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As Of Filer Filing For·On·As Docs:Size 5/09/17 Ionis Pharmaceuticals Inc 10-Q 3/31/17 52:7M |
Document/Exhibit Description Pages Size 1: 10-Q Ionis Pharmaceuticals Inc 10-Q 3-31-2017 HTML 502K 2: EX-10.1 Material Contract HTML 569K 3: EX-10.2 Material Contract HTML 154K 4: EX-10.3 Material Contract HTML 86K 5: EX-31.1 Certification -- §302 - SOA'02 HTML 21K 6: EX-31.2 Certification -- §302 - SOA'02 HTML 21K 7: EX-32.1 Certification -- §906 - SOA'02 HTML 19K 14: R1 Document and Entity Information HTML 42K 15: R2 Condensed Consolidated Balance Sheets (Unaudited) HTML 95K 16: R3 Condensed Consolidated Balance Sheets (Unaudited) HTML 31K (Parenthetical) 17: R4 Condensed Consolidated Statements of Operations HTML 72K (Unaudited) 18: R5 Condensed Consolidated Statements of Comprehensive HTML 35K Income (Loss) (Unaudited) 19: R6 Condensed Consolidated Statements of Cash Flows HTML 114K (Unaudited) 20: R7 Basis of Presentation HTML 23K 21: R8 Significant Accounting Policies HTML 132K 22: R9 Investments HTML 125K 23: R10 Fair Value Measurements HTML 65K 24: R11 Line of Credit Arrangement HTML 23K 25: R12 Collaborative Arrangements and Licensing HTML 42K Agreements 26: R13 Segment Information and Concentration of Business HTML 74K Risk 27: R14 Significant Accounting Policies (Policies) HTML 161K 28: R15 Significant Accounting Policies (Tables) HTML 77K 29: R16 Investments (Tables) HTML 126K 30: R17 Fair Value Measurements (Tables) HTML 61K 31: R18 Segment Information and Concentration of Business HTML 70K Risk (Tables) 32: R19 Significant Accounting Policies, Revenue HTML 101K Recognition (Details) 33: R20 Significant Accounting Policies, Cash, Cash HTML 21K Equivalents and Short-term Investments (Details) 34: R21 Significant Accounting Policies, Inventory HTML 19K Valuation (Details) 35: R22 Significant Accounting Policies, Basic and Diluted HTML 58K Net Income (Loss) per Share (Details) 36: R23 Significant Accounting Policies, Accumulated Other HTML 41K Comprehensive Loss (Details) 37: R24 Significant Accounting Policies, Convertible Debt HTML 27K and Segment Information (Details) 38: R25 Significant Accounting Policies, Stock-Based HTML 70K Compensation Expense (Details) 39: R26 Investments, Contract Maturity of HTML 32K Available-for-Sale Securities (Details) 40: R27 Investments, Summary of Investments (Details) HTML 91K 41: R28 Investments, Investments Temporarily Impaired HTML 53K (Details) 42: R29 Fair Value Measurements, Fair Value Measurements HTML 74K on a Recurring Basis (Details) 43: R30 Fair Value Measurements, Fair Value Measurements HTML 49K Using Significant Unobservable Inputs (Level 3) (Details) 44: R31 Line of Credit Arrangement (Details) HTML 42K 45: R32 Collaborative Arrangements and Licensing HTML 40K Agreements, Biogen (Details) 46: R33 Collaborative Arrangements and Licensing HTML 57K Agreements, Bayer (Details) 47: R34 Collaborative Arrangements and Licensing HTML 84K Agreements, Novartis (Details) 48: R35 Segment Information and Concentration of Business HTML 51K Risk, Segment Information (Details) 49: R36 Segment Information and Concentration of Business HTML 35K Risk, Revenue from Significant Partners (Details) 51: XML IDEA XML File -- Filing Summary XML 84K 50: EXCEL IDEA Workbook of Financial Reports XLSX 68K 8: EX-101.INS XBRL Instance -- ions-20170331 XML 1.57M 10: EX-101.CAL XBRL Calculations -- ions-20170331_cal XML 171K 11: EX-101.DEF XBRL Definitions -- ions-20170331_def XML 644K 12: EX-101.LAB XBRL Labels -- ions-20170331_lab XML 1.59M 13: EX-101.PRE XBRL Presentations -- ions-20170331_pre XML 892K 9: EX-101.SCH XBRL Schema -- ions-20170331 XSD 142K 52: ZIP XBRL Zipped Folder -- 0000874015-17-000033-xbrl Zip 173K
(A) |
Ionis and Bayer have entered into a License Agreement dated May 1, 2015, as amended (the “Agreement”) in respect of ISIS-FXIRx, including option rights to a Factor XI follow-on compound and a [***] compound;
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(B) |
Under the Agreement, Ionis has completed certain clinical and non-clinical studies for ISIS-FXIRx, including the “Isis Completion Activities” and has identified and designated a follow-on Development Candidate targeting Factor XI incorporating Ionis’ liver-targeted Conjugate Technology, [***];
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(C) |
The Agreement provides for an Option for Bayer to license ISIS-FXIRx-2 upon the designation of a Development Candidate and Bayer is exercising its Option to ISIS-FXIRx-2 to obtain the license to ISIS-FXIRx-2 in accordance with this Amendment #1; and
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(D) |
To expedite the Development of ISIS-FXIRx and ISIS-FXIRx-2, Ionis will conduct the Ionis Development Activities described in this Amendment #1.
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1. |
DEFINITIONS - Appendix 1 of the Agreement shall be amended by adding or amending the definitions as set forth in Appendix 1A attached hereto this Amendment #1.
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1.7a(i) |
Ionis Development Activities for ISIS-FXIRx. Ionis will use Commercially Reasonable Efforts to Complete the phase IIb clinical trial set forth in Schedule 1.7a attached to this Amendment #1 for ISIS-FXIRx (such study, the “CS5 Study”), in accordance with the timelines specified therein. Ionis and Bayer will collaborate in the creation of a detailed protocol for the CS5 Study to be finalized no later than [***], however, Ionis will [***] regarding [***] of the CS5 Study and such [***] shall be consistent with Schedule 1.7a.
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1.7a(ii) |
Ionis Development Activities for ISIS-FXIRx-2. Ionis will use Commercially Reasonable Efforts to Complete the [***], and [***] the Phase I Clinical Trial, in each case as expressly set forth in Schedule 1.7a to this Amendment #1 for ISIS-FXIRx-2 (such [***], collectively, the “Non-Clinical Studies” and such Phase I Clinical Trial, the “CS1 Study”). Ionis and Bayer will collaborate in the creation of detailed protocols for the Non-Clinical Studies and the CS1 Study no later than [***]; however, Ionis will [***] regarding [***] of the Non-Clinical Studies and the CS1 Study and such [***] shall be consistent with Schedule 1.7a.
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1.7a(iii)
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Amendment Data Package. As soon as practicable following Completion of each of the Non-Clinical Studies, the CS1 Study and the CS5 Study (the CS1 Study and CS5 Study, collectively the “Amendment-Clinical Studies”), Ionis will deliver to Bayer, as applicable, [***]. All such information described in this paragraph collectively the “Amendment Data Package”.
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1.7a(iv)
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Information Exchange. Prior to the Decision Deadline, Ionis shall keep Bayer regularly informed on the Ionis Development Activities. The Parties (including the appropriate clinical and non-clinical personnel of each Party) shall regularly meet in person or hold a telephone conference to share and discuss the progress of ongoing Ionis Development Activities as well as any available new data and results from ongoing or completed Ionis Development Activities, including but not limited to minutes of the Data and Safety Monitoring Board and/or any other relevant safety documentation. Each Party’s Alliance Manager will facilitate and set the agenda for such meetings and otherwise coordinate such interactions between the Parties.
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1.7a(v)
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Bayer Development Activities. For the avoidance of doubt, irrespective of the Ionis Development Activities and subject to payment by Bayer of the license fee pursuant to Section 7.3.1 of the Agreement (as amended by this Amendment #1), Bayer has the right to initiate at any time additional Development activities with regard to ISIS-FXIRx and/or ISIS-FXIRx-2. Bayer shall consult and coordinate with Ionis prior to initiating any such Development activities. In setting up its Development activities, Bayer shall reasonably consider Ionis’ comments and shall not conduct any Development activity that would have a material negative impact on the Completion of the Ionis Development Activities.”
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2.5.1 |
Section 1.9.2(a)(ii) – In the first sentence of Section 1.9.2(a)(ii) the words “first [***]” are deleted and replaced with the words “first [***]”.
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“1.9.2(c)
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Supplies for the IONIS Development Activities. Upon Ionis’ request, Bayer will ([***]) provide Ionis with approximately [***] of API for ISIS-FXIRx purchased by Bayer under Purchase Order No. [***], for Ionis’ use in the CS5 Study and together with such API will provide Ionis with such minimum documentation related to Bayer’s transport and storage of such API that Ionis reasonably requires to comply with Applicable Law (including GMP and GCP); for clarity and notwithstanding anything to the contrary, Ionis shall remain responsible for [***] of such API for use in the CS5 Study. In addition, [***], Bayer agrees that Ionis may use in the CS5 Study the Finished Drug Product in Ionis’ possession (or the possession of Ionis’ CMO) that was previously ordered by Bayer under Purchase Order No. [***], and Ionis will [***] for such Finished Drug Product.
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2.5.3 |
Section 1.9.3 of the Agreement shall be deleted in its entirety and replaced with the following:
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“1.9.3 |
After Ionis Completes the CS5 Study. After Ionis completes the CS5 Study, and upon Bayer’s delivery of a Continuation Notice to Ionis, upon Bayer’s request, Ionis will deliver to Bayer any inventory of cGMP API, Finished Drug Product and packaged Clinical Study material for ISIS-FXIRx in Ionis’ possession on the terms set forth on Schedule 1.9.2(a) of the Agreement (except for any API Bayer delivered to Ionis for the CS5 Study, which will be returned to Bayer free of charge) and taking into account any amounts Bayer previously paid Ionis for any such material.”
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“1.9.4 |
After Ionis Completes the Non-Clinical Studies and CS1 Study. After Ionis completes the Non-Clinical Studies and the CS1 Study and upon Bayer’s delivery of a Continuation Notice to Ionis, upon Bayer’s request, Ionis will provide to Bayer any inventory of cGMP API, Finished Drug Product and packaged Clinical Study material for ISIS-FXIRx-2 in Ionis’ possession on the terms set forth on Schedule 1.9.2(a) of the Agreement.”
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“1.9.5
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Joint CMC Plan. Following Completion of the Ionis Development Activities and Bayer’s delivery of a Continuation Notice, Bayer will be responsible for supplying API and Finished Product for all future Development and Commercialization. To facilitate Bayer’s efforts in that regard, within the first [***] days after the Amendment Date, the Parties’ CMC teams will discuss and mutually agree on a joint CMC plan for technology transfer for API and Finished Drug Product Manufacturing for ISIS-FXIRx and ISIS-FXIRx-2, however, Bayer will [***] to set up the CMC plan; provided, further, that such [***] will not permit Bayer to [***] to conduct any activity that [***]. Each Party will use Commercially Reasonable Efforts to conduct their respective activities under the mutually agreed CMC plan.”
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2.A(i) |
Within [***] ([***]) days following Bayer’s receipt of the last document required to constitute the Amendment Data Package (the “Decision Deadline”), Bayer shall deliver written notice to Ionis indicating that Bayer will either (i) continue the Development and Commercialization of one or both of ISIS-FXIRx and/or ISIS-FXIRx-2 in accordance with the Agreement (such notice, a “Continuation Notice”), or (ii) terminate the Agreement either (x) in its entirety or (y), subject to Bayer having delivered to Ionis a Drug Discovery Request Notice regarding [***] prior to delivering the notice of termination, with respect to ISIS-FXIRx and ISIS-FXIRx-2 only (such notice, a “Termination Notice”).
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2.A(ii) |
If, by the Decision Deadline, Bayer delivers a Continuation Notice to Ionis, then on the earlier of (i) [***] ([***]) days following Bayer’s delivery of such Continuation Notice, or (ii) Initiation by Bayer of a Clinical Study of ISIS-FXIRx-2 following delivery of the Continuation Notice, Bayer shall pay to Ionis within [***] days following receipt of an invoice from Ionis a milestone payment of $[***].
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2.A(iii) |
If, by the Decision Deadline, Bayer delivers a Termination Notice to Ionis, then the Agreement will automatically terminate, as the case may be, either (i) with respect to ISIS-FXIRx and ISIS-FXIRx-2 or (ii) in its entirety, the provisions of Section 11.3 of the Agreement will apply and all rights to ISIS-FXIRx, ISIS-FXIRx-2 and, as the case may be, [***] will revert back to Ionis.
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“3.3.4 |
Ionis Development Activities. Ionis will be responsible for all costs associated with the Ionis Development Activities under Schedule 1.7a, including any costs associated with changes to the Amendment-Clinical Studies required by a Regulatory Authority.”
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6.2 |
Section 5.2.1 shall be amended to no longer refer to the milestone payment for Completion of the CS IV Study, but to the milestone payment following delivery of a Continuation Notice by Bayer pursuant to Article 2.A(ii). The following sentence shall be added at the end of Section 5.2.1:
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7.1 |
Section 7.2 shall no longer apply to ISIS-FXIRx-2, and Section 7.2.1 is deleted in its entirety.
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10.1 |
13.8. Notices. For notices Ionis delivers to Bayer, the company shall be Bayer AG, having an address at Müllerstr. 178, 13353 Berlin. Section 13.8 shall be deemed amended accordingly.
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11. |
Appendix 5 (Isis Core Technology Patents) and Appendix 7 (Isis Product-Specific Patents) shall be deleted in their entirety and replaced by Appendix 5A (Ionis Core Technology Patents) and Appendix 7A (Ionis Product-Specific Patents) attached hereto this Amendment.
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12.1 |
All provisions of the Agreement not altered by this Amendment shall remain in force unaltered. All provisions of the Agreement altered by this Amendment shall only be altered as far as expressly stated in this Amendment.
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12.2 |
The miscellaneous clauses as set out in Section 13 of the Agreement shall apply mutatis mutandis to this Amendment.
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Berlin,
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Feb 13, 2017
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Carlsbad, CA USA
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(Place)
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(Date)
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(Place)
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(Date)
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Bayer AG
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Ionis Pharmaceuticals, Inc.
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ppa. /s/ Julio Triana
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Name: Julio Triana
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Name: B. Lynne Parshall
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Function/Title: Chief Financial Officer
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Function/Title: Chief Operating Officer
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i. V. /s/ Xin Ma
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Name: Dr. Xin Ma
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Function/Title:
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Head of New Product | ||
Commercialization &
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Portfolio Strategy
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This ‘10-Q’ Filing | Date | Other Filings | ||
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Filed on: | 5/9/17 | 8-K | ||
For Period end: | 3/31/17 | |||
2/10/17 | ||||
1/1/17 | 4 | |||
5/1/15 | ||||
List all Filings |
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