|
|
|
|
|
Delaware
|
000-30111
|
76-0474169
|
(State or other jurisdiction of
incorporation or organization)
|
(Commission File Number)
|
(I.R.S. Employer
Identification Number)
|
o
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
o
|
Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12)
|
o
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d‑2(b))
|
o
|
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
|
Item 9.01
|
Financial Statements and Exhibits
|
Exhibit No.
|
Description
|
|
10.1
|
|
Second Amendment to Collaboration and License Agreement with Bristol-Myers Squibb Company dated November 2, 2016.
|
|
Lexicon Pharmaceuticals, Inc.
|
|
|
|
|
|
|
|
Date: November 7, 2016
|
By:
|
/s/ Brian T. Crum
|
|
|
Brian T. Crum
|
|
|
Vice
President and General Counsel
|
Exhibit No.
|
|
Description
|
10.1
|
|
Second Amendment to Collaboration and License Agreement with Bristol-Myers Squibb Company dated November 2, 2016
|
1.
|
The terms in this Amendment with initial letters capitalized shall have the meaning set forth in this Amendment and if not defined in this Amendment shall have the meaning set forth in the Collaboration Agreement. Unless otherwise expressly stated, the Sections referred to herein refer to the Sections in the Collaboration Agreement.
|
2.
|
The following are hereby added to the Collaboration Agreement as new Sections 1.107, 1.108 and 1.109, respectively:
|
3.
|
Section 2.5.1 of the Collaboration Agreement is hereby deleted in its entirety and replaced with the following:
|
4.
|
The heading to Section 5.4 of the Collaboration Agreement is hereby amended and restated in its entirety as follows:
|
5.
|
Section 5.4.2 of the Collaboration Agreement is hereby amended and restated in its entirety as follows:
|
Milestone Event
|
|
Payments for LG921 Target
|
First Indication
|
|
|
Commencement of a Phase 2 Trial
|
|
U.S. $[**]
|
Commencement of a Phase 3 Trial
|
|
[**]
|
NDA Filing
|
|
[**]
|
MAA Filing
|
|
[**]
|
MHLW Filing
|
|
[**]
|
NDA Approval
|
|
[**]
|
MAA Approval
|
|
[**]
|
MHLW Approval
|
|
[**]
|
Total
|
|
U.S. $34,500,000
|
Second and Third Indications
|
|
|
Commencement of a Phase 3 Trial
|
|
U.S. $[**]
|
NDA Filing
|
|
[**]
|
MAA Filing
|
|
[**]
|
MHLW Filing
|
|
[**]
|
NDA Approval
|
|
[**]
|
MAA Approval
|
|
[**]
|
MHLW Approval
|
|
[**]
|
Total
|
|
U.S. $16,000,000
|
Sales Performance Milestones
|
|
|
First time Contract Year Net Sales greater than U.S. $
[**]
|
|
U.S. $[**]
|
First time Contract Year Net Sales greater than U.S. $
[**]
|
|
[**]
|
First time Contract Year Net Sales greater than U.S. $
[**]
|
|
[**]
|
Total
|
|
U.S. $40,000,000
|
Milestone Event
|
|
Payments for Lexicon Target other than LG921 Target
|
IND filing
|
|
U.S. $1,500,000
|
Commencement of a Phase 2 Trial
|
|
2,500,000
|
Commencement of a Phase 3 Trial
|
|
5,000,000
|
NDA Filing
|
|
5,000,000
|
MAA Filing
|
|
2,500,000
|
NDA Approval or MAA Approval (upon the first to occur)
|
|
8,500,000
|
Total
|
|
U.S. $25,000,000
|
6.
|
Section 5.4.3 of the Collaboration Agreement is hereby amended and restated in its entirety as follows:
|
7.
|
Section 5.5.2 of the Collaboration Agreement is hereby amended and restated in its entirety as follows:
|
Aggregate Annual Worldwide
Net Sales of Lexicon Products acting through LG921 Target in Contract Year
|
|
Royalty on Net Sales
|
Under U.S. $
[**]
|
|
[**]%
|
From U.S. $
[**]
to U.S. $
[**]
|
|
[**]
%
|
From U.S. $
[**]
to U.S. $
[**]
|
|
[**]
%
|
Above $
[**]
|
|
[**]
%
|
Aggregate Annual Worldwide
Net Sales of Lexicon Products acting through Lexicon Targets other than LG921 Target in Contract Year
|
|
Royalty on Net Sales
|
Under U.S. $500,000,000
|
|
4.0%
|
From U.S. $500,000,000 to U.S. $1,000,000,000
|
|
4.5%
|
Above $1,000,000,000
|
|
7.0%
|
8.
|
Pursuant to Section 2.5.3 of the Collaboration Agreement, BMS hereby notifies Lexicon of its election to discontinue further Research Program Activities with respect to the LG921 Target, effective as of Lexicon’s filing of an IND with respect to the first Lexicon Product acting through the LG921 Target. Notwithstanding any other provisions of the Collaboration Agreement, BMS agrees to provide prompt, reasonable assistance in providing documents and other information generated by BMS for the Lexicon Product acting through the LG921 Target and cooperation to Lexicon in support of Lexicon’s efforts to prepare and file such IND. Notwithstanding any other provisions of the Collaboration Agreement, for each of the Program Compounds listed in
Exhibit A
hereto, sufficient preclinical work to support the filing of an IND shall be deemed to have been completed at the time BMS notified Lexicon of its election to discontinue further Research Program Activities with respect to the LG921 Target.
|
9.
|
This Amendment shall not amend or modify the covenants, terms, conditions, rights and obligations of the parties under the Collaboration Agreement, except as specifically set forth herein. The Collaboration Agreement shall continue in full force and effect in accordance with its terms as amended by this Amendment. This Amendment shall not amend or modify the covenants, terms, conditions, rights and obligations of the parties under any other agreement between the parties.
|
10.
|
This Agreement may be executed in counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument.
|