Exhibit 01. Lilly and AtaiBeckley: the CVR.
Ten places where the press release and the signed agreement do not say the same thing.
| Term | Announced | Signed | Section |
|---|---|---|---|
| Efforts obligation | Not stated. | “to use Commercially Reasonable Efforts”: VLS-01 toward the First Milestone and Third Milestone, BPL-003 toward the Second Milestone, each carving out “the treatment of MDD or GAD”. “supersede any standard of efforts or implied covenant of good faith and fair dealing”. “The Holders shall not be entitled to specific enforcement of Section 4.3”. | §4.3(a)(i), §4.3(a)(ii); §4.3(b); §6.4, p. 17; 18; 23 |
| Milestone Offset Amount | “(a) $1.00 per share ... (b) $0.50 per share ... (c) $1.00 per share”. No offset stated. | $1.00 minus any Milestone Offset Amount; likewise $0.50 minus any Milestone Offset Amount. “Milestone Offset Amount” means an amount equal to (a) fifty percent (50%) of any payments that Parent or any of its Affiliates or their respective successors or permitted assigns makes or is obligated to make to a Third Party to the extent allocable to an applicable CVR Product in exchange for any license to, or other right to use or practice, any Necessary IP. “Third Party” means any Person other than the Company, Parent, Merger Sub, or any of their respective controlled Affiliates. | §1.1; §1.1 Third Party; §4.2, p. 1, 4; 7; 17 |
| Phase 3 outside the US | “initiation of a Phase 3 clinical trial of VLS-01”. Jurisdiction not stated. | “Phase 3 Clinical Trial” means a human clinical trial of a product that is designed to demonstrate that such product is safe and effective for an indication and is intended to form the basis for Regulatory Approval by the FDA or equivalent Regulatory Authority and that meets the definition of a Phase 3 clinical trial as described in 21 C.F.R. § 312.21(c), or its successor regulation thereto or foreign equivalents. | §1.1, p. 3-7 |
| Initiation | Not defined. | “Initiation” means, with respect to a clinical trial of a product, the first dosing of such product in the first patient in such clinical trial. | §1.1, p. 3-7 |
| Indication | Not stated. | “Qualifying Indication” means an indication for the treatment of major depressive disorder (“MDD”), treatment-resistant depression (“TRD”) or generalized anxiety disorder (“GAD”). | §1.1, p. 3-7 |
| BPL-003 rescheduling | “DEA rescheduling of BPL-003” | the issuance of an interim final rule, final rule, order or other similar agency determination by the U.S. Drug Enforcement Agency (the “DEA”) having the effect of rescheduling FDA-approved mebufotenin benzoate nasal spray from schedule I to schedules II, III, IV or V (the “BPL Scheduling”); provided, for clarity, that the BPL Scheduling enables the prescribing of such FDA-approved Second CVR Product as a schedule II, III, IV, or V product. | §1.1 Second Milestone, p. 5-6 |
| VLS-01 rescheduling | “DEA rescheduling of VLS-01” | the issuance of an interim final rule, final rule, order, or other similar agency determination by the DEA rescheduling FDA-approved N,N-Dimethyltryptamine (DMT) from schedule I to schedule II, III, IV or V (the “VLS Scheduling”); provided, for clarity, that the VLS Scheduling enables the prescribing of such FDA-approved First CVR Product as a schedule II, III, IV, or V product. | §1.1 Third Milestone, p. 6-7 |
| Regulatory Approval | “U.S. regulatory approval” | “Regulatory Approval” means, with respect to a particular country or other regulatory jurisdiction, the approvals from the necessary Regulatory Authority to import, export, market, promote, distribute, and sell a pharmaceutical or biologic product in such country or region, including pricing approvals and reimbursement approvals that are necessary for the commercial sale of a pharmaceutical or biologic product in a given country or regulatory jurisdiction. | §1.1, p. 5-6 |
| Product scope | “related to the BPL-003 and VLS-01 programs” | “First CVR Product” means the pharmaceutical product candidate known as “VLS-01” controlled by the Company that consists of the Company’s investigational proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT), as such pharmaceutical product candidate exists as of the date of this Agreement, together with any Insubstantial Changes thereto. “Second CVR Product” means the pharmaceutical product candidate known as “BPL-003” controlled by the Company that consists of the Company’s investigational proprietary intranasal formulation of mebufotenin benzoate, as such pharmaceutical product candidate exists as of the date of this Agreement, together with any Insubstantial Changes thereto. | §1.1, p. 5-6 |
| Early termination | Not stated. | This Agreement will automatically terminate ... upon the earliest to occur of ... (c) the delivery of a written notice of termination duly executed by Parent and the Acting Holders. | §6.8, p. 24 |
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