Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 1 of 13 PageID #: 1236
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`C.A. No. 15-cv-109-IMK
`
`
`
`
`
`
`
`SALIX PHARMACEUTICALS, INC. and
`DR. FALK PHARMA GmbH,
`
`
`Plaintiffs,
`
`v.
`
`
`MYLAN PHARMACEUTICALS, INC. and
`MYLAN, INC.,
`
`
`Defendants.
`
`
`
`DECLARATION OF ALAN VICTOR SAFDI, M.D., F.A.C.G.
`
`I.
`
`INTRODUCTION
`
`1.
`
`I, Alan Victor Safdi, M.D., F.A.C.G, have been retained as an expert witness on
`
`behalf of plaintiffs Salix Pharmaceuticals, Inc. (“Salix”) and Dr. Falk Pharma GmbH (“Dr. Falk
`
`Pharma”) (collectively, “Plaintiffs”) in this patent. I understand that Plaintiffs have sued
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`defendants Mylan Pharmaceuticals, Inc. and Mylan, Inc. (“Mylan”) for infringement of certain
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`claims of U.S. Patent No. 8,865,688 (the “’688 patent”) based on Mylan’s filing of an
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`Abbreviated New Drug Application (“ANDA”) seeking approval to market and sell a generic
`
`version of Salix’s Apriso® product before the expiration of the ’688 patent (“Mylan’s ANDA
`
`product”).
`
`II.
`
`ACADEMIC AND PROFESSIONAL QUALIFICATIONS
`
`2.
`
`3.
`
`My curriculum vitae is attached as Exhibit 1 to this report.
`
`I am a Board Certified gastroenterologist practicing with the Ohio
`
`Gastroenterology and Liver Institute. I have practiced gastroenterology since January 1983 and
`
`have over thirty-two years of experience in the field, with clinical expertise in inflammatory
`
`
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`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 1
`
`

`
`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 2 of 13 PageID #: 1237
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`bowel disease (“IBD”), including ulcerative colitis. I am currently on the staff of Mercy West
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`Hospital, Norwood Endoscopy Center, Tri-State Endoscopy Center, and The Christ Hospital.
`
`4.
`
`For the past twenty-seven years, I have served as the President for the Ohio
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`Gastroenterology and Liver Institute, and I am the President of Consultants for Clinical
`
`Research, a position I have held since 1990. I am also Co-Chairman of the Section of
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`Inflammatory Bowel Disease for the Ohio GI and Liver Institute.
`
`5.
`
`I am a Fellow in the American College of Gastroenterology and a Diplomate of
`
`the American Board of Internal Medicine as well as a Diplomate of the American Board of
`
`Gastroenterology.
`
`6.
`
`In addition to my position as a clinician, I serve as Medical Director of Tri-State
`
`Endoscopy Center (since 2005), as President of Ohio Gastroenterology Society (since 2012), and
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`as President of GCGA Physicians (Ohio Gastroenterology and Liver Institute) (since 1988). I
`
`have also served as Chairman of the Section of Gastroenterology at Deaconess Hospital (1986-
`
`2011) and as Chairman of the Cincinnati Crohn’s & Colitis Medical Advisory Committee (2007-
`
`2010).
`
`7.
`
`I am also a member of various professional societies, including the American
`
`Society of Internal Medicine, the American Society for Gastrointestinal Endoscopy, Ohio
`
`Gastroenterology Society, Ohio State Medical Association, Digestive Disease National
`
`Coalition, and The American Gastroenterology Association.
`
`8.
`
`I have also actively conducted research in my field of practice, participating as a
`
`principal investigator in approximately 132 clinical research projects and as a sub-investigator in
`
`approximately 439 clinical research projects, including a number of studies regarding the
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`treatment of IBD and the use of mesalamine in the treatment of ulcerative colitis.
`
`2
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 2
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 3 of 13 PageID #: 1238
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`9.
`
`I have performed studies on a variety of mesalamine drugs including Apriso®. I
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`have performed studies involving dissolution of pH-dependent mesalamine in the form of
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`Asacol®. I have been involved with Salix as a consultant, researcher, and speaker bureau
`
`representative. I have also been involved in investigator-initiated studies with Salix.
`
`10.
`
`I consider myself to be an expert in in the field of gastroenterology and more
`
`particularly in the treatment of ulcerative colitis.
`
`III.
`
`INSTRUCTIONS FROM COUNSEL AND MATERIALS CONSIDERED
`
`11.
`
`I was asked by Plaintiffs’ counsel to provide my understanding of the term
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`“remission is defined as a DAI score of 0 or 1” in the ’688 patent. (Stimart Ex. 41 [’688 patent]
`
`at Claims 1, 16.)
`
`12.
`
`In arriving at my opinions herein, I have relied on the ’688 patent, the ’688 patent
`
`prosecution history, as well as my education, experience, and knowledge in the field. I reserve
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`the right to supplement this Declaration based on additional information that is made available to
`
`me between now and the time of the Markman hearing, and to consider and respond to any
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`declaration regarding claim construction of any terms in the ’688 patent that may be presented on
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`behalf of Mylan in this action.
`
`IV.
`
`SCIENCE AND TECHNICAL BACKGROUND
`
`A.
`
`13.
`
`The Gastrointestinal Tract
`
`The human luminal gastrointestinal tract consists of four major sections—the
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`esophagus, the stomach, the small intestine, and the large intestine (or colon). As shown in the
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`figure below, the small intestine consists of three sections—the duodenum, located just after the
`
`
`1 “Stimart Ex.___” refers to the Exhibits to the Declaration of Tryn T. Stimart In Support of
`Plaintiffs’ Opening Brief on Claim Construction, filed concurrently.
`
`3
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 3
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 4 of 13 PageID #: 1239
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`stomach; the jejunum; and the ileum. The colon consists of five sections—the right (ascending)
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`colon including the cecum; the transverse colon; the left (descending) colon; the sigmoid colon;
`
`and the rectum:
`
`
`
`14.
`
`The latter part of the ileum, the last section of the small intestine, is called the
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`terminal (or distal) ileum. The terminal ileum is where the small intestine connects to the colon
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`at the ileocecal valve, which controls the passage of the contents from the small intestine into the
`
`cecum, which is the beginning of the colon.
`
`B.
`
`15.
`
`Ulcerative Colitis
`
`Ulcerative colitis is a gastrointestinal disorder wherein the inner lining of the
`
`colon becomes inflamed. In ulcerative colitis, it is believed that the cells from the immune
`
`system attack the inner lining of the bowel (the mucosa), causing inflammation, and in some
`
`cases, ulcerations. The causes of ulcerative colitis are not fully understood, and no medical cure
`
`is known.
`
`16.
`
`Ulcerative colitis is a chronic, relapsing condition, where patients may experience
`
`repeated cycles of exacerbations (acute or active phase) and remissions. If the patient’s ulcerative
`
`4
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 4
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 5 of 13 PageID #: 1240
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`colitis is in the active phase, the patient exhibits exacerbated symptoms of ulcerative colitis, and
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`aggressive treatment, and in some rare cases hospitalization, is required. When the active phase
`
`of the disease has subsided, the remission phase is relatively symptom free, with a relatively
`
`normal appearing colon. It is necessary to treat most patients with medical therapy (such as
`
`mesalamine) continually over long periods of time to maintain remission and prevent relapse.
`
`C.
`
`Use of Mesalamine to Treat and Maintain the Remission of Ulcerative Colitis
`
`17. Mesalamine (i.e., 5-aminosalicylic acid or 5-ASA) is an anti-inflammatory drug
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`used to treat inflammatory bowel diseases, including ulcerative colitis. Mesalamine is also a
`
`locally-acting or topically active drug, which means that it must make physical contact with the
`
`inflamed intestinal mucosa to reduce inflammation.
`
`D.
`
`18.
`
`Apriso®
`
`Apriso® is indicated for use in adults 18 years of age or older for the maintenance
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`of remission of ulcerative colitis. The recommended dose and administration for maintenance of
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`remission of ulcerative colitis in adults is 1.5 g (four Apriso® capsules) orally once daily in the
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`morning, with or without food, where the formulation is an extended release capsule, each
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`capsule containing 0.375 mg of mesalamine.
`
`V.
`
`THE ’688 PATENT
`
`A. Overview of the Claimed Invention
`
`19.
`
`The ’688 patent is entitled, “Compositions and Methods for Treatment of Bowel
`
`Diseases with Granulated Mesalamine.” The ’688 patent issued on October 21, 2014, from U.S.
`
`Application No. 12/573,081, filed on October 2, 2009, which claims priority to U.S. Provisional
`
`Application No. 61/102,807, filed on October 3, 2008, and U.S. Provisional Application No.
`
`61/109,708, filed on October 30, 2008.
`
`5
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 5
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 6 of 13 PageID #: 1241
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`20.
`
`In general, the ’688 patent is directed to methods of maintaining remission of
`
`ulcerative colitis for at least 6 months by administering a once daily 1.5 g dose of granulated
`
`mesalamine in the morning without food. (See, e.g., Stimart Ex. 4 [’688 patent] at claim 1.)
`
`21.
`
`As described in the ’688 patent, Salix conducted numerous clinical studies to
`
`establish the safety and efficacy of a once daily dose of a 1.5 g granulated mesalamine
`
`formulation without food for the maintenance of remission of ulcerative colitis. The results of
`
`Salix’s clinical studies surprisingly demonstrated that Salix’s granulated mesalamine
`
`formulation—commercialized as Apriso®—could be administered once daily at a low 1.5 g dose
`
`without food and effectively maintain remission of ulcerative colitis in adults for six months.
`
`B.
`
`22.
`
`Asserted Claims
`
`I understand Plaintiffs are asserting claims 1, 2, 3, and 16 of the ’688 patent
`
`against Mylan (“the asserted claims”), which provide (with the claim term I am opining on in
`
`bold and italics):
`
`Claim
`
`1
`
`U.S. Patent No. 8,865,688
`
`A method of maintaining the remission of ulcerative colitis in a subject comprising
`administering to the subject a granulated mesalamine formulation comprising four
`capsules each comprising 0.375 g of granulated mesalamine once per day in the
`morning, without food, wherein:
`
`said method maintains remission of ulcerative colitis in a subject for a period of at
`least 6 months of treatment;
`
`remission is defined as a DAI score of 0 or 1;
`
`the granulated mesalamine formulation is not administered with antacids;
`
`and wherein 85% to 90% of the mesalamine reaches the terminal ileum and colon.
`
`2
`
`3
`
`The method of claim 1, wherein the granulated mesalamine formulation is a
`delayed and extended release formulation.
`
`The method of claim 2, wherein delayed and extended release comprises first
`releasing mesalamine in the ileum and continuing to release mesalamine
`
`6
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 6
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 7 of 13 PageID #: 1242
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`throughout the terminal ileum and colon.
`
`16
`
`A method of maintaining the remission of ulcerative colitis in a subject comprising
`advising the subject that granulated mesalamine should not be taken with antacids
`and administering to the subject granulated mesalamine formulation comprising
`four capsules each comprising 0.375 g of granulated mesalamine once per day in
`the morning, without food, wherein:
`
`said method maintains remission of ulcerative colitis in a subject for a period of at
`least 6 months of treatment;
`
`remission is defined as a DAI score of 0 or 1;
`
`the granulated mesalamine formulation is not administered with antacids;
`
`and wherein 85% to 90% of the mesalamine reaches the terminal ileum and colon.
`
`
`(Stimart Ex. 4 [’688 patent] at claims 1, 2, 3, 16 (emphasis added).)
`
`C.
`
`23.
`
`Person of Ordinary Skill in the Art
`
`I understand that the ’688 patent must be read from the perspective of a person of
`
`ordinary skill in the relevant art at the time the invention was made.
`
`24.
`
`In my opinion, the person(s) of ordinary skill to whom the ’688 patent is directed
`
`is a gastroenterologist or other medical professionals with experience diagnosing, treating, and/or
`
`prescribing medication to treat patients suffering from ulcerative colitis, and similar diseases and
`
`conditions. The person(s) of ordinary skill may also include individuals who have an advanced
`
`degree in medicine, pharmacy, pharmaceutics, or a related field (e.g., chemistry, biochemistry,
`
`pharmacokinetics/pharmacodynamics) with practical experience associated with ulcerative
`
`colitis.
`
`D.
`
`25.
`
`“Remission is Defined as a DAI Score of 0 or 1”
`
`Claims 1 and 16 of the ’688 patent contain the limitation that “said method
`
`maintains remission of ulcerative colitis in a subject for a period of at least 6 months of
`
`7
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 7
`
`

`
`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 8 of 13 PageID #: 1243
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`treatment; remission is defined as a DAI score of 0 or 1.” (Stimart Ex. 4 [’688 patent] at claim
`
`1, claim 16.)
`
`26.
`
`Based on my review of the ’688 patent, the ’688 patent prosecution history and
`
`my education, knowledge, and experience as practicing gastroenterologist, the term “remission is
`
`defined as a DAI score of 0 or 1” as used in claims 1 and 16 means “remission is defined as a
`
`rectal bleeding subscore of 0 and a mucosal appearance subscore of less than 2.”
`
`27.
`
`The specification describes, in part, the results of two independent, randomized,
`
`double-blind, placebo-controlled trials conducted in 562 adult subjects in remission from
`
`ulcerative colitis. (See, e.g., Stimart Ex. 4 [’688 patent] at 6:43-60; 17:1-38.) The patients were
`
`randomized to receive 1.5 g mesalamine in capsules, or a placebo, once daily for six months.
`
`(Stimart Ex. 4 [’688 patent] at 6:57-58; 17:13-15.) The primary efficacy endpoint was the
`
`proportion of patients who remained relapse-free (i.e. maintained remission) after 6 months of
`
`treatment. (Stimart Ex. 4 [’688 patent] at 6:58-60; 17:18-21.) The results in both studies
`
`demonstrated that the proportion of subjects who remained relapse-free at six months was greater
`
`for the granulated mesalamine formulation than for placebo. (Stimart Ex. 4 [’688 patent] at
`
`17:21-23.)
`
`28.
`
`As described in the specification (see, e.g., Stimart Ex. 4 [’688 patent] at 25:32-
`
`35; 26:21-24 and 51-53; 28:3-8; 33:27-31) ulcerative colitis (“UC”) disease activity was assessed
`
`in these clinical trials using a modified Sutherland Disease Activity Index (“DAI”), which is a
`
`“sum of a four subscores based on stool frequency, rectal bleeding, mucosal appearance on
`
`endoscopy, and physician’s rating of disease activity. Each subscore can range from 0 to 3, for a
`
`total possible DAI score of 12.” (Stimart Ex. 4 [’688 patent] at 17:7-12.)
`
`8
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`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 8
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 9 of 13 PageID #: 1244
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`29.
`
`The specification further describes the DAI parameters used in the clinical trials
`
`to define “remission” (i.e., “relapse-free”) and, alternatively, “relapse.”
`
`30.
`
`Specifically, the “Detailed Description” of the invention states, “patients with
`
`documented UC remission (revised Sutherland Disease Activity Index [DAI] subscores: rectal
`
`bleeding 0; mucosal appearance < 2) were randomized 2:1 to receive 1.5 g granulated
`
`mesalamine in capsules, or a placebo, once daily for 6 months.” (Stimart Ex. 4 [’688 patent] at
`
`6:53-58 (emphasis added).) Thus, patients who entered the trials were in remission if they had a
`
`rectal bleeding subscore of 0 and a mucosal appearance subscore of less than 2.
`
`31.
`
`The “Detailed Description” of the invention further states that “[t]he primary
`
`efficacy endpoint was the proportion of patients who remained relapse free after 6 months of
`
`treatment (relapse defined as a rectal bleeding subscore ≥ 1 and a mucosal appearance
`
`subscore ≥ 2 per DAI; UC flare or UC symptoms leading to withdrawal; or initiated medication
`
`used to treat UC).” (Stimart Ex. 4 [’688 patent] at 6:53-60 (emphasis added).) Likewise,
`
`Example 5 of the ’688 patent states:
`
`Relapse, as used herein, included, for example, a rectal bleeding subscale score
`of 1 or more and a mucosal appearance subscale score of 2 or more using the
`DAI. The analysis of the intent-to-treat population was a comparison of the
`proportions of subjects who remained relapse-free at the end of six months of
`treatment. In both studies, the proportion of subjects who remained relapse-free at
`six months was greater for granulated mesalamine formulation than for placebo.
`
`(Stimart Ex. 4 [’688 patent] at 17:15-23 (emphasis added); see also Stimart Ex. 4 [’688 patent] at
`
`26:56-58 (Example 9); 28:60-62 (Example 10) (similarly defining relapse).)
`
`32.
`
`Numerous Examples in the ’688 patent further describe the clinical trials
`
`assessing maintenance of remission over a 6 month treatment period and similarly define
`
`remission. (See Stimart Ex. 4 [’688 patent] at 25:32-35 (Example 8); 26:21-24 & 51-53
`
`(Example 9); 28:3-8 (Example 10); col. 33:27-31 (Example 11).)
`
`9
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 9
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 10 of 13 PageID #: 1245
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`33.
`
`Thus, the specification defines relapse in terms of the two objective DAI
`
`subscores—a rectal bleeding subscale score of 1 or more and mucosal appearance subscale score
`
`of 2 or more. A person of ordinary skill in the art would understand that relapse is the opposite
`
`of remission (i.e., relapse free) such that remission would require a rectal bleeding subscale
`
`score of 0 (because relapse required a subscale score of 1 or more) and a mucosal appearance
`
`subscale score of less than 2 (because relapse required a subscale score of 2 or more). As
`
`described above, this is consistent with how remission was defined in the patients with
`
`documented UC remission who entered the trials. The use of objective criteria, as opposed to
`
`subjective (e.g., stool frequency and physician assessment), is also consistent with my clinical
`
`practice, and in my experience the practice of others in my field. As a treating physician, my
`
`focus is on objective components as opposed to patient memory or physician impressions that are
`
`subject to ambiguity.
`
`34.
`
`Thus, in my opinion, the term “remission is defined as a DAI score of 0 or 1” in
`
`claims 1 and 16 of the ’688 patent means “remission is defined as a rectal bleeding subscore of 0
`
`and a mucosal appearance subscore of less than 2.”
`
`35.
`
`Further, in my opinion, it would be improper to read “remission is defined as a
`
`DAI score of 0 or 1” in claims 1 and 16 and assume that it means a DAI score of 0 or 1 based on
`
`the sum of all four DAI subscores, as Mylan proposes.2 A person of ordinary skill in the art
`
`would understand that the definition of remission can vary among clinical trials and thus would
`
`look to the specification for information of how remission was defined in each clinical trial. The
`
`specification consistently describes that remission in the two clinical trials assessing efficacy was
`
`2 I understand from counsel that Mylan’s proposed construction is “remission is a DAI score of 0
`or 1 as calculated by the sum of the four subscores based on stool frequency, bleeding, mucosal
`appearance on endoscopy, and physician’s rating of disease activity.”
`
`10
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`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 10
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`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 11 of 13 PageID #: 1246
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`defined as limited to a rectal bleeding subscore of 0 and a mucosal appearance subscore of less
`
`than 2—the objective components. Thus, a person of ordinary skill in the art would understand
`
`that remission as claimed was limited in the same respect.
`
`36. My interpretation of the term “remission is defined as a DAI score of 0 or 1” also
`
`comports with published literature. For example, Cooney et al., Outcome Measurement in
`
`Clinical Trials for Ulcerative Colitis: Towards Standardization, TRIALS 8(17):1-9 (2007)
`
`(“Cooney”), was published on June 25, 2007. Cooney is a review article discussing various
`
`indices for outcome measurement in clinical trials for ulcerative colitis. (Stimart Ex. 20) Cooney
`
`discusses a need for a consensus on the definition of disease remission in ulcerative colitis, as
`
`there were at the time of publication thirteen scoring systems but none were properly validated.
`
`(Stimart Ex. 20, Cooney at 1: Abstract].) Cooney recognizes that “disease remission has been
`
`neither defined nor validated. Remission is the outcome that matters in clinical trials, so
`
`agreement on the definition of remission is essential. Defining remission should logically be the
`
`starting point of agreeing how to measure disease activity in ulcerative colitis.” (Stimart Ex. 20,
`
`Cooney at 5.) Cooney then notes that “there are, however, at least three definitions of remission
`
`for ulcerative colitis.” (Stimart Ex. 20, Cooney at 5.) Accordingly, in my opinion, one must look
`
`to the definition of remission used in the clinical trials as provided in the specification of the
`
`’688 patent, which relies on only two subscores.
`
`
`
`11
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`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 11
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 12 of 13 PageID #: 1247
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`
`
`Dated: January 14, 2016
`
`
`
`____________________________
`
`
`
`
`
`
`
`Alan V. Safdi, M.D. F.A.C.G.
`
`
`
`
`
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 12
`
`

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`Case 1:15-cv-00109-IMK Document 77 Filed 01/14/16 Page 13 of 13 PageID #: 1248
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`CERTIFICATE OF SERVICE
`
`
`
`I hereby certify that on the 14th day of January, 2016, I electronically filed a true and
`
`correct copy of DECLARATION OF ALAN VICTOR SAFDI, M.D., F.A.C.G. with the Clerk
`
`of the Court using the CM/ECF system, which will send notification of such filing to the
`
`following counsel of record:
`
`Gordon H. Copland
`William J. O’Brien
`Christopher A. Lauderman
`STEPTOE & JOHNSON, PLLC
`400 White Oaks Blvd.
`Bridgeport, WV 26330
`gordon.copland@steptoe-johnson.com
`william.obrien@steptoe-johnson.com
`chris.lauderman@steptoe-johnson.com
`
`Robert L. Florence
`Micheal L. Binns
`Melanie Black Dubis
`PARKER POE ADAMS & BERNSTEIN LLP
`3355 Lenox Road, Suite 750
`Atlanta, GA 30326
`robertflorence@parkerpoe.com
`michealbinns@parkerpoe.com
`melaniedubis@parkerpoe.com
`
`SCHRADER BYRD & COMPANION, PLLC
`
`/s/ James F. Companion
`James F. Companion (#790)
`Yolonda G. Lambert (#2130)
`The Maxwell Centre
`32-30th Street, Suite 500
`Wheeling, WV 25003
`(304) 233-3390
`jfc@schraderlaw.com
`ygl@schraderlaw.com
`
`Attorney for Plaintiffs Salix Pharmaceuticals,
`Inc. and Dr. Falk Pharma GmbH
`
`OF COUNSEL:
`
`Mary W. Bourke
`Kristen Healey Cramer
`Dana K. Severance
`Daniel M. Attaway
`WOMBLE CARLYLE SANDRIDGE & RICE,
`LLP
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`MBourke@wcsr.com
`KCramer@wcsr.com
`DSeverance@wcsr.com
`DAttaway@wcsr.com
`
`
`
`Tryn T. Stimart
`WOMBLE CARLYLE SANDRIDGE & RICE
`LLP
`8065 Leesburg Pike, 4th Floor
`Tysons Corner, VA 22182
`TStimart@wcsr.com
`
`
`
`
`
`
`
`GeneriCo, Flat Line Capital
`Exhibit 1050 Page 13