Execution Version
Exhibit 10.30
Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.
Collaboration and License Agreement
Between
Sage Therapeutics, Inc.,
Biogen MA Inc.
and
Biogen International GmbH
Dated November 27, 2020
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table of contents
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1. |
| DEFINITIONS |
| 1 |
1.1 |
| Definitions |
| 1 |
2. |
| GOVERNANCE |
| 30 |
2.1 |
| Alliance Manager |
| 30 |
2.2 |
| Joint Steering Committee |
| 31 |
2.3 |
| Joint Development Committee |
| 34 |
2.4 |
| Joint Commercialization Committee |
| 36 |
2.5 |
| Joint Medical Affairs Subcommittee. |
| 39 |
2.6 |
| Joint Manufacturing Committee. |
| 41 |
2.7 |
| Resolution of Committee Disputes |
| 42 |
2.8 |
| General Committee Authority |
| 43 |
3. |
| DEVELOPMENT |
| 44 |
3.1 |
| Diligence; Standards of Conduct |
| 44 |
3.2 |
| Joint Development Plans |
| 44 |
3.3 |
| Operational Responsibilities for Development; Additional Development |
| 45 |
3.4 |
| Development Costs |
| 46 |
3.5 |
| Development Reports |
| 46 |
3.6 |
| Clinical Study Reporting |
| 46 |
3.7 |
| Joint Program Activities Records |
| 46 |
3.8 |
| Technology and Materials Transfer |
| 47 |
3.9 |
| Development Subcontracts |
| 47 |
3.10 |
| Licensed [**] Product Development |
| 48 |
4. |
| MEDICAL AFFAIRS ACTIVITIES |
| 48 |
4.1 |
| Diligence; Standards of Conduct |
| 48 |
4.2 |
| Joint Medical Affairs Plans |
| 48 |
4.3 |
| Operational Responsibilities for Medical Affairs Activities |
| 49 |
4.4 |
| Medical Affairs Costs |
| 50 |
4.5 |
| Medical Affairs Reports |
| 50 |
5. |
| COMMERCIALIZATION |
| 50 |
5.1 |
| Diligence; Standards of Conduct |
| 50 |
5.2 |
| Joint Commercialization Plans |
| 51 |
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5.3 |
| Commercialization Principles |
| 52 |
5.4 |
| Operational Responsibilities for Commercialization |
| 52 |
5.5 |
| Commercialization Costs |
| 53 |
5.6 |
| Commercialization Reports |
| 53 |
5.7 |
| Pricing Matters; Distribution |
| 53 |
5.8 |
| Uniform Training |
| 54 |
5.9 |
| Detail Costs; Authority over Sales Forces |
| 54 |
5.10 |
| Joint Commercialization Costs Allocation |
| 54 |
5.11 |
| Advertising and Promotional Materials in Profit-Share Territory |
| 55 |
5.12 |
| Coordination of Operational Activities |
| 56 |
5.13 |
| Territorial Restrictions |
| 56 |
5.14 |
| Commercialization Subcontracts |
| 57 |
6. |
| REGULATORY |
| 58 |
6.1 |
| Regulatory Lead Responsibilities |
| 58 |
6.2 |
| Assignment |
| 59 |
6.3 |
| Biogen Territory |
| 59 |
6.4 |
| Communications with Regulatory Authorities |
| 59 |
6.5 |
| Regulatory Meetings |
| 59 |
6.6 |
| Submissions |
| 60 |
6.7 |
| Costs of Regulatory Affairs |
| 60 |
6.8 |
| Right of Reference |
| 60 |
6.9 |
| Recalls, Market Withdrawals or Corrective Actions |
| 60 |
6.10 |
| Reporting Adverse Events |
| 61 |
6.11 |
| Priority Review Voucher |
| 61 |
7. |
| MANUFACTURE |
| 61 |
7.1 |
| Manufacturing Responsibilities |
| 61 |
7.2 |
| Manufacturing Plans |
| 61 |
7.3 |
| Manufacturing Costs |
| 62 |
7.4 |
| [**] Manufacturing Assumption Rights |
| 62 |
7.5 |
| Supply Agreement |
| 62 |
7.6 |
| Second Source and Biogen Manufacturing Sites |
| 63 |
7.7 |
| Reporting; Shortages |
| 63 |
7.8 |
| Technology Transfer to Biogen |
| 63 |
8. |
| LICENSES |
| 64 |
ii
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8.1 |
| License Grants |
| 64 |
8.2 |
| Sublicensing |
| 65 |
8.3 |
| Third Party In-Licenses Payments |
| 67 |
8.4 |
| Combinations |
| 68 |
8.5 |
| No Other Rights |
| 69 |
9. |
| PAYMENTS |
| 69 |
9.1 |
| Upfront Fee |
| 69 |
9.2 |
| Equity Investment |
| 69 |
9.3 |
| Licensed Product Reconciliation of Shared Costs; Profit Sharing |
| 69 |
9.4 |
| Finance Working Group |
| 71 |
9.5 |
| Sage Opt-Out |
| 72 |
9.6 |
| Licensed Products Regulatory/Commercial Milestone Payments |
| 73 |
9.7 |
| Licensed Products Sales Milestone Payments |
| 74 |
9.8 |
| Licensed 217 Product and Licensed 324 Product Royalties |
| 77 |
9.9 |
| Royalty Reductions |
| 72 |
9.10 |
| Other Amounts Payable |
| 79 |
9.11 |
| Payment Terms |
| 79 |
10. |
| CONFIDENTIALITY AND PUBLICATION |
| 83 |
10.1 |
| Nondisclosure and Non-Use Obligations |
| 83 |
10.2 |
| Publication and Publicity |
| 85 |
10.3 |
| Press Release, Public Announcements and Other Public Disclosure |
| 86 |
11. |
| REPRESENTATIONS, WARRANTIES AND COVENANTS |
| 87 |
11.1 |
| Mutual Representations and Warranties as of the Execution Date and Effective Date |
| 87 |
11.2 |
| Representations and Warranties of Sage as of the Execution Date and Effective Date |
| 88 |
11.3 |
| Warranty Disclaimer |
| 91 |
11.4 |
| Certain Covenants |
| 91 |
11.5 |
| Additional Covenants of the Parties |
| 92 |
11.6 |
| [**] |
| 92 |
11.7 |
| Exclusivity |
| 93 |
12. |
| INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE |
| 93 |
12.1 |
| General Indemnification by Biogen |
| 93 |
12.2 |
| General Indemnification by Sage |
| 94 |
12.3 |
| Indemnification Procedure |
| 94 |
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12.4 |
| Certain Third Party Claims Related to Licensed Products in the Profit-Share Territory |
| 94 |
12.5 |
| Limitation of Liability |
| 95 |
12.6 |
| Insurance |
| 95 |
13. |
| INTELLECTUAL PROPERTY |
| 95 |
13.1 |
| Inventorship |
| 95 |
13.2 |
| Ownership |
| 96 |
13.3 |
| Disclosure of Inventions |
| 96 |
13.4 |
| Prosecution and Maintenance of Patents |
| 96 |
13.5 |
| Third Party Infringement, Defense and Post-Grant Proceedings |
| 100 |
13.6 |
| Patent Extensions |
| 104 |
13.7 |
| Orange Book Listings |
| 104 |
13.8 |
| Third Party Rights |
| 104 |
13.9 |
| Common Interest |
| 104 |
13.10 |
| Trademarks |
| 105 |
14. |
| TERM AND TERMINATION |
| 105 |
14.1 |
| Term |
| 105 |
14.2 |
| Termination Prior to Effective Date |
| 105 |
14.3 |
| Termination by Biogen for Convenience |
| 105 |
14.4 |
| Termination for Material Breach |
| 105 |
14.5 |
| Termination for Insolvency |
| 106 |
14.6 |
| Effect of Termination by Sage for Cause or for Biogen’s Insolvency, or by Biogen for Convenience |
| 107 |
14.7 |
| Biogen Right of Termination for Cause or for Sage’s Insolvency |
| 111 |
14.8 |
| Effect of Expiration or Termination; Survival |
| 111 |
15. |
| MISCELLANEOUS |
| 112 |
15.1 |
| Assignment |
| 112 |
15.2 |
| Governing Law |
| 113 |
15.3 |
| Dispute Resolution |
| 113 |
15.4 |
| Entire Agreement; Amendments |
| 115 |
15.5 |
| Severability |
| 115 |
15.6 |
| Headings |
| 115 |
15.7 |
| Waiver of Rule of Construction |
| 115 |
15.8 |
| Interpretation |
| 115 |
15.9 |
| No Implied Waivers; Rights Cumulative |
| 116 |
iv
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15.10 |
| Notices |
| 116 |
15.11 |
| Compliance with Export Regulations |
| 117 |
15.12 |
| Force Majeure |
| 117 |
15.13 |
| Relationship of the Parties |
| 118 |
15.14 |
| Performance by BIMA and BIG |
| 118 |
15.15 |
| Coordination between BIMA and BIG |
| 119 |
15.16 |
| Expenses |
| 119 |
15.17 |
| Counterparts |
| 119 |
15.18 |
| Performance by Affiliates |
| 119 |
15.19 |
| Binding Effect; No Third Party Beneficiaries |
| 119 |
15.20 |
| Further Assurances |
| 119 |
15.22 |
| HSR Act |
| 120 |
v
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SCHEDULES
SCHEDULE 1.1.110 |
| Existing Sage Agreements |
SCHEDULE 1.1.165 |
| Major Development Activities |
SCHEDULE 1.1.167 |
| Major Medical Affairs Activities |
SCHEDULE 1.1.195 |
| Ongoing 217 Studies |
SCHEDULE 1.1.227 |
| Preapproved Subcontractors |
SCHEDULE 1.1.260 |
| SAGE-[**] |
SCHEDULE 1.1.261 |
| SAGE-217 |
SCHEDULE 1.1.262 |
| SAGE-324 |
SCHEDULE 1.1.268 |
| Sage Licensed Patents as of the Execution Date |
SCHEDULE 3.2.1 |
| Joint Development Plans |
SCHEDULE 7.5 |
| Supply Agreements Material Terms |
SCHEDULE 7.8.2 |
| Sage Third Party Manufacturing Agreements |
SCHEDULE 9.3.3.2 |
| Profit and Loss Statement |
SCHEDULE 10.3.1 |
| Joint Press Release |
SCHEDULE 11.2.17 |
| Proceedings |
SCHEDULE 13.8 |
| Third Party Rights |
SCHEDULE 15.21 |
| Tax Partnership Agreement Terms |
vi
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COLLABORATION and License AGREEMENT
This COLLABORATION AND LICENSE AGREEMENT (this “Agreement”), dated as of November 27, 2020 (the “Execution Date”), is entered into by and between Sage Therapeutics, Inc., a Delaware corporation having its principal place of business at 215 First Street, Cambridge, Massachusetts 02142, U.S.A., (“Sage”), and Biogen MA Inc., a corporation organized under the laws of the Commonwealth of Massachusetts having an office at 225 Binney Street, Cambridge, MA 02142 (“BIMA”), and Biogen International GmbH, a Gesellschaft mit beschränkter Haftung organized under the laws of Switzerland, whose registered office is at Neuhofstrasse 30, 6340 Baar, Switzerland (“BIG”, together with BIMA, collectively, “Biogen”). Sage and Biogen are referred to in this Agreement individually as a “Party” and collectively as the “Parties.”
RECITALS:
WHEREAS, Sage is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing novel medicines to treat central nervous system (CNS) disorders;
WHEREAS, Biogen is a global pharmaceutical company engaged in the research, development and commercialization of products useful in the treatment and prevention of human diseases and conditions; and
WHEREAS, Sage and Biogen desire to collaborate to Develop, Manufacture, perform Medical Affairs Activities with respect to and Commercialize the Licensed 217 Products and the Licensed 324 Products in the Profit-Share Territory (all as defined below), and Biogen desires to obtain, and Sage desires to grant to Biogen, an exclusive license in the Biogen Territory and a co-exclusive license in the Profit-Share Territory, in each case, to Develop, Manufacture, perform Medical Affairs Activities with respect to and Commercialize the Licensed 217 Products and the Licensed 324 Products, all in accordance with the terms and conditions set forth herein; and
WHEREAS, Biogen desires to have an exclusive option under certain circumstances to be granted an exclusive license in the Biogen Territory and a co-exclusive license in the Profit-Share Territory, in each case, to Develop, Manufacture, perform Medical Affairs Activities with respect to and Commercialize the Licensed [**] Products, all in accordance with the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, will have the respective meanings set forth below:
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Notwithstanding any provision in this Agreement to the contrary, if there is a Change of Control of a Party during the Term, such Party will be deemed not to Control any Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property rights, subject matter or product or component thereof that are owned or in-licensed immediately prior to such Change of Control by such Acquirer of such acquired Party, except if (A) such Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property rights, subject matter or product or component thereof owned or in-licensed by the Acquirer were generated from participation by employees or consultants of such Acquirer in furtherance of Development, Manufacturing, Medical Affairs Activities or Commercialization activities with respect to Licensed Products under this Agreement after such Change of Control, (B) any Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property, subject matter or product or component thereof owned or in-licensed by such Third Party were not used in the performance of Development, Manufacturing, Medical Affairs Activities or Commercialization activities with respect to Licensed Products under this Agreement prior to the consummation of such Change of Control, but after the consummation of such Change of Control, such acquired Party or any of its Affiliates uses any such Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property or proprietary subject matter in the performance of Development, Manufacturing, Medical Affairs Activities or Commercialization activities with respect to Licensed Products under this Agreement, or (C) prior to the consummation of such Change of Control, such acquired Party or any of its Affiliates also Controlled such Patents, Regulatory Approvals, Regulatory Submissions, Know-How or other intellectual property rights, subject matter or product or component thereof owned or in-licensed by such Acquirer, in each of which cases ((A)–(C)), such Patents, Regulatory Approvals, Regulatory Materials, Know-How or other intellectual property rights, subject matter or product or component thereof owned or in-licensed by such Acquirer will be deemed Controlled by the acquired Party for purposes of this Agreement.
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Joint Commercialization Costs specifically exclude any FTE Costs, Out-of-Pocket Costs and other costs and expenses: [**].
If any cost or expense is directly or reasonably allocable to more than one Commercialization cost category set forth above, then such cost or expense will only be counted
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once (i.e., as a Joint Commercialization Cost with respect to only one such category). No cost or expense included as a Joint Commercialization Cost will (A) also be included as a Joint Development Cost or a Joint Medical Affairs Cost, (B) be (or have been) included in the calculation of Net Sales as a deduction from the total amount billed or invoiced on sales of the applicable Licensed Product in the Profit-Share Territory, or (C) be an amount for which one Party or the other is solely responsible under this Agreement. Joint Commercialization Costs will be recognized and calculated in accordance with GAAP.
Joint Development Costs specifically exclude any FTE Costs, Out-of-Pocket Costs and other costs and expenses [**].
If any cost or expense is directly or reasonably allocable to more than one Joint Development Cost category above, then such cost or expense will only be counted once (i.e., as a Joint Development Cost with respect to only one such category). No cost or expense included as a Joint Development Cost will: (1) also be included as a Joint Commercialization Cost or a Joint Medical Affairs Cost; or (2) be an amount for which one Party or the other is solely responsible under this Agreement. Joint Development Costs will be recognized and calculated in accordance with GAAP.
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Joint Medical Affairs Costs specifically exclude any FTE Costs, Out-of-Pocket Costs and other costs and expenses [**].
If any cost or expense is directly or reasonably allocable to more than one Joint Medical Affairs Cost category above, then such cost or expense will only be counted once (i.e., as a Joint Medical Affairs Cost with respect to only one such category). No cost or expense included as a Joint Medical Affairs Cost will: (i) also be included as a Joint Development Cost or a Joint Commercialization Cost; or (ii) be an amount for which one Party or the other is solely responsible under this Agreement. Joint Medical Affairs Costs will be recognized and calculated in accordance with GAAP.
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for Manufacturing activities with respect to a Sage Molecule or Licensed Product performed by or on behalf of a Party or its Affiliates, [**]%) of the actual costs of materials consumed or incorporated into, and direct labor and other actual costs incurred in the performance of such Manufacturing activities specifically related or reasonably allocable to the relevant Sage Molecule or Licensed Product, as applicable, including: ordinary course quality assurance costs, stability testing cost, characterization testing, quality control, release testing of drug substance and drug product, reasonably allocable equipment maintenance costs, customs and duty and charges levied by governmental authorities, labelling and packaging, failed lot charges, excess and obsolete inventory write-off, and manufacturing scrap incurred in the ordinary course of production (and not attributable to the gross negligence of such Party or its Affiliates), reasonably allocable cost of freight into or between Manufacturing sites, technology transfer costs related to new processes or facilities, any actual amounts paid by a Party or its Affiliate to a contract manufacturing organization Subcontractor that are solely and specifically related to the Manufacture of such Licensed Product (or Sage Molecules included therein or any components of the foregoing), including capacity reservation or cancellation fees paid to a Third Party, and costs to manage arrangements with contract manufacturing organizations that are specifically related or reasonably allocable the Manufacture of a Sage Molecule or Licensed Product (including to qualify or audit Manufacturing sites of such contract manufacturing organizations utilized in the Manufacture of a Sage Molecule or Licensed Product), plus a reasonable allocation of the Manufacturing site’s fixed and direct overhead consistent with the applicable Party’s costing methodology, including leasing costs and depreciation for capital expenditures for equipment (but not other capital expenses) and facilities costs, in each case, to the extent specifically related or reasonably allocable to the relevant Sage Molecule or Licensed Product (or components of the foregoing), which will be calculated in accordance with GAAP; provided that any such allocation of overhead will be made on the basis of normal capacity operation of the relevant facility and in any event will exclude (a) except as otherwise set forth in this definition, any costs and charges related to excess, idle or unused manufacturing capacity and (b) allocation of general corporate overhead; provided, further that such allocation of overhead may take into account idle capacity at a Party or its Affiliate’s own Manufacturing sites that was originally reserved under the Manufacturing Plan in good faith and not more than [**] in advance for Manufacture of the relevant Sage Molecule or Licensed Product and such idle capacity if not otherwise able to be filled by such Party or its applicable Affiliates despite reasonable efforts to do so.
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[**].
Such amounts will be determined consistent with a Selling Party’s customary practices and in accordance with GAAP. It is understood that any accruals for individual items reflected in Net Sales are periodically (at least [**]) trued up and adjusted by each Selling Party consistent with its customary practices and in accordance with GAAP.
Notwithstanding anything to the contrary set forth in this Agreement, [**].
In the case of any Combination Product sold in a given country and reporting period, Net Sales for the purpose of determining royalties and Sales Milestone Events of the Combination Product in such country will be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B), where A is the invoice price of the applicable Sage Molecule if sold separately in the same indication in such country, and B is the total invoice price of the Other Components in the Combination Product, if sold separately in the same indication in such country.
If, on a country-by-country basis in a particular reporting period, the Licensed Product is sold separately in the same indication in a country, but the Other Components in the Combination Product are not sold separately in the same indication in such country, then Net Sales for the purpose of determining royalties and Sales Milestone Events of the Combination Product for such country will be calculated by multiplying actual Net Sales of the Combination Product by the fraction A/C, where A is the invoice price of the Sage Molecule if sold separately in the same indication in such country, and C is the invoice price of the Combination Product in such country.
If, on a country-by-country basis in a particular reporting period, the Licensed Product in the Combination Product is not sold separately in the same indication in such country, but the Other Components included in the Licensed Product are sold separately in the same indication in such country, then Net Sales for the purpose of determining royalties and Sales Milestone Events of the Combination Product for such country will be calculated by multiplying actual Net Sales of the Combination Product by the fraction (C-B)/C, where B is the invoice price of the Other Components included in such Combination Product if sold separately in the same indication in such country, and C is the invoice price of the Combination Product in such country.
If neither the Licensed Product nor the Other Components are sold separately in the same indication in a given country during a particular reporting period, then Net Sales will be calculated based on [**].
Any disputes between the Parties relating to the calculation of Net Sales under this Section 1.1.184 (Net Sales) based on non-cash consideration or allocation of Net Sales for a Combination Product will be resolved pursuant to the dispute resolution procedures in Section 15.3.5 (Expert Arbitration).
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43
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45
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IF " DOCVARIABLE "SWDocIDLocation" 4096" = "1" " DOCPROPERTY "SWDocID" ActiveUS 185387629v.1" ""
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[**].
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IF " DOCVARIABLE "SWDocIDLocation" 4096" = "1" " DOCPROPERTY "SWDocID" ActiveUS 185387629v.1" ""
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IF " DOCVARIABLE "SWDocIDLocation" 4096" = "1" " DOCPROPERTY "SWDocID" ActiveUS 185387629v.1" ""
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IF " DOCVARIABLE "SWDocIDLocation" 4096" = "1" " DOCPROPERTY "SWDocID" ActiveUS 185387629v.1" ""
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Any subcontract permitted under this Section 5.14 (Commercialization Subcontracts) must be consistent with the terms of this Agreement, including that the Subcontractor undertakes in writing commercially reasonable obligations of confidentiality and non-use regarding Confidential Information that are substantially the same as those undertaken by the Parties with respect to Confidential Information pursuant to Article 10 (Confidentiality and Publication) hereof, and each Party will use reasonable efforts to require that the Subcontractor undertakes in writing to assign or exclusively license back (with the right to sublicense) to such Party all intellectual property with respect to the Licensed Products developed in the course of performing any such work. Without limitation of the foregoing, during the Term, each Party will, within a reasonable time thereafter, notify the other Party with respect to any Commercialization activities for the Licensed Products that such Party has subcontracted to any [**] for the Profit-Share Territory. However, in respect of any and all subcontracts entered into by either Party pursuant to this Section 5.14 (Commercialization Subcontracts), subject to Section 12.4 (Certain Third Party Claims Related to Licensed Products in the Profit-Share Territory) and Section 5.5 (Commercialization Costs), such Party will remain responsible for the work allocated to, and payment to, such Subcontractors to the same extent it would if it had done such work itself and compliance by its Subcontractors with the applicable provisions of this Agreement.
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217 Regulatory/Commercial Milestone Event | 217 Regulatory/Commercial Milestone Payment | |||
| For the 1st of either MDD or [**] (but not both) | For PPD | For [**] | For [**] |
[**] | [**] | [**] | [**] | [**] |
[**] | [**] | [**] | [**] | [**] |
[**] | [**] | [**] | [**] | [**] |
4. First Commercial Sale in the United States of a Licensed 217 Product | [**] | [**] | [**] | [**] |
[**] | [**] | [**] | [**] | [**] |
The maximum total amount payable by Biogen to Sage under this Section 9.6.1 (Licensed 217 Products Regulatory/Commercial Milestones) for all Licensed 217 Products under this Agreement is Four Hundred Seventy Five Million Dollars ($475,000,000).
324 Regulatory/Commercial Milestone Event | 324 Regulatory/Commercial Milestone Payment | ||
| For [**] | For [**] | For [**] |
[**] | [**] | [**] | [**] |
[**] | [**] | [**] | [**] |
[**] | [**] | [**] | [**] |
[**] | [**] | [**] | [**] |
[**] | [**] | [**] |
[**] |
The maximum total amount payable by Biogen to Sage under this Section 9.6.2 (Licensed 324 Products Regulatory/Commercial Milestones) for all Licensed 324 Products under this Agreement is Five Hundred Twenty Million Dollars ($520,000,000).
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Non-Opt-Out Right 217 Sales Milestone Event | 217 Sales Milestone Payment |
annual Net Sales of Licensed 217 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
annual Net Sales of Licensed 217 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
annual Net Sales of Licensed 217 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
Opt-Out Right 217 Sales Milestone Event | 217 Sales Milestone Payment |
annual Net Sales of Licensed 217 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
annual Net Sales of Licensed 217 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
annual Net Sales of Licensed 217 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
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Non-Opt-Out Right 324 Sales Milestone Event | 324 Sales Milestone Payment |
annual Net Sales of Licensed 324 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
annual Net Sales of Licensed 324 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
annual Net Sales of Licensed 324 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
Opt-Out Right 324 Sales Milestone Event | 324 Sales Milestone Payment |
annual Net Sales of Licensed 324 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
annual Net Sales of Licensed 324 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
annual Net Sales of Licensed 324 Products in the Territory in a Calendar Year first equaling or exceeding $[**] | [**] |
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Annual Net Sales in a Given Calendar Year of a Licensed 217 Product or a Licensed 324 Product in the Biogen Territory | Royalty Rate Paid on the Portion of Annual Net Sales of a Licensed 217 Product in the Biogen Territory | Royalty Rate Paid on the Portion of Annual Net Sales of a Licensed 324 Product in the Biogen Territory |
Portion less than $[**] | [**]% | [**]% |
Portion equal to or greater than $[**] but less than $[**] | [**]% | [**]% |
Portion equal to or greater than $[**] | [**]% | [**]% |
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9.8.3 Annual Net Sales in a Given Calendar Year of a Licensed Product in the United States | Royalty Rate Paid on the Portion of Annual Net Sales of a Licensed 217 Product in the Territory in the United States | Royalty Rate Paid on the Portion of Annual Net Sales of a Licensed 324 Product in the Territory in the United States |
Portion less than $[**] | [**]% | [**]% |
Portion equal to or greater than $[**] but less than $[**] | [**]% | [**]% |
Portion equal to or greater than $[**] | [**]% | [**]% |
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For clarity, and notwithstanding any provision to the contrary set forth in this Agreement, [**]. Specific aspects or details of Confidential Information will not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is encompassed by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information will not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.
The terms and conditions of this Agreement are hereby deemed to be the Confidential Information of each Party.
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[**]
[**]
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[**].
14.7.2.5 Further Assurances. Each Party will execute all reasonable documents and take all such further actions as may be reasonably requested by the other Party, at such other Party’s cost, in order to give effect to the foregoing clauses.
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If to Sage, to: | Sage Therapeutics, Inc. 215 First Street Cambridge, MA 02142 Attention: Chief Operating Officer (with copy to) General Counsel Email:[**] and [**]
|
With a copy to (which will not constitute notice): | Gibson Dunn & Crutcher LLP 555 Mission Street San Francisco, CA 94105-0921 Attention: Karen A. Spindler Email: KSpindler@gibsondunn.com
|
If to Biogen, to: | Biogen MA Inc. 225 Binney Street Cambridge, MA 02142 Attention: Chief Legal Officer Email: [**]
|
With a copy to (which will not constitute notice): | Ropes & Gray LLP Prudential Tower 800 Boylston Street Boston, MA 02199-3600 Attention: Hannah Freeman Email: [**] |
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice will be deemed to have been given: (a) when delivered if personally delivered on a Business Day (or if delivered or sent on a non-Business Day, then on the next Business Day); (b) as of the date transmitted by electronic transmission (with complete transmission confirmed); (c) on the Business Day of receipt if sent by overnight courier or facsimile; or (d) on the Business Day of receipt if sent by mail. Any notice delivered by electronic transmission will be confirmed by a hard copy delivered as soon as practicable thereafter by the method described in clauses (c) or (d) above.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
Sage Therapeutics, Inc. |
| Biogen MA Inc. | ||||
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BY: |
| /s/ Jeff Jonas, M.D. |
| BY: |
| /s/ Michel Vounatsos |
NAME: |
| Jeff Jonas, M.D. |
| NAME: |
| Michel Vounatsos |
TITLE: |
| Chief Executive Officer |
| TITLE: |
| Chief Executive Officer |
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| Biogen International, GmbH | ||
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| BY: |
| /s/ Fred Lawson |
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|
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| NAME: |
| Fred Lawson |
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|
|
| TITLE: |
| Director |
[Signature Page to Collaboration and License Agreement]
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