Shareholder Representative Services LLC v. Gilead Sciences, Inc. and Gilead Biopharmaceutics Ireland Corporation
162, 2017
| Del. | Dec 12, 2017Background
- The parties contracted in a merger agreement that promised milestone payments (including a $50 million third milestone) tied to “receipt of Regulatory Approval of CAL-101 … as a first-line drug treatment … for a Hematologic Cancer Indication.”
- Schedule 1.1 to the agreement listed diseases including Chronic Lymphocytic Leukemia (CLL), which was the scheduled disease at issue.
- Gilead obtained European regulatory approval for CAL-101 as a first-line treatment for adult CLL patients with 17p deletion or TP53 mutation — a genetic subset constituting roughly 5–15% (est. ~10%) of the CLL population.
- The Court of Chancery found “Hematologic Cancer Indication” ambiguous, admitted parol evidence, concluded the parties intended the term to mean a disease listed in Schedule 1.1, and held that approval limited to the small genetic subset did not satisfy the disease-level first-line approval required to trigger the milestone.
- The Delaware Supreme Court affirmed the Chancery Court’s factual findings and legal resolution of the ambiguity; Justice Seitz (joined by Justice Traynor) dissented, arguing the plain meaning of the contract entitled the seller to the milestone because the approval was for CLL, a disease in Schedule 1.1.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does “Hematologic Cancer Indication” refer to a disease listed in Schedule 1.1 or can it be satisfied by approval limited to a genetic subset? | Term should be read with reference to Schedule 1.1; EU approval for CLL satisfies the trigger. | The term is ambiguous and should be read to require disease-level approval; approval limited to a small subset does not trigger payment. | Court found ambiguity, considered parol evidence, and held the parties intended a disease-level approval; subset approval did not trigger payment. |
| Was the European first-line approval for CAL-101 (limited to 17p/TP53 CLL patients) sufficient to trigger the third milestone? | Approval for CLL (a scheduled disease) suffices regardless of genetic qualifiers. | Approval covered only a small subset (~10%) and thus did not constitute the disease-level approval the parties sought. | Court held the subset approval was insufficient; no milestone payment due. |
Key Cases Cited
- BLGH Holdings LLC v. enXco LFG Holding, LLC, 41 A.3d 410 (Del. 2012) (contract interpretation principles and ambiguity analysis)
- Nemec v. Shrader, 991 A.2d 1120 (Del. 2010) (courts enforce parties’ chosen contractual terms even if commercially unwise)
