estta tracking number: estta1049764 04/17/2020

Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov

ESTTA Tracking number: ESTTA1049764

Filing date: 04/17/2020

IN THE UNITED STATES PATENT AND TRADEMARK OFFICEBEFORE THE TRADEMARK TRIAL AND APPEAL BOARD

Proceeding 92060205

Party PlaintiffJeffrey Kaplan

CorrespondenceAddress

ADAM S GOLDMANTHE CONCEPT LAW GROUP PA6400 N ANDREWS AVE, STE 500FORT LAUDERDALE, FL 33309UNITED [email protected], [email protected], [email protected]

Submission Testimony For Plaintiff

Filer's Name Adam S. Goldman, Esq.

Filer's email [email protected]

Signature /Adam S. Goldman/

Date 04/17/2020

Attachments Gray Notice of Filing_PUBLIC.pdf(2586276 bytes )

http://estta.uspto.gov

P a g e | 1

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD

Jeffrey Kaplan, In re: Registration Nos. 841768, 845518, 2236642

Petitioner, Mark: SEA & SKI

v. Cancellation No. 92060205

Faulding Health Care (IP) Holdings, Inc.

Registrant.

_________________________________/

NOTICE OF FILING OF CERTIFIED TESTIMONIAL DEPOSITION OF

THOMAS GRAY

Petitioner Retrobrands USA, LLC, pursuant to Trademark Rules of Practice 2.123 and

2.125, 37 C.F.R. §§ 2.123 and 2.125, and TBMP §§ 703.01(k) and 703.01(l), files a certified

transcript of the May 2, 2019 testimonial deposition of Thomas Gray with the Trademark Trial

and Appeal Board contemporaneously herewith. The copy of the transcript is corrected pursuant

to 37 C.F.R. § 2.125(c) and TBMP § 703.01(n).

Although the original transcript has been labeled in its entirety as “ATTORNEYS’ EYES

ONLY (TRADE SECRET/COMMERCIALLY SENSITIVE),” Petitioner has made necessary

redactions to the submission for public viewing.

Dated: April 17, 2020.

THE CONCEPT LAW GROUP, P.A.

6400 N Andrews Avenue, Suite 500

Fort Lauderdale, Florida 33309

(T): 754.300.1500

By: /s/ Adam S. Goldman

Alexander D. Brown

[email protected]

Adam S. Goldman

[email protected]

P a g e | 2

Counsel for Petitioner

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that a true and correct copy of the foregoing has been filed with the

Board and furnished via E-Mail to all counsel on the below Service List on April 17, 2020.

By: /s/ Adam S. Goldman

SERVICE LIST

McCarter & English, LLP

Lori J. Shyavitz, Irene M. Hurtado

[email protected]

[email protected]

Counsel for Registrant

1 IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD

2

3 JEFFREY KAPLAN, )

)

4 Petitioner, )

)

5 v. ) Cancellation No: 92060205

)

6 FAULDING HEALTH CARE (IP) )

HOLDINGS, INC. )

7 )

Registrant. )

8 )

9 ------------------------------------------------------

10 DEPOSITION OF

11 THOMAS GRAY

12 Thursday, May 2, 2019

13 ------------------------------------------------------

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DEPOSITION OF THOMAS GRAY

ATTORNEYS' EYES ONLY (TRADE SECRET/COMMERCIALLY SENSITIVE)

PAGE 1

1 APPEARANCES:

2 For the Petitioner: Mr. Adam S. Goldman

The Concept Law Group

3 6400 North Andrews Avenue

Suite 500

4 Fort Lauderdale, FL 33309

754-300-1500

5 [email protected]

6 For the Registrant: Ms. Lori J. Shyavitz

Ms. Irene M. Hurtado

7 McCarter & English

265 Franklin Street

8 Boston, MA 02110

617-449-6561

9 [email protected]

[email protected]

10

11 Also Present: Ernest Martinez

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1 The deposition of Thomas Gray was taken by

2 counsel for the Petitioner at the offices of Parker &

3 Crofford, 1230 Second Avenue South, Nashville,

4 Tennessee, on Thursday, May 2, 2019, beginning at

5 9:00 A.M., for all purposes under the Tennessee Rules

6 of Civil Procedure.

7 It is agreed that Gina Hunter, Licensed Court

8 Reporter, may swear the witness, take the deposition,

9 and afterwards reduce the same to typewritten form,

10 and that the reading and signing by the witness

11 is not waived.

12 All formalities as to caption, certificate,

13 transmission, filing, et cetera, are waived. All

14 objections, except as to the form of the questions

15 are reserved to on or before the hearing.

16 -----------------------------------------------------

17 INDEX

18 THOMAS GRAY: PAGE

19 Examination by Mr. Goldman ................... 5

20 100

21 Examination by Ms. Shyavitz .................. 95

22

23

24

25

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1 EXHIBITS

2 NUMBER DESCRIPTION PAGE

3 Exhibit 1 Miller School of Medicine 34

July 3, 2018

4

Exhibit 2 Miller School of Medicine 37

5 July 13, 2018

6 Exhibit 3 August 31, 2006 Email 89

7

8

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1 THOMAS GRAY,

2 having first been duly sworn or affirmed,

3 testified as follows:

4 EXAMINATION

5 BY MR. GOLDMAN:

6 Q. Good morning, Mr. Gray. As I mentioned earlier, my

7 name is Adam Goldman and I'm the counsel for the

8 petitioner in the trademark proceeding titled Jeffrey

9 Kaplan versus Faulding Healthcare IP Holdings, Inc. Can

10 you state your full name for the record?

11 A. Thomas Mitchell Gray.

12 Q. I'll refer to you as Mr. Gray if that's all right.

13 A. Mitch.

14 Q. Mitch. Go got it, Mitch. Mitch, have you ever

15 been deposed before?

16 A. Yes.

17 Q. About how many times?

18 A. Twice before I believe.

19 Q. Any involvement with trademark proceedings or

20 anything having to do with a trademark?

21 A. No. Two.

22 Q. What were the nature of those two times, the cases?

23 A. Litigations.

24 Q. And involving what generally?

25 A. One was the SEA & SKI business with the seller --

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1 Q. Uh-huh.

2 A. -- out of Australia. And the other one was related

3 to another company that we had, so --

4 Q. Okay. Just to go over a couple of ground rules.

5 You understand today I'm going to be asking you

6 questions under oath?

7 A. Sure.

8 Q. When you give an answer, make sure it's verbal

9 instead of a head nod or an huh-huh or uh-huh. It makes

10 it difficult for the court reporter to take it down.

11 Okay?

12 A. I understand.

13 Q. As we're going through the questions and answers

14 today, let me finish a question and then you can answer.

15 Again, that can create confusion on the record.

16 Okay?

17 A. Okay.

18 Q. If you don't understand a question, let me know and

19 I'll be happy to rephrase it.

20 A. Okay.

21 Q. Are you taking any medications or is there anything

22 else affecting your ability to testify truthfully today?

23 A. No.

24 Q. Mitch, what did you do to prepare for your

25 deposition today?

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1 A. Reread my deposition of several years ago and the

2 one I gave I think last year.

3 Q. Did you give a deposition in this case?

4 A. Well, it was a statement.

5 Q. A declaration?

6 A. Declaration.

7 Q. And then you mentioned one other thing. I didn't

8 catch it. So, you reread your declaration and what

9 else?

10 A. There were two declarations, I believe. One was in

11 '15 and one was in '17 or '17.

12 Q. Did you speak with John McCook about your

13 deposition today?

14 A. No.

15 Q. Did you speak with Niven Narain?

16 A. Yes.

17 Q. When did you speak to Mr. Narain?

18 A. Day before yesterday.

19 Q. What did you talk about?

20 A. Chronology.

21 Q. In what respect?

22 A. The timing of the studies that we had for the

23 31510.

24 Q. Was that it?

25 A. Yep.

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1 Q. Did you discuss Mr. Narain's deposition testimony?

2 A. No, we didn't and nor did I read it.

3 Q. About how long did you talk to Mr. Narain?

4 A. I probably talked to him for a half an hour.

5 Q. Did you speak with James Mercer?

6 A. Yes, I did speak with James I think day before

7 yesterday, as well.

8 Q. And what did you talk about with Mr. Mercer?

9 A. Chronology, as well.

10 Q. In terms of what?

11 A. Different projects that we had worked on together

12 trying to get SEA & SKI and/or BABY BLANKET back into --

13 to try to bundle those two products and get them back

14 into the marketplace.

15 Q. Did you talk about Mr. Mercer's deposition

16 testimony?

17 A. No. He mentioned a statement that he made in his

18 deposition, but -- and he hoped that it didn't hurt the

19 deposition, but other than that we didn't, no.

20 Q. And what statement was that?

21 A. Something in the regards of your -- the petitioner,

22 whatever he is in this, is being a thief. Something

23 like that. I don't know what it was.

24 Q. And he was concerned that that might hurt the case?

25 A. Well, he said he probably shouldn't have said it,

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1 but he was angry.

2 Q. Okay. Anything else you talked about with

3 Mr. Mercer?

4 A. No. Just the chronology of -- to recollect the

5 timeline just because it has been a number of years that

6 this has gone on.

7 Q. Mitch, do you know who Jeff Kaplan is?

8 A. No. I know he is the guy that's trying to take the

9 trademark, but I've never met him, never talked to him.

10 Q. You had no knowledge -- well, actually, when did

11 you first learn who Mr. Kaplan was?

12 A. Probably after this action was filed, I think

13 sometime in '14 or '15.

14 Q. Have you done any research on Mr. Kaplan or his

15 company RetroBrands?

16 A. No.

17 Q. I'm going to hand you -- we're actually -- we're

18 not going to mark it because it's already in the record,

19 but I'm going to hand you --

20 (Off-the-record discussion.)

21 BY MR. GOLDMAN:

22 Q. Mr. Gray, I'm handing you the declaration that you

23 submitted in this case on -- or the declaration is dated

24 February 15, 2019. Do you see that?

25 A. I will when I put my glasses on. Yes.

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1 Q. If you want, take a minute to flip through it. I

2 want to make sure that this is a true and accurate

3 representation, a true and correct copy, of the

4 declaration that you submitted in connection with

5 Faulding's trial period in this case.

6 A. (Reviewing document.) I am assuming this is the

7 same that I read yesterday or the day before.

8 Q. And you can see, I've just tabbed it for your

9 references, the exhibits. See, on the side it says A,

10 B, and C.

11 A. I did not review exhibits or anything; just my

12 statements.

13 Q. Fair enough. Let's turn to paragraph 1. And for

14 any paragraph that we're going to go through today, make

15 sure you take the time to read it. I'm not here to

16 trick you.

17 A. Sure.

18 Q. So, go ahead and read paragraph 1 and let me know

19 when you're finished.

20 A. (Reviewing document.) Okay.

21 Q. Mitch, how long have you been the president and CEO

22 of Pathfinder Management?

23 A. Since '97, maybe '96.

24 Q. And how long have you been the CEO of Radiant

25 Technologies?

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1 A. I don't know. When it was -- when we initiated the

2 company and until we closed it.

3 Q. Do you recall when you initiated the company?

4 A. No, I don't. I'm guessing somewhere around 2004 or

5 '5.

6 Q. Tell me generally, what is Pathfinder Management's

7 business.

8 A. It's managing projects. I get involved in a number

9 of projects. We manage the financials, the start-up

10 capital, to get a company up on its feet.

11 Q. What type of projects does Pathfinder get involved

12 with?

13 A. Anything from sales into retailers. Developing

14 products for sale into various retail outlets. That's

15 one -- one of the things. We also got involved in

16 pharma-related projects. We started Cytotech, which

17 evolved into Berg, which is a company now that's -- has

18 clinical trials going for cancer and other things.

19 Started another company last year, services to the

20 pharma tech industry.

21 Q. Did you say that Pathfinder started Cytotech?

22 Cytotech.

23 A. Yeah. Pathfinder licensed a technology from the

24 University of Miami and from that Cytotech was born and

25 which evolved into Berg.

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1 Q. I want to really break this down into different

2 components of Pathfinder's business. So, I understand

3 that you're involved with funding certain, I guess you

4 call them, projects?

5 A. Managing the financial side and/or the development

6 of some of those businesses; helping make decisions with

7 people that we hire, people that are knowledgeable in

8 those industries; justifying a spend. That type of

9 thing.

10 Q. Do you provide the capital for these projects?

11 A. Yes, we do.

12 Q. And about how many different projects is Pathfinder

13 providing the capital for?

14 A. Currently, just -- just the one. We -- I retired

15 in '15. I was asked to come back and manage another

16 project in the beginning of '18 and I'm currently doing

17 that. And that company did about 12 million last year.

18 Q. Is that company related to anything in this

19 trademark or litigation?

20 A. You're sitting in the building. You know, we --

21 no, it's not.

22 Q. Okay.

23 A. We service -- we provide services to the pharma

24 industry.

25 Q. So, outside of providing capital, I guess advising

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1 in financial decisions, you mentioned you -- Pathfinder

2 is also involved with the development of products?

3 A. Yes.

4 Q. So, tell me about that side of Pathfinder

5 Management.

6 A. For a number of years I traveled. I was a vendor

7 to Walmart. I developed product lines to sell into the

8 big box arena, whether it was Sam's Club or Walmart.

9 Q. What type of products?

10 A. We developed artwork in China, you know, dog bones

11 out of South Africa, just various products that we had

12 the opportunity to move into.

13 Q. How do you determine what products, you know,

14 Pathfinder wants to get involved with in that field --

15 in that area?

16 A. We're approached by companies that want to have

17 access to a Walmart. We had a relationship with

18 Walmart. A former Walmart president was a partner of

19 mine.

20 Q. When you say develop products, what aspects of the

21 development are you typically involved with?

22 A. Reviewing their costs, trying to make sure that, in

23 fact, there is a marketable -- it's a marketable

24 project. That's why we ended up taking a lot of the

25 opportunities to China to get them built or manufactured

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1 there. And we worked in Africa expertly (sic) doing the

2 same -- quite extensively doing the same thing,

3 developing product lines.

4 Q. About how many products are in the Pathfinder

5 portfolio today?

6 A. We're out of -- like I said, I retired in '15 and

7 came back out of retirement to run this business here.

8 Q. Okay. So, when you retired in 2015, about how many

9 products were in the Pathfinder portfolio?

10 A. We were pretty much limited to managing Berg and

11 our pharma project. It pretty much absorbed our -- our

12 bandwidth.

13 Q. Has Pathfinder Management ever been involved with

14 the development of products concerning lotions or skin

15 products?

16 A. Yes.

17 Q. Okay. Which ones?

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11 BY MR. GOLDMAN:

12 Q. Let's take a look at paragraph 4. And go ahead and

13 read it and let me know when you're finished.


15 Q. Actually, even before we get into that, you

16 mentioned FootLogics and Proderm before. Does

17 Pathfinders still have an interest or connection to

18 FootLogics?

19 A. No.

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24 Q. Why was Pathfinder interested in the SEA & SKI

25 brand?

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1 A. Market entry. We were taking on the Ponsus mousse

2 line, which we believed was an excellent vehicle for a

3 number of applications. SEA & SKI was -- it had market

4 penetration in a number of -- a number of stores, a

5 great number of stores. And we felt like that was a --

6 that we could piggyback onto that opportunity.

7 Q. Let's move to paragraph 6.

8 A. Okay.

9 Q. When did Pathfinder begin selling SEA & SKI brand

10 products?

11 A. Well, Pathfinder wasn't the actual sales company.

12 We were a management company. To be clear, it was

13 either Faulding Consumer or Radiant, whenever that

14 change transpired. So, that would have been the sales

15 vehicle. But I think we bought it in '3 and actually

16 became involved in -- I don't recall, it was either '3

17 or '4 when we were actually involved in the sales. I

18 think -- I want to say that when we first -- when we

19 first came onboard all the sales had been pretty well

20 made for that year and we were -- when we came in we

21 were going to be involved in the next sale cycle.

22 Q. Do you recall at the time which products were being

23 sold into the marketplace?

24 A. There was, I think, 15 SKUs and I couldn't tell you

25 what they all were.

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1 Q. Was it just suntan lotion or was it other products

2 as well?

3 A. Well, it was their entire lineup of products

4 containing SPFs and/or suntanning lotions. Suntanning

5 oils that didn't require an SPF. It was just a

6 moisturizer and a very dangerous, in my opinion, way to

7 be in the sun. I mean, they actually put oil on their

8 bodies and let the sun bake them and I didn't agree with

9 that, but I -- you know, I don't tell anybody else how

10 to manage their suntan.

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1 Q. Let's take a look at paragraph 9.

2 A. Okay.

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1 MS. SHYAVITZ: Objection. States the

2 witness' prior testimony.

3 BY MR. GOLDMAN:

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17 Q. Did Faulding or Pathfinder or Radiant create a

18 spray suntan lotion product around this time?

19 A. We had spray formulas available to us. They were

20 already making spray at our manufacturer. It was just a

21 -- all we had to do is add the SEA & SKI fragrance, if

22 will.

23 Q. Did that actually occur?

24 A. No.

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4 Q. So, there was no SEA & SKI spray products sold from

5 2003 to 2009?

6 A. I don't believe so. If they were, they were in a

7 -- they were not in an aerosol. I don't recall if we

8 had a pump spray. I want to say that I know one was

9 developed. I don't if it got into the lineup. It has

10 been a long time ago.

.

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1 Q. We'll get into that in a minute. Let's look at

2 paragraph 10.

3 A. Okay.

4 Q. Did Faulding have a website that advertised and

5 offered SEA & SKI brand products for sale prior to 2005;

6 do you know?

7 A. Yeah, they had a website when we took -- when we

8 bought it they already had an existing website in 2003.

9 Q. Why does it say from 2005 to 2007 in paragraph 10?

10 In other words, if you took it over in '03, why wouldn't

11 it say from 2003 to 2007?

12 A. I'm not sure, but I think, you know, that that's

13 very easily discovered. If you need that badly enough

14 we'll make sure that you have -- we can get you records

15 that there was a website that was operating if that's a

16 point of contention for you.

17 Q. Well, I won't get in -- I mean, we're pretty far

18 along in this case and documents like that have already

19 been request. But it's neither here nor there as we sit

20 here today. So, Faulding didn't have a website --

21 MS. SHYAVITZ: I object. The response

22 that we -- yes, documents were requested and the

23 requested documents have been produced to the extent

24 that they exist and are not protected by any privilege

25 or work product.

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1 BY MR. GOLDMAN:

2 Q. So, Faulding did not have a website that advertise

3 and sold SEA & SKI brand products after 2007?

4 A. I don't know for what year for sure that we stopped

5 the website.

6 Q. And, Mitch, I'm just -- this is your declaration

7 which you signed under oath. Why are the --

8 A. And what year was this?

9 Q. This is the one you just signed in February.

10 A. That would have been provided to me and I don't

11 have direct recollection. So, if that's what was

12 provided to me, that's -- you know, I probably -- that's

13 what I said.

14 Q. As we go through this declaration today, and I mean

15 this honestly, if there is anything that's in here that

16 you don't recall --

17 A. I don't recall specific dates. I recall that we

18 operated a website. I knew that there was a website in

19 '03 and for some period of time we -- we had a website

20 that was maintained.

21 Q. So then, why in your declaration under oath are

22 there specific dates?

23 A. There were probably provided to me. I probably

24 asked. I don't recall what the chronology was of this.

25 Q. Do you understand that this declaration was

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1 submitted under oath?

2 A. I understand exactly that it's under oath. And I'm

3 telling you that that would have been provided to me.

4 And truthfully, that would have been what was provided

5 to me. I don't -- you're asking me if I have a direct

6 recollection of when it stopped. I don't. So, that

7 number would have been provided to me and that's what I

8 would have put down and I would have relied on that.

9 Q. Who owned the SEA & SKI mark in 2005; do you

10 recall?

11 A. Faulding -- the mark would have been Faulding

12 Healthcare.

13 Q. Okay. If you could turn to Exhibit A in your

14 declaration. And let's look at -- do you see the number

15 in the bottom right-hand corner?

16 A. Exhibit A.

17 Q. Yeah. See the number in the bottom right-hand

18 corner, it says Faulding and it has a number?

19 A. Yes.

20 Q. See if you can turn to 17243. It's about --

21 A. It must be descending here. I'm not seeing it.

22 MS. SHYAVITZ: 17243?

23 MR. GOLDMAN: Yeah.

24 BY MR. GOLDMAN:

25 Q. Do you see under the picture it says SEA & SKI is

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1 privately owned by Radiant Technologies of Nashville,

2 Tennessee?

3 A. I see that.

4 Q. To your knowledge, did Radiant Technologies own the

5 SEA & SKI brand?

6 A. I think the registration resided at Faulding

7 Healthcare. Radiant was the marketing arm.

8 Q. So, Radiant didn't actually own the brand; is that

9 right?

10 A. No, they didn't.

11 Q. Let's go to paragraph 11 of your declaration.

12 A. Okay.

18 Q. At this time in 2005, what did Pathfinder know

19 about CoQ10?

20 A. That's kind of a broad statement -- or broad

21 question. But what do you need specifically?

22 Q. Yeah. So, you know, this is the first reference in

23 your declaration, I believe, to CoQ10. When did you or

24 anybody at Pathfinder or Faulding first line that, I

25 guess, CoQ10 would make sense in a suncare line?

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1 A. I had made several trips to the University of Miami

2 to their derm department and reviewed a number of

3 projects they were working on related to sun damage,

4 that type of thing. They were the third largest derm

5 school, I believe at the time, in the United States and

6 number one in sun damage or skin cancer-related studies,

7 research.


25 BY MR. GOLDMAN:

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3 A. No.

4 Q. I'm going to --

5 A. Not in -- not at the very beginning of the

6 conversations with the University of Miami.

7 MR. GOLDMAN: Would you mark this?

8 MS. SHYAVITZ: Thank you.

9 (Exhibit No. 1 was marked.)

10 BY MR. GOLDMAN:

11 Q. So, I'm handing you what we are marking as

12 Petitioner's Exhibit 1. If you would take a minute to

13 look at it.

14 A. Okay.

15 Q. Do you recognize Petitioner's Exhibit 1?

16 A. It has been a long time ago, but, yeah, I do

17 believe I've seen this before.

18 Q. And this is an article -- news article from the

19 University of Miami School of Medicine entitled

20 University of Miami, Leonard M. Miller School of

21 Medicine, to Pathfinder Management, Inc., sign exclusive

22 licensing agreement for coenzyme Q10 formulations. Did

23 I read that right?

24 A. Yes.

25 Q. And it's dated July 22nd, 2005?

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1 A. Uh-huh.

2 Q. This was right at the time that the license

3 agreement was executed; right?

4 A. Yeah.

5 Q. Is there any reference to SEA & SKI in this

6 article?

7 A. No.

8 Q. Why is that?

9 MS. SHYAVITZ: Objection.

10 MR. GOLDMAN: Strike the question.

11 THE WITNESS: We didn't discuss products

12 --

13 MS. SHYAVITZ: You don't have to answer.

14 BY MR. GOLDMAN:

15 Q. Yeah. Do you see in the second paragraph, in the

16 second sentence it reads: The company, meaning PMI,

17 Pathfinder Management, Inc., hopes the products will

18 provide patients, especially those with cancer, with a

19 better quality of life. Each year in the United States

20 more than 500,000 people die of cancer.

21 A. Uh-huh. Yes.

22 Q. But cancer research and providing patients with

23 care was not a focal point of this license agreement?

24 A. Of this license agreement. The question you asked

25 earlier is did I have cancer -- or drug development on

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1 my mind when I approached them. I did not. We

2 approached them much earlier in the year and our

3 conversations, and the reason we were there, was for

4 formulation around SEA & SKI. And this particular

5 product -- or this formulation, in our minds when we

6 first were reviewing it, was to prevent potentially the

7 development of a skin cancer. As we were developing our

8 relationship with the University of Miami, they had

9 opened our eyes to a formulation that was showing huge

14 Q. And you recognize that this article talks about

15 therapeutic options for ill patients and it's -- and

16 CoQ10's potential formulation use for treatments of

17 cancer and skin sores; correct?

18 A. Correct.

19 Q. Is there anything in this article that talks about

20 use of CoQ10 for nonpatients, meaning patients with

21 cancer?

22 A. You'll have to rephrase the question. I'm not sure

23 what you're asking.

24 Q. Yeah. This entire article -- and disagree with me

25 if you want, but this entire article focuses on

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1 explaining the license agreement as a hope that CoQ10

2 can provide cancer patients with better qualities of

3 life; right?

4 MS. SHYAVITZ: Objection. The article

5 speaks for itself.

6 THE WITNESS: Okay.

7 BY MR. GOLDMAN:

8 Q. You can answer the question.

9 A. I can answer the question?

10 MS. SHYAVITZ: Yes.

11 THE WITNESS: The last time I couldn't,

12 so --

13 BY MR. GOLDMAN:

14 Q. She'll let you know.

15 A. Yes, this particular article speaks to that.


17 BY MR. GOLDMAN:

18 Q. I'm handing you what we're marking as Petitioner's

19 Exhibit 2.

20 A. Okay.

21 Q. If you can take a couple of minutes to read it.

22 I'm not going to be asking you detailed questions about

23 --

24 A. I see this is when you printed it. What -- it's a

25 2006 article. (Reviewing document.) Okay.

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1 Q. Is there any mention of SEA & SKI in this article?

2 A. No.

3 Q. This article is titled, for the record, UM -- UM

4 Miller School Researcher's Identify how Q10 Fights

5 Cancer, Present Findings at Top International Cancer

6 Conference, and it's dated April 3rd, 2006. So, based

7 on this article it appears at this time that the

8 researchers had at least some initial research to

9 suggest that Q10 could help fight cancer; is that your

10 understanding?

11 MS. SHYAVITZ: Objection. The contents

12 of the article speak for itself. You can answer to the

13 extent you can.

14 THE WITNESS: At this time and much

15 earlier, actually.

16 BY MR. GOLDMAN:

17 Q. The last full paragraph on page 1, the paragraph

18 that begins the UM group; do you see where I am?

19 A. Uh-huh.

20 Q. The very last two sentences, it says: Pathfinder

21 Management has licensed the technology, and then, quote,

22 we see great opportunities for this technology while

23 improving overall quality of live in the management of

24 cancer. Do you see that?

25 A. Yes. And I agree with it.

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7 BY MR. GOLDMAN:

8 Q. So, what --

9 A. So --

10 Q. Go ahead.

11 A. You know, I have nothing against you personally,

12 but that's a ridiculous question.

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6 Q. Let's look at paragraph 12. I forgot to mention

7 this earlier, but any time you want to take a break, let

8 me know.

9 A. I'm good. I'm trying to get you out of here as

10 quick as possible.


12 BY MR. GOLDMAN:

13 Q. Go ahead. So, paragraph 12.

14 A. Okay.

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18 A. Well, I owned it so I didn't have to go far for

19 that conversation. But I did speak also with, you know,

20 the people that were managing the -- I think it was

21 Faulding Consumer, the sales team. They were very

22 excited about it at the time. So, you know, we spoke to

23 sales people. We spoke to retailers about what we had.

24 Especially after 2007 we were all very excited after

25 clinical trials started.

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1 Q. Let me back the question up. Initially, when you

2 first were interested in the possibility of even

3 incorporating the CoQ10 technology, who were you talking

4 to about this potential?

5 A. Researchers at the University of Miami.

6 Q. Does that include Niven Narain?

7 A. Not limited to. Niven was a -- he worked there and

8 he was a student there. Dr. Schachner was the head of

9 the derm department and I had a number of conversations

10 with him as well.

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16 BY MR. GOLDMAN:

17 Q. Did there come a time where these conversations

18 stopped?

19 A. I work with Niven still today.

20 Q. Okay.

21 A. He came to work for the company in 2008. I work

22 with Joaquin still today. All my relationships are

23 pretty mature. Joaquin is a business partner of mine

24 today in another venture. I keep saying I'm going to

25 retire. But if I stop and think about it, I don't think

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1 I have.

2 Q. How many discussions would you say you had from

3 that 2004 time frame forward about the specific

4 incorporation of CoQ10 technology into SEA & SKI

5 products?

6 A. With whom?

7 Q. Anyone?

8 A. Ongoing with Jimmy. Jimmy would like to have it in

9 his BABY BLANKET even now.

10 Q. That's James Mercer?

11 A. Yeah.

12 Q. Okay.

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.

16 Q. Understood. By 2005 had you ever involved with the

17 product development, testing, and regulatory approval

18 process for a pharmaceutical product?

19 MS. SHYAVITZ: Objection; compound. You

20 can answer.

21 THE WITNESS: Go -- repeat the question.

22 BY MR. GOLDMAN:

23 Q. By 2005 had you ever been involved with product

24 development, testing, and/or regulatory approval for a

25 pharmaceutical product?

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1 A. No.

2 MS. SHYAVITZ: The same objection.

3 BY MR. GOLDMAN:

4 Q. Did you speak to anybody about this process at that

5 time?

6 A. Yeah, I did. I spoke to a great number of people.

22 those things, to be completed within two to three years?

23 MS. SHYAVITZ: Objection; compound and

24 vague. You can answer.

25 THE WITNESS: We didn't believe that it

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1 would be two to three years for -- for an approval, but

2 we thought we would have our clinical trials done and a

3 drug amount established within two to three years for a

4 topical. The formulation was already developed.

5 BY MR. GOLDMAN:

6 Q. And that was around 2007?

7 A. By 2006 -- late 2006 we had the formula developed

8 and sometime in 2007 the trial began and I think by

9 2008, late maybe, that we had the results from that

10 trial. So, I think we had met our goals as far as

11 proving safety and efficacy, which we would then rely on

12 that data for an OTC product.

13 Q. Okay. This is the first I'm hearing about that

14 study. So, tell me about those clinical studies and

15 trials. Who conducted them?

16 A. Well, we paid a third party to conduct them.

17 Q. Who was that third party?

18 A. I don't remember where we conducted them. We have

19 the results. I don't remember the -- may I ask the

20 question of Ernie? Am I allowed to?

21 MS. SHYAVITZ: No.

22 THE WITNESS: I don't recall the name of

23 where we conducted the trial.

24 BY MR. GOLDMAN:

25 Q. And what was the subject of the trial?

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1 A. It was safety for the -- you have to start there.

2 We had already had the formula on animals. We did hire

3 an animal study.

4 Q. What was the formula?

5 A. It's -- well, I'm not going to divulge what the

6 formula is.

7 Q. Okay. And I'm not asking you to divulge a trade

8 secret here.

9 A. So, it was a phospholipid CoQ10 formula. And

10 that's as far as I'll go.

11 Q. That's fair enough.

12 A. Okay.

13 Q. So, those studies were performed in around 2007,

14 2008?

15 A. In human. We had in '6 developed the formula

16 already and had in primate.

17 Q. And what were the results of the study?

18 A. That it was safe for that level of -- that level of

19 percentage of our active was safe in the formulation and

20 we also had efficacy on squamous cell carcinoma, basal

21 cell carcinoma, and, of course, the safety factor.

22 Q. So, why not incorporate that into your SEA & SKI

23 products?

24 A. We had not -- we don't have an approved drug or an

25 approved level. Knowing 3 1/2, 4, or 5 percent maybe

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1 works, whatever those percentages are. But does 1

2 percent work? You know, you got to go back and repeat

3 those kinds of things. But what we also learned in

4 visiting with the medical side was that the likelihood

5 of us treating squamous cell carcinoma or basal cell

6 carcinoma with just a topical cream, which could, in

7 fact, metastasize and cause, you know, other issues,

8 that we probably would not be well-received into the

9 marketplace because that's -- the doctors excise those,

10 and that we would need to have an injectable drug as

11 well if that were possible -- we didn't even know if it

12 were possible -- to travel with that drug. So, if they

13 were doing a topical, they would also get an injection

14 of that same drug to help. And, of course, those are

15 additional studies, but to demonstrate that you didn't

16 have -- you didn't metastasize from your topical

17 cancers.

18 Q. So -- and I apologize, you may have explained it.

19 A. But probably not well. It has been awhile.

20 Q. So, remind me, the studies were successful in what

21 respects?

22 A. At a certain percentage -- again, we don't know

23 what that base percentage of efficacy would be, but we

24 knew that at the percentage that we tried that it was

25 successful in clearing squamous cell carcinoma, basal

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1 cell carcinoma, and that it was safe.

2 Q. Did anybody tell you that the process from there to

3 getting a product approved by the FDA could take two to

4 three years?

5 MS. SHYAVITZ: Objection; vague. You

6 can answer.

7 THE WITNESS: There are -- there are all

8 different timelines. It just depends on -- on the

9 material itself. Being topical is -- certainly there is

10 a possibility of it being faster to market, if you will,

11 than maybe an injectable. You can imagine the

12 difference. There is fast-tracking if you have

13 something. I'll give you a good example. Can we get to

14 market within a three-year period on an EB? Most

15 likely.

16 BY MR. GOLDMAN:

17 Q. What is an EB?

18 A. The other study that I told you we were doing in

19 the -- at the university. It's the skin sloughing off

20 children. Usually they die before they're adults. If

21 it's an unmet need, it's an orphan-drug status, there is

22 all kinds of fast-tracking capabilities that the FDA has

23 and you're subject to their decisions. But fast-

24 tracking and orphan drug status can typically get you to

25 market much sooner than normal pathways.

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1 Q. Has it surprised you that it's 2019 and the studies

2 began in 2007 and from what I understand the CoQ10

3 technology clinical studies and trials are still in

4 phase two?

5 A. Yes, it's -- it has surprised me. But it surprised

6 a lot of -- it surprised a lot of companies on a lot of

7 drugs on how long it takes to get to market.

8 Q. But specifically for this drug.

9 A. Well, for any drug. You know, some of them make it

10 to market very quickly, just depending on an unmet need,

11 that type of thing. We believe that because we're using

12 an endogenous molecule that it -- it had a great chance

13 to be on a faster track that this. But you are also

14 battling, you know, the clinical trials themselves of

15 proof of efficacy and you're -- when you go to the

16 injectable, I'm referring to the injectable now, it's a

17 much steeper development pathway. And the decision was

18 made to start moving in that direction.

19 Q. When was that decision made?

20 A. I want to say '8, 2008. And I believe we completed

21 the formulation and our first in-human in 2011.

22 Q. Did you ever talk to James McCook -- is that James

23 McCook?

24 A. John.

25 Q. John McCook. John McCook about how long this

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1 process might take, the product development, testing,

2 regulatory approval for a product incorporating CoQ10?

3 Did you ever talk to him about how long that process

4 might take?

5 A. May take. Yes.

6 Q. And what did he say?

7 A. There are drugs that take 11, 12 years to get to

8 market. Many drugs only are able to go to market in the

9 last three years of their patent life, which is why we

10 have the high cost of drugs.

11 Q. When did you discuss that with him?

12 A. Numerous times and we had those -- we had those

13 conversations at the very beginning before we ever

14 invested.

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9 Q. You may be familiar with this, but are you aware

10 that Dr. Narain has stated that only 1 in every 100

11 phase one trials actually becomes a drug?

12 A. I thought it was three, but maybe it is one. I do

13 remember it's a very low number.

14 Q. So, in essence, there was anywhere from a 99 to 97

15 percent chance that the clinical studies that were being

16 done on the CoQ10 technology would not yield favorable

17 results; right?

18 A. I disagree with that and I think that the proof is

19 -- you know, it's going to happen and we will have an

20 approved drug. The FDA is very excited about this drug.

21 It's a safe molecule. So, when the rest of the world is

22 working with a chemical-based compound and we're working

23 with an endogenous molecule, I would say that our -- our

24 stats go up tremendously that we're going to be -- first

25 of all, we're using a compound that has been in the

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1 marketplace for about 60 years, safe, its in all kinds

2 of lotions. It's used in food items. So, it's not a --

3 it's not an unfamiliar product. It's the claim set that

4 is the difficulty.

5 Q. Uh-huh. And believe me, I hope it does get

6 positive results.

7 A. It will. I am a hundred percent confident of that.

8 There is no doubt in my mind. Does this happen as soon

9 as I would like it to? No.

10 Q. At the time that you started this process in '05

11 with the license agreement --

12 A. Uh-huh.

13 Q. -- you would agree that there was a significant

14 chance that the studies would not yield favorable

15 results just strictly based on historical success rates?

16 A. No, I wouldn't agree.

17 Q. And why is that?

18 A. Because I saw the clinical results, animal results.

19 I mean, when you treat mice and, you know, they have a

20 melanoma and it goes away it's -- it's pretty

21 incredible. And when you're doing that with an

22 endogenous molecule, I feel like I have a pretty good

23 shot of getting it approved.

24 Q. And you don't think -- okay. And you don't think

25 that's the case with other people in other companies

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1 that --

2 A. I think most companies --

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6 Q. Do you know any other drugs incorporating

7 endogenous molecules that have not been successful in

8 terms of getting to market and getting approved?

9 A. Well, again, it comes down to efficacy. You know,

10 I think people try, but do they have efficacy. And

11 we're demonstrating efficacy. So, it's not apples to

12 apples. If they're demonstrating efficacy, they

13 probably make it to market. Now, again, what market are

14 you picking? Not all markets are profitable. Is it

15 even worth the research in doing it? So, there is a lot

16 that goes into all of those decisions.

17 MR. GOLDMAN: Okay. Our court reporter

18 needs a break. I think we could all use a break. Let's

19 take a couple of minutes.

20 (Short break in the proceedings.)

21 BY MR. GOLDMAN:

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24 Q. After phase three, which again I understand is

25 trials in patients, assuming the trials yield, you know,

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1 favorable results in order to get an OTC product to

2 market, does it have to go through the FDA approval

3 process?

11 Q. Do you know about how long the FDA approval process

12 takes?

13 A. For what?

14 Q. For approval, let's say, of one of the -- the drugs

15 that you're developing now for skin cancer.

16 A. Again, that's all over the map. It just depends.

17 If it's an unmet need approval processes can be -- and

18 going from where? From where we are today or from where

19 we started in the beginning without even a formulation?

20 I mean, that's --

21 Q. After successful phase three results.

22 A. After successful phase -- some are approved before

23 you have a phase three result.

24 Q. And when --

25 A. But you have to -- you have to continue on with the

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1 trial in tandem. So, in other words, for EB, being a

2 good example, an unmet need, proven to be safe, you

3 could file for an expedited approval. You might get

4 approved in, you know, two, but required to follow up

5 with any of those patients that are being treated as a

6 phase three trial, continuing. I hope that answers your

7 question.

8 Q. And the FDA approval process, I understand it can

9 be expedited. But what is your understanding of the

10 range of time frames for approval from the FDA after a

11 phase three trial?

12 A. Again, it just depends on the results of the

13 safety. You know, there is a lot that goes into that.

14 So, if you're having some safety issues, side-effect

15 issues, I couldn't tell you what the longest is, but I

16 am -- you know, I could tell you that you could still be

17 18 months getting approval. It could be longer than that

18 if you were having side-effect issues and they may ask

19 you to do even follow-up studies. They may approve you

20 but make you do other studies on the follow up on your

21 side effects.

22 Q. Let's look at paragraph 17.

23 A. Okay.

24 Q. You testify later in this declaration that Faulding

25 sold the remaining inventory of SEA & SKI suncare lotion

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1 products through the end of 2009; is that right?

2 A. We sold them into the industry in 2009.

3 Q. Say that again.

4 A. We sold product, shipped product, in 2009.

5 Q. So, you ceased shipping products at the end of

6 2009?

7 A. Somewhere in 2009 I believe. I don't believe that

8 we shipped any in '10. We may have to discounters. We

9 had, I think, an expiration in midsummer of '10.

10 Q. What do you mean an expiration?

11 A. An expiration date in midsummer of '10 on some

12 products. And so, those -- anything that had less than

13 one-year shelf life had to go into a discounter for an

14 immediate sale.

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21 Q. This is Cross Brands?

22 A. Yeah. They became Cross Brands, this group of

23 people from late '14 through '15, they eventually became

24 Cross Brands. They didn't have a company -- when we

25 started dealing with them in '15 they didn't have a

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1 company to sign a contract with. But after they

2 formalized their relationship, then we signed a

3 contract.

4 Q. So, throughout all of these conversations, just so

5 I'm clear, the SEA & SKI brand is not being sold in the

6 market; right?

7 A. From -- 2010 was our last product in the line. We

8 had the Navajo brand.

9 Q. Yeah. A better question is, SEA & SKI branded

10 suncare -- suntan lotion products were not being sold in

11 the market; right?

12 A. Well, SEA & SKI SPF sun protection was being sold

13 in the market.

14 Q. Right. I'm asking just suntan lotion. From the

15 end of 2009 or 2010 through the license agreement with

16 Cross Brands in 2016, it was not available on the

17 market; right?

18 A. I don't think it was -- the lotions -- the full

19 lineup of products that we had, no, those weren't

20 available.

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24 Q. Why isn't that in your declaration, any of these

25 efforts to bundle?

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1 MS. SHYAVITZ: Objection; the contents

2 of his declaration -- Mr. Gray's declaration speak for

3 themselves -- speaks for itself.

4 BY MR. GOLDMAN:

5 Q. That's okay, don't worry about the question. Go to

6 paragraph 21.

7 A. Okay.

16 Q. Do you know whether -- now, moving to paragraph 21.

17 Do you know whether Navajo ever sold SEA & SKI-branded

18 sunglasses?

19 A. I believe they did. I mean, I was -- I was sent

20 pairs of them. Did I see them in stores? I didn't

21 personally.

22 Q. Do you know when they stopped selling SEA &

23 SKI-branded sunglasses?

24 A. No, I don't. I don't know the dates. I didn't --

25 I didn't manage it.

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17 Q. Turn to paragraph 19 in the declaration. Actually,

18 look at paragraph 18 and paragraph 19 together, if you

19 will.

20 A. Okay.

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21 A. And what I think I'm referring to there is because

22 of this litigation, it's through that period of time

23 when you guys -- well, not you, but somebody decided

24 that they would like to take over the brand without

25 paying for it. And I won't say what I think about that.

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1 Q. You can if you would like.

2 A. Through that -- no. Through that period of time in

3 question, you know, there was products in the

4 marketplace. And we were continuing to work to try to

5 get something put together. I'm not a big fan of this

6 action here, but it is what it is and I'm trying to deal

7 with it.

8 Q. Did Pathfinder, Faulding, anybody, notify the

9 public that the brand was being reformulated -- that the

10 formulation was being worked on after it stopped selling

11 suncare lotion in the marketplace?

12 A. No, we didn't notify the public. I don't think I'm

13 required to.

14 Q. Well, you understand that at least as of 2014 the

15 brand could not be found in the marketplace; right?

16 A. No, I understand that.

17 Q. So, and -- I mean, did you look at paragraph 23

18 yet?

19 A. No, I'm sorry, I didn't. Yes.

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22 BY MR. GOLDMAN:


24 A. Uh-huh.

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2 Q. Let's look at paragraph 27. We're almost done.

3 A. Okay.

4 Q. Are you familiar with the agreement that's

5 referenced in paragraph 27 as Exhibit C?

6 A. With Cross Brands?

7 Q. Yes.

8 A. I haven't reviewed it in a while, but, you know,

9 yes, I'm familiar with it being put together.

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11 Q. I've got one more document that I want to look at

12 with you.


14 BY MR. GOLDMAN:

15 Q. And I'll represent, this is actually two different

16 documents.

17 A. Okay.

18 Q. It's Bates number Faulding 017011 through 017012 --

19 I'm sorry, 013.

20 A. You're asking me to go ahead and read these?

21 Q. Yeah, please.

22 A. The entire documents?

23 Q. Yep.


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4 Q. That Pathfinder assigned -- well, let me backup.

5 There is a trademark registration for Dermal Integration

6 Technology; are you familiar with that?

7 MS. SHYAVITZ: Objection; relevance.

8 THE WITNESS: I don't recall.

9 BY MR. GOLDMAN:

10 Q. Okay. So, you don't recall assigning Pathfinder's

11 interest in the trademark to Ponsus in 2010?

12 MS. SHYAVITZ: Objection; relevance.

13 And also, I'm going to object to this line of

14 questioning as it exceeds the scope of Mr. Gray's

15 declaration. The Dermal Integration Technology

16 trademark is not the subject matter of this proceeding.

17 MR. GOLDMAN: Well, I'm trying to

18 understand what the new Dermal Integration Technology

19 is.

20 MS. SHYAVITZ: Well, the ownership of

21 that mark has absolutely no bearing on this proceeding.

22 MR. GOLDMAN: Well, it light of his

23 representation that he doesn't remember what it is, then

24 I'll -- I don't need to go there. I may be finished.

25 Let's take a couple of minutes. I'll look through my

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1 notes and see if I have any more questions for you.

2 THE WITNESS: Thank you.

3 (Short break in the proceedings.)

4 MR. GOLDMAN: Mitch, thank you for your

5 time today. I don't have any further questions.

6 MS. SHYAVITZ: I have a few.

7 EXAMINATION

8 BY MS. SHYAVITZ:

9 Q. Earlier today Mr. Goldman introduced an article

10 marked as Exhibit 1. Can I please refer you to that

11 article?

12 A. Okay.

13 Q. If you look on page 1, five lines down from the

14 beginning of the article you'll see a sentence that

15 reads: As part of the agreement, PMI will find,

16 research and develop, and market the most promising

17 over-the-counter and prescription drug opportunities for

18 the CoQ10 formulations. What does this mean?

19 A. Well, we were going to fund a cancer research

20 project.

21 Q. And PMI, that's Pathfinder Management, Inc.; right?

22 A. Yes.

23 Q. Was PMI also going to fund an over-the-counter

24 product?

25 A. Yes.

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12 but I'm not sure -- you're tripping me up more than

13 Adam.

14 Q. Let's shift gears.

15 A. Okay.

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20 Q. Can I please direct you to paragraph 25 of your

21 declaration. Just let me know when you've had a chance

22 to read it.

23 A. Sure.

24 Q. This paragraph talks about your business

25 relationship with James Mercer; correct?

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1 A. Yes.

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1 Q. And you and he, Mr. Mercer, had conversations about

2 these topics; correct?

3 A. Yes.

4 Q. Could you please look at paragraph 27 of your

5 declaration and let me know when you've had a chance to

6 read it?

7 A. Okay.

18 Q. Thanks very much. I have no further questions.

19 MR. GOLDMAN: I have one.

20 EXAMINATION

21 BY MR. GOLDMAN:

22 Q. Referencing paragraph 25 and your communications

23 with Mr. Mercer, Faulding has not produced, to your

24 knowledge, any documents demonstrating any of these

25 conversations; is that correct?

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1 A. I haven't reviewed --

2 MS. SHYAVITZ: Objection.

3 THE WITNESS: I haven't reviewed any

4 documentation personally.

5 BY MR. GOLDMAN:

6 Q. To your knowledge, no documents regarding these

7 conversations have been produced; is that right?

8 MS. SHYAVITZ: Objection; asked and

9 answered. You can answer.

10 THE WITNESS: I have no -- I have no

11 knowledge of written documentation.

12 MR. GOLDMAN: No further questions.

13 (Proceedings concluded at 11:45 A.M.)

14

15

16

17

18

19

20

21

22

23

24

25

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1 REPORTER'S CERTIFICATE

2 I, Gina R. Hunter, Licensed Court Reporter,

3 and Notary Public for the State of Tennessee, hereby

4 certify that I reported the foregoing proceedings at

5 the time and place set forth in the caption thereof;

6 that the proceedings were stenographically reported

7 by me; and that the foregoing proceedings constitute

8 a true and correct transcript of said proceedings

9 to the best of my ability.

10 I FURTHER CERTIFY that I am not related to

11 any of the parties named herein, nor their counsel,

12 and have no interest, financial or otherwise, in the

13 outcome or events of this action.

14 IN WITNESS WHEREOF, I have hereunto affixed

15 my official signature and seal of office this

16 12th day of May, 2019.

17

18

19

20

<%8338,Signature%>

21 -------------------------------

GINA HUNTER, LCR

22 AND NOTARY PUBLIC FOR THE

STATE OF TENNESSEE

23

LCR No. 639 Expires 6/30/2020

24

25 Notary Commission Expires 8/20/2019

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2011 57:21 85:13

2012 70:21 71:2,25

2013 78:17 79:4,6,9

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2015 14:8 16:1

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2017 93:2

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ad 70:21 71:1,2

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adam 2:2 5:7 97:13

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78:1

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61:11 93:3

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95:15 97:2

ahead 10:18 15:12

39:8 42:10 44:13

89:20

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53:20

amount 24:5 53:3

64:5,7 65:9 67:21

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amounts 98:11

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78:16 81:8

anymore 24:17

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18th Clay County TN



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University of Miami Leonard M. Miller School of Medicine and Pathfinder Management, Inc. Sign Exclusive Licensing Agreement for Coenzyme Q10 Formulations

7/22/2005

The University of Miami Leonard M. Miller School of Medicine and Pathfinder Management, Inc. (PMI) today announced the signing of a worldwide exclusive license agreement. The deal gives PMI an exclusive license agreement for the technology and products described in UM's patent application entitled "Topical

Coenzyme 010 Formulations and Methods of Use."

As part of the agreement, PMI will fund research, and develop and market the most promising over the counter and prescription drug opportunities for the CoQ10 formulations. The company hopes the products will provide patients, especially those with cancer, with a better quality of life. Each year in the United States more than

500,000 people die of cancer.

University of Miami School of Medicine researchers found that a very potent antioxidant, ubiquinone, more

commonly referred to as Coenzyme Q10 or CoQ10 that occurs naturally in the body can be delivered to cancer cells in culture and in animals to restore apoptosis, which is the normal programmed cell death that goes awry in the disease process.

"The most amazing part is that we've been able to restore a cancer cell's ability to kill itself, while not

impacting normal cells," said Niven R. Narain, director of transdermal delivery /cutaneous cancer research in the

Department of Dermatology and Cutaneous Surgery at the Miller School of Medicine. Researchers believe this treatment has an advantage over other cancer therapies. "Chemotherapy

affects both normal and cancer cells, but based on the data we've seen, it would appear that Coenzyme Q10

only impacts the cancer cells," said Indushekhar Persaud, chief bioengineer for drug delivery therapeutics in the

Department of Dermatology and Cutaneous Surgery at the Miller School of Medicine.

"This significant work is an excellent model for the important outcomes of basic science research, to offer new opportunities for exploring therapeutic options in ill patients. It is the laboratory bench to bedside paradigm we all seek," said Lawrence A. Schachner, M.D., chairman of the Department of Dermatology and Cutaneous

Surgery at the Miller School of Medicine. The scientists have examined various ways to deliver the CoQ10, including through the skin. "We are

always looking for new innovative and versatile products to combine with our own novel trans -dermal delivery technologies in an effort to expand our product lines," said Lan Strickland, chief marketing officer of PMI. "This

agreement enables PMI and its partners to work with new drug delivery systems beyond trans -dermal delivery.

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By collaborating with the University of Miami School of Medicine we hope to offer novel both over the counter UM NOTICE OF and prescription products that will help alleviate pain and improve the quality of life for thousands of patients." PRIVACY PRACTICES: This goal is shared by S. L. Hsia, Ph.D., director of the Transdermal Delivery/Cutaneous Biology

English Laboratory in the Department of Dermatology and Cutaneous Surgery at the Leonard M. Miller School of Medicine. "It is amazing that such early laboratory studies show that a benign compound such as CoQ10 can cause cancer cells to selectively kill themselves without harm to normal cells. Our entire team looks forward to one day bringing the benefit and hope of this technology to many cancer patients."

"It is always a good feeling to have the opportunity to do well commercially with cutting -edge technologies, while at the same time benefiting humanity," echoed Mitch Gray, president an chief executive officer of PMI.

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About the University of Miami Leonard M. Miller School of Medicine The University of Miami Leonard M. Miller School of Medicine has earned international acclaim for research, clinical care, and biomedical innovations. Among its centers of excellence are Bascom Palmer Eye Institute, the UM /Sylvester Comprehensive Cancer Center, the Diabetes Research Institute, and the Miami Project to Cure Paralysis.

About Pathfinder Management, Inc. Pathfinder Management, Inc., founded in 1995, is a private company with a balanced portfolio of subsidiaries, equity positions and investments in mature and emerging markets; companies targeting government and corporate customers as well as consumers; and companies selling B2B (Business to

Business) as well as B2C (Business to Consumer).

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UM Miller School Researchers Identify How Cog10 Fights Cancer,

Present Findings at Top International Cancer Conference

4/3/2006

Miami, FL (April 3) -- Researchers from the Department of Dermatology and Cutaneous Surgery at the

University of Miami Leonard M. Miller School of Medicine have identified how Coenzyme Q10 inhibits a protein

that plays a vital role in cancer. The researchers, Niven R. Narain and Indushekhar Persaud, presented findings

at last year's meeting of the American Association for Cancer Research on the ability of CoQ10, a powerful

antioxidant, to inhibit melanoma in the lab. They are now reporting their new findings showing how CoQ10

works and expanding its use at this year's AACR meeting, April 1 to 5 in Washington, D.C.

Bc1-2 is a protein that tells cells when to shut themselves off, a normal process called apoptosis. But in

malignant cells this programmed cell death is switched off, allowing cancer to proliferate and spread. Bd-2 and

CoQ10 are present in both normal and malignant human cells but the ratio changes in malignant cells. Cancer

cells have more Bcl -2 and less CoQ10 than normal cells. Narain and Persaud examined that relationship and

found that when they administered more CoQ10 to melanoma and prostate tumors in the lab the level of Bcl -2

dropped, and the tumors got smaller. This is the first time researchers have established a correlation between

the Bd-2 protein family and Coenzyme Q10.

The Bd-2 protein shows such promise as a therapeutic target that it is a major research theme at this year's

AACR, which is considered by oncologists to be one of the most important cancer research meetings in the

world. The AACR put out a call for investigators to pursue data on the genetic and chemical workings of this

protein family. "We already had the data on both the protein and gene, data which shows a significant down -

regulation of Bc1-2 by CoQ10," said Persaud, Chief Bioengineer for Drug Delivery Therapeutics in the

Department of Dermatology and Cutaneous Surgery at the UM Miller School of Medicine.

"Last year we found that CoQ10 was inducing apoptosis," said Narain, Director of Transdermal

Delivery/Cutaneous Cancer Research in the Department of Dermatology and Cutaneous Surgery. "What we've

found now is that a protein family called Bc1-2 is responsible for conferring resistance to many

chemotherapeutic drugs and to radiation. Bd-2 is a soldier on behalf of cancer." Bcl -2 takes away the ability of a

cell to kill itself and it is over -expressed in many cancers, making the tumor cells resistant to treatment and

more likely to grow and spread. In laboratory testing, CoQ10 reverses that, restoring the cancer's susceptibility

to chemo and radiation, and fighting the tumor cells by itself. Since CoQ10 occurs naturally in the cell, it

promises to have few side effects. "We're using something that is already nestled in the mitochondria)

membrane, alongside Bcl -2 in the cell."

"I feel that this technology will usher in a new wave of hope and comfort for those afflicted by cancer," said S. L.

Hsia, Ph.D., director of the Transdermal Delivery/Cutaneous Biology Laboratory in the Department of

Dermatology and Cutaneous Surgery. Persaud and Narain presented two posters at the AACR conference - one with their new data on the Bcl- 2 /CoQ10 relationship in melanoma and another showing efficacy against

prostate cancer in the lab.

The UM group developed a novel way to combine CoQ10 with phospholipids, which are prolific in the skin,

effectively creating a way to deliver CoQ10 through the skin with a cream. There is tremendous interest among

researchers and biotechnology companies to develop this promising knowledge into human therapies. "We are

looking forward to further investigating Coenzyme Q10's mechanism of action with the UM Miller School of

Medicine," said Lan Strickland, General Manager, Dermal Technology Business Unit at Pathfinder Management,

Inc., in Nashville, Tennessee. Pathfinder Management has licensed the technology. "We see great opportunities

for this technology while improving overall quality of life in the management of cancer."

Narain and Persaud are two of many UM Miller School physicians and researchers participating in the 97th

Annual AACR meeting. Joseph D. Rosenblatt, M.D., Associate Director for Clinical and Translational Research

at the University of Miami Sylvester Comprehensive Cancer Center, is chairing a panel on disparities in cancer

outcomes; medical oncologist Khaled Tolba, M.D., has an oral presentation on immune response in cancer; and

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7/13/2018 News - University of Miami School of Medicine

Claire Croutch, Ph.D., a fellow in the laboratory of Microbiology and Immunology associate professor Lawrence

Boise, Ph.D., is presenting research on a promising new arsenic -based cancer therapy. To learn more, visit the

AACR conference web site at http : / /www.aacr.org /page5902.aspx.

UNIVERSITY OF MIAMI

UM /Sylvester opened in 1992 to provide comprehensive cancer services and today serves as the hub for

cancer -related research, diagnosis, and treatment at the University of Miami Leonard M. Miller School of

Medicine. UM /Sylvester handles 1,400 inpatient admissions annually, performs 3,000 surgical procedures, and

treats 3,000 new cancer patients. All UM /Sylvester physicians are on the faculty of the Miller School of

Medicine, South Florida's only academic medical center. In addition, UM /Sylvester physicians and scientists are

engaged in 200 clinical trials and receive more than $31 million annually in research grants. UM /Sylvester at

Deerfield Beach recently opened to better meet the needs of residents of Broward and Palm Beach Counties.

This 10,000 square -foot facility at I -95 and S.W. 10th Street offers appointments with physicians from six cancer

specialties, complementary therapies from the Courtelis Center, and education and outreach events.

http://www.sylvester.org.

Kelly Kaufhold Office of Communications University of Miami Leonard M. Miller School of Medicine

305 -243 -5184 Pager 305 -376 -6468 kkaufhold @med.miami.edu

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