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Ionis Pharmaceuticals Inc. – ‘10-Q’ for 6/30/20 – ‘EX-10.2’

On:  Wednesday, 8/5/20, at 5:17pm ET   ·   For:  6/30/20   ·   Accession #:  874015-20-115   ·   File #:  0-19125

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  As Of               Filer                 Filing    For·On·As Docs:Size

 8/05/20  Ionis Pharmaceuticals Inc.        10-Q        6/30/20   59:10M

Quarterly Report   —   Form 10-Q
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10-Q        Ionis Pharmaceuticals Inc 10-Q 6-30-2020            HTML   1.37M 
 2: EX-10.1     Material Contract                                   HTML     20K 
 3: EX-10.2     Material Contract                                   HTML     43K 
 4: EX-31.1     Certification -- §302 - SOA'02                      HTML     24K 
 5: EX-31.2     Certification -- §302 - SOA'02                      HTML     24K 
 6: EX-32.1     Certification -- §906 - SOA'02                      HTML     19K 
13: R1          Document and Entity Information                     HTML     70K 
14: R2          Condensed Consolidated Balance Sheets (Unaudited)   HTML    120K 
15: R3          Condensed Consolidated Balance Sheets (Unaudited)   HTML     33K 
                (Parenthetical)                                                  
16: R4          Condensed Consolidated Statements of Operations     HTML    106K 
                (Unaudited)                                                      
17: R5          Condensed Consolidated Statements of Comprehensive  HTML     44K 
                Income (Loss) (Unaudited)                                        
18: R6          Condensed Consolidated Statements of Stockholders'  HTML     91K 
                Equity (Unaudited)                                               
19: R7          Condensed Consolidated Statements of Cash Flows     HTML    121K 
                (Unaudited)                                                      
20: R8          Basis of Presentation                               HTML     22K 
21: R9          Significant Accounting Policies                     HTML    254K 
22: R10         Investments                                         HTML    156K 
23: R11         Fair Value Measurements                             HTML     73K 
24: R12         Income Taxes                                        HTML     24K 
25: R13         Collaborative Arrangements and Licensing            HTML     57K 
                Agreements                                                       
26: R14         Segment Information                                 HTML    142K 
27: R15         Basis of Presentation (Policies)                    HTML     24K 
28: R16         Significant Accounting Policies (Policies)          HTML    301K 
29: R17         Significant Accounting Policies (Tables)            HTML    173K 
30: R18         Investments (Tables)                                HTML    157K 
31: R19         Fair Value Measurements (Tables)                    HTML     70K 
32: R20         Collaborative Arrangements and Licensing            HTML     48K 
                Agreements (Tables)                                              
33: R21         Segment Information (Tables)                        HTML    137K 
34: R22         Basis of Presentation (Details)                     HTML     26K 
35: R23         Significant Accounting Policies, Revenue            HTML     66K 
                Recognition (Details)                                            
36: R24         Significant Accounting Policies, Contracts          HTML     19K 
                Receivable (Details)                                             
37: R25         Significant Accounting Policies, Deferred Revenue   HTML     20K 
                (Details)                                                        
38: R26         Significant Accounting Policies, Noncontrolling     HTML     27K 
                Interest in Akcea (Details)                                      
39: R27         Significant Accounting Policies, Cash, Cash         HTML     27K 
                Equivalents and Investments (Details)                            
40: R28         Significant Accounting Policies, Inventory          HTML     30K 
                Valuation (Details)                                              
41: R29         Significant Accounting Policies, Basic and Diluted  HTML     78K 
                Net Income (Loss) per Share (Details)                            
42: R30         Significant Accounting Policies, Convertible Debt   HTML     23K 
                (Details)                                                        
43: R31         Significant Accounting Policies, Segment            HTML     20K 
                Information (Details)                                            
44: R32         Significant Accounting Policies, Stock-Based        HTML     82K 
                Compensation Expense (Details)                                   
45: R33         Significant Accounting Policies Amendments to       HTML     19K 
                Equity Plan (Details)                                            
46: R34         Significant Accounting Policies, Share Repurchase   HTML     25K 
                Program (Details)                                                
47: R35         Investments, Contract Maturity of                   HTML     38K 
                Available-for-Sale Securities (Details)                          
48: R36         Investments, Summary of Investments (Details)       HTML     97K 
49: R37         Investments, Investments Temporarily Impaired       HTML     50K 
                (Details)                                                        
50: R38         Fair Value Measurements (Details)                   HTML     99K 
51: R39         Income Taxes (Details)                              HTML     33K 
52: R40         Collaborative Arrangements and Licensing            HTML     78K 
                Agreements, Biogen (Details)                                     
53: R41         Collaborative Arrangements and Licensing            HTML     59K 
                Agreements, AstraZeneca (Details)                                
54: R42         Collaborative Arrangements and Licensing            HTML     23K 
                Agreements, Janssen Biotech, Inc. (Details)                      
55: R43         Segment Information (Details)                       HTML     92K 
57: XML         IDEA XML File -- Filing Summary                      XML     99K 
12: XML         XBRL Instance -- form10q_htm                         XML   3.00M 
56: EXCEL       IDEA Workbook of Financial Reports                  XLSX     90K 
 8: EX-101.CAL  XBRL Calculations -- ions-20200630_cal               XML    168K 
 9: EX-101.DEF  XBRL Definitions -- ions-20200630_def                XML    703K 
10: EX-101.LAB  XBRL Labels -- ions-20200630_lab                     XML   1.57M 
11: EX-101.PRE  XBRL Presentations -- ions-20200630_pre              XML    926K 
 7: EX-101.SCH  XBRL Schema -- ions-20200630                         XSD    133K 
58: JSON        XBRL Instance as JSON Data -- MetaLinks              321±   467K 
59: ZIP         XBRL Zipped Folder -- 0000874015-20-000115-xbrl      Zip    290K

‘EX-10.2’   —   Material Contract

This Exhibit is an HTML Document rendered as filed.  [ Alternative Formats ]

 C: 
Exhibit 10.2

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.  SUCH EXCLUDED INFORMATION HAS BEEN MARKED WITH “[***]”.
 
AMENDMENT NO. 2
 
This Amendment No. 2 (the “Amendment”) to the Strategic Collaboration Agreement dated July 31st, 2015, as previously amended by Amendment No. 1 dated October 18, 2018 (the “Agreement”), is made by and between

 
(1)
ASTRAZENECA AB, a company incorporated in Sweden under no. 556011-7482 with its registered office at SE-151 85 Södertälje, Sweden (“AstraZeneca”) and
 
 
(2)
IONIS PHARMACEUTICALS, INC., a Delaware corporation, (formally known as Isis Pharmaceuticals, Inc.) having its principal place of business at 2855 Gazelle Court, Carlsbad, California 92010 U.S.A. (“Ionis”),
 
and is made effective as of April 30, 2020 (the “Amendment Effective Date”).

Recitals

WHEREAS, in accordance with the Agreement, AstraZeneca is Developing from the [***] Program both (i) [***] Products including [***] (each, a “[***] Product”) and (ii) [***] Products (each, a “[***] Product”); and
 
WHEREAS, the Parties desire to amend and restate certain terms and conditions of the Agreement with respect to [***] Products under the [***] Program.
 
Agreement
 
NOW, THEREFORE, in consideration of the mutual covenants contained in this Amendment, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:
 
1.
Definitions
 
Any capitalized term not separately defined in this Amendment shall have the meaning ascribed to it in the Agreement.
 
2.
Modifications
 
 
a.
With respect to the [***] Program, AstraZeneca will use Commercially Reasonable Efforts to [***] of the [***] Product known as [***] by [***].
 
b.
Notwithstanding the provisions of Section 6.4 of the Agreement, upon the earlier of:
 
 
(i)
[***] by AstraZeneca, its Affiliates or Sublicensees with respect to [***]; and
 
 
(ii)
[***],
 
in accordance with Section 6.5.5 of the Agreement, AstraZeneca will pay to Ionis US$ [***], which shall satisfy AstraZeneca’s obligations under Section 6.4 of the Agreement for the separate Product Milestone Event Payments of US$[***] for each of [***] and [***] for the Licensed Program that is the [***] Program.
 
If AstraZeneca, its Affiliates or Sublicensees are unable to achieve [***] by [***] for [***] due to [***] or any action or failure to act by a Third Party that is beyond the reasonable control of AstraZeneca, its Affiliates or Sublicensees, provided that AstraZeneca has taken all reasonable actions that would, in the normal course, be expected to have allowed such [***] by [***], then AstraZeneca will provide prompt written notice to Ionis containing sufficient detail and supporting documentation of the inability to achieve such [***], such notice to be provided no later than [***] (unless AstraZeneca becomes aware after [***] of the inability to achieve such [***], in which case AstraZeneca shall provide such notice as soon as practicable). Within [***] after such notice, the Parties will meet to discuss in good faith and agree upon an alternative timeframe applicable to such Product Milestone Event Payment. If the Parties cannot in good faith agree on such an alternative timeframe, then either Party may refer the matter to the Senior Vice President for Early CVRM of AstraZeneca and the Executive Vice President and Chief Corporate Development Officer of Ionis (the “Senior Executives”) for resolution. The Senior Executives will meet as soon as reasonably possible thereafter and use their good faith efforts to mutually agree upon an alternative timeframe applicable to such Product Milestone Event Payment. Notwithstanding anything herein to the contrary, under no circumstances will the Product Milestone Event Payment corresponding to [***] be due later than the due date for achievement of [***] for [***] as determined pursuant to Section 6.5.5 of the Agreement.
 
c.
Notwithstanding the provisions of Section 6.4 of the Agreement, in respect of the Licensed Program that is the [***] Program, if the following Product Milestone Events are first achieved by a [***] Product, then the corresponding Product Milestone Event Payments in TABLE 1 shall be amended to read as:
 
TABLE 1
 
Product Milestone Event
Product Milestone Event Payment
(Applicable only if first achieved by a [***]
Product)
[***]
$[***]
[***]
$[***]
 
For clarity, in respect of the Licensed Program that is the [***] Program, if the foregoing Product Milestone Events are first achieved by a [***] Product, then the corresponding Product Milestone Event Payments shall be as set forth in TABLE 1 of Section 6.4 of the Agreement without amendment.

 
d.
Notwithstanding that both [***] Products and [***] Products arise from the [***] Program, for purposes of Section 6.7 (Royalty Payments) of the Agreement, [***] Products shall be treated as arising from one Licensed Program (and royalties will be due on [***] Products in accordance with Section 2(e) below) and [***] Products shall be treated as arising from another Licensed Program (and royalties will be due on [***] Products in accordance with Section 6.7 of the Agreement).

 
e.
Solely with respect to such Licensed Program applicable to [***] Products, TABLE 2 in Section 6.7.1 (AstraZeneca Full Royalty) of the Agreement shall be amended to read as follows:
 
TABLE 2
Royalty Tier
Annual Worldwide Net Sales of Products from a Licensed Program
(Applicable onlyto[***]
Products)
 
Royalty
Rate
1
For the portion of Annual Worldwide Net Sales < $[***]
[***]%
2
For the portion of Annual Worldwide Net Sales > $[***] but < $[***]
[***]%
3
For the portion of Annual Worldwide Net Sales > $[***] but < $[***]
[***]%
4
For the portion of Annual Worldwide Net Sales > $[***]
[***]%
 
 
f.
The following shall be added as Section 6.14 to the Agreement: 
 
“6.14. Commercial Milestones for [***] Products.

As partial consideration for the rights granted to AstraZeneca hereunder, in accordance with Section 6.5.5, AstraZeneca will pay to Ionis the milestone payments as set forth in TABLE 3 below when a milestone event listed in TABLE 3 is first achieved by AstraZeneca, its Affiliates or Sublicensees with respect to a [***] Product:
 
TABLE 3
Commercial Milestone Event
If aggregate Net Sales of all [***]
Products sold by AstraZeneca, its
Affiliates or Sublicensees in a given
Calendar Year exceeds the amount
stated below for such Calendar Year:
Commercial Milestone Event Payment
then AstraZeneca will pay to Ionis:
US$ [***]
US$ [***]
US$ [***]
US$ [***]
US$ [***]
US$ [***]
US$ [***]
US$ [***]
US$ [***]
US$ [***]
US$ [***] US$ [***]
US$ [***] US$ [***]

In the event that in a given Calendar Year more than one of the foregoing thresholds set forth in TABLE 3 is exceeded, AstraZeneca will pay to Ionis a separate milestone payment with respect to each such threshold that is exceeded in such Calendar Year. Each milestone payment in this Section 6.14 will be payable only upon the first achievement of such milestone event in a given Calendar Year and no amounts shall be due for subsequent or repeated achievements of such milestone in subsequent Calendar Years.”
 
 
3.
Amendment Effective Date
 
This Amendment shall become effective on the Amendment Effective Date.
 
 
4.
Entire Agreement
 
This Amendment, together with the Agreement, constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. The Agreement together with this Amendment supersedes all prior agreements, whether written or oral, with respect to the subject matter of the Agreement, as amended. Each Party confirms that it is not relying on any representations, warranties, or covenants of the Party except as specifically set out in the Agreement as amended. Nothing in this Amendment is intended to limit or exclude any liability or fraud. The Parties hereby agree that subject to the modifications specifically stated in this Amendment, all other terms and conditions of the Agreement shall remain in full force and effect.
 
[Remainder of page intentionally blank. Signatures follow.]

Execution
 
THIS AMENDMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above.

ASTRAZENECA AB (publ.)
IONIS PHARMACEUTICALS, INC.
 
 
  
 
Signature:
/s/ Regina Fritsche-Danielson
  
Signature:
 
 
  
 
Name:
Regina Fritsche-Danielson
  
Name:
 
 
  
 
Title:
 
SVP and Head of Research and Early Development, Cardiovascular, Renal and Metabolic
  
Title: 
CEO


Dates Referenced Herein   and   Documents Incorporated by Reference

This ‘10-Q’ Filing    Date    Other Filings
Filed on:8/5/208-K
For Period end:6/30/204
4/30/20
10/18/184,  8-K
 List all Filings 

7 Subsequent Filings that Reference this Filing

  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 2/21/24  Ionis Pharmaceuticals Inc.        10-K       12/31/23  103:18M
 2/22/23  Ionis Pharmaceuticals Inc.        10-K       12/31/22  110:25M
 2/25/22  Ionis Pharmaceuticals Inc.        10-K       12/31/21  106:22M
 2/24/21  Ionis Pharmaceuticals Inc.        10-K       12/31/20  111:23M
12/31/20  Ionis Pharmaceuticals Inc.        S-8        12/31/20    7:376K                                   Broadridge Fin’l So… Inc
 8/07/20  Ionis Pharmaceuticals Inc.        S-8         8/10/20    5:159K                                   Broadridge Fin’l So… Inc
 8/07/20  Ionis Pharmaceuticals Inc.        S-3ASR      8/10/20    3:275K                                   Broadridge Fin’l So… Inc

1 Previous Filing that this Filing References

  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 4/24/20  Ionis Pharmaceuticals Inc.        DEF 14A     6/04/20    1:6.1M                                   Broadridge Fin’l So… Inc
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