IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE
FORTIS ADVISORS LLC, :
:
Plaintiff, :
:
v. : C.A. No. 12147-VCS
:
SHIRE US HOLDINGS, INC., :
:
Defendant. :
MEMORANDUM OPINION
Date Submitted: June 2, 2017
Date Decided: August 9, 2017
Joel Friedlander, Esquire and Christopher Quinn, Esquire of Friedlander & Gorris,
P.A., Wilmington, Delaware and William S. Ohlemeyer, Esquire, Robin A. Henry,
Esquire and Jack Wilson, Esquire of Boies, Schiller & Flexner LLP, Armonk, New
York, Attorneys for Plaintiff.
Stephen C. Norman, Esquire and Jaclyn Levy, Esquire of Potter, Anderson &
Corroon LLP, Wilmington, Delaware; John D. Donovan, Jr., Esquire of Ropes &
Gray LLP, Boston, Massachusetts; and David B. Hennes, Esquire and Adam M.
Harris, Esquire of Ropes & Gray LLP, New York, New York, Attorneys for
Defendant.
SLIGHTS, Vice Chancellor
Parties to a merger agreement dispute the right of the seller’s representative
to receive certain contingent post-closing payments. Plaintiff, Fortis Advisors LLC
(“Fortis”), in its capacity as Stockholders’ Agent for the former stockholders of
SARcode Bioscience Inc. (“SARcode”), alleges that Defendant, Shire US Holdings,
Inc. (“Shire”), has breached the provisions of the parties’ agreement by refusing to
pay so-called milestone payments that Fortis alleges are past due.
Shire acquired SARcode pursuant to an Agreement and Plan of Merger by and
among Shire, Owl Merger Sub, Inc., SARcode Bioscience Inc., and Fortis Advisors
LLC, as Stockholders’ Agent Dated as of March 23, 2013 (the “Merger
Agreement”). At the time the parties entered into the Merger Agreement, SARcode
was in the process of developing and seeking regulatory approval for a drug,
Lifitegrast, that showed promise to treat the signs and symptoms of dry eye disease.
The Merger Agreement set forth a structure whereby the parties agreed to share the
risks and rewards of developing Lifitegrast by allocating merger consideration
between fixed up front payments and subsequent contingent payments that depended
on Shire’s ability to shepherd the drug through clinical trials and regulatory
approvals. This arrangement allowed SARcode to monetize its at-risk investment in
Lifitegrast while securing the promise of financial rewards if the drug continued to
be developed successfully and ultimately was commercialized. For Shire, the
milestone payments allowed it to hedge against future risks inherent in the drug’s
1
development and commercialization by allocating the price it would ultimately pay
for SARcode between an initial upfront payment and subsequent payments that
would become due only if the defined milestones were reached per the agreed upon
schedule.
In its Verified First Amended and Supplemental Complaint (the
“Complaint”), Fortis alleges that two of the designated milestones have been
achieved. This, in turn, has triggered Shire’s obligation to make $425 million in
milestone payments to former SARcode stockholders. Shire denies that the two
milestones have been met and has refused Fortis’ demands to make the milestone
payments. The Complaint asserts a single Count for breach of contract. Shire has
moved to dismiss the Complaint under Court of Chancery Rule 12(b)(6) on the
ground that Fortis’ claim of breach is premised on a construction of the Merger
Agreement that cannot be reconciled with its clear and unambiguous terms.
After carefully considering the parties’ arguments, I conclude that Shire’s
proffered construction of the relevant provisions of the Merger Agreement is the
only reasonable construction. Because Fortis has failed to proffer a competing
reasonable construction of the operative language, it has failed to state a claim for
breach of contract. Accordingly, the motion to dismiss must be GRANTED.
2
I. FACTUAL BACKGROUND
The facts are drawn from allegations in the Complaint, documents integral to
the Complaint and matters of which the Court may take judicial notice.1 As it must
at this stage of the proceedings, the Court assumes all well-pled facts in the
Complaint are true.2
A. The Parties
Prior to the Merger Agreement, SARcode was a privately-held
biopharmaceutical company based in Brisbane, California. By the terms of the
Merger Agreement, Fortis serves post-merger as the “sole agent and attorney-in-
fact” for and on behalf of the former SARcode stockholders.
Shire is a Delaware corporation and subsidiary of Shire PLC, a global
biopharmaceutical company, whose United States headquarters is located in
Lexington, Massachusetts. Shire acquired SARcode in March 2013.
1
In re Crimson Exploration Inc. S’holder Litig., 2014 WL 5449419, at *8 (Del. Ch.
Oct. 24, 2014); In re Gardner Denver, Inc., 2014 WL 715705, at *2 (Del. Ch. Feb. 21,
2014). See also Reiter v. Fairbank, 2016 WL 6081823, at *5 (Del. Ch. Oct 18, 2016)
(“where a complaint quotes or characterizes some parts of a document but omits other parts
of the same document, the Court may apply the incorporation-by-reference doctrine to
guard against the cherry-picking of words in the document out of context.”).
2
Crimson, 2014 WL 5449419, at *8.
3
B. SARcode’s Development of Lifitegrast
Prior to the Shire acquisition, SARcode developed Lifitegrast as a treatment
for dry eye disease. Dry eye disease is diagnosed by an eye care professional based
on tests for objective signs of the disease, such as staining or tear break-up time
(signs), and subjective symptoms reported by patients, such as eye dryness or
discomfort (symptoms).
SARcode developed Lifitegrast to Phase III clinical trials. Phase III clinical
trials are performed to test both efficacy and safety of drugs using larger patient
populations than are involved in Phase I and Phase II trials. Prior to the Merger
Agreement, SARcode had conducted a Phase II clinical trial and a Phase III clinical
trial (OPUS-1) that had successfully established the efficacy and safety of Lifitegrast
in reducing the signs of dry eye disease. These clinical trials demonstrated the
commercial potential of Lifitegrast and their results attracted the interest of several
pharmaceutical companies that sought to acquire development rights for the drug.
A second Phase III clinical trial (OPUS-2) was designed and initiated in late
2012 to evaluate the efficacy, safety and tolerability of Lifitegrast. The OPUS-2
Study had two co-primary efficacy endpoints that were specified in the OPUS-2
Study Protocol. One efficacy endpoint, the co-primary sign endpoint, was designed
to evaluate Lifitegrast’s effectiveness in treating the signs of dry eye disease while
the other efficacy endpoint, the co-primary symptom endpoint, would evaluate the
4
drug’s effectiveness in treating the symptoms of dry eye disease. The OPUS-2 Study
was underway when Shire approached SARcode with an interest in acquiring the
company and, by extension, Lifitegrast. Shire and SARcode began negotiating the
Merger Agreement in early 2013.
C. The Merger Agreement
At the time SARcode and Shire entered into the Merger Agreement, the
OPUS-2 Study was ongoing and Lifitegrast was many steps away from
commercialization. To share the risks and rewards of further development of the
drug, the parties included in the Merger Agreement a number of additional payments
to SARcode stockholders that were contingent upon the drug successfully achieving
certain defined milestones. These milestones are divided into several categories,
described in § 9.1 of the Merger Agreement, only one of which is relevant to the
current dispute. That category of milestone payments, the “Base Case Milestones,”
is triggered by the occurrence of the OPUS-2 Study Endpoint Achievement Date
(the “Achievement Date”). When the Achievement Date is reached, former
SARcode stockholders are entitled to receive $175 million for the OPUS-2
Successful Completion Milestone.
Following achievement of the OPUS-2 Successful Completion Milestone and
regulatory approval of the drug, Shire is required to make an additional $250 million
payment for the Base Case Approval Milestone. If certain revenue targets are met
5
following commercialization, former SARcode stockholders would be eligible for
another $100 million for the Base Case Revenue Milestone. Fortis alleges that it is
currently due the OPUS-2 Successful Completion Milestone Payment and the Base
Case Approval Milestone Payment.
As noted, all of the Base Case Milestones are contingent upon the occurrence
of the Achievement Date. That term is defined in the Merger Agreement as follows:
“OPUS-2 Study Endpoint Achievement Date” shall be deemed to occur
upon receipt by or on behalf of Parent, or one of its Affiliates,
Licensees, or other transferees, of audited final tables, figures and
listings from the OPUS-2 Study (x) that demonstrate that both
components of the co-primary efficacy endpoints of the OPUS-2 Study
as specified in the OPUS-2 Study Protocol have been achieved and (y)
which do not, in a significant and clinically meaningful respect, result
in a materially less favorable safety/tolerability profile (e.g., treatment
emergent adverse events, Serious Adverse Effects, etc.), taken as a
whole, for the Product than for corresponding data generated for the
Product in the OPUS-1 Study, which less favorable safety/tolerability
profile would reasonably be expected to significantly reduce
anticipated Product Sales (it being understood that such determination
pursuant to this clause (y) shall be made in accordance with
Section 9.3).3
If the Achievement Date is reached, the former SARcode stockholders are
eligible to receive the Base Case Milestones payments at various designated
intervals defined, in relevant part, as:
3
Opening Br. of Shire US Hldgs., Inc. in Supp. of its Mot. to Dismiss the Verified First
Am. and Supplemental Compl. (“Opening Br.”), Ex. 1 (“Merger Agreement”) §1.1.
6
(a) Base Case Milestones. If the OPUS-2 Study Endpoint Achievement
Date shall have occurred:
(i) OPUS-2 Success. Within ten (10) business days following the
OPUS-2 Study Endpoint Achievement Date (the “OPUS-2 Successful
Completion Milestone”), Parent shall notify the Stockholders’ Agent
that the OPUS-2 Successful Completion Milestone has been satisfied
and shall, within twenty (20) business days following the date of
achievement of the OPUS-2 Successful Completion Milestone, pay or
cause to be paid in accordance with Section 9.2(b), $175,000,000 (such
amount, the “OPUS-2 Successful Completion Milestone Payment”);
(ii) Base Case Regulatory Approval. Within ten (10) business days
following receipt by or under the authority of Parent (or any of its
Affiliates, Licensees or other transferee) of the first Regulatory
Approval in the United States for a Product for the Covered Indication
with the co-primary Sign and Symptom specified in the OPUS-2 Study
Protocol included in the “Indications and Usage” section of the label of
the Product (the “Base Case Approval Milestone”), Parent shall notify
the Stockholders’ Agent that the Base Case Approval Milestone has
been satisfied and shall, within twenty (20) business days following the
date of achievement of the Base Case Approval Milestone, pay or cause
to be paid in accordance with Section 9.2(b), $250,000,000 (such
amount, the “Base Case Approval Milestone Payment”) . . . .
(iii) Base Case Revenue Milestone. If the Base Case Approval
Milestone has been achieved, then within sixty (60) days following the
first time on which Product Sales within any four consecutive calendar
quarters exceed $750,000,000 (the “Base Case Revenue Milestone”),
Parent shall notify the Stockholders’ Agent that the Base Case Revenue
Milestone has been satisfied and shall, within five (5) business days
after such notification, pay or cause to be paid in accordance with
Section 9.2(b), $100,000,000 (such amount, “Base Case Revenue
Milestone Payment”).4
4
Merger Agreement § 9.1(a)(i)–(iii).
7
The Merger Agreement defines several other terms that appear in the
definition of Achievement Date and are relevant to the determination of whether the
Achievement Date has occurred. The term “OPUS-2 Study” is defined as:
“OPUS-2 Study” means the Phase III clinical trial for Lifitegrast to be
conducted in accordance with the OPUS-2 Study Protocol, as further
described on Schedule C.5
The OPUS-2 Study Protocol is defined as:
“OPUS-2 Study Protocol” means the Company’s Protocol Number
1118-Dry-300, dated November 6, 2012, as amended from time to time
in accordance with this Agreement.6
Importantly, the Merger Agreement separately defines the prior Phase III
clinical trial, the OPUS-1 Study, as:
“OPUS-1 Study” means the Phase III clinical trial for Lifitegrast
conducted by or on behalf of the Company in accordance with the
Company Protocol Number 1118-KCS-200, dated May 27, 2011, as
amended August 5, 2011.7
Both parties were represented by sophisticated counsel in connection with the
negotiation, drafting and execution of the Merger Agreement. As noted, the Merger
Agreement was finalized on March 23, 2013.
5
Merger Agreement § 1.1
6
Id.
7
Id.
8
D. Regulatory Approval of Lifitegrast
Following the Merger Agreement, and at the completion of the OPUS-2 Study
in November 2013, Shire informed Fortis that the OPUS-2 Study had achieved the
co-primary symptom endpoint but had failed to achieve the co-primary sign
endpoint. In a December 5, 2013 press release, Shire publicly reported that
“Lifitegrast did not meet the pre-specified co-primary endpoint for the sign of
inferior corneal staining score (change from baseline to Week 12) using fluorescein
staining compared with placebo (p-value = 0.6186).”8
Shire designed and initiated an additional Phase III clinical trial called the
OPUS-3 Study in November 2014. In early 2015, Shire filed a New Drug
Application (“NDA”) with the United States Food and Drug Administration
(“FDA”) for Lifitegrast. The data Shire submitted to the FDA included evidence
from the OPUS-2 Study, the OPUS-1 Study and other previous trials. In October
2015, the FDA issued a complete response letter in which it declined to approve
Lifitegrast based on the data submitted in the NDA and requested additional data
demonstrating the efficacy of the drug to treat the symptoms of dry eye disease.
On October 16, 2015, apparently believing that the Achievement Date had
occurred, Fortis wrote to Shire to inquire whether it intended to make the
8
Pl. Fortis Advisor LLC’s Verified First Am. and Supplemental Compl. (“Compl.”) ¶ 21.
9
$175 million OPUS-2 Successful Completion Milestone Payment. Later that month,
on October 27, 2015, Shire announced that the OPUS-3 Study had been completed
and the data from that clinical trial showed that Lifitegrast had achieved the symptom
endpoint, data which would be provided to the FDA in a refiled NDA. Shire
responded to Fortis’ inquiry regarding the OPUS-2 Successful Completion
Milestone Payment on November 12, 2015, stating that none of the Base Case
Milestones had been met (or ever would be met) because the Achievement Date had
not occurred given that the OPUS-2 Study had failed to meet the sign co-primary
endpoint.
In February 2016, Shire refiled its NDA with the FDA and included the
OPUS-3 Study data in its application. With this data in hand, on July 11, 2016, the
FDA approved Lifitegrast, under the brand name Xiidra, to treat the signs and
symptoms of dry eye disease. The FDA also approved the language and content of
the Xiidra label that had been proposed by Shire. On July 12, 2016, the label
appeared on the Shire website and showed graphical representations of the results
from the clinical trials submitted to the FDA. Following approval by the FDA of
Lifitegrast under the brand name Xiidra, Fortis alleged that the former SARcode
stockholders were now due the Base Case Approval Milestone Payment in addition
to the previously earned OPUS-2 Successful Completion Milestone Payment.
10
E. Procedural History
On March 29, 2016, Fortis filed its Verified Complaint alleging a breach of
the Merger Agreement. Shire moved to dismiss the complaint on April 19, 2016.
On July 29, 2016, with briefing on the motion to dismiss complete, Fortis moved to
amend the complaint to update its allegations with facts relating to the FDA approval
of Lifitegrast and the approval of the Xiidra label, which Fortis alleged entitled the
former SARcode stockholders to the Base Case Approval Milestone Payment. Fortis
opposed the motion. After a hearing on the motion to amend, the Court granted
Fortis leave to file its amended complaint which it did on November 8, 2016.
The Complaint sets forth a single count of breach of contract. Shire moved to
dismiss on December 9, 2016, arguing that Fortis’ reliance upon an unreasonable
interpretation of the plain and unambiguous language of the Merger Agreement as
the basis for its breach of contract claim warranted dismissal under Court of
Chancery Rule 12(b)(6) for failure to state a claim.
II. ANALYSIS
While the parties agree that the language of the Merger Agreement is clear and
unambiguous, they disagree on how that language should be interpreted. Shire’s
motion to dismiss can be granted at this procedural stage only if its proffered
interpretation stands apart as the lone reasonable construction of the Merger
Agreement. After carefully considering both parties’ proffered constructions of the
11
relevant provisions of the Merger Agreement, for the reasons that follow, I conclude
that Shire’s construction is reasonable and that Fortis’ construction is unreasonable.
A. Motion to Dismiss Standard
The standards governing this motion to dismiss for failure to state a claim
under Rule 12(b)(6) are now well settled:
(i) all well-pleaded factual allegations are accepted as true; (ii) even
vague allegations are ‘well-pleaded’ if they give the opposing party
notice of the claim; (iii) the Court must draw all reasonable inferences
in favor of the non-moving party; and (iv) dismissal is inappropriate
unless the ‘plaintiff would not be entitled to recover under any
reasonably conceivable set of circumstances susceptible of proof.’9
Questions involving contract interpretation can be answered as a matter of law
on a motion to dismiss “[w]hen the language of a contract is plain and
unambiguous.”10 Dismissal of a contract dispute under Rule 12(b)(6) is proper,
however, “only if the defendants’ interpretation is the only reasonable construction
as a matter of law.”11 If the Plaintiff has offered a reasonable construction of the
contract, and that construction supports the claims asserted in the complaint, then
9
Savor, Inc. v. FMR Corp., 812 A.2d 894, 896–97 (Del. 2002) (citations omitted).
10
Capital Corp. v. GC Sun Hldgs., L.P., 910 A.2d 1020, 1030 (Del. Ch. 2006).
11
VLIW Tech., LLC v. Hewlett-Packard Co., 840 A.2d 606, 615 (Del. 2003).
12
the Court must deny the motion to dismiss even if the defendant’s construction is
also reasonable.12
B. The Parties’ Competing Constructions of the Operative Language
By the clear terms of the Merger Agreement, the Base Case Milestone
payments are not due unless the Achievement Date has occurred.13 Under Fortis’
interpretation of the Merger Agreement, the clinical data that may be considered
when determining whether both co-primary efficacy endpoints have been achieved
for purposes of assessing whether the Achievement Date has occurred is not limited
to the OPUS-2 Study, but can incorporate data from prior clinical trials as well. As
Fortis points out, the sign endpoint was achieved in the OPUS-1 Study. The
symptom endpoint was achieved in the OPUS-2 clinical trial. Therefore, according
to Fortis, the Achievement Date has occurred. Once that occurred, Fortis argues it
was due the OPUS-2 Successful Completion Milestone Payment. And because
Lifitegrast has now received regulatory approval following the Achievement Date,
Fortis claims that Shire must also make the Base Case Approval Milestone Payment.
12
See Vanderbilt Income and Growth Assocs., L.L.C. v. Arvida/JMB Managers, Inc., 691
A.2d 609, 613 (Del. 1996) (“On a motion to dismiss for failure to state a claim, a trial court
cannot choose between two differing reasonable interpretations of ambiguous
documents.”).
13
Merger Agreement § 9.1(a).
13
Shire, on the other hand, argues that the Achievement Date has not occurred,
which forecloses Fortis from claiming that either the OPUS-2 Successful
Completion Milestone Payment or the Base Case Approval Milestone Payment are
due.14 Under Shire’s construction of the definition of Achievement Date, the clinical
data must demonstrate that both sign and symptom co-primary efficacy endpoints
were achieved in a specific clinical trial, the OPUS-2 Study. Because the OPUS-2
Study did not establish the sign efficacy endpoint, Shire contends that the
Achievement Date did not and never will occur.
C. Shire’s Construction of the Merger Agreement is Reasonable
In support of its construction, Shire begins by pointing to the definition of
Achievement Date which occurs “upon receipt . . .of audited final tables, figures and
listings from the OPUS-2 Study (x) that demonstrate that both components of the
co-primary efficacy endpoints of the OPUS-2 Study as specified in the OPUS-2
Study Protocol have been achieved . . .”15 Shire notes that this definition explicitly
requires that the data triggering the occurrence of the Achievement Date come “from
14
Although not directly at issue in this action, Shire’s construction would also forever
preclude payment of the Base Case Revenue Milestone Payment regardless of Shire’s
ability to hit the defined revenue targets. This is because, under Shire’s construction, the
Achievement Date has not occurred and will never occur. As noted, the occurrence of the
Achievement Date is a precondition to all of the Base Case Milestones payments, including
the Base Case Revenue Milestone.
15
Merger Agreement § 1.1.
14
the OPUS-2 Study.” The OPUS-2 Study, in turn, is defined as “the Phase III clinical
trial for Lifitegrast to be conducted in accordance with the OPUS-2 Study Protocol,
as further described on Schedule C.”16 The parties separately defined the OPUS-1
Study to mean “the Phase III clinical trial for Lifitegrast conducted by or on behalf
of the Company in accordance with the Company Protocol Number 1118-KCS-200,
dated May 27, 2011, as amended August 5, 2011.”17
According to Shire, by separately defining the OPUS-1 and OPUS-2 studies,
the Merger Agreement makes clear that the studies and the data from each study are
distinct. And by expressly linking the Achievement Date to the receipt of data “from
the OPUS-2 Study,” and no other study, Shire argues that the only reasonable
construction of the definition of Achievement Date is that the OPUS-2 Study data is
the exclusive data relevant to determining whether the Achievement Date has
occurred.
Moreover, Shire contends that any results reached in the OPUS-2 Study must
be statistically significant in order to “achieve” the co-primary endpoints. In this
regard, Shire points to the OPUS-2 Study Protocol which specifies that “[s]tatistical
significance is required for both the sign and the symptom for treatment success.”18
16
Id.
17
Id.
18
Opening Br., Ex. 2 (“OPUS-2 Study Protocol”) at 73.
15
As Shire highlights, the OPUS-2 Study Protocol goes on to provide that statistical
significance for the co-primary sign and symptom endpoints was a “p-value” of less
than or equal to 0.05.19
If the Merger Agreement is construed to require that the determination of
whether the Achievement Date has occurred be assessed by reference to OPUS-2
Study data only, and that the OPUS-2 Study data must reach statistical significance
in order to “achieve” the co-primary endpoints, Fortis’ demand for payment of the
Successful Completion Milestone Payment and the Base Case Approval Milestone
Payment fizzles. This is because the Merger Agreement clearly provides that to
reach the Achievement Date, “both components of the co-primary efficacy endpoints
of the OPUS-2 Study as specified in the OPUS-2 Study Protocol [must] have been
achieved . . .”20 With this construction in mind, Shire maintains that the payments
Fortis has demanded in this litigation are not due and will never become due.
Shire’s interpretation of the Merger Agreement is reasonable. By its clear
terms, the definition of the Achievement Date requires that data “from the OPUS-2
Study” demonstrate that the sign and symptom co-primary efficacy endpoints have
19
Id. at 71, 73. As explained in the Complaint, a “p-value is the probability of obtaining a
result at least as extreme as the result that was actually observed when the then null
hypothesis (in this case, that there is no relationship between Lifitegrast and the observed
symptom or sign) is true.” Compl. ¶ 21.
20
Merger Agreement § 1.1 (emphasis supplied).
16
been achieved. No other data is referenced in the definition and no other provision
of the Merger Agreement suggests that the parties intended other data to be relevant
to the determination of whether the Achievement Date has occurred. Shire’s
construction harmonizes and gives meaning to all of the provisions in the Merger
Agreement, including those that identify and define the OPUS-1 Study as separate
and distinct from the OPUS-2 Study. It is also reasonable to construe the definition
of Achievement Date as requiring that results from the OPUS-2 Study be statistically
significant given that the OPUS-2 Study Protocol, which lays out how the OPUS-2
study is to be conducted, requires statistically significant results.21
Having determined that Shire’s proffered construction is reasonable, however,
does not end the inquiry. Shire’s construction cannot prevail on a motion to dismiss
if Fortis’ construction of the same provisions is also reasonable.
D. Fortis’ Construction is Unreasonable
Fortis maintains that the Merger Agreement makes clear that data from
clinical trials other than the OPUS-2 Study can be considered when determining
whether the Achievement Date has occurred. This construction rests on three
principal arguments. First, Fortis contends that the absence of any language
expressly excluding data from clinical trials other than the OPUS-2 Study in the
21
OPUS-2 Study Protocol at 73 (“Statistical significance is required for both the sign
and the symptom for treatment success.”).
17
definition of Achievement Date reflects the parties’ intent that such data could and
should be considered when determining whether the Achievement Date has
occurred. Indeed, according to Fortis, in order for Shire’s construction of the
operative language to make sense, the Court would have to insert additional
language into the definition of Achievement Date. Specifically, Fortis argues that
the following bracketed and bold language would need to be added:
“OPUS-2 Study Endpoint Achievement Date” shall be deemed to occur
upon receipt . . . of audited final tables, figures and listings from the
OPUS-2 Study (x) that demonstrate that both components of the co-
primary efficacy endpoints of the OPUS-2 Study as specified in the
OPUS-2 Study Protocol have been achieved [in the OPUS-2 clinical
trial relying only on audited final tables, figures and listings from
the OPUS-2 clinical trial and without reliance on any data from any
other trial or study] . . .
Fortis contends that “without the addition of this language not contained in the actual
text of the Merger Agreement, the OPUS-2 Study Endpoint Achievement Date
simply does not have the limitation that Shire seeks to impose.”22
Second, Fortis argues that not only does the definition of Achievement Date
not explicitly exclude data from prior studies, it makes clear that the parties did, in
fact, contemplate that data from other clinical trials would be included. Specifically,
Fortis points to the definition of OPUS-2 Study, a term incorporated in the definition
Pl. Fortis Advisors LLC’s Mem. in Opp’n to Shire’s Mot. to Dismiss the Verified First
22
Am. and Supplemental Compl. (“Answering Br.”) 34.
18
of Achievement Date, and argues that while the OPUS-2 Study Protocol is defined
separately from the OPUS-1 Study Protocol, the contractual language makes clear
that a Phase III clinical trial need only be conducted “in accordance with” the OPUS-
2 Study Protocol in order to constitute part of the OPUS-2 Study as referenced in the
Achievement Date definition.23 According to Fortis, in order “to be in accordance
with” the OPUS-2 Study Protocol, the clinical trial need not be identical to the
OPUS-2 Study, but rather need only be conducted in “a way that agrees with or
follows” the OPUS-2 Study Protocol.24 Furthermore, Fortis argues that while Shire
highlights the use of the definite article “the” in the definition of OPUS-2 Study,25
as in “the Phase III clinical trial,”26 the Merger Agreement itself indicates that, when
23
Merger Agreement § 1.1 (defining OPUS-2 Study).
24
Answering Br. 20 n 7 (citing Merriam-Webster’s Dictionary Online,
https://www.merriam webster.com/dictionary/in%20 accordance%20with.).
25
Specifically, Shire argues that “[t]he use of the definite article—‘the’—means that the
term that follows (i.e., ‘Phase III clinical trial’) is a ‘unique or a particular member of its
class.’”) Opening Br. 32 (citing to Merriam-Webster Dictionary Online,
http://www.merriamwebster.com/dictionary/the). In this way, Shire contends that “[t]he
word ‘the’ makes clear that the parties were referring to one particular clinical trial of
Lifitegrast.” id. (emphasis in original).
26
Merger Agreement §1.1 (“OPUS-2 Study” means the Phase III clinical trial for
Lifitegrast to be conducted in accordance with the OPUS-2 Study Protocol, as further
described on Schedule C.)
19
construing its provisions, “the singular . . . shall include the plural . . .”27 Thus, Fortis
would read that provision as stating “the Phase III clinical trials.”28
Third, Fortis argues that once the Xiidra label was approved by the FDA and
publicly made available on Shire’s website, Fortis was able to confirm that, contrary
to Shire’s representations, the OPUS-2 Study had, in fact, achieved both co-primary
efficacy endpoints. Indeed, according to Fortis, the FDA approval and the contents
of the Xiidra label confirm that the former SARcode stockholders are entitled to an
additional Base Case Milestone Payment as well as providing further evidence that
both co-primary efficacy endpoints have in fact been achieved for purposes of
determining whether the previously earned milestone payments are due.29
Fortis’ construction of the Merger Agreement is unreasonable. As for its first
argument—that the parties’ intent to allow data from the OPUS-1 Study to be
considered in the definition of Achievement Date can be gleaned from the absence
of any express exclusion of such data from the definition—Fortis’ proffered
27
Merger Agreement § 11.9(b).
28
The definition of “OPUS-2 Study” would then read: “OPUS-2 Study” means the Phase
III clinical trials for Lifitegrast to be conducted in accordance with the OPUS-2 Study
Protocol, as further described on Schedule C.
29
Fortis argues that when the Xiidra product label was released by Shire it “contain[ed]
data sufficient to show that the OPUS-2 clinical trial produced data demonstrating the
efficacy of the sign and symptom endpoints such that the [Achievement Date] occurred”
because “[i]t notes that a ‘larger reduction . . . favoring Xiidra was observed in three of the
four studies.’” Answering Br. 22.
20
construction turns a “four corners” construction of the definition inside out. The
canon of construction expresio unius est exclusio alterius—to express or include one
thing implies the exclusion of the other—seems particularly apt here.30 The fact that
the parties decided separately to define the OPUS-1 and OPUS-2 studies as different
Phase III clinical trials, and then designated the data “from the OPUS-2 Study” as
relevant to the determination of whether the Achievement Date had occurred, clearly
and unambiguously reflects an intent that only that data should be considered when
assessing whether both the sign and symptom co-primary efficacy endpoints had
been achieved. Indeed, as Shire points out, only Fortis’ proffered construction
requires the insertion of language not present in the Merger Agreement in order for
the contract to get Fortis where it wants to go. Specifically, the Court would have
to insert the bold and bracketed text in order for Fortis’ construction to be reasonable:
upon receipt . . . of audited final tables, figures and listings from the
OPUS-2 Study [or the OPUS-1 Study] (x) that demonstrate that both
components of the co-primary efficacy endpoints of the OPUS-2 Study
as specified in the OPUS-2 Study Protocol have been achieved
30
Shintom Co., Ltd. V. Audiovox Corp., 888 A.2d 225, 230 (Del. 2005). To require that
parties to a contract expressly exclude all that they intend to exclude, when the relevant
contact language is expressly inclusive, would present a challenge to scriveners that would
be extraordinarily difficult, if not impossible, to meet. Here, the express reference to the
OPUS-2 Study data within the definition of Achievement Date would have been
unnecessary and, indeed, confusing if the parties had intended for the definition to include
other, unspecified data as well.
21
Of course, this new language that Fortis would have the Court blue-pencil into
the Merger Agreement ignores that the Merger Agreement both defines the OPUS-
2 Study as a separate Phase III clinical trial from the OPUS-1 Study and requires
that the “audited final tables, figures and listings” that demonstrate both co-primary
efficacy endpoints have been achieved come “from the OPUS-2 Study.”31 By
ignoring these provisions, Fortis’ proffered construction requires the Court to render
them superfluous—something Delaware courts do not do when engaging in contact
construction.32
Fortis’ second argument—that the definition of OPUS-2 Study clearly and
unambiguously allows for data from other clinical trials to be used to satisfy the
Achievement Date—is likewise unpersuasive. To support this contention, Fortis
31
Merger Agreement § 1.1.
32
See O’Brien v. Progressive Northern Ins. Co., 785 A.2d 281, 287 (Del. 2001). For the
first time at oral argument, Fortis raised a new argument that the phrase “from the OPUS-
2 Study” is merely a “temporal trigger” that identifies the time at which the determination
of whether the OPUS-2 Endpoint Achievement Date has occurred is to be made. Oral Arg.
on Def.’s Mot. to Dismiss the Verified First Am. and Supplemental Compl. (“Oral Arg.
Tr.”) 37–38. This argument was not previously raised in Fortis’ briefing and is therefore
waived. See Emerald P’rs v. Berlin, 2003 WL 21003437, at *43 (Del. Ch. Apr. 28, 2003)
(“It is settled Delaware law that a party waives an argument by not including it in its
brief.”). Even if the argument were not waived, however, I would reject it in any event.
The unambiguous language of the Merger Agreement clearly states that the “audited final
tables, figures, and listings from the OPUS-2 Study” must “demonstrate that both
components of the co-primary efficacy endpoints of the OPUS-2 Study as specified in the
OPUS-2 Study Protocol have been achieved . . .” Nothing in this language suggests that
the parties intended it to mean that the receipt of OPUS-2 Study data would act simply as
a “temporal trigger” after which data from any and all other Phase III clinical trials will be
evaluated to determine whether both endpoints had been achieved.
22
argues that, while the OPUS-2 Study is defined as “the Phase III clinical trial for
Lifitegrast to be conducted in accordance with the OPUS-2 Study Protocol . . .,” the
Merger Agreement makes clear that “the singular . . . shall include the plural” and,
therefore, it is reasonable to include other unspecified Phase III clinical trials within
that definition.33 Fortis correctly quotes Section 11.9(b) but shoots well wide of the
mark in arguing that it somehow supports its construction of Shire’s milestone
payment obligations.
Even when one changes singular terms to plural within the definition of
OPUS-2 Study, the language from that definition still does not support the notion
that data from multiple clinical trials should be considered when assessing whether
both co-primary efficacy endpoints have been achieved as contemplated in the
definition of Achievement Date. The OPUS-2 Study is clearly defined as a clinical
trial that is “to be conducted.”34 Applying the Merger Agreement’s rule of
construction to change the singular terms to plural, the definition of OPUS-2 Study
would read “the Phase III clinical trials for Lifitegrast to be conducted in accordance
with the OPUS-2 Study Protocol . . .”35 The OPUS-1 Study, however, had already
been conducted by the time the Merger Agreement was executed. That fact is
33
Merger Agreement § 11.9(b).
34
Merger Agreement § 1.1.
35
Id. (emphasis added).
23
evident from the definition of OPUS-1 Study, which is “the Phase III clinical trial
for Lifitegrast conducted by or on behalf of the Company in accordance with the
Company Protocol Number 1118-KCS-200 . . .”36 The Merger Agreement,
therefore, clearly and unambiguously differentiates between the OPUS-1 Study that
had been conducted and the OPUS-2 Study (and perhaps other Phase III trials) that
were to be conducted. Adding plural terms to the definition of OPUS-2 Study does
nothing to change this temporal reality.37
Fortis engages in even more strained interpretive gymnastics when it argues
that any data from any clinical trial conducted “in accordance with” the OPUS-2
Study Protocol can be considered when determining whether the Achievement Date
has occurred. This construction just outright ignores that the OPUS-1 and OPUS-2
studies were conducted pursuant to separately defined protocols. Moreover, even if
the OPUS-1 Study was conducted “in accordance with” the OPUS-2 Study Protocol,
a point Shire disputes at full throat, Fortis simply cannot explain how that clinical
trial could fit within the definition of Achievement Date when that term is defined
36
Id. (emphasis added).
37
This, of course, assumes that the context here requires singular terms to be converted to
plural. The rule of construction upon which Fortis relies within § 11.9(b) applies only
“wherever the context requires.” Given that the OPUS-1 and OPUS-2 studies were both
separately defined in the Merger Agreement, and the provisions at issue here are clear and
unambiguous as drafted, it is difficult to discern anything about this “context” that
“requires” a conversion of terms from singular to plural.
24
to include only clinical trials “to be conducted” in accordance with the OPUS-2
Study Protocol. To reiterate, the OPUS-1 Study had already been conducted at the
time of the Merger Agreement, a fact that is undisputed and is, in any event, clear
from the definition of the OPUS-1 Study in the Merger Agreement. For these
reasons, it is unreasonable to construe the definition of OPUS-2 Study as
encompassing data from multiple clinical trials in addition to the OPUS-2 Study.38
As for Fortis’ third and final basis to argue that the Achievement Date has
occurred—that the Xiidra label provides irrefutable evidence the OPUS-2 Study did
achieve both co-primary efficacy endpoints—the argument ignores that the Merger
Agreement clearly and unambiguously requires that the study data achieve statistical
significance. And it glosses over the fact that Fortis has not pled that the Xiidra label
showed a statistically significant result for the OPUS-2 Study. To get around the
reference to statistical significance in the OPUS-2 Study Protocol, Fortis contends
that the reference to the OPUS-2 Study Protocol within the definition of the
Achievement Date is simply intended to identify the co-primary efficacy endpoints
38
I note that the Complaint is devoid of any well-pled allegations that would allow the
Court reasonably to infer that the OPUS-1 Study, which was conducted in accordance with
Company Protocol Number 1118-KCS-200, dated May 27, 2011, as amended August 5,
2011, was conducted “in accordance with” the OPUS-2 Study Protocol, a separately
defined protocol designed well after the OPUS-1 Study. The Complaint makes no effort
to compare the two protocols factually, scientifically or otherwise. Fortis’ “in accordance
with” construction, therefore, appears to be of post-pleading vintage. In any event, the
construction cannot be squared with the clear and unambiguous terms of the contract and
must be rejected for that reason alone.
25
as defined in the OPUS-2 Study Protocol; it does not, however, reflect an intent to
incorporate all aspects of the OPUS-2 Study Protocol, including the requirement of
statistical significance, within the Achievement Date definition. To characterize this
construction as fanciful would be charitable.
In advancing its proffered construction, Fortis would have the Court ignore
that the OPUS-2 Study Protocol, in its entirety, is an attached schedule to the Merger
Agreement and is thereby expressly incorporated as part of the entire agreement.39
By incorporating the entire OPUS-2 Study Protocol into their agreement without
conditions or limitations, the parties unambiguously reflected their intent that all
aspects of the protocol, including its detailed specifications for statistical
significance, would become elements of their contract, equally as essential as any
other element.40 Fortis’ attempt to read out of the OPUS-2 Study Protocol the
39
See Merger Agreement, Schedule C. At § 11.4 of the Merger Agreement, the parties
agreed that the schedules to the Merger Agreement were incorporated as part of the parties’
entire agreement. See Merger Agreement § 11.4(a)(i) (“This Agreement and the documents
and instruments delivered pursuant hereto, including the exhibits hereto, the Company
Disclosure Schedule and the other schedules hereto, and the Escrow Agreement:
(i) together constitute the entire agreement among the parties with respect to the subject
matter hereof . . .”).
40
See Realty Growth Inv. Council of Unit Owners of Pilot Pointe, 453 A.2d 450, 454 (Del.
1982) (holding that documents incorporated by reference into a contract must be
considered by the court when discerning the parties’ intent); Green Plains Renewable
Energy, Inc. v. Ethanol Hldg. Co., LLC, 2015 WL 590493, at *6 (Del. Super. Ct. Feb. 9,
2015) (holding that the operative contract’s express “identification of all schedules to the
[contract] as being part of the ‘entire agreement’ is sufficient to satisfy the incorporation
by reference standard.”); accord Kerly v. Battaglia, 1990 WL 199507, at *4 (Del. Super.
Ct. Nov. 21, 1990) (noting that parties may limit the incorporation by reference of other
26
provisions that undermine its construction of the Achievement Date definition
cannot be countenanced.
Moreover, as noted, Fortis has not attempted to plead that the Xiidra label
shows that the co-primary efficacy endpoints were achieved in a statistically
significant manner. Rather, it construes the data on the label as revealing only that
the OPUS-2 Study demonstrated that the reduction for the sign endpoint was
favorable for Lifitegrast as compared to the placebo.41 Fortis contends that this
means that the sign endpoint was “achieved” in the OPUS-2 Study if one construes
the term “achieved,” an undefined term, in accordance with its ordinary dictionary
meaning. According to Fortis, as used in the operative language, “achieve” means
“to reach or attain”; it does not mean or require that the study produce statistically
agreements by designating “only certain provisions” of the other agreement to be
incorporated into the contract at issue).
41
Fortis argues that Shire has denied it access to the actual data from the OPUS-2 Study
even though it is contractually entitled to this data. According to Fortis, the actual data
would allow it to determine if the results in the OPUS-2 Study were, in fact, statistically
significant. Yet this is not the breach of contract claim Fortis brought in this action. If
Fortis believes that it has been denied access to information that it is entitled, by contract,
to receive, it may bring that claim and Shire may raise its defenses. The fact that the
information has not been produced thus far, however, does not and cannot alter the fact
that the clear and unambiguous terms of the Merger Agreement do not support the breach
of contract claim that Fortis has asserted. As an aside, I cannot help but observe that it
would be remarkable if the OPUS-2 Study actually did achieve statistically significant
results when Shire reported to the FDA in a NDA, against its interest, that the study did not
meet the co-primary Sign endpoint with statistical significance. See Transmittal Aff. of
Jaclyn C. Levy, Ex. A at 37 (the NDA was incorporated by reference in the Complaint).
27
significant results. This construction, of course, ignores the details of the OPUS-2
Study Protocol where the parameters of the study are set forth in detail, including
the population of patients to be tested, the number of study participants and how they
would be sourced and screened, the methodology by which participants would be
assigned to the Lifitegrast or placebo cohorts, the mechanics for the testing
procedures and, importantly, the manner by which the outcomes would be evaluated
for statistical significance. Under these circumstances, there is simply no room to
embed a general dictionary definition for “achieve” within the definition of
Achievement Date when the detailed ingredients of the OPUS-2 Study Protocol fully
occupy the space.42
III. CONCLUSION
To state a claim for breach of contract, Fortis must proffer a reasonable
construction of the operative terms of the Merger Agreement that would support its
claim of breach. It has not done so. On the other hand, Shire’s construction is
42
See Brinckerhoff v. Enbridge Energy Co., Inc., 159 A.3d 242, 254 (Del. 2017) (observing
that “settled rules of contract interpretation requir[e] that the court prefer specific
provisions over more general ones.”). Although the Court is bound to a four corners
analysis of the Merger Agreement unless the contractual language is ambiguous, I pause
to note that it makes eminent sense that these two parties would require statistical
significance as the measure for “achievement” in this context when seeking an objective
means by which to determine whether milestones have been reached. While Fortis’
interpretation would leave the trigger point for the milestone payments as something more
fluid and open to debate, I cannot fathom that two sophisticated parties with hundreds of
millions of dollars on the line would have been so cavalier.
28
entirely reasonable. Because Shire’s construction reveals that it has not breached
the Merger Agreement, Shire’s motion to dismiss the Complaint must be
GRANTED.
IT IS SO ORDERED.
29