definition of “European Territory” shall be added as Section 1.196 as follows:
“European Territory” means the European Union and, as applicable, any Major Market which was a member state of the EU as of the Execution Date, but which subsequently ceases to be a member state of the EU for any reason, including withdrawal. For the avoidance of doubt, any country which was a member state of the EU as of the Execution Date (other than a Major Market), but which subsequently ceases to be a member state of the EU for any reason, including withdrawal, shall not be considered part of the European Territory as from the date of its effective withdrawal from the EU.
2.9
The
definition of “Tier 2 Countries” shall be replaced with the following
“Tier 2 Countries” means the European Union (other than Major Markets located in the European Union) (including, notwithstanding the definition of European Union hereunder, any non-Major Market member state of the European Union as of the Effective Date which subsequently ceases to be a member state of the European Union for any reason, including withdrawal), and all current and future members of the European Free Trade Association, or the Commonwealth of Independent States, Brazil, Russia, India, China, South Korea, Australia, New Zealand, Canada, Mexico, Chile, Argentina, Turkey, Taiwan, Singapore, Saudi Arabia, Kuwait, United Arab Emirates, Qatar, and Israel.
3.
Amendment
of Positive Results Definition
Section 3.1.3 of the Agreement shall be deleted and replaced by the following effective as of the Amendment Effective Date:
3.1.3 Decision Points and Positive Results for Development Activities. The Development Plan sets forth certain decision points associated with the completion of certain clinical studies (the “Decision Points”). At each Decision Point, within [**] after the earlier of (i) [**] and (ii) [**], the JSC shall determine whether or not Positive Results have been achieved. With respect to a given Decision Point, “Positive Results” means, based
on review of [**] (in the case of clause (i)) or [**] (in the case of clause (ii)) the following, as applicable:
(a) in the case of [**],[**];
(b) in the case of [**], [**]; and
(c) in all other cases, [**].
If Positive Results have not been achieved, then (a) Sanofi may elect to terminate this Agreement as set forth in Section 12.3.2(i)(b) or (b) the JSC may elect to immediately discontinue or cancel all or part of any Development activities under the Development Plan that are conditioned on the achievement of Positive Results with respect to the applicable Decision Point, including any ongoing or planned
clinical studies or regulatory filings, or to
Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.
modify the Development Plan as it deems appropriate in good faith, in the interest of securing Regulatory Approval for a Licensed Product in the Field in the Major Markets in the Territory.
4.
Amendment
of Development Milestone Payments
As a result of the amendment of the initial Development Plan pursuant to Section 1 hereof, Section 7.2.1(a) of the Agreement shall be replaced with the following effective as of the Amendment Effective Date:
(a)
Development Milestones.
(i)
achievement
of Positive Results (as determined in accordance with Section 3.1.3(a)) with respect to [**],[**]; provided that, if [**], this milestone payment shall become payable concurrently with [**];
(ii)
achievement of Positive Results (as determined in accordance with Section 3.1.3(c)) from [**],[**];
(iii)
achievement of Positive Results (as determined in accordance with Section 3.1.3(c)) from [**],[**];
(iv)
achievement
of Positive Results (as determined in accordance with Section 3.1.3(b)) from [**],[**]; and
(v)
[**], one hundred million Dollars ($100,000,000).
5.
Amendment to Royalties for Major Markets (ex-US)
5.1
Section
7.3.1(iii) of the Agreement shall be deleted and replaced by the following effective as of the Amendment Effective Date:
(iii) For the European Territory:
(a)for that portion of aggregate Net Sales of all Licensed Products in the European Territory during a Calendar Year less than or equal to [**], a royalty rate of [**];
(b)for that portion of aggregate Net Sales of all Licensed Products in the European Territory during a Calendar Year greater than [**], but less than or equal to [**], a royalty rate of [**]; and
(c)for that portion of aggregate Net Sales of all Licensed Products in the European Territory during a Calendar Year greater
than [**], a royalty rate of [**].
5.2
Section 7.3.1(iv) of the Agreement shall be deleted and replaced by the following effective as of the Amendment Effective Date:
(iv) For all countries in the Territory, other than the United States and those countries in the European Territory (such countries, “ROW”), the royalty rate shall be [**] of aggregate Net Sales of all Licensed Products in ROW.
6.
No
other Amendment. Except as expressly modified by this Amendment, the Agreement remains in full force and effect.
7.
Other applicable provisions. This Amendment shall be considered part of the Agreement and Section 13.8 of the Agreement shall be interpreted to include this Amendment as part of the Parties’ agreement. Article 13 of the Agreement is incorporated herein by reference and shall apply hereto.
Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.
THIS AMENDMENT No. 1 TO COLLABORATION AND LICENSE AGREEMENT IS EXECUTED by the authorized representatives of the parties as of the date first written above.