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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________
`
` MYLAN PHARMACEUTICALS, INC.,
` Petitioner,
` v.
` ICOS CORPORATION,
` Patent Owner.
` ________
`
` Case IPR2017-00323
` Patent 6,943,166 B1
` _________
`
` Telephonic Hearing: April 27, 2017
` 12:01 p.m. to 12:28 p.m.
` Tampa, FL
`Before ZHENYU YANG, SHERIDAN SNEDDEN, and SUSAN
`L.C. MITCHELL, Administrative Patent Judges
`Reported By: Janet Hall
`Job No. 123390
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`MYLAN - EXHIBIT 1037
`Mylan Pharmaceuticals Inc. v. ICOS Corporation - IPR2017-00323
`
`

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` TELEPHONIC HEARING
` April 27, 2017
`
` Telephonic hearing, reported by
`Janet Hall, a Registered Professional Reporter
`and Florida Notary Public.
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` A P P E A R A N C E S:
`WILSON SONSINI GOODRICH & ROSATI
`Attorneys for Petitioner
` 701 Fifth Avenue
` Seattle, Washington 98104
`BY: STEVE PARMELEE, ESQ. (of counsel)
` JAD MILLS, ESQ. (both counsel via phone)
`
`
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
`Attorney for Patent Owner
` 901 New York Avenue, NW
` Washington, DC 20001
`BY: MAUREEN QUELER, ESQ. (via phone)
` JOSHUA GOLDBERG, ESQ. (via phone)
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` HEARING - 4/27/17
` P R O C E E D I N G S
` JUDGE YANG: Good afternoon. This
` is a conference call for IPR2017-00323.
` I'm Judge Yang. With me on the line are
` Judges Snedden and Mitchell.
` We'd like to start with a roll call.
` Who do we have for petitioner,
` please?
` MR. PARMELEE: This is Steve
` Parmelee, lead counsel for Petitioner.
` And also Jad Mills, my co-counsel.
` JUDGE YANG: Okay. Thank you.
` Welcome.
` And for Patent Owner, please?
` MS. QUELER: Good morning. This is
` Maureen Queler, for Patent Owner. And
` with me is my colleague, Josh Goldberg.
` JUDGE YANG: All right. Thank you.
` Welcome.
` And it sounds like we have a court
` reporter on the line?
` THE REPORTER: Yes, ma'am. My name
` is Janet Hall. And I'm participating from
` Tampa, Florida. Good morning.
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` JUDGE YANG: Thank you. Thank you.
` Petitioner, I suppose you arranged
` for the court reporter?
` MR. PARMELEE: Yes, we did,
` your Honor.
` JUDGE YANG: Okay. So when the
` transcript is available, would you please
` file it into the record?
` MR. PARMELEE: We certainly will.
` Thank you.
` JUDGE YANG: Thank you.
` Petitioner, you requested this call.
` So why don't you start?
` MR. PARMELEE: Certainly.
` JUDGE YANG: Yes.
` MR. MILLS: We appreciate the Panel
` granting our request for the call today so
` that we can explain the basis for our
` concerns in the POPR and why we think some
` short additional briefing on a few points
` will be helpful to the Panel.
` To address the specifics of our
` request, I'm going to ask my co-counsel,
` Jad Mills, to speak to those details.
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` HEARING - 4/27/17
` Mr. Mills?
` MR. MILLS: Yes. Thank you.
` So, Your Honors, we believe that
` we've made an adequate threshold showing
` regarding the public availability of the
` sildenafil NDA, which is Exhibit 1008.
` The patent owner has raised several
` questions, things that we view are
` speculation. And they're essentially
` arguing that, if they can raise a
` reasonable doubt as to the public
` availability of the document, that the
` Board shouldn't institute -- we don't
` think that's the appropriate standard.
` But we also think that the record, as it
` exists, and also the available as-is,
` contradicts several of the patent owner's
` questions and assertions.
` And so, if we -- one of the things
` we mention in our petition, in our letter
` at Exhibit 1031, actually provides
` evidence from the FDA. This is a public
` record. Despite Patent Owner's assertion,
` it's not inadmissible hearsay; because it
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` HEARING - 4/27/17
` is a self-authenticating public record.
` And on the bottom of that page, Exhibit
` 1031, it says Date Created. And that date
` created -- March 27, 1998 -- refers to the
` table above, which provides links for each
` of the documents. And next to each of
` those links it provides the hyperlink
` posting date for those documents.
` Now, we also have available to us --
` and we'd like to be able to discuss -- a
` document from the FDA, the FDA webpage,
` which actually explains that when a drug
` approval or tentative approval letter for
` labeling text for review is available, the
` hyperlink posting date will take you to
` the source document. And that FDA
` document has a list of all of the FDA
` approved documents. It provides the
` approval date for those documents. And it
` provides the hyperlink posting date for
` the letter, the label, and the review as
` they become available. And so for certain
` documents one can look and see that the
` approval date may vary somewhat from the
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` HEARING - 4/27/17
` posting date. For instance, there's an
` Accolate tablets that was posted a couple
` of days after the approval date. But it
` confirms exactly what Exhibit 1031 says;
` that for Viagra the approval was on
` March 27, 1998, and that the hyperlink
` posting date for these materials was
` March 27, 1998. And we believe that that
` confirms exactly what we said in the
` petition regarding the public availability
` of the document.
` JUDGE YANG: Okay. Let me stop you
` here. I just want to clarify one thing.
` Since you give the exhibit number,
` 1031, I suppose it was filed together with
` the petition and then referred to in the
` petition?
` MR. MILLS: So Exhibit 1031 was
` filed with the petition and was referred
` to in the petition. That's the document
` that has the Date Created at the bottom of
` the list of hyperlinks.
` JUDGE YANG: I understand. I
` understand. Thank you for that
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` HEARING - 4/27/17
` clarification.
` But you mentioned a second FDA
` document available to you. Is that also
` filed with the petition? Or is that
` something additional you intend to submit
` with your reply if you were given that
` opportunity?
` MR. MILLS: There is a separate
` document that was not discussed in the
` petition that is directly responsive to
` Patent Owner's arguments that perhaps the
` FDA website didn't exist in 1998 or that
` the practices for posting of the Viagra
` label were unclear. And that document, we
` would ask that we could submit that
` document for the Board's review as part of
` the reply.
` JUDGE YANG: Okay. I understand you
` have a couple of other points. But just
` for my benefit, let's hear what Patent
` Owner has to say on this specific issue.
` And we'll come back to you on the other
` two points you have later.
` MS. QUELER: Thank you, Your Honor.
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` HEARING - 4/27/17
` Maureen Queler for Patent Owner.
` With respect to Exhibit 1031,
` Petitioner is essentially requesting our
` reply because they disagreed with our
` interpretation of the dates on
` Exhibit 1031.
` Exhibit 1031, it's important to
` know, is not the prior art relied on. The
` prior art relied on was Exhibit 1008. The
` petitioner is trying to use Exhibit 1031
` to show that another exhibit was publicly
` available.
` But a disagreement about the facts
` is not sufficient good cause to warrant a
` reply. We believe -- especially if
` Petitioner believes that their initial
` showing was adequate, as they said. We
` don't see any reason why the Board can't
` weigh the evidence that was in the
` petition and come to a decision on that
` evidence. I think that's well within the
` Panel's purview.
` But it was Petitioner's choice to
` only rely on a date printed on Exhibit
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` HEARING - 4/27/17
` 1031. They did not submit any declaration
` or any information explaining what that
` date meant or any of this information that
` they're now coming forward with after our
` preliminary response regarding FDA
` publishing practices, hyperlink posting
` dates. None of this information was in
` the petition.
` And I think it's important that
` Petitioner failed to say anything about
` the fact that they could not have done
` that prior petition. And, in fact, they
` thought their petition was adequate.
` Nothing indicates that this information
` from the FDA or this document from the FDA
` is new or was not available prior to the
` petition.
` So they made a choice to rely only
` on the date printed on Exhibit 1031. In
` response to their strategy we dedicated a
` good portion of our response to addressing
` their deficiencies in the evidence. We do
` not think that relying on this date met
` the threshold required to establish that
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` HEARING - 4/27/17
` the petition was based on prior
` publication. It's a well-known threshold
` at this point that the petitioner has.
` So allowing a reply at this late
` stage with respect to Exhibit 1031 -- and
` with respect to all of what Petitioner is
` raising right now -- would be especially
` prejudicial to the Patent Owner who would
` not have time now to properly analyze and
` fully reply to this new evidence.
` Petitioner delayed in raising this
` issue, which should also weigh against
` authorization of the reply. The
` preliminary response was filed well over a
` month ago. We have less than two months
` left until the statutory deadline. And so
` we would also -- Patent Owner would
` request a sur-reply, if any reply was
` granted, to respond to this new evidence.
` And there would also need to be time for
` the Panel to review the new evidence.
` So I think, in addition to there
` being no good cause on the substantive
` issues, there is also a timing issue that
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` HEARING - 4/27/17
` warrants denial of Petitioner's request.
` And that goes to all of their points, but
` especially this alleged new evidence that
` they're raising.
` JUDGE YANG: All right.
` Petitioner, you have a chance to
` respond to that. Make it very succinct,
` please.
` MR. MILLS: Yes, Your Honor.
` So I'll start with the issue of the
` timing. So the patent owner raised an
` issue that there's two months left for the
` Board to reach its decision. If the Board
` does grant us an opportunity to file a
` reply, we're willing to do that within
` five business days. We believe that that
` provides adequate opportunity for the
` Board to consider the information. And,
` as we mentioned, we do believe that it is
` in the Board's interest to have a full
` briefing and information available to it
` so that it can make a full decision.
` With respect to Patent Owner's
` argument that they relied on what was in
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` HEARING - 4/27/17
` the petition and focused their preliminary
` response on that, we would say, I think,
` that this is not a "gotcha" game where --
` the point of this is for them to be able
` to rely on misleading statements and
` questions. The patent owner started
` speculating -- you know. Perhaps the
` website didn't exist. Perhaps the
` Internet didn't exist. You know. Perhaps
` the links don't actually go to what they
` purport to go to. You know. These are
` all evidentiary issues.
` They say that this is a disagreement
` on the facts. But there is no
` countervailing evidence from the patent
` owner. The evidence is here. We believe
` that the evidence confirms the case that
` we put forward. And if the Board is
` inclined to entertain their speculation
` about what the evidence shows, then we
` would simply ask an opportunity to address
` that and show that the statements, the
` questions are not correct.
` JUDGE YANG: All right. So that's
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` HEARING - 4/27/17
` all for the first issue.
` The second one. Petitioner, please
` summarize your position. Please.
` MR. MILLS: Yes.
` So the second issue is, in some
` degree, related. One of the patent
` owner's responses to the documentary
` evidence that we submitted with the
` petition is to rely on subsequent FDA
` documents and suggesting that for a sample
` of documents that -- or a sample of drugs
` that were approved after sildenafil, that
` were approved in 2001, for that sample
` there was a delay. And they're
` essentially arguing that, because there
` was some delay for that sample, that that
` means that the sildenafil could not have
` been published on the dates that the FDA
` says that it was published.
` And so we would like to be able to
` briefly address that issue.
` The second issue, after they address
` the category of FDA -- I'll call them
` business practices -- that there was a
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` HEARING - 4/27/17
` redaction time that was later required.
` And that that redaction time could have
` slowed things down. We think that that
` so-called business practice doesn't
` undermine the actual evidence about what
` happened in this case for this specific
` drug.
` JUDGE YANG: Patent Owner, I heard
` you saying your previous statement applies
` to all the issues. But if you have
` anything additional here, specific to this
` one, please go ahead.
` MS. QUELER: Thank you, Your Honor.
` With respect to this argument about
` the redaction time that the FDA takes and
` the time the FDA needs to review, I think
` this is a somewhat different issue than
` the date on Exhibit 1031.
` Petitioner chose to rely only on the
` bare words of 21 C.F.R. 314.430; that some
` documents would be, and I quote,
` "immediately available" after drug
` approval. They did not submit any
` declaration or any other evidence
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` HEARING - 4/27/17
` establishing what the actual publishing
` practices of the FDA are or what this,
` quote, "immediately available" term meant
` within the context of the FDA. This is
` despite all the case law -- for example,
` In Re: Hall -- that explains the
` importance of actual evidence to establish
` the practice of a publishing entity.
` So on these deficiencies alone,
` Petitioner failed to establish that
` Exhibit 1008 is a printed publication.
` And we have gone through this in our
` response at Pages 16 to 21.
` But, in addition, in our response we
` raised two reasons why the FDA publishing
` can be delayed. This demonstrates that
` the petitioner's bare assertions regarding
` what the term "immediately available"
` meant were insufficient. And now
` Petitioner wants the chance to respond to
` our hypothetical.
` This is not the type of new evidence
` that warrants good cause to reply.
` They complain that the Patent
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` HEARING - 4/27/17
` Owner's evidence -- or our exhibits
` undermine their actual evidence of public
` availability. But, really, outside the
` words of the statute -- and I guess
` they're relying on date of the 1031, which
` is, again, not the prior art that they're
` relying on -- there really is nothing to
` undermine. They have just said that this
` C.F.R. says "immediately available." And
` we gave some examples because of the lack
` of evidence that they provided.
` So, really, good cause does not
` exist to allow them a redo at this stage.
` They had plenty of words left in their
` petition. They chose just to rely on the
` bare words of the statute. They did not
` put any declarations. They did not find
` these FDA documents before. So, to the
` extent that Petitioner is also concerned
` about the relevance of these documents
` that Patent Owner submitted, we believe
` that judging relevance is also well within
` the Court's purview and does not warrant a
` reply.
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` HEARING - 4/27/17
` So on this issue, in addition to the
` points that were raised earlier, we think
` that Petitioner's mere desire to respond
` to our argument is not sufficient good
` cause for a reply.
` JUDGE YANG: All right.
` Petitioner, if you desire to reply
` to this Patent Owner's arguments right
` now, please give a quick one. Please.
` MR. MILLS: I would say, just very
` briefly, that the petitioner does have
` more one than basis for the public
` availability of Exhibit 1008. Among those
` are the bases that we discussed previously
` about the actual publication on the FDA
` website, as demonstrated by the public
` records from the FDA. But another basis
` is that the regulation and the law that
` applies here makes these documents
` immediately available.
` And so our briefing that we'd like
` to address to address Patent Owner's new
` argument raised in this preliminary
` response for the first time is their
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` HEARING - 4/27/17
` argument that the actual delays both
` undermine what the law says about these
` being immediately available, and also that
` that should somehow undermine what
` actually happened in fact.
` And so we would ask the Board to
` permit us some space for briefing on that
` issue.
` JUDGE YANG: All right.
` Moving on to the third issue you
` want to address.
` MR. MILLS: Yes, Your Honor.
` So the patent owner preliminary
` response contains a misstatement or an
` exaggeration, stating that the petition
` completely omits the discussion of the
` 100 mg maximum dose. As we've outlined in
` our email, we did not omit the fact that
` there was a 100 mg dose in the Viagra
` approval.
` Underlying Patent Owner's argument
` appears to be an implicit and unsupported
` claim construction that is not outlined in
` their papers, but that a 20 mg dose is
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` HEARING - 4/27/17
` somehow a maximum, tolerable maximum
` approved or maximum approvable dose or
` something of that nature. But that is
` something that isn't supported by the
` specification of the patent. We offered a
` claimed instruction that demonstrates why
` that isn't the case; that the word
` "maximum" in the claim merely addresses
` the fact that there is a difference
` between a daily dose and a unit dose. And
` that the daily dose that falls within the
` claim is a 20 mg dose. It can take place
` as a single 20 mg unit dose. It can take
` place as two 10 mg unit doses. Whatever
` math is involved to get from whatever unit
` dose is being used up to the daily dose.
` As we explained in the petition, we
` had several bases for looking at the 25 mg
` dose and why a person that's filling the
` order would do so, including the fact that
` that was the FDA recommended dose for
` patients over 65, which I'm sure the Board
` will appreciate that men over 65 is not an
` insubstantial quotient for those taking
`
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`

`

`Page 22
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` HEARING - 4/27/17
` this particular medication. As well as
` the fact that the 25 mg dose gives you
` more than half of the potency of the
` 100 mg dose, even though the 100 mg dose
` is four times higher. And those were the
` bases or some of the bases for looking at
` that dose.
` The patent owner has suggested that
` there is a preferred dose, and that that
` is the 100 mg dose. And that's based on
` certain patients who were tolerating the
` drug well, advancing up to a 100 mg dose,
` even though that wasn't the dose that they
` were put on originally. And we'd like to
` be able to make clear in our briefing,
` that's not an FDA preferred dose. It's
` not the FDA recommended dose -- at least,
` for patients over age 65, it's 25. And
` for other patients it's 50. It's
` certainly not 100 mg.
` JUDGE YANG: All right.
` Patent Owner, your response, please.
` MS. QUELER: Thank you, Your Honor.
` I think this last issue really
`
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`

`Page 23
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` HEARING - 4/27/17
` highlights the true nature of Petitioner's
` request, which is really trying to get the
` last word in here. They've repeated over
` and over why they want this reply, but
` they have not established any good cause,
` which is a really high threshold for
` authorization of a reply to a preliminary
` response.
` They're really just, again --
` especially with this particular point on
` the 100 mg -- trying to use a reply to
` respond to something that they just did
` not agree with in our preliminary
` response.
` As a first matter we completely
` disagree that any facts or law were
` misstated. We stand by our argument that
` the petitioner failed to address the
` 100 mg of sildenafil in its evaluation of
` whether one would choose the maximum dose
` of sildenafil at 20 mg per day. We fully
` briefed this at Pages 24 through 36 of our
` preliminary response. But now it seems,
` especially with the argument that we just
`
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`

`

`Page 24
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` HEARING - 4/27/17
` heard, that they're trying to get in
` arguments on claim construction, they're
` arguing their case, they're trying to
` reply to us. And this is just not proper
` and not establishing good cause for a
` reply.
` Identifying and evaluating
` arguments, the statements or alleged
` misstatements of the facts and the law
` are, again, well within the purview of the
` leave of this Panel.
` So a petitioner isn't always going
` to be happy, to be honest, with how a
` patent owner characterizes the facts and
` the law.
` So a disagreement over what we think
` the focus of the petition was really does
` not establish a cause for reply. It's
` their chance, their attempt to get the
` last word in when they were already given
` a full chance, a very full chance, to
` address this issue in the petition.
` So I think this highlights, really,
` the true nature the request. And, again,
`
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`

`

`Page 25
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` HEARING - 4/27/17
` I do not believe that anything establishes
` good cause to warrant a reply.
` Just as a last word, I'd like to
` request that, if the Board is considering
` granting the petitioner a reply, we would
` request the opportunity to reply in a
` sur-reply to all of the petitioner's new
` evidence and all their new art.
` Thank you, Your Honor. That's all I
` have, unless the Panel has any questions.
` JUDGE YANG: Not at this time.
` Petitioner, you do get the last word
` here on that last issue. Do you have
` anything to add?
` MR. MILLS: Yes. Just very briefly.
` I think I counted, perhaps about
` eight times, that the patent owner said
` that there's a good cause standard for the
` reply. We disagree that that's a
` standard; that we must demonstrate good
` cause. We believe that the briefing would
` be helpful to the Board. And we believe
` that's adequate for the Board to grant the
` briefing.
`
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`

`

`Page 26
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` HEARING - 4/27/17
` We would say that our request is
` that we be permitted ten pages of briefing
` and that we be given five business days to
` do so.
` JUDGE YANG: All right. I'm going
` to put you, the counsel for both sides on
` hold while this panel discusses these
` issues. Please, stay online. And we'll
` be back as soon as possible.
` MS. QUELER: Thank you, Your Honor.
` JUDGE YANG: All right.
` (Recess, 12:22 p.m. to 12:27 p.m.)
` JUDGE YANG: All right. The Panel
` is back on the phone. Do we still have
` counsel for both sides?
` MR. MILLS: Yes, Your Honor.
` MS. QUELER: Yes, Your Honor.
` JUDGE YANG: All right. Great.
` Thank you.
` So on the issue of reply.
` Petitioner, you might want to take a look
` at the Rule 42.018(c). It specifically
` says: "A petitioner may seek leave to
` file a reply to the preliminary response.
`
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` HEARING - 4/27/17
` Any such request must make a showing of
` good cause."
` So on this specific issue, Patent
` Owner was correct. And the Panel believes
` that the petitioner has not made a showing
` of good cause. So the request to file a
` reply to the preliminary response is
` denied.
` Does anyone have any question?
` MS. QUELER: No.
` Thank you, Your Honor.
` JUDGE YANG: Petitioner?
` MR. MILLS: Thank you, Your Honor.
` JUDGE YANG: All right. Then this
` call is adjourned.
` Thank you.
` (Adjourned, 12:28 p.m.)
` o0o
`
`TSG Reporting - Worldwide 877-702-9580
`
`

`

`Page 28
`
` CERTIFICATE
`STATE OF FLORIDA )
` : SS
`COUNTY OF HILLSBOROUGH)
` I, Janet Hall, a Registered
`Professional Reporter and Florida Notary Public,
`do hereby certify:
` I was authorized to and did
`stenographically report the foregoing telephonic
`hearing, Pages 4 through 27; and that the
`transcript is a true record of the hearing.
` I further certify that I am not
`related to any of the parties to this action by
`blood or marriage and that I am in no way
`interested in the outcome of this matter.
` In witness whereof, I have hereunto
`set my hand this 1st day of May, 2017.
`
` ______________________
` JANET HALL, RPR, FPR
` FL Commission FF 191256
` Expires 2/17/19
`
`TSG Reporting - Worldwide 877-702-9580
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`

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