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Ionis Pharmaceuticals Inc – ‘10-K’ for 12/31/18 – ‘EX-10.70’

On:  Friday, 3/1/19, at 2:39pm ET   ·   For:  12/31/18   ·   Accession #:  874015-19-45   ·   File #:  0-19125

Previous ‘10-K’:  ‘10-K’ on 2/28/18 for 12/31/17   ·   Next:  ‘10-K’ on 3/2/20 for 12/31/19   ·   Latest:  ‘10-K’ on 2/21/24 for 12/31/23   ·   4 References:   

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

 3/01/19  Ionis Pharmaceuticals Inc         10-K       12/31/18  103:21M

Annual Report   —   Form 10-K   —   Sect. 13 / 15(d) – SEA’34
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10-K        Ionis Pharmaceuticals Inc 10-K 12-31-2018           HTML   1.80M 
 2: EX-10.67    Material Contract -- exhibit10_67                   HTML    515K 
 3: EX-10.68    Material Contract -- exhibit10_68                   HTML   1.18M 
 4: EX-10.69    Material Contract -- exhibit10_69                   HTML     41K 
 5: EX-10.70    Material Contract -- exhibit10_70                   HTML     43K 
 6: EX-21.1     Subsidiaries List -- exhibit21_1                    HTML     30K 
 7: EX-23.1     Consent of Experts or Counsel -- exhibit23_1        HTML     33K 
 8: EX-31.1     Certification -- §302 - SOA'02 -- exhibit31_1       HTML     39K 
 9: EX-31.2     Certification -- §302 - SOA'02 -- exhibit31_2       HTML     39K 
10: EX-32       Certification -- §906 - SOA'02 -- exhibit32_1       HTML     34K 
17: R1          Document and Entity Information                     HTML     66K 
18: R2          Consolidated Balance Sheets                         HTML    121K 
19: R3          Consolidated Balance Sheets (Parenthetical)         HTML     45K 
20: R4          Consolidated Statements of Operations               HTML    111K 
21: R5          Consolidated Statements of Comprehensive Income     HTML     59K 
                (Loss)                                                           
22: R6          Consolidated Statements of Stockholders' Equity     HTML    129K 
23: R7          Consolidated Statements of Stockholders' Equity     HTML     37K 
                (Parenthetical)                                                  
24: R8          Consolidated Statements of Cash Flows               HTML    178K 
25: R9          Consolidated Statements of Cash Flows               HTML     37K 
                (Parenthetical)                                                  
26: R10         Organization and Significant Accounting Policies    HTML    392K 
27: R11         Investments                                         HTML    140K 
28: R12         Long-Term Obligations and Commitments               HTML     95K 
29: R13         Stockholders' Equity                                HTML    139K 
30: R14         Income Taxes                                        HTML    168K 
31: R15         Collaborative Arrangements and Licensing            HTML    169K 
                Agreements                                                       
32: R16         Segment Information and Concentration of Business   HTML    114K 
                Risk                                                             
33: R17         Employment Benefits                                 HTML     33K 
34: R18         Legal Proceedings                                   HTML     36K 
35: R19         Quarterly Financial Data (Unaudited)                HTML    204K 
36: R20         Organization and Significant Accounting Policies    HTML    450K 
                (Policies)                                                       
37: R21         Organization and Significant Accounting Policies    HTML    303K 
                (Tables)                                                         
38: R22         Investments (Tables)                                HTML    141K 
39: R23         Long-Term Obligations and Commitments (Tables)      HTML     92K 
40: R24         Stockholders' Equity (Tables)                       HTML    132K 
41: R25         Income Taxes (Tables)                               HTML    170K 
42: R26         Collaborative Arrangements and Licensing            HTML    106K 
                Agreements (Tables)                                              
43: R27         Segment Information and Concentration of Business   HTML    114K 
                Risk (Tables)                                                    
44: R28         Quarterly Financial Data (Unaudited) (Tables)       HTML    203K 
45: R29         Organization and Significant Accounting Policies,   HTML     43K 
                Basis of Presentation (Details)                                  
46: R30         Organization and Significant Accounting Policies,   HTML    128K 
                Basic and Diluted Net Income (Loss) per Share                    
                (Details)                                                        
47: R31         Organization and Significant Accounting Policies,   HTML    164K 
                Revenue Recognition - Adoption of Topic 606                      
                (Details)                                                        
48: R32         Organization and Significant Accounting Policies,   HTML    117K 
                Revenue Recognition - Revenue Sources (Details)                  
49: R33         Organization and Significant Accounting Policies,   HTML     58K 
                Revenue Recognition - Deferred Revenue (Details)                 
50: R34         Organization and Significant Accounting Policies,   HTML     31K 
                Cost of Products Sold (Details)                                  
51: R35         Organization and Significant Accounting Policies,   HTML     65K 
                Research, Development and Patent Expenses                        
                (Details)                                                        
52: R36         Organization and Significant Accounting Policies,   HTML     40K 
                Accrued Liabilities (Details)                                    
53: R37         Organization and Significant Accounting Policies,   HTML     36K 
                Noncontrolling Interest in Akcea Therapeutics,                   
                Inc. (Details)                                                   
54: R38         Organization and Significant Accounting Policies,   HTML     34K 
                Cash, Cash Equivalents and Short-Term Investments                
                (Details)                                                        
55: R39         Organization and Significant Accounting Policies,   HTML     37K 
                Inventory Valuation (Details)                                    
56: R40         Organization and Significant Accounting Policies,   HTML     68K 
                Property, Plant and Equipment (Details)                          
57: R41         Organization and Significant Accounting Policies,   HTML     33K 
                Long-Lived Assets (Details)                                      
58: R42         Organization and Significant Accounting Policies,   HTML     34K 
                Stock-Based Compensation Expense (Details)                       
59: R43         Organization and Significant Accounting Policies,   HTML     57K 
                Accumulated Other Comprehensive Loss (Details)                   
60: R44         Organization and Significant Accounting Policies,   HTML     37K 
                Convertible Debt (Details)                                       
61: R45         Organization and Significant Accounting Policies,   HTML     32K 
                Segment Information (Details)                                    
62: R46         Organization and Significant Accounting Policies,   HTML     96K 
                Fair Value Measurements on a Recurring Basis                     
                (Details)                                                        
63: R47         Organization and Significant Accounting Policies,   HTML     47K 
                Fair Value Measurements - Novartis Future Stock                  
                Purchase (Details)                                               
64: R48         Organization and Significant Accounting Policies,   HTML     37K 
                Income Taxes (Details)                                           
65: R49         Investments, Contract Maturity of                   HTML     51K 
                Available-for-Sale Securities (Details)                          
66: R50         Investments, Summary of Investments (Details)       HTML    100K 
67: R51         Investments, Investments Temporarily Impaired       HTML     63K 
                (Details)                                                        
68: R52         Long-Term Obligations and Commitments, Long-Term    HTML     46K 
                Obligations (Details)                                            
69: R53         Long-Term Obligations and Commitments, Convertible  HTML    106K 
                Notes (Details)                                                  
70: R54         Long-Term Obligations and Commitments, Financing    HTML     56K 
                Arrangements (Details)                                           
71: R55         Long-Term Obligations and Commitments, Research     HTML     49K 
                and Development and Manufacturing Facilities                     
                (Details)                                                        
72: R56         Long-Term Obligations and Commitments, Maturity     HTML     58K 
                Schedules (Details)                                              
73: R57         Long-Term Obligations and Commitments, Operating    HTML     86K 
                Leases (Details)                                                 
74: R58         Stockholders' Equity, Preferred and Common Stock    HTML     62K 
                (Details)                                                        
75: R59         Stockholders' Equity, Stock Plans (Details)         HTML    109K 
76: R60         Stockholders' Equity, Stock Option Activity         HTML     91K 
                (Details)                                                        
77: R61         Stockholders' Equity, Restricted Stock Unit         HTML     65K 
                Activity (Details)                                               
78: R62         Stockholders' Equity, Stock-based Compensation      HTML     43K 
                Expense (Details)                                                
79: R63         Stockholders' Equity, Stock-based Valuation         HTML     56K 
                Information (Details)                                            
80: R64         Income Taxes, Loss Before Income Tax (Benefit)      HTML     38K 
                Expense (Details)                                                
81: R65         Income Taxes, Income Tax (Benefit) Expense          HTML     58K 
                (Details)                                                        
82: R66         Income Taxes, Reconciliation of Statutory to        HTML    128K 
                Effective Tax Rate (Details)                                     
83: R67         Income Taxes, Deferred Tax Assets and Liabilities   HTML     71K 
                (Details)                                                        
84: R68         Income Taxes, Tax Credit Carryforwards (Details)    HTML     42K 
85: R69         Income Taxes, Tax Act (Details)                     HTML     36K 
86: R70         Income Taxes, Gross Unrecognized Tax Benefits       HTML     49K 
                (Details)                                                        
87: R71         Collaborative Arrangements and Licensing            HTML    188K 
                Agreements, Biogen (Details)                                     
88: R72         Collaborative Arrangements and Licensing            HTML    110K 
                Agreements, AstraZeneca (Details)                                
89: R73         Collaborative Arrangements and Licensing            HTML     96K 
                Agreements, Bayer (Details)                                      
90: R74         Collaborative Arrangements and Licensing            HTML     76K 
                Agreements, GSK (Details)                                        
91: R75         Collaborative Arrangements and Licensing            HTML     87K 
                Agreements, Janssen Biotech, Inc. (Details)                      
92: R76         Collaborative Arrangements and Licensing            HTML     94K 
                Agreements, Roche (Details)                                      
93: R77         Collaborative Arrangements and Licensing            HTML    129K 
                Agreements, Novartis (Details)                                   
94: R78         Collaborative Arrangements and Licensing            HTML     66K 
                Agreements, PTC Therapeutics (Details)                           
95: R79         Collaborative Arrangements and Licensing            HTML     33K 
                Agreements, External Project Funding (Details)                   
96: R80         Segment Information and Concentration of Business   HTML    124K 
                Risk, Segment Information (Details)                              
97: R81         Segment Information and Concentration of Business   HTML     39K 
                Risk, Revenue from Significant Partners (Details)                
98: R82         Employment Benefits (Details)                       HTML     37K 
99: R83         Legal Proceedings (Details)                         HTML     39K 
100: R84         Quarterly Financial Data (Unaudited) (Details)      HTML    158K  
102: XML         IDEA XML File -- Filing Summary                      XML    186K  
101: EXCEL       IDEA Workbook of Financial Reports                  XLSX    152K  
11: EX-101.INS  XBRL Instance -- ions-20181231                       XML   5.64M 
13: EX-101.CAL  XBRL Calculations -- ions-20181231_cal               XML    333K 
14: EX-101.DEF  XBRL Definitions -- ions-20181231_def                XML   1.77M 
15: EX-101.LAB  XBRL Labels -- ions-20181231_lab                     XML   3.36M 
16: EX-101.PRE  XBRL Presentations -- ions-20181231_pre              XML   2.19M 
12: EX-101.SCH  XBRL Schema -- ions-20181231                         XSD    295K 
103: ZIP         XBRL Zipped Folder -- 0000874015-19-000045-xbrl      Zip    414K

‘EX-10.70’   —   Material Contract — exhibit10_70

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

 C: 
Final Execution Version

Exhibit 10.70

CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4), 240.24B-2

AMENDMENT NO. 4
 
This Amendment No. 4 (the “Amendment”) to the Collaboration, License and Development Agreement dated December 7th, 2012 (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, CA 92010 (“Ionis”),
 
and is made effective as of October 18th, 2018 (the “Amendment Effective Date”).
 
Recitals
 
WHEREAS, the Parties desire to further amend and restate certain terms and conditions of the Agreement.
 
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
 
Section 7.1.1 of the Agreement is hereby deleted in its entirety and replaced by the following:

Final Execution Version
 
“7.1.1. Integrated Product Plans.  AstraZeneca will prepare a Development and global integrated Product plan or a comparable document consistent with AstraZeneca’s then current internal practices for AstraZeneca’s internal programs outlining key aspects of the Development of each Product licensed by AstraZeneca under Section 6.1.1, Section 6.1.2 and Section 6.1.3 through all Approvals as well as, as Development proceeds and when such information is available, key aspects of worldwide regulatory strategy, pricing and market access strategy, market launch, and Commercialization (each plan or other such document, an “Integrated Development Plan” or “IDP”).  On a Product-by-Product basis, for each Product licensed by AstraZeneca under Section 6.1.1, Section 6.1.2 or Section 6.1.3, as the case may be, AstraZeneca will prepare each IDP no later than [***] for such Product, and the IDP will contain high level information consistent with AstraZeneca’s development and commercialization plans for its similar products at similar stages of development and commercialization in the same AstraZeneca franchise, including material updates, timelines, goals, and the criteria AstraZeneca will use to make internal decisions relating to the Product, provided however that it will be at AstraZeneca’s sole discretion whether to and in what format to provide any information which (i) AstraZeneca is required not to share even under confidentiality pursuant to restrictions imposed by any Third Party, or (ii) contains AstraZeneca Confidential Information regarding the use of AstraZeneca’s other portfolio compounds used alone or in combination with other AstraZeneca or Third Party products.  Once AstraZeneca has prepared an IDP, AstraZeneca will update it consistent with AstraZeneca’s standard practice (including if the IDP is updated and presented to an AstraZeneca internal committee) but at least Annually and will provide such updates to Ionis.  AstraZeneca and Ionis will meet (through the JSC or as the Parties may otherwise agree) on a yearly basis to discuss the draft of the IDP and AstraZeneca will consider, in good faith, any proposals and comments made by Ionis for incorporation in the final IDP.  AstraZeneca and Ionis will [***], to discuss the status of execution of the IDP.  Additionally, subject to any restrictions imposed by any Third Party, AstraZeneca may provide more frequent updates in the case of extraordinary material events (e.g. approvals, regulatory feedback, etc.) as deemed appropriate by AstraZeneca.  For the avoidance of doubt, information provided by AstraZeneca to Ionis pursuant to this Section 7.1.1 shall be treated by Ionis as AstraZeneca’s Confidential Information subject to the provisions in Article 13.  Notwithstanding the foregoing, on a Gene Target-by-Gene Target basis, AstraZeneca’s obligations to provide Ionis with information or reports under this Section 7.1.1 will terminate if Ionis independently or for or with an Affiliate or Third Party engages in any activity to discover, research or develop an ASO designed to bind to the RNA that encodes such Gene Target in the Field other than in the course of performing its obligations under, or to the extent permitted by, this Agreement.”
 

 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 and any prior Amendments thereto 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.
 

 5.
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:
  
/s/ Brett Monia
  
             
 
Name:
Regina Fritsche Danielson
  
Name:
Brett Monia
  
             
 
Title:
VP and Head of IMED CVRM
  
Title:
Chief Operating Officer
  


4 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
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Filing Submission 0000874015-19-000045   –   Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)
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