Amgen Inc. v. Amneal Pharmaceuticals et al

Filing 485

MEMORANDUM OPINION. Signed by Judge Mitchell S. Goldberg on 9/18/2019. (lak)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

AMGEN INC.,
Plaintiff,
v.
AMNEAL PHARMACEUTICALS
LLC, et al.,
Defendants.

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Civ. No. 16-853-MSG
CONSOLIDATED

MEMORANDUM OPINION
GOLDBERG, J.

September 18, 2019

The current dispute between the parties revolves around a settlement agreement in a HatchWaxman patent infringement case.
Plaintiff Amgen, Inc. (“Amgen”) originally brought claims against Defendants Sun
Pharmaceutical Industries, Ltd., Sun Pharma Global Fze, and Sun Pharmaceutical Industries, Inc.
(collectively, “Sun”) in response to Sun filing an Abbreviated New Drug Application (“ANDA”)
for its generic Cinacalcet tablets.

The Parties settled, entered into a Litigation Settlement

Agreement (“Agreement”) on October 24, 2017, and thereafter stipulated to dismissal of all claims
against Sun. As detailed more fully below, part of this Agreement set forth Amgen’s obligations
if other manufacturers of generic Cinacalcet entered the market at risk.
From December 28, 2019 to January 2, 2019, generic manufacturer Watson Laboratories,
Inc. (“Watson”) and its corporate parent Teva Pharmaceutical Industries Ltd. (“Teva”) released a
generic Cinacalcet into the market. In response to Teva’s launch, Sun filed the present motion to
enforce the Agreement. Sun asserts that, based on Teva’s market activity and Amgen’s deficient
response, the Agreement grants a license to Sun and allows it to launch and sell its generic
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Cinacalcet product. 1 (Oral Ar. Tr. at 21, ECF No. 481, June 13, 2019). For the reasons set forth
below, I conclude that Sun has misconstrued its rights under the Agreement, and that the
Agreement does not entitle Sun to a license to sell and market its generic Cinacalcet product.
I. BACKGROUND
A. The ’405 Patent
The ’405 patent, entitled “Rapid Dissolution Formulation of Calcium Receptor-Active
Compound,” was issued on June 28, 2016 and assigned to Amgen. Amgen also holds an approved
New Drug Application (“NDA”) No. 21-688 for Cinacalcet hydrochloride tablets. (Id.) Amgen
sells Cinacalcet hydrochloride tablets in the United States under the tradename Sensipar®. (Id.)
On September 29, 2016 Amgen sued Sun, alleging that Sun infringed the ’405 patent.
(Compl., ECF No. 1 in C.A. No. 16-cv-882, at ¶ 7.) 2 The original complaint asserted that Sun
committed an act of infringement under 35 U.S.C. § 271(e)(2)(A) by submitting an ANDA to
obtain approval to engage in the manufacture, use, sale, or importation of its generic Cinacalcet
hydrochloride before the expiration of the ’405 patent. (Id. at ¶ 40.) On February 23, 2017,
Amgen’s suit against Sun was consolidated with other cases brought against several other drug
manufacturers that filed similar ANDAs for generic Cinacalcet products.
On October 24, 2017, Sun and Amgen settled this infringement action by entering into the
Agreement at issue. (Agreement, ECF No. 437-1.) The parties do not dispute that the Agreement
is binding, enforceable, and governs the present dispute. Under the Agreement, Sun filed a

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Sun also requests limited discovery concerning the Amgen-Teva agreement, followed by
an evidentiary hearing. Because I disagree with Sun’s reading of the Agreement, I will not order
discovery as requested.
2

All citations are to the docket for C.A. No. 16-853 unless noted otherwise.

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stipulation of dismissal conceding that the ’405 patent was valid and enforceable, and would be
infringed by “the manufacture, use, sale, offer to sell, importation or distribution [of its generic
Cinacalcet product] in or for the United States ....” (Stip. of Dismissal, ECF No. 248, at ¶ 4.) The
Honorable Gregory M. Sleet (now retired), who was originally assigned to this case, signed the
aforementioned stipulation of dismissal on November 2, 2017, terminating the civil case against
Sun. (Dismissal Order, ECF No. 253.) 3
B. The Teva Launch and Subsequent Amgen-Teva Settlement Agreement
After the Amgen-Sun settlement and dismissal of Sun’s claims, other defendants in the
consolidated infringement action proceeded to trial. On August 24, 2018, I entered a judgment of
non-infringement in favor of Piramal Healthcare UK Ltd., Amneal Pharmaceuticals LLC, and
Watson. 4 (J. Order, ECF No. 386.) Despite this judgment, Watson could not yet enter the market
because its ANDA was still pending approval of the Food and Drug Administration. (Amgen’s
Br., ECF No. 455, at 7.)
On December 27, 2018, the FDA approved Watson’s Cinacalcet ANDA. (Id.) On
December 28, 2018, Watson, through its corporate parent, Teva, launched a generic Cinacalcet
product, infiltrating the market with approximately six-weeks-worth of stock through its
distribution network. (Id.). Shortly thereafter, on January 2, 2019, Amgen and Teva reached a
settlement agreement whereby Teva acknowledged that its generic product infringed the ’405
patent and agreed that it would immediately cease sales of this product. (Id.) Importantly,
downstream distributors who had received Teva’s generic product were not involved in these

On May 18, 2017, Chief Judge D. Brooks Smith of the United States Court of Appeals
for the Third Circuit designated me as a visiting judge for the District of Delaware, pursuant to 28
U.S.C. § 292(b), to handle this and other Delaware cases.
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On September 20, 2018, Amgen filed a timely appeal of the judgments of noninfringement. (Notice of Appeal, ECF No. 397.)
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negotiations, nor were they parties to the Agreement. (See Agreement, ECF No. 437). Also, on
January 2, 2019, in order to comply with its notification duties outlined in section 5.3 of the
Agreement, Amgen notified Sun of Teva’s launch and of their subsequent settlement. (Agreement,
ECF No. 437-1, § 5.3; Letter, ECF No. 455-1, Ex. D.)
C. Relevant Portions of the Litigation Settlement Agreement
Sun premises its position that it is entitled to a license on Section 5 of the Agreement,
which is titled “LICENSE.” I will briefly summarize the relevant terms of Section 5.
Section 5.1 states that from “the Entry Date through the expiration of the last to expire
claim of the Licensed Patents,” Sun and its Affiliates will be given a right and license to “make,
have made, use, sell, offer to sell, import and distribute the Defendant’s Product in or for the United
States.” (Agreement, ECF No. 437-1, § 5.1.)
Section 5.2 defines the “Entry Date” as the earlier of certain events which are set forth in
sections 5.2(a) and (b). Section 5.2(a) is not pertinent to resolution of this motion. Section 5.2(b)
states that the “Entry Date” could be the earlier of “the Launch of a Generic Cinacalcet Product by
a Third Party, Amgen, or an Amgen Affiliate, except as provided under Section 5.5.” (Id. at §
5.2(b) (emphasis added). Section 1 of the Agreement further defines the underlined terms.
According to Section 1, the term “Launch” means the “first sale in the United States, with
regard to a Generic Cinacalcet Product.” (Id. at § 1.9.) The term “Generic Cinacalcet Product”
means “an oral drug product containing Cinacalcet HCL that is sold, offered for sale or distributed
in the United States as an Authorized Generic or under an FDA finally approved ANDA that refers
to and is AB rated with the Amgen Product as the reference-listed drug.” (Id. at § 1.4.) Finally,
“Third Party” is defined as “any entity or person that is not a Party or an Affiliate of a Party.” (Id.
at § 1.6.) Substituting these definitions into Section 5.2(b), as I have done in bold below, provides

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a clearer understanding of the meaning of this Section 5.2(b):
For the purposes of this Settlement Agreement, the “Entry Date” shall mean the
earlier of:
the first sale in the United States, with regard to a Generic Cinacalcet
Product (an oral drug product containing Cinacalcet HCL that is sold,
offered for sale, or distributed in the United States as an authorized generic
or under an FDA finally approved ANDA that refers to and is AB rated
with the Amgen Products as the referenced listed drug) by any entity or
person that is not a Party or an Affiliate of a Party, Amgen or an Amgen
Affiliate, except as provided by section 5.5.
Importantly, the last portion of Section 5.2(b) references Section 5.5. Section 5.5 outlines
Amgen’s obligations if a Third Party engages in an “At-Risk Launch.” It states:
If a Third Party Launches a Generic Cinacalcet Product without authorization
… from Amgen and there has not been a Final Court Decision of noninfringement and/or invalidity of the Licensed Patents with respect to the
Generic Cinacalcet Product that in fact was the subject of the Third Party Launch
(an “At Risk Launch”) then:
(a) If within ten (10) Business Days from Defendants having provided Amgen
formal written notice of an At Risk Launch, Amgen does not … (ii) enter
into an agreement with each such Third Party selling such Generic
Cinacalcet Product requiring each such Third Party to cease and desist from
selling such Generic Cinacalcet Product form the market within 30 days of
such agreement, then Amgen will not seek a temporary restraining order or
preliminary injunction against Defendants making, having made, selling,
offering to sell, importing and distributing the Defendant’s Product at risk,
provided none of the Defendants’ at risk making, having made, sales, offer
for sale, importation, or distribution begin before the date that is the eleventh
(11th) Business Day after the At Risk Launch (subject to 5.4) and
Defendants’ at risk making, having made, sales, offer for sale, importation,
or distribution cease on such date as the Third Party’s Generic Cinacalcet
Product is no longer offered for sale, whether by mutual agreement or
otherwise. Defendants shall give Amgen notice immediately upon deciding
to begin temporarily making, having made, selling, offering to sell,
importing and/or distributing the Defendant’s Product under this Paragraph
of the Settlement and agree that such temporary making, having made,
selling, offering to sell, importing, and distributing shall end on such date as
the Third Party Generic Cinacalcet Product is no longer offered for sale,
whether by mutual agreement or otherwise. Defendants shall also make
commercially reasonable efforts to remove the Defendants’ Product from
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sale in the United states if the Third Party is also required to remove its
Generic Cinacalcet Product from sale in the United States.
(Id. at § 5.5). 5 It is worth emphasizing that the first part of section 5.5 explains that an “At Risk”
Launch occurs when a “Third Party” launches a Generic Cinacalcet Product without authorization.
II. DISCUSSION
Amgen argues that the court does not have subject matter jurisdiction to hear this dispute.
Given the notification by Amgen to Sun that Sun was not authorized to launch their Product
pursuant to the Agreement, along with the Stipulation of Dismissal, Section 8.3 which states that
the court shall retain jurisdiction over the Agreement, I find that there is jurisdiction to hear Sun’s
motion to enforce the Agreement.
Sun urges that, based on Amgen’s deficient response to Teva’s market entry, it is entitled
to a license to sell its generic Cinacalcet. (See generally Sun Br.) I conclude that Sun’s proposed
interpretation of the Agreement is not correct because it would require finding that the parties
intended to include substantial contractual language that is starkly absent in the Agreement. Such
a result would not align with the intentions manifested in the Agreement, and thus does not trigger
Sun’s license under section 5.2. The basis for these conclusions follows.
A. Subject Matter Jurisdiction
1. The Parties’ Positions
In response to Sun’s motion to enforce, Amgen first argues that this court lacks subject
matter jurisdiction because there is no case or controversy. (Amgen’s Br., ECF No. 455, at 9).
Amgen posits that there is no real controversy and that Sun is seeking an advisory opinion from

There are two subparts to Section 5.5 – an (a) and (b). According to Sun, Section 5.5(b)
addresses what should occur if Sun would go to market during a Third Party at Risk Launch (Sun
motion, p. 6). This did not occur. And Amgen does not seem to rely on 5.5(b). Therefore, I have
not set forth that subpart.
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the court. Amgen presses that Sun’s motion to enforce the settlement agreement does not create
jurisdiction, unless there has been a breach of contract allegation, and because no such allegation
has been raised, there is no jurisdiction. (Id. at 9-10.)
Sun disagrees and responds that Amgen’s implicit threat of litigation created a justiciable
controversy, and in any event, both the Agreement and the Stipulation of Dismissal state that the
court shall retain jurisdiction to resolve any disputes under the Agreement. (Sun’s Reply Br., ECF
No. 465, at 1-2.) Sun asserts that there is a case or controversy to be heard, and thus there is
jurisdiction, primarily because Amgen notified Sun, after the Teva launch, that Sun could not enter
the market. (Id. at 1-3.) Sun further explains that it is prepared to enter the market, and has made
substantial investments into its generic product to reach an injunction type controversy, which
would ultimately bring the same issue before the court. (Oral Ar. Tr. at 28-29, ECF No. 481, June
13, 2019.)
2. Analysis
Generally, a district court has jurisdiction to enforce a settlement agreement entered into
by litigants in a case pending before it. Leonard v. Univ. of Del., 204 F. Supp. 784, 786 (D. Del.
2002). In discussing jurisdiction in the declaratory judgment context, the United States Supreme
Court has stated that “the question in each case is whether the facts alleged, under all the
circumstances, show that there is a substantial controversy, between parties having adverse legal
interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”
MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007) (internal quotations omitted).
Courts must look to the facts of each case to differentiate between hypothetical and actual
controversies. Tabletop Media, LLC v. AMI Entm’t Network, LLC, 2017 WL 4511351, at *3 (D.
Del. Oct. 10, 2017). Immediacy and reality are satisfied by allegations of “(1) an injury-in-fact,

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i.e. a harm that is concrete and actual or imminent ... (2) that is ‘fairly traceable’ to the defendant’s
conduct, and (3) redressable by a favorable decision.” Prasco LLC v. Medicis Pharm. Corp., 537
F.3d 1329, 1338 (Fed. Cir. 2008). Adverse parties must have a dispute over “legal rights, i.e., ‘an
underlying legal cause of action that the declaratory defendant could have brought or threatened
to bring.’” Tabletop Media, 2017 WL 4511351, at *3.
In the patent context, “the case or controversy requirement may be satisfied if the patentee
affirmatively puts the other party in the position where the party must ‘either pursu[e] arguably
illegal behavior or abandon that which he claims a right to do.’” Id.; see also, Prasco, 537 F.3d at
1339.
Here, Amgen has asserted its right to prevent Sun from entering the market. The January
2, 2019 letter to Sun from Amgen’s counsel clearly illustrates this point. In that letter, Amgen
advises that it had received information about an anticipated launch by Watson (Teva), and that
subsequently Teva had agreed to cease selling its generic product. Amgen then affirmatively
advises Sun that it is not “authorized to launch their Product pursuant to Paragraph 5.5(a), of the
Litigation Settlement Agreement.” (Letter, ECF No. 437-1, Ex D.) In response to this letter, Sun
has pressed its rights to a license under the Agreement, and Amgen has vigorously opposed Sun’s
position that they obtained a license to enter the market. Under these circumstances, Sun certainly
has a reasonable apprehension of litigation should it choose to act upon its interpretation of the
Agreement.
Amgen also argues that jurisdiction is lacking because Sun’s motion rests on anticipation
of an event (e.g. launch) that may or may not occur—that is, whether Sun will sell Cinacalcet.
Amgen asserts that “Sun does not allege that it intends to, and is in fact prepared to, start selling
generic product immediately.” (Amgen’s Br., ECF No. 455, at 9.) But this is not the case. At

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oral argument on Sun’s motion, I specifically asked Sun’s counsel when they planned to launch
and they responded, “in a couple weeks.” (Oral Arg. Tr. at 28-29, ECF No. 481, June 13, 2019.)
This representation further creates a reasonable apprehension of litigation necessary to defeat
Amgen’s lack of jurisdiction arguments.
The language of the Agreement provides another reason to find that jurisdiction exists.
Section 8.3 states, “Defendants and Amgen agree that the United States District Court for the
District of Delaware retains jurisdiction over this Settlement Agreement and that the Parties agree
that they are subject to personal jurisdiction in District of Delaware and/or venue is proper in the
District of Delaware with regard to all disputes concerning the Settlement Agreement.”
(Agreement, ECF No. 437-1, § 8.3.) The parties’ Stipulation of Dismissal also expressly states
that “[t]he Court retains jurisdiction over Plaintiff and Defendants for purposes of enforcing the
terms of the Settlement Agreement and this Stipulation of Dismissal and Order.” (Stip. of
Dismissal, ECF No. 253.)
For all of the above reasons, I conclude that I have jurisdiction to resolve the parties dispute
over the Agreement.
B. The Agreement Does Not Grant Sun a License
1. The Parties’ Positions
Sun urges that, based on Amgen’s deficient response to Teva’s market entry, it is entitled
to a license to sell its generic Cinacalcet. Sun’s argument rests primarily on its claim that despite
Teva’s launch and downstream sales, Amgen did not contract with each downstream distributor to
effectuate a cease and desist regarding the selling of the Teva product. Per Sun’s reading of the
Agreement, such authorized downstream sales trigger application of section 5.2 of the Agreement,
thus granting Sun a license to enter the market. (See generally, Sun’s motion to enforce and reply

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brief, ECF No. 465).
Amgen’s response focuses on several sections of the Agreement. First, Amgen notes that
a “Launch” under section 5.2(b) is defined under section 1.9 as “the first sale in the United States,
with regard to a Generic Cinacalcet Product.” (Amgen’s Br., ECF No. 478, at 13.) In conjunction
with that language, Amgen also references section 1.4 where Generic Cinacalcet Product is defined
as “an oral drug product containing Cinacalcet HCL that is sold, offered for sale, or distributed in
the United States as an Authorized Generic or under an FDA finally approved ANDA that refers
to and is AB rated with the Amgen Product as the reference-listed drug.” (Oral Ar. Tr. at 34-35,
ECF No. 481, June 13, 2019.)

Relying on these two definitions, Amgen argues that the

downstream sales by distributors that Sun relies upon were not a “Launch” that would trigger a
license under section 5.2(b), because downstream sales can never be “the first sale in the United
States” of the particular generic in question. (Id.)
Amgen also emphasizes that an at-risk launch, like Teva’s launch, does not trigger a license
under section 5.2, unless the exceptions of section 5.5 apply. (Id.) Focusing on these exceptions,
Amgen stresses that it entered into a settlement agreement with Teva within ten business days of
Teva’s at-risk launch, fulfilling its duties under section 5.5(a)(ii), thus preventing Sun from
obtaining a license under section 5.1.
2. Analysis
While the Agreement is multi-layered, its interpretation essentially depends on whether
Amgen was obligated to effectuate a cease and desist not only with Teva, after Teva briefly entered
the market, but also with distributors who had received Teva’s product.
The United States Court of Appeals for the Third Circuit has stated that “[a] settlement
agreement is a contract and is interpreted according to local law.” Wilcher v. City of Wilmington,

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139 F.3d 366, 372 (3d Cir. 1998); Shell’s Disposal & Recycling, Inc. v. Lancaster, 504 F. App’x
194, 200 (3d Cir. 2012). “Basic contract principles apply to settlement agreements.” Williams v.
Metzler, 132 F.3d 937, 946 (3d Cir. 1997).
The Agreement provides that it shall be construed and governed by Delaware law.
(Agreement, ECF No. 437-1, § 8.3.) Under Delaware law, a contract is ambiguous when “the
provisions in controversy are reasonably or fairly susceptible of different interpretations or may
have two or more different meanings.” Rhone-Poulenc Basic Chem. Co. v. Am. Motorists Ins.
Co., 616 A.2d 1192, 1196 (Del. 1992); see also Eagle Indus. v. DeVilbiss Health Care, 702 A.2d
1228, 1231 (Del. 1997) (stating that ambiguity arises when provisions are reasonably susceptible
to at least two possible meanings). The appropriate test for ambiguity in a contract is “not what
the parties to the contract intended it to mean, but what a reasonable person in the position of the
parties would have thought it meant.” Rhone-Poulenc, 616 A.2d at 1196. To preserve the
expectations that formed the basis for the contractual relationship, the court must consider the
contract as a whole and give effect to each provision of the agreement. GMG Capital Inc. v.
Athenian Venture, 36 A.3d 766, 779 (Del. 2012). While the intention of the parties will be given
priority, a single provision will not be construed in a way that controls the entire agreement and
runs counter to the agreement’s overall scheme or creates an absurd result. See E.I. du Pont de
Nemours v. Shell Oil Co., 498 A.2d 1108, 1113 (Del. 1985); FriendFinder Network Inc. v.
Penthouse Glob. Media, Inc., 2017 WL 2303982, at *13 (Del. Ch. May 26, 2017).
Sun’s position that it is entitled to a license is based on several sections of the Agreement.
Sun first notes that, under Section 5.1 and 5.2(b), an “Entry Date” of “Generic Cinacalcet by a
Third Party” occurred on December 28, 2018, when Teva launched its generic Cinacalcet product.
Sun then references the Agreement’s definition of “Third Party” which states that a “Third Party”

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is “any entity or person that is not a Party or an Affiliate of a Party.” (Agreement, ECF No. 4371, § 1.6.) Sun argues that the broad definition of “Third Party” includes not only Teva, but also
third-party distributors who received and distributed the generic Cinacalcet for a short period of
time. And because Amgen did not enter into a cease and desist agreement with Third Party
distributors, Sun urges that under the Agreement, Amgen has granted Sun a license to distribute
its generic Cinacalcet. In short, according to Sun, not only was Amgen required to police Teva’s
initial launch sales, but additionally, Amgen was required to “adequately police the market of all
third-party entities selling the Generic Cinacalcet product”. (Sun’s Br., ECF No. 437, at 5-6.)
Sun is correct that the definition of “Third Party” under § 1.6 is broad and, when read in a
vacuum, could arguably encompass third-party distributors. But Sun ignores the fact that Section
5.2(b), where the term “Third Party” appears, also plainly states that “the Launch of a Generic
Cinacalcet Product” is subject to the provisions of Section 5.5 (emphasis added). Thus, the
wording of Section 5.5 must be analyzed.
The pertinent language of Section 5.5 is set forth on page 5 of this Opinion. The language
from this Section contains various conditions and provisos, takes many detours, and is difficult to
untangle.
Section 5.5 has 3 subparts: a preamble, subpart (a), and subpart (b). Starting with the
preamble, the parties agree that the first part of the preamble, requiring that a third party must
launch without authorization, occurred when Teva launched on December 28, 2018. (Oral Arg.
Tr. at 20, 35, ECF No. 481, June 13, 2019.) As for the second preamble requirement, there is also
agreement that this requirement has been met because there has not been a final court decision of
non-infringement regarding Teva’s generic. (Oral Arg. Tr. at 36, ECF No. 481, June 13, 2019.)
Indeed, the infringement case between Amgen and Teva is still pending in the Federal Circuit.

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The next section, section 5.5(a), states that if within 10 days of notice of at risk launch,
Amgen does not: (i) file a temporary restraining order or preliminary injunction “prohibiting any
further sale of such Generic Cinacalcet Product, or (ii) enter into an agreement with each such
Third Party selling such Generic Cinacalcet Product requiring each such Third Party to cease and
desist from selling such Generic Cinacalcet Product from the market within 30 days of such
agreement, then Amgen will not seek a temporary restraining order or preliminary injunction”
against Sun if Sun were to distribute its generic at risk. (Agreement, ECF No. 437-1, § 5.5.)
Untangling this language and reading it in conjunction with relevant definitions, I conclude
that Section 5.5(a)(i)(ii) means that if Amgen has entered into an effective cease and desist with
Teva, then Amgen has complied with this section and may seek a temporary restraining order or
preliminary injunction if Sun enters the market at risk. Put another way, a license to Sun has not
been granted.
Amgen stresses it complied with Section 5.5(a)(ii) as it did in fact enter into a cease and
desist agreement with Teva five days after Teva entered the market. Sun reads this language
differently, urging that it obligates Amgen to effectuate “any further sale of such Generic
Cinacalcet Product” by both Teva and all Third-Party distributors. In short, relying on language
that simply does not exist, Sun insists that Amgen must have “policed the market,” – that is, policed
both Teva and Third-Party distributors. I disagree with Sun’s interpretation for several reasons.
First and foremost, Amgen’s cease and desist obligations under the Agreement refers to
Third Parties who engaged in at risk launch. (See Agreement, ECF No. 437-1, § 5.5) (emphasis
added.) It is undisputed that distributors and resalers did not engage in at-risk launch – only Teva
did. Thus, reading the agreement as a whole, I conclude that a “Third Party” does not include
distributors.

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As noted several times, section 5.5 is only triggered when a “Third Party Launches a
Generic Cinacalcet Product without authorization ....” Once notified of that launch, Amgen did as
it was obligated to do – “(ii) enter into an agreement with each such Third Party selling such
Generic Cinacalcet Product requiring each such Third Party to cease and desist from selling ....”
The Agreement is absolutely silent that this obligation also includes distributor resales and
downstream purchasers. In fact, the Agreement plainly speaks to, and is only triggered by, an atrisk launch or a launch which is defined as the “first sale” of a generic. (Agreement, ECF No. 4371, § 1.9.) It is undisputed that the first sale of generic Cinacalcet was by Teva and not third-party
distributors.
Second, there simply is no language in the Agreement to support Sun’s contention that
Amgen agreed to remove all generic products from the market, or that Amgen had a duty to police
the entire market after such a launch. Sun’s interpretation of section 5.5 is only possible if I were
to find that the terms “Launch” and “selling” are identical within the Agreement. Such a reading
would however render the section 1.9 definition of “Launch” meaningless. Construing the term
“Launch,” as Sun proposes, to also include selling by Third Party distributors would place
burdensome duties on Amgen that were not expressly agreed upon in the drafting of the
Agreement.
Indeed, the term “such,” which precedes “Third Party” in Section 5.5(a) serves as limiting
language and supports my conclusion. Read as a whole, the phrase “each such Third Party”
language used in Section 5.5(a)(ii) relates back to, and references the party identified in the first
sentence of section 5.5: “If a Third Party Launches a Generic Cinacalcet Product without
authorization.” (Id. at § 5.5.) Reading section 5.5 as a whole, “each such Third Party” can only
refer to Teva because only the generic manufacturer has the ability to be the first to sell the specific

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generic Cinacalcet product in the United States. And Teva was the only third party to have
“Launched” a generic Cinacalcet. (Id.) By reaching an agreement with Teva to cease and desist
its sales of its generic product, Amgen successfully complied with the terms of section 5.5, again
preventing Sun from obtaining a license under section 5.2.
III. CONCLUSION
For all the reasons set forth above, the Litigation Settlement Agreement will be enforced
in accordance with the plain meaning of the terms as used and defined in the Agreement. Under
this construction, Sun is not granted a license to market its Generic Cinacalcet Product at this time. 6

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Sun also requested limited discovery concerning agreements between Amgen and Teva
made before the December 28, 2018 Teva Launch. This motion is DENIED because insufficient
facts were plead to show a likelihood that such prior agreements were made. An appropriate order
follows from this opinion.

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