Document/ExhibitDescriptionPagesSize
1: 10-Q Quarterly Report HTML 2.63M
2: EX-10.1 Material Contract HTML 51K
3: EX-10.3 Material Contract HTML 172K
4: EX-10.4 Material Contract HTML 74K
5: EX-10.5 Material Contract HTML 144K
6: EX-10.6 Material Contract HTML 189K
7: EX-10.7 Material Contract HTML 70K
8: EX-10.8 Material Contract HTML 146K
9: EX-31.1 Certification -- §302 - SOA'02 HTML 31K
10: EX-31.2 Certification -- §302 - SOA'02 HTML 31K
11: EX-32.1 Certification -- §906 - SOA'02 HTML 29K
17: R1 Cover Page HTML 81K
18: R2 Condensed Consolidated Balance Sheets HTML 164K
19: R3 Condensed Consolidated Balance Sheets HTML 35K
(Parenthetical)
20: R4 Condensed Consolidated Statements of Operations HTML 104K
21: R5 Condensed Consolidated Statements of Comprehensive HTML 54K
Loss
22: R6 Condensed Consolidated Statements of Cash Flows HTML 135K
23: R7 Condensed Consolidated Statements of Shareholders? HTML 91K
Equity
24: R8 Description of Business, Basis of Presentation and HTML 42K
Consolidation and Significant Accounting Policies
25: R9 Fair Value Measurements HTML 64K
26: R10 Collaborative and Licensing Arrangements HTML 110K
27: R11 Restricted Cash and Investments HTML 59K
28: R12 Inventories HTML 36K
29: R13 Property, plant and equipment HTML 44K
30: R14 Intangible Assets HTML 76K
31: R15 Income Taxes HTML 35K
32: R16 Supplemental Balance Sheet Information HTML 78K
33: R17 Debt HTML 78K
34: R18 Product Revenue HTML 79K
35: R19 Loss Per Share HTML 41K
36: R20 Share-Based Compensation Expense HTML 64K
37: R21 Accumulated Other Comprehensive Income (Loss) HTML 45K
38: R22 Shareholders? Equity HTML 35K
39: R23 Restricted Net Assets HTML 31K
40: R24 Commitments and Contingencies HTML 35K
41: R25 Segment and Geographic Information HTML 47K
42: R26 Description of Business, Basis of Presentation and HTML 41K
Consolidation and Significant Accounting Policies
(Policies)
43: R27 Fair Value Measurements (Tables) HTML 58K
44: R28 Collaborative and Licensing Arrangements (Tables) HTML 120K
45: R29 Restricted Cash and Investments (Tables) HTML 55K
46: R30 Inventories (Tables) HTML 37K
47: R31 Property, plant and equipment (Tables) HTML 42K
48: R32 Intangible Assets (Tables) HTML 77K
49: R33 Supplemental Balance Sheet Information (Tables) HTML 85K
50: R34 Debt (Tables) HTML 77K
51: R35 Product Revenue (Tables) HTML 89K
52: R36 Loss Per Share (Tables) HTML 40K
53: R37 Share-Based Compensation Expense (Tables) HTML 58K
54: R38 Accumulated Other Comprehensive Income (Loss) HTML 45K
(Tables)
55: R39 Segment and Geographic Information (Tables) HTML 40K
56: R40 Description of Business, Basis of Presentation and HTML 43K
Consolidation and Significant Accounting Policies
(Details)
57: R41 Fair Value Measurements (Details) HTML 67K
58: R42 Collaborative and Licensing Arrangements - HTML 43K
Recognized Revenue (Details)
59: R43 Collaborative and Licensing Arrangements - HTML 63K
Novartis (Details)
60: R44 Collaborative and Licensing Arrangements - HTML 82K
Ociperlimab Option, Collaboration and License
Agreement and China Broad Market Development
Agreement (Details)
61: R45 Collaborative and Licensing Arrangements - Amgen HTML 65K
(Details)
62: R46 Collaborative and Licensing Arrangements - Funding HTML 39K
Expenses (Details)
63: R47 Collaborative and Licensing Arrangements - HTML 33K
Financing Liability (Details)
64: R48 Collaborative Arrangements - Amounts and HTML 47K
Classification of Payments (Income/(Expense)
(Details)
65: R49 Restricted Cash and Investments - Restricted Cash HTML 29K
(Details)
66: R50 Restricted Cash and Investments - Short-Term HTML 42K
Investments (Details)
67: R51 Restricted Cash and Investments - Equity HTML 56K
Securities with/without Readily Determinable Fair
Values and Equity-Method Investments (Details)
68: R52 Restricted Cash and Investments - Fair value of HTML 34K
Common Stock and Warrants (Details)
69: R53 Inventories (Details) HTML 36K
70: R54 Property, plant and equipment - Tabular Disclosure HTML 50K
(Details)
71: R55 Property, plant and equipment - Narratives HTML 36K
(Details)
72: R56 Intangible Assets - Intangible Assets Outstanding HTML 42K
(Details)
73: R57 Intangible Assets - Useful Life (Details) HTML 34K
74: R58 Intangible Assets - Future Amortization Expense HTML 34K
(Details)
75: R59 Intangible Assets - Expected Amortization Expense HTML 51K
(Details)
76: R60 Income Taxes (Details) HTML 35K
77: R61 Supplemental Balance Sheet Information - Allowance HTML 37K
For Credit Loss (Details)
78: R62 Supplemental Balance Sheet Information - Schedule HTML 44K
of Prepaid Expenses and Other Current Assets
(Details)
79: R63 Supplemental Balance Sheet Information - Schedule HTML 41K
of Other Non-current Assets (Details)
80: R64 Supplemental Balance Sheet Information - Schedule HTML 41K
of Accrued Expenses and Other Payables (Details)
81: R65 Supplemental Balance Sheet Information - Schedule HTML 36K
of Other Long-term Liabilities (Details)
82: R66 Debt - Short-term and Long-term Debt Obligations HTML 83K
(Details)
83: R67 Debt - Narratives (Details) HTML 112K
84: R68 Product Revenue - Product Sales (Details) HTML 60K
85: R69 Product Revenue - Accrued Sales Rebates and HTML 35K
Returns (Details)
86: R70 Loss Per Share (Details) HTML 46K
87: R71 Share-Based Compensation Expense - Share Options HTML 70K
and Incentive Plan (Details)
88: R72 Share-Based Compensation Expense - Shares Issued HTML 41K
Under Employee Share Purchase Plan (Details)
89: R73 Share-Based Compensation Expense - Expense HTML 34K
Recognized (Details)
90: R74 Accumulated Other Comprehensive Income (Loss) HTML 62K
(Details)
91: R75 Shareholders? Equity (Details) HTML 41K
92: R76 Restricted Net Assets (Details) HTML 34K
93: R77 Commitments and Contingencies - Commitments HTML 55K
(Details)
94: R78 Segment and Geographic Information - Narratives HTML 48K
(Details)
95: R79 Segment and Geographic Information - Schedule of HTML 39K
Revenue by Geographic Area (Details)
98: XML IDEA XML File -- Filing Summary XML 175K
96: XML XBRL Instance -- bgne-20220630_htm XML 2.47M
97: EXCEL IDEA Workbook of Financial Reports XLSX 170K
13: EX-101.CAL XBRL Calculations -- bgne-20220630_cal XML 214K
14: EX-101.DEF XBRL Definitions -- bgne-20220630_def XML 752K
15: EX-101.LAB XBRL Labels -- bgne-20220630_lab XML 1.75M
16: EX-101.PRE XBRL Presentations -- bgne-20220630_pre XML 1.12M
12: EX-101.SCH XBRL Schema -- bgne-20220630 XSD 210K
99: JSON XBRL Instance as JSON Data -- MetaLinks 439± 652K
100: ZIP XBRL Zipped Folder -- 0001651308-22-000139-xbrl Zip 801K
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
FIRST AMENDMENT TO COLLABORATION AGREEMENT
This Amendment to the Collaboration Agreement (“Amendment”) is entered into as of April
20, 2022 (the “Amendment Effective Date”) by and among Amgen Inc., a Delaware corporation having its principal place of business at One Amgen Center Drive, Thousand Oaks, California91320-1799 (“Amgen”), BeiGene Switzerland GmbH, a Swiss corporation with a principal place of business at Aeschengraben 27, 4051 Basel, Switzerland (“BeiGene”), and BeiGene, Ltd., a Cayman Islands exempted company incorporated with limited liability with its registered offices c/o Mourant Governance Services (Cayman) Limited, 94 Solaris Avenue, P.O. Box 1348, Grand Cayman
KY1-1108, Cayman Islands (“BeiGene Parent”). BeiGene and Amgen are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” This Amendment amends that certain Collaboration Agreement (the “Agreement”), entered into as of October 31, 2019, by and between Amgen and BeiGene and, solely with respect to Section 13.6 thereof, BeiGene Parent. Capitalized terms used but not defined herein have the meanings given to them in the Agreement.
RECITALS
WHEREAS, the Agreement contains certain terms and conditions relating to the financial responsibilities of the Parties in connection with the development and commercialization
of certain Amgen proprietary Products for the treatment of oncology-related diseases and conditions; and
WHEREAS, the Parties desire to amend the Agreement upon the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties, intending to be legally bound hereby, do agree as follows:
AGREEMENT
1.Amendment to Section 1.48 of the Agreement. Section 1.48 of the Agreement is hereby amended and replaced in its entirety as follows:
“Section 1.48 “Costs” means both internal and external costs and expenses (including the cost of allocated FTEs at the FTE Rate and Sales
Force FTEs at the Sales Force FTE Rate). [*]”
2.New Section 1.170. The following is hereby inserted as a new Section 1.170 of the Agreement:
“Section 1.170 “Hainan Bo Ao” shall mean Pilot Zone in the Hainan province where Bo Ao Product may be stored and then imported into the Collaboration Territory with a patient application prior to Regulatory Approval for the Bo Ao Product in the Collaboration Territory.”
3.New Section 1.171. The following is hereby inserted as a new Section 1.171 of the Agreement:
“Section 1.171 “Bo Ao Support Costs” means all actual and, if reasonably practicable, documented
costs incurred by Amgen and/or its Affiliates and pre-approved pursuant to the Supply Agreement, if applicable, [*]”
4.New Section 1.172. The following is hereby inserted as a new Section 1.172 of the Agreement:
“Section 1.172 “Product Team” means, for any Product [*].”
5.New Section 1.173. The following is hereby inserted as a new Section 1.173 of the Agreement:
“Section 1.173 “Work Package Team” means, for any Product [*].”
6.Amendment
to Section 7.1.2 of the Agreement. The following text is hereby inserted as a new Section 7.1.2(d), Section 7.1.2(e), Section 7.1.2(f), and Section 7.1.2(g), respectively, of the Agreement: [*]
7.Amendments to Section 7.2 of the Agreement.
a.The first paragraph of Section 7.2 (Profit Sharing) of the Agreement is hereby amended and replaced in its entirety as follows:
“Section 7.2 Profit Sharing.
(a) Prior to the Transition Date designated by the Joint Steering Committee (generally the second Launch Readiness Review for a Product) for an In-Line Product (the “Transition Date”) pursuant to Section 3.1.1 (Transition
and Development of Products) and Section 5.1.2(b) (Initial In-Line Product Transition), [*] set forth in the definition of “Commercialization and Related Costs.” The Joint Steering Committee has designated the Transition Date for each In-Line Product as follows: XGEVA®, [*]; BLINCYTO®, [*]; and Kyprolis®, [*].
For the avoidance of doubt, [*] from Amgen to BeiGene pursuant to Section 3.1.1 (Transition and Development of Products) and Section 5.1.2(b) (Initial In-Line Product Transition).
(b) [*] set forth in the definition of “Commercialization and Related Costs” for each Pipeline Product until [*] prior to the anticipated launch date for such Pipeline Product (such date to be designated for each Pipeline Product by the Joint Alliance
Committee and subject to adjustment by the Joint Alliance Committee in the event the anticipated launch date changes) (such date, the “Initiation Date”).
(c) The Parties will share in Profits generated by Products in the Collaboration Scope: (i) with respect to In-Line Products, beginning on [*] and ending upon [*] for such In-Line Product; (ii) with respect to Pipeline Products, beginning on [*] and ending upon [*] for such Pipeline Product; and (iii) for such longer period as set forth in Section 5.1 for each Retained In-Line Product and each Retained Pipeline Product (i.e., for so long as such Retained In-Line Product or Retained Pipeline Product, as applicable, is sold in the Collaboration Territory); in each case as follows:”
2
b.Section
7.2.3 (FTE Rate) of the Agreement is hereby amended and restated in its entirety as follows:
“Section 7.2.3. FTE Rate.
(a) The FTE Rate used for calculation of Costs pursuant to this Article VII (Financial Consideration) with respect to any activity will be the relevant FTE Rate for [*] in which such activity was undertaken.
(b) Effective as of [*], the Parties agree that the Costs (calculated using the development FTE Rate (as defined in Section 1.72(i)) or commercial FTE Rate (as defined in Section 1.72(ii)), as applicable) of FTEs performing Product Team/Work Package Team strategy activities (i.e. Support to advise on the China specific aspects of the Global Development Plan) for Pipeline Products incurred by the Parties or their respective Affiliates: (i) prior to Regulatory Approval,
in accordance with the Development Plan and Development Budget will be deemed Amgen Pipeline Product Global Development Costs and subject to Global Development Cost-Share Payments in accordance with Section 7.1.2 (Global Development Cost Share) and (ii) after Regulatory Approval (including strategy activities for new indications or label expansion after Regulatory Approval), in accordance with the Commercialization Plan and Commercialization Budget, will be deemed to be Commercialization and Related Costs and included in the collaboration profit sharing pursuant to Section 7.2 (Profit Sharing). The Product Team and Work Package Team FTEs will be initially set, and shall in no event exceed, [*] to support the Pipeline Products. The table below sets out the 2021 baseline budget for Product Team/Work Package Team strategy FTEs based on the Pipeline Product portfolio as of the Amendment Effective Date. [*]
(c) The
Product Team and Work Package Team FTE allocation for Pipeline Products will be adjusted by Amgen [*] based on relevant factors, [*].”
c.The following is hereby inserted as a new Section 7.2.8 of the Agreement:
“Section 7.2.8 Hainan Bo Ao Cost-Share Matters. Notwithstanding anything to the contrary in this Agreement, with respect to the AMG 510 (also known as sotorasib or LUMAKRAS®) Product (the “Bo Ao Product”), the Parties desire to initiate the Profit-sharing arrangement set forth in Section 7.2 prior to applicable Initiation Date, subject to the following terms and conditions:
(a) Commercialization
and Related Costs. Prior to the applicable Initiation Date, costs (including Costs for outside services and expenses (e.g., consultants, agency fees, etc.)) for the following activities shall be considered “Commercialization and Related Costs” for purposes of determining “Amgen Costs” or “BeiGene Costs,” as applicable:
(i) [*];
(ii) Medical Affairs Activities Costs incurred in connection with Hainan Bo Ao in or for the Collaboration Territory prior to commercialization and during commercialization;
(iii) all Costs incurred by the Parties or their respective Affiliates associated with any recalls of the Bo Ao Product in the Collaboration Scope and in or for the Collaboration Territory;
(iv) all Costs incurred by the Parties or their respective
Affiliates with respect to product liability claims for the Bo Ao Product in the Collaboration Scope in the Collaboration Territory;
3
(v) all Costs incurred by the Parties or their respective Affiliates associated with any returns and withdrawals of the Bo Ao Product in the Collaboration Scope in the Collaboration Territory;
(vi) any Third Party IP Payments to the extent not already included in Manufacturing Actual Costs; and
(viii) all unrecovered Indirect taxes, including, for the avoidance of doubt, unrecovered VAT surcharge, incurred by either Party arising with respect to payments to be made under Section 7.2.7 (Calculation of Collaboration Profits). [*]
Commercialization
and Related Costs for purposes of this Section 7.2.8 shall not include [*] or any Cost subject to an indemnification obligation under Article XIII.
(b) Manufacturing Actual Costs. The Manufacturing Actual Costs incurred with respect to the Bo Ao Product in connection with Hainan Bo Ao shall be deemed “Amgen Costs” for purposes of the calculations set forth under Section 7.2 (Profit Sharing).
(c) Net Revenues. Net Revenues from the sale or transfer for value of the Bo Ao Product in Hainan Bo Ao shall be considered “Net Revenues” for purpose of Section 7.2 (Profit Sharing).
(d) Support Costs. Bo Ao Support Costs incurred with respect to Bo Ao Product in connection with Hainan Bo Ao
shall be deemed “Amgen Costs” for purposes of the calculations set forth under Section 7.2 (Profit Sharing).”
8.Amendment to Section 7.9 of the Agreement. Section 7.9 (Overruns) of the Agreement is hereby supplemented and amended by adding the following at the end of the existing Section 7.9:
“Without limiting the foregoing, the Parties further agree as follows:
(a) While the final overrun calculation is based on annual amounts, the Parties agree to perform quarterly assessments of cost variances for the Overrun Categories shown below, recognizing that both Parties have quarterly reporting requirements.
(b) In any given calendar quarter, the quarterly profit share and development cost share calculations will reflect up to a maximum of [*] of
the planned amounts of the “Overrun Categories” (with an exception for materiality described in Section 7.9(e) below).
(c) To the extent costs exceed [*] of the budgeted amount in a given calendar quarter, the following shall apply: The Parties agree that they will track variances above [*] of the planned amount into subsequent calendar quarters, to comply with the annual nature of the cost overage calculation in this Section 7.9. [*] If, at a later time, joint approval is obtained from each Party’s finance representative to the JAC for additional activities and related spending beyond the [*] cap, an adjustment will be made in the subsequent period.
(d) To the extent costs are below budget in a given calendar quarter, actual variances resulting in underspend will be reimbursable in a subsequent period to the extent costs are for a pre-agreed upon activity that had
a timing difference and the rationale for the variance is communicated, along with the rationale for why the activity/spend will be performed in a subsequent period. The Parties may agree to a new activity to take the place of the activity that did not occur and the costs of such activity will be reimbursed if under the [*] expense cap, unless otherwise agreed. Agreement will be obtained by each Party’s finance representatives to the JAC.
4
(e) The Parties have agreed to a US$[*] dollar threshold for calendar quarter reconciliation of cost overruns, to eliminate the inefficient analysis of greater than [*] variance for smaller dollar amount categories. [*]
(f) Costs will be evaluated for overrun in the following manner: [*]
(g) The
baseline for the overrun calculation pursuant to this Section 7.9 will be the most recently approved Global Development Budget or Commercialization Budget, as applicable.”
9.New Section 7.12 of the Agreement. The following is hereby inserted as a new Section 7.12 of the Agreement:
“Section 7.12 Additional Cost-Share Matters. The Parties expect that from time-to-time one Party may perform activities that are the responsibility of the other Party or a Party may request that the other Party provide services or conduct activities that are not contemplated by the Agreement. In these instances, if the JAC approves such activities and the budget for such activities, the Party performing the activity for the benefit of the other Party shall be reimbursed
for the reasonable costs of providing such services or conducting such activities. Such costs shall be documented in writing and the Party providing such service shall be reimbursed quarterly to the Party performing such service concurrently with the Compensating Payment made pursuant to Section 7.2.7 (Calculation of Collaboration Profits). As of the Effective Date, the Parties have agreed that Amgen shall be reimbursed for the following activities as set forth below: [*]”
10.Supply Price Schedule. The Supply Price Schedule is hereby amended to include the following as a new row:
[*]
[*]
11.Miscellaneous.
a.Except
as specifically amended above, the Agreement shall continue to be in full force and effect.
b.This Amendment and its effect are subject to and shall be construed and enforced in accordance with the laws of the State of New York, U.S.A.
c.This Amendment may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts will be deemed an original, will be construed together and will constitute one and the same instrument. Signature pages of this Amendment may be exchanged by facsimile or other electronic means without affecting the validity thereof.
5
IN
WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.