Pharmascience Inc. v. Meda AB et al - Nov 16, 2021 - Part 3

4:03PM Nov 16, 2021

Speakers:

MR. de SOUSA

JUSTICE ZINN

Keywords:

batches

document

pharma

validation

launch

milligram

exhibit

pms

fc

noc

scroll

manufactured

chang

page

science

correct

date

december

witness

email

Sorry, you may have to zoom out a little or if you can scroll down on on page eight. And then if you see there's the section forecast reports. And there's two scenarios. And there is reference to launch first to market reg approval being a 50% chance and launch second to market being a 50% chance. So again, anticipation of potential generic competition as of this time in 2013. It's a

possibility, yes.

When in fact, it's, uh, you've pegged it at a 5050 chance that someone may beat you to market.

The reason we put 5050 is because we don't know. So that was the reason for that.

And if we could turn up PMS production 143, which is which was marked as exhibit 11, I believe. And I believe as of this timeframe, if we scroll down, we'll see the same reference to a 50% chance of being first to market 50% chance of being second. Yes.

If you could actually scroll back up, please Miss torrent? Okay. And we see there's a reference in the projected launch date. And I believe you discussed this briefly this morning to NOC plus five days for narcotic lock license. And I just want to clarify, confirm that's five business days, right. That was the assumption Yes. The quickest possible would be five business days.

I don't know if that's the quickest possible that was the estimate we use.

And then if I could ask to turn up at PMS, 144. And I don't believe this was looked at this morning. So I'll give you a moment. Midship Do you recognize this document?

I do. It's the stage report for zolpidem, passing the submission gate.

And I would ask that we mark this at the as the next exhibit and it's FC number is 203.

C 203, then is exhibit 23.

And if you could scroll down a little please Miss Torrance. And what I want to look at as the launch assumption, so if we can maybe move it over, I know, the the window of our images gets in the way so that Miss ship can see the whole statement. So you're gonna have to move it to the you're gonna have to scroll to the right so that we can actually read the launches there. That does it. You're good. Can you see that now to midship? That works for me.

Yes, I can. Okay.

And, and so here we see the reference to a new patent being listed. And and there is a and it goes on to say either someone files before PMS, then we would launch it their decision or we are first to file and we launch it our decision. And it says in both cases will probably be same time. So when the patent was listed, the expectation was that either you pharma science or another generic was going to have to file a notice of allegation, correct?

Yes.

And I and filing in NOAA, I think you went through that this morning. But that means sending a notice to the innovator company here being Valley in a meta about zolpidem. Yes.

And so, here whether you had to bring the end of the NOC proceeding or someone else did, you'd be looking at entering the market at the same time at the conclusion of the litigation. That's the reference we see here. Yes. And so at this point, you're no longer preparing to launch in March or April of 2015. But targeting I believe you said May 2016? Correct.

And, and that's because I believe your words was the launch strategy was now accounting for pnoc litigation or for litigation as opposed to based on right LaTorre approval.

That's correct.

And then at some point in early 2015, from a science you realize that Apotex received an NOC correct

i I'll take your word for it. I don't know when a protects got your noc.

And

so we'll go there in a moment. But you were surprised when Apotex received an NOC ahead of a pm NOC proceeding Correct? You thought any generic would have to go through the mental see regulations?

That's reasonable, yes.

And if we could turn to FCW, document number 287, please. And Miss ship in your role you're familiar with with notice of appliances, right. You've seen notice of compliance documents?

Yes, I have. Okay.

And I'll let you take a moment but can we scroll through this and

so she can see both pages?

Do you recognize this document?

I believe this is from the Health Canada and see bulletin board or their posting of noc. Right. Yes.

And it's showing the manufacturer is Apotex Incorporated, and the date of the compliance notice being December 31 2014. Yes, and if we just can scroll down to the we see the reference product is subblocks. Yes, and the company is Mata. Yes. We'd like to mark this as the next exhibit please.

24.

And so this shows us that Apotex received an NOC on December 31 2014. But you don't remember when farm assignment Science found out about have gone to having received an NOC

I did not know when we were aware of this No.

But it was likely shortly after it happened within a few months.

I believe so. Yes.

And pharma science had no control over the fact that Apotex received in NOC correct you couldn't have done anything to stop at the Texas NOC correct. And farm science was not involved in Apotex obtaining an NOC in December 2014. Correct? Correct.

And Miss shippin in your wall, you would have been familiar with IMS data you will have seen and reviewed IMS data over the years

Yes, in my role I didn't use it but I'm familiar with it the marketing department tended to use it more than I would in my role

in in pharma science had no way to to prevent Apotex from obtaining in an OC correct for zolpidem. Correct

and, and what Apotex did with it sold on product was totally independent of what pharma science was doing with it so good and product Correct. Um, and I'm gonna ask that we turn up PMS production 87, please and scroll to the far left And and so this is a document. I'm showing the IMS data for the zolpidem market in in Canada. And we'll happy to scroll across, can you slowly scroll across so she can see sort of the months that are covered? You'll see it starts in January 2015.

Just this has been if I can just say something as miss shifted indicates she's not entirely familiar with IMS material and indicated who she relies on for that. It occurs to me this I believe there are admissions on this document. So I don't know where this these this line of questions is going up. I'm just going to flag that. Not sure if the witness has already indicated her lack of familiarity and comfort with this type of data. So just flagging that right now in case I need to object I know that technology can be a problem, but I'll just say that for now.

Well, let's see what we get to.

Yeah. And so I know that I didn't start with a Do you recognize this? I'm attempting to orient the witness, and I don't appreciate the leading objection as to what counsel would like the witness to do with it. I hadn't even asked a question yet. But we could finish scrolling to the right. And just show the the end date month we can't see it. So you're gonna have to move it to the

left. Is December 2018.

Yes, I just want to make sure Miss ship can see it. I believe she and I have the same setup and so that the pictures were in the way can you see it now? Miss ship?

I see December 2008. Yes. Okay.

And so have you seen this particular document before with the IMS data for sub lanoxin in the time period we just scrolled through?

I don't believe I have

in would you have seen documents like this about the sub sub Linux market at the time when you were in the role?

No, I would not.

And you aren't personally aware of when you don't recall when Apotex made its first sale of zolpidem in Canada,

I don't know.

Before we leave this document, Miss Barrett, and and I don't know whether agreement there may be with respect to it. But I'm wondering if we shouldn't be marking it for identification just so that I can attach it to this last little minute question. Is somebody going to have done

it's agreed upon so I'm assuming we could mark it as a full exhibit. I wanted to speak to Miss ship about it if she had seen it previously, but I believe the document itself is already agreed upon. So you can give it an exhibit. We can give it an exhibit number.

That's fine. It'll be one less document for Mr. Vincent to address on Friday morning. So we're content to have it marked as an exhibit.

Okay, so what I've seen number is this document looks like so you're talking over each other 146 146 That will be exhibit 25. Thank you.

In Michigan Apotex is pharma sciences top competitor, correct.

What do you mean by top?

It's their most significant competitor. It's the largest generic company in Canada.

It's a major competitor to farm science. Yes.

It's the largest generic company in Canada has been for many years.

It is yes.

And it was the largest in the 2014 to 2018 time period.

Yes.

And in it I just wanted Make sure because I think I'm not sure the original answer was was clear but Apotex is pharma sciences top competitor correct.

The reason why I'm struggling with that is it depends on the mole kill because we don't compete against a protects with all their molecules. So it's molecule specific.

Well, so in general in your time in the sales department at pharma science, Apotex has been the primary generic competition for pharma science Correct.

Not it's a major competitor to us, but I wouldn't call it primary because there's many other generic companies in Canada that are major competitors as well. So it really is molecule specific

so Miss ship Do you remember testifying in a in a case this summer on July 22 2021 In PMS versus Pfizer Canada, does that sound familiar? Yes. Okay I'm gonna pull up a transcript from that proceeding page 304 to 305 from the July 22 2021 day and you were under oath when you testified and in that trial correct Yes. Should be page 304 to 305 Sorry we're having a moment of technical difficulties

Yeah

Give us one moment please Apologies. Okay, I think we should be back in business will be show screening in in a moment here. We found the date. And if I can turn your your attention to page 304 You'll see there's a question starting at line 26. In your time in the sales department selling department at FAMAS science who have been your primary generic competitors and the answer is at the top of page 305. The top competitors would be the first one would be Apotex. Second would be Teva, and then activist Milan and Sandoz would be other significant competitors. Midship where you asked that question, and did you give that answer? Yes, I did.

Sorry. Just as in the witnesses being misled. We can run a breakout room. But

wait a minute, wait a minute, wait a minute. Can we ask the witness to be put into a breakout room while we have this discussion? Please?

Sheena Graco D'souza fears you can go ahead. Okay, what's your objection here?

So this isn't message ships transcript with Raman, which you can actually see at the bottom of page 306, line 20 I know because I lead Miss Raymond, I asked her this question. And my friends have the index on the front page. So my friends put a misleading question to miss ship. She agreed with it, I guess, mistakenly. But it's it's completely improper. I mean, it's just wrong. But it's improper. It's it, my friend should be misleading witness like this.

Um, obviously, as we just saw on the page we are on there's transcript on this day of both witnesses, and it appears that may have been confusion. It was certainly not on purpose. But there is transcript from both witnesses on this day. So

I don't know what the solution is. There was an answer that Miss ship said she gave that testimony. It's clearly not true.

I didn't think of back in and tell her that she didn't in fact, make that Thank you. Thank you. Miss Raymond. Is that you say it was

Miss Lynn Raymond, who will be testifying on I believe, Wednesday or Thursday this week.

Okay. Let's say let's be Miss shipped back in.

Thank you, Miss ship. during your absence, it was pointed out that in fact, the statement that you were taken to in that transcript was not made by you. It was made by Miss Lin Raymond. So your answer, as people are fond of saying you miss remembered? You're gonna strike you answer from the from the record, you did not make that statement. Thank you. And Miss ship.

Do you disagree with Miss Raymond's characterization of the market?

I have no reason to disagree with it.

And lastly, I would ask if we could pull up pharma science 150. It's FC 209. In midship, do you recognize this document?

Yes, this would be a subsequent gait a commercial gait report for Zopa.

And I'd ask that we mark this as the next exhibit

is exhibit 26.

It looks like this one is dated March 29 2016.

Correct? That's correct. Yes.

Okay. And so this is, this is about nine months before approval in the real world. Having been December 2016.

Yes.

And midway down page one in the project history highlights section. Are you able to see that blue box with the

I can't see the far right of it.

Let us see if we can move it here. That's better. Thank you. You'll see in the the second paragraph, there's a reference to during the validation of the 10 milligram strength at Abrams, Oh, s results were obtained for the dissolution F two. And then it concludes that therefore an additional quantity of API needs to be ordered in order to have sufficient API to complete the validation at at Royal Mt. Are you able to see that? Yes. Okay. And in OH S that means out of specification? Yes. And so this indicates there were issues with the 10 milligram validation batch.

With this particular batch, yes.

The dissolution test results were not within the regulatory limits.

I'm not technical is not your area of expertise. So they were out of spec. I don't know what that means. Exactly.

Okay. And this is this was a problem for regulatory and marketing purposes. It needed to be corrected,

needed to be resolved in another batch produced, yes.

Okay, so you would have needed to make new new tablets and retest?

Yes.

Which would have required additional time? Yes. And also, as we see here required additional API.

Yes.

To make the extra batches you hadn't originally planned on?

Right, we had enough API to do the validation and Abrams, we would need more API to make it up to do the subsequent validation at Royal Mt.

And that needed to be completed in the validation completed in order To enter the market, correct?

Abrams only not Royal Mint.

And I believe you, you said earlier you, pharma science received its notice of compliance, it actually received the copy of the notice of compliance resulted in on January 5. Yes.

And what did and we discussed earlier, but you would have needed another five business days approximately for the narcotics license, at least. Yes. And so that having been received on a Friday, you would have been looking at, at a minimum, January 12 as the earliest date.

I don't know if it's at a minimum, I know we use five working days as the projected amount of time. So whenever we received it, we could sell after that. It could be less it could be more I don't know. And

did you see any documents in the gating report reviews we've done today that suggested it would be less than five days? No. Thank you very much like Miss ship. That's all of our questions.

Thank you. Thank you. You have any examination? No, you're

No, Your Honor.

Thank you very much. Miss ship, you can log off.

Thank you. Thanks.

No justice. Then we had used our friends. We had use our friends timeline and asked Miss Chang, Serna Chang who is the next witness to join at 1145 So maybe if we just take five minutes, we can contact her now and ask her to join immediately or let's let's take

10 minutes.

Justice then my apologies. I am being told I might not have marked that very last document. Document 150 It's FC 209. The last document that we were

see tonight is exhibit 26 Okay, Mark

if we can go a whole trial without somebody forgetting to mark an exhibit it'll be the exception to

the rule. My friend and I are already guilty today. So here we go.

But that wouldn't was more. Okay, let's take 10 minutes and you can contact her and then see where we go.

Okay, thank you so much.

Thank you very much.

recording stopped Oh? Check 123. That's live transcription test one two. Again 123

Yeah,

just I'm just I'm doing that so I can keep the transcription the deck connected.

I understand. You're just speaking to this time. The chicken

you so can you hear me?

Miss Chang? Yes, I can hear you. Okay, perfect.

So we'll be restarting in a few minutes. I'll put you in the waiting room in the meantime.

Thank you resume. recording in progress thank you right away. Yes, please?

Well, yes.

Are you ready to be sworn in? Yes. According to what I have here, you've chosen to make a solemn affirmation. Is that correct? That's correct. Okay, so to start, I'll ask you to state your name, your occupation and your professional identities.

So my name is Serena Chang, my occupation is Senior Project Manager. And you said the occupational address. So so my address is the 766 0/5 Avenue in Laval.

You'd only affirm that the evidence to be given by you to the court shall be the truth, the whole truth and nothing but the truth. Can you say I do. I do.

Thank you, Miss James, did you roll the Thank you.

Good morning, this thing in my name. Can you just confirm that you have no document in front of you and you're alone in the room there?

That's right. I confirm there's no documents in front of me and no one in the room

with me. Okay, thank you. Where are you currently employed?

I'm currently employed at pharma science.

And what is your current position?

I'm a senior project man. As part of the r&d Global department,

how long have you had that position for?

So I've been in this position since November 2020.

And what are your current responsibilities?

So I have to seek approval for all those see submission that we have with health authorities.

And when did you start working at pharma science?

I started working at pharma science back in 2012.

And what were your first responsibilities when you were hired?

So my first responsibility Whereas as a project sorry as a process validation specialist part of the process validation team

How long were you in that position

I was in that position for one year

and after that one year where did you move in the company

So I moved to the cleaning validation department As a cleaning validation not a specialist

and How long did you hold that position for

So I stayed there Are for about two years until April 2015

And where did you move at noon April 25

Okay so in April 2015 The project management team as a junior project management Project Manager sorry

And after In that role in 2015 Did you change roles

Yeah so I was promoted to Project Manager in November 2008 And then afterwards recently too Senior Project Manager

Thank you now are you familiar with the molecules open them

Yes ma'am

and when did you first become involved with that molecule

So when I first joined the Project Management Team in 2015

And what are you expected to do in that role First of all

so is expected to complete the commercial activities that are required For the launch Stop eating

What was the status of this whole But then project when you join that project

So we have received the IP hold letter from Health Canada regarding the dosi And We were also involved in a little litigation for Win We were waiting for a favorable decision

Do you have to do any training or work to become familiar with the file

yes the price project manager was Sin Pascal was stolen who provided me that training on the phone

and when Steps remain to be done when you're doing In 2016 So

we had to complete All the commercial activities for long At point a launch date was planning For late 2016 And it kept on shifting

Now had pharmacists manufacture Have any batches of PMS open them as of the date you joined the project

Yes we had We had manufacturer r&d battery submission batches

okay thank you and just as then I won't bore you With the details but in the agreed statements Facts paragraphs 3132 and 33 there are details On the submission batches that were made manufactured by Pharmascience of PMS old No Miss Chang Did you have to order any zolpidem here When you began as project management Only 15

I did not have to worry order because there was already an order in place

And what was the quantity in that order that was in place

it was 43 kilograms of API

And you had determined the question For that order

so the quiet is established base On the demand from the marketing team

And did you discuss the expected loss State with anyone when you took over As a project manager in 25th

Yes So we did discuss about the launch State and They kept on shifting to the ongoing litigation

Thank you I'm going to put a document up on the screen It's farmer signs pretty Section 165 and 50 courts benefit that's FC 224 Just bear with me one moment I'm just gonna reorganize Is my screen

here sure

And can you just begin by telling me Do you recognize The document that you see on your screen there

Yes I do What is it

so this is an email that I sent regarding a meeting for zolpidem odd

okay Just as in can we mark that as the next exhibit

exhibit 27

Thank you Now Miss Chang When did you Send us email

So this email was sent on On January 20 of 2000 16

m Looking at the first line of your Email in blue it's Thank you for your presence at today Meeting what does that refer to

refers to a meeting that we had Add on top it I'm earlier that day What was the purpose of that meeting the purpose The meeting was to discuss an aisle All the commercial activities that need To be completed before launch

and What was your expected launch date At this time if you know from This document

yes I think It's mentioned if you scroll down a little bit Further down yes so it was January 15 2007 70

And what was the man manufacturing strategy for the launch At this point

So we will Have to Complete validation batches from both sites, meaning Abrams and Ryan mount and launch from the large, larger site, which is where a month?

And what prior work, if any, had been done at the April's manufacturing site.

So the prior to this date, is that what you mean? That's right. Okay. So we had initiated the validation batches.

And what sort of work needed to be done in order to manufacture zolpidem at Royal Mint?

We need to scale up the batches on larger equipment.

Okay, and if we can just scroll up a little bit to the top of the second page. It says, Dear all you will find below the presentation for this afternoon's meeting and what does that refer to?

So your first to an attachment, PowerPoint presentation that I was going to use during the meeting?

Okay, so we'll close that document and open up pharma science production 166, which is fc two to five. And Miss Chang, I've got that on the screen. And by the way, if you'd like us to scroll just instruct us to scroll or enlarge at any time. But I'll just begin by asking you Do you recognize this document? Yes, I do. And what is it?

So that was the presentation that I have attached? For the purpose of the meeting?

Okay, just as in can we mark that as the next exhibit?

It'll be exhibit 28.

Thank you. Now, can we just turn to the third page of that document? And Miss Chang, can you just explained the slide?

Yes. So basically, this explain a bit the the strategy for the launch of zolpidem. The first line is regarding the five milligram strength, basically, to complete the validation at the Abraham site, which is a smaller scale batches, then complete the validation on the larger scale batches that were amount and eventually be able to launch after that. On the second line, this represents the situation for the 10 milligram. So we were adopting the same strategy, except that we have encountered an O S, on the validation batch at Abrams.

And you're referred to Royal MT is that what the RMT refers to in the center of that page? That's right. Okay. And oh s situation, what does that stand for that acronym?

So it stands for our specification, okay, and what does that mean? So it means that the results do not meet the specification establish,

okay, can we turn to the fourth page of this document? And you just explain to the court what you were communicating with the slide.

So, I was expressing that the situation or the plan of action for zolpidem ODT, five milligram basically, the validation batches were completed from the Abraham site. We were planning to go manufacturing engineering batch first at Ray amount, followed by then the validation batches. And then we would be have a readiness for launch.

And and we turned it the fifth page. And you just explain what you were communicating with the slide.

Yes. So to the OAS, that was encounter, we had to complete the investigation for the 10 milligram at Abrams site, following that then update the masters and complete the manufacturing of the validation lotsa at a brand site and issue the Validation Report. So then afterwards, we could move to the engineering batch at random on site and followed by the validation batches as well and completion at the world on site, so that we can complete this activity and be ready for launch.

Now we'll close that document and I'll just ask you about someone named any boy. Are you familiar with someone by that name? Yes, I am. Who is she?

So she's responsible for overseeing the process validation team.

Okay. And did you communicate at all with her in respect to the zolpidem project?

Yes, I did. And she supported me for any activities related to process validation.

Okay, thank you and justice, and that's a witness that's coming before the court later. So we'll turn them to PMS production farm assigns production 157, which is FC 216.

And I'll just ask Do you recognize this Oh hold on one second we're having technical difficulties Ask And we'll just scroll down to the Bottom Just for some context here And I'll just ask Do you recognize this document

Yes

I do What is this document

so this is an email that I sent To start team to be able to call Five which lots could be Use for lunch

okay and then we mark that as the next exhibit just Then exhibit

29

And when did you send That email

cycle To the email it says December For first 2016

okay and Can you just explain With reference to this portion of this email it's read what the Purpose of this email was

So basically it's to explain which lot could be used for launch as some batches manufacture we're Short dated

okay and what does Short dated me

Short dated means that they will have less than six months of permission shelf life at launch

Okay And why does it say here on this page He took the five milligram strength at eight drums could not be used for launch

because people Short data

There's a lot number obviously give you the number right now 496085 and gray tech Next under the five milligram Where was that one man factory

so this batch was manufactured at remote

Okay I'm gonna close that document and turn out Pharmascience production 158 which is FC 217

And I'll just Have a scroll to the bottom of that die document again To begin with, do you recognize this document? Yes, I do. And what is it?

So it was an email for which I was informing certain teams that the release of salt BM would take have priority over another product to be released around the same time.

Let me mark that as an exhibit, just as in for I forget,

exhibit 30.

And when did you send that email to the team?

So this email was sent on December 5 2016.

And why did you all you said there was zolpidem, you had to inform the team about zolpidem in relation to another product and what was the other product?

It was an Fadiman XR,

and why did you need to let the team members know about the priority situation?

So in case there's any capacity issuing the teams, they would know which one to prioritize.

Okay, now, there's a line on the first page, we'll just go there. It's in gray, and it says 496085, packaged in 683, eight, et cetera. And what's the 496085? What does that refer to you?

So that's a lot number of the bulk that was manufacture for the five milligram.

Okay. And when you say bulk, what does that refer to?

So it refers to the product that was manufactured and not packaged yet.

Okay. And I'm just going to turn temporarily to PMS 25, which is FC 84. And do you recognize this document Miss Chang? Yes,

I do. And what is it? So this is the executed batch record of the bulk plot? 496085.

Okay, thank you in advance, we did mark that as in the grid,

exhibit 31.

And then if we just turn to page three of this document, and maybe just zoom in a little bit for tangs benefit. And can you just tell me when and where the bulk lot for 496085 is manufactured?

Yes. So this was manufactured on in July 2016, we can say see the date indicated the word says date, fabric, so on the document.

Okay. Thank you. And then just back to page one. Can you just tell me the batch size for that product?

Yes. So this was a batch size of 500,000 tablets.

Okay. And so then I'll just go back to FC 217, which was exhibit 30. And what does the number there? So we're looking on that screen it says packaged in 600 838. And what is this 600 838 referred to?

So this is the lat number assigned to the package product from the box number 496085.

Okay, and what was the expiry date then for that lot?

For the package lock for

the 600 838. Okay,

so assuming there's a 24 month shelf life, it means that the expiration date would be July 2018. Okay,

thank you. Now, we'll just switch topics, we can close that document. And just as an aside, just as then we have agreed statement of facts paragraph 27 and 28. Pharma science received its NOC in respect of zolpidem, tartrate, sublingual, orally disintegrating tablets, five and 10 MG on December the seventh 2016. And then paragraph 28, December 15, of 2016. is the date that pharma science began selling its PMF zolpidem product. And Miss Chang, can you just explain to the court why pharma science did not begin selling zolpidem on the date that it received? Its NOC

Yes. So So basically, we had to receive our updated commercial license or narcotic license for as a PM before we would be able to

launch the product. And how long did that take?

Like a few days? Yeah, it took a few days.

Okay. And where ultimately was the five milligram zolpidem product manufactured for launch commercial launch?

So the 5 million was launched from the Abrams.

Okay, where was the 10 milligram product launch from?

Sorry, I went too far what I just said. So the five milligram was from the gram on site and the 10 milligram is from the Abrahamsson

Okay, thank you I was concerned to thank you so much. Those are all my questions and I think opposing counsel will have some questions for you now as well.

Thank you. Welcome. Thank you very much,

Mark

so I, I think it's 1130 We can go to the lunch break. That should be enough time but I guess we can sort of reassess around then. If that's okay with you justice.

I have cross examination for an hour that about right

Well, I think my friend went to a few of the documents that might have speeded Quicken things up so I'm hoping maybe we can get under that but I mean, your hands

on in your hands, it's 1130. Normally I wouldn't take a break for another hour. I see. We have to afternoon. I prefer we push on that.

That's fine with me. was Jane can you hear me okay

yes I can hear you okay

you mentioned You joined the project manager role on April 25 That's right And I think you said you You receive some training from Mr Pascal

Yes from Mr Pascal

yes Mr Roscoe my apologies And that would have involved getting you up to speed on the project and everything that occurred up until that point like to turn to exhibit 11 which is actually See 202 Is this a doctor If you've seen before, you would have seen.

Yes, I have seen this document.

And it's a commercial gait report.

That's right.

I think it's dated. And just let me know if you want me to scroll around or zoom in, but this one appears to be dated February 2014.

Yes, that's what it's indicated on the document. Okay.

And at this point, the development of PMS zolpidem is underway.

And that's right. I believe it was even submitted already.

I'm not sure if it was submitted already. I think we heard that it was made 28th or 29th 2014 when the NDS was filed, or maybe we're confused.

Okay. Yeah, no, that's right. Sorry, I just saw the submission date and dictated on the document. It says May 29 2014.

Okay. And at that point, that was the plan date were a little bit earlier than then may 2014. as of the date of this document. Okay. Um, and we see that the projected NOC date. That's the notice of compliance date is March 30 2015. At this point,

that's what's indicated on the document. Yes.

And the projected launch date was April 9 2015.

Yes, that's what's indicated on the document.

Okay. And so at this point, farm science was planning to launch its PMS, zolpidem product around this time.

That's what was playing at that time. Yes. Okay.

And I think we also heard earlier today, and maybe you can confirm that farmer science had not manufactured validation batches at this point.

As at the point of February 2014, correct. That's right.

And that's not surprising because pharma science typically does validation batches about a year prior to anticipated launches.

As a will depends on the launch strategy. But the that's, that could be one of the plan that we would have. I was not involved at that time. So I would be able to confirm, okay.

If we can move to FC 206. I'm not sure if this is a exhibit yet. This is another commercial gate report. Seven, I think it's exhibit 17. Apologies. This is another document you would have looked at as part of your onboarding to your role in 2015.

Yes, I would have looked at or being aware of. Okay.

And this document is dated July 30 2014. Do you see that? Yes, I do. Okay, and in turn, if we scroll down a little bit, there's I think that's good. The last gate, we can see this submission was May 29 2014. That's what says indicated. Yes. Okay. And if we scroll down to launch drivers scroll too far. We see that it's litigation. And that's because at this point, Farmer science was aware of the patent being listed on the patent register. Are you familiar with the this sort of fact or underlying fact

and I cannot confirm that the date at which decade the report was issue, it was known as I was not. I was not the project manager. Okay.

What are we just switch back to 202, which was the document that we were just looking at. And if we can scroll down the launch driver there was regulatory approval.

That's what's indicated. Yes.

And at that point, that sort of the, the, the thing that would be holding back from a science from receiving its NOC is Health Canada issuing the NOC.

That would be my understanding, but again, I was not the project manager at the time.

Okay. And then I understand. Let's move to to production 150, which is FC 209. That's exhibit 26. So this is jumping ahead in time. And it's a data report from March 29 2016.

That's what's indicated. Yes.

And so this is one that you would have seen as part of your role as a product manager. That's right. And this is about nine months in advance of receiving a notice of compliance for PMS, zolpidem?

That's about right, yes, eight

or nine months. And if we scroll down to page

one,

there's the project history and highlights and I just like to flag that second paragraph and perhaps you can scroll over a little bit just to see and I think you touched upon this with my friend Mr. Jersey. But we see that during the validation of the 10 milligram strength that Abrams O L S results were obtained for the dissolution F two. Do you recall the out of scope results for that validation batch?

Yes, sir. I do. Recall we did encounter an O S for validation much of the time that would grant strength yes

okay and then it's also noting that an additional quantity of API needed to be ordered to have sufficient sufficient API to complete validation at Royal match

that's right Okay

and so pharma science encountered this delay or complication and validating its product

Is that a question

Yes

Yeah So we did encounter We did it countering always which of course added some delays in completing the validation From the Abraham site In order so we had to we did have to resolve it and it was results afterwards

okay

And that's all requires not only Additional But additional API to be ordered

so With the additional API was ordered to be able to connect Please the validation The Room on site yes

Okay

And I just like to Go to FC one Number 36

Now

I believe this is a validation Report

yes that's what's interesting Process validation report yes

Go is this the document that you would have Have seen as part of your role

Yes I do see the stuff document okay

And if we scroll down to page two We can see that There's three batches referred to To hear See Oh 371 Oh 372 And oh 373 Right Okay In. This is for 120,000 dosage form tabs.

And so that's the batch size. Yes, that's what's indicated on the top right corner of the, of the document. Okay.

Scrolling to page seven, please we see that that there's a manufacturing date indicated at section 1.4.

That's right. The manufacturing dates are indicated there.

And those are between June 4 and 15 2015. That's right. And, and so these were manufactured about 18 months in advance of pharmacy sciences anticipated launch.

And so about. Yep. Except that at that time, like I mentioned before, the launch date kept on shifting, but it's about there. Okay.

And this report was generated about 12 months before lodging in the real world begins January 2016.

So the report date is indicated on the first page, I believe. That's right. So yes, issue the 27th of January 2016.

Perhaps we could make this the next exhibit just a sin? See, 1362

I believe it's like corrupt and stupid. Cesar.

Yesterday, Mr. Josephson,

thank you exhibit 32.

Moving to pharma science production at wine, which is FC 140. This is another Validation Report.

That's right. That's another validation process validation

report. Okay, and again, that's for the five milligram dosage. That's right. And if we go down to page five, section 1.4. There's four batches here. It seems.

Yes.

And 491610. There's a superscript one next to it. If we scroll down, I think there's a footnote. And it seems that that batch was rejected.

And he said, That's what it says that it's it's not considered a validation batch. Okay.

Scrolling back up. And so there's three other batches here. I don't need to list them out. But those are the three that were manufactured July and August 2016.

That's what's indicated in the table. Yes. Okay.

And so, this batch or these three batches, were necessary for pharma science to be in a position to come to market.

So these batch needed to be completed in order to complete the process validation at the royaumont site.

Okay. And is that part of that is part of pharma sciences launch strategy.

And so, it's part in order to be able to launch and validation needs to be completed from a particular site. So this was completed doubt that was the intention of the validation.

Move to FC 130 Oh, maybe I can mark this one as well.

33 Thank you.

So FC 137 is my next document. This is another Validation Report.

That's right. That's another process Validation Report.

Suggested then I believe that was still FC 136 Was it not?

Now is SC 140 I believe. Okay, my my politics is exhibit 33 Is that correct? Counsel?

That's my recollection. Okay. Thank you. And so this one's dated December 19 2016.

That's what's indicated on the document. Yes.

And that's after pharmacy science received its notice of clients in the real world.

And, yes, the notice of compliance was shoot early December,

okay. These validation batches weren't available to Pharmascience at launch, or upon receiving their notice of compliance.

And I am not sure what these validation batches are trading about. So we can probably have more details if we go to the section where the list of all the batches

where do we go down to page six?

So I just remind notes, what document are we looking at now?

This is FC 137. And it's a validation report dated December 19 2016. And I'll let Miss Jang correct me if I'm mistaken.

Thank you.

That's correct. Yeah. So the the validation, the batches of that the Validation Report that were targeted for this are listed here in Section 1.4.

And these were manufactured between June 19. And the 25th 2015.

That's right.

And, if so, and that's just to confirm, that's around 18 months before receiving the NOC.

That's about Yes. The time with the expected launch date at that time, even if it was still shifting, yes.

Okay. And I think if we can scroll to page 78, we can jump down. Or maybe it's section 1.9 may have a typo in my notes. Okay. And just this conclusion, if you could read that you don't need to read it out loud. Just review it, please. Okay, and so what's this? What this is indicating is that the product does not consistently and reproducibly meet its quality attributes and product specifications?

That's what the last sentence says yes. Okay.

And so this was an issue for pharma science.

So basically, I believe my my colleague, anybody will be able to clarify this point. But as I mentioned before, before, and as we can even see, this was the initial validation that we have done, and that we have obtained an O S.

So I think we're seeing a couple o SS, or maybe that's what we were looking at in the summary sheet

was the same one. Yes.

Okay. Can we mark this justice in as the next exhibit?

34.

And then moving to FC 138? Is another validation report from December 2016.

That's the date indicated? Yes. Okay.

And I think this would have been a few days maybe in between the NOC and the narcotics license being received.

And yes, so the NOC was received December 7, I believe.

And moving to page seven three different batches. For the 10 milligram dose.

That's what's indicated Yes, in Section 1.4.

And these were manufactured between April and May 2016.

Yes, that's information that is presented. Yeah.

And these this is Another batch that was required for pharma science to validate and launch.

So again, in order to be able to complete the validation, prior to launch, we need three batches. And these are the three batches that we manufacture. Yes.

Is that to replace the the three batches that were out of spec?

And this is my understanding, but I'm believed that anybody would be able to confirm this. Okay.

And, and so just to recap, we don't need to share this screen moment. I think we saw a few validation batches, the first of which were manufactured around June 2015. Is that correct?

And, yeah, that's correct.

And that's about 18 months before the expected approval?

Yes, that's correct.

And then, I think we just covered was pharma science manufacture a second set of valid validation batches in April or May 2016. That was for the 10 milligram.

And that's, I believe, what you showed earlier, according to the Validation Report.

And we saw that there were some snags in the real world, a batch being manufactured out of specification.

Yes, yes, we did have an outer specification on a 10 milligram strength from the matt Abrahams site.

And this required further tablets to be manufactured.

Correct in order to be able to complete the process validation. Okay.

And further to the order.

Yes, so the further API was to cover for the right amount site manufacturing. Okay.

And just to jump back to exhibit 11. FC 202. And, at this point, this is February 2014, just to re situate ourselves

correct what's indicated on the document? Yes.

And at this point, pharma science was planning on launching in April 2015.

That's what's also indicated on the document Yes.

Apologies. I don't think I marked that last Validation Report, which was FC 138.

You did? No. I did. It'll be exhibit 35.

Thank you. And so returning back to exhibit 11. So this is about 14 months prior to anticipated launch.

And that's about Correct. Yes.

And what we saw in the real world was that pharma science manufactured validation batches about 18 months in advance of launch. June 2015.

Yes, that's, that's what, that's what was. That's what had happened.

Yes. Okay. And so in, in the real world, there was about four months more runway, so to speak. If here we're planning on a 2015 April launch

so yes, we can consider there was a four month difference. Although like I said that the projected launch date when I took over the project kept on shifting. Okay.

Why don't we go to you FC 216 And that's exhibit 29.

And I think you discuss this with my friend, Mr. draughty. This is your email chain from December 2016.

Can you would it be possible to scroll down just to be sure about the email that was initiated back then. Okay. Thank you.

Okay. And I think you went over this chart a little bit with my friend. And these are the different lots for the five milligram dosage and the 10 milligram dosage.

That's correct.

And we see that the Lot C 0371372 and 373. Were not able to be used.

That's correct. They were not used for lunch as they were considered short data.

Okay. And from a 10 milligram perspective, see, oh, 447457 and 458. Can can be used.

Sorry, so can you could you repeat, please?

This chart is indicating that those last three, I think this is the last three that we looked at 447457 and four or five, eight. It's projected that you could use these.

And that's what it's mentioned. Yes. Okay.

But the validation report that we were just looking at, that was from a couple weeks later, that's when it was issued.

And I don't remember the exact date that of the Validation Report. I ftsa was already It was December 2016.

It was December 9 2016. We can go back if you'd like to 138.

So yes, it's indicated the December 9 2016. Yep.

And jumping back to exhibit 29. Sorry, that 216. Just the next one. For the five milligram dosage form. We see there's three batches. 491611496085 and 600144.

Yes, I see those. Those lugs

Yes. And those are the three lots from the five milligram perspective that could be used.

That's what's indicated in the table.

And so, and there's three lots for the five milligram and three lots for the 10 milligram. It's I think it says for 491606. And let me know if you need to scroll over that was not available for launch. says no.

491606. The last, the last one of the 10 milligram you're referring to? Right? That's right. So it's indicated? No for to be used for launch.

Okay. You can go to FC two to four. She's exhibit 27. This is an email from January 2016. Correct. January 20.

That's right. That's what's indicated.

Okay. And I think you mentioned earlier today that you were discussing the project status for PMS, zolpidem,

that's correct. During the meeting, basically, that was held that day.

Okay. And this is about one year in advance of launching PMS, zolpidem in the real world.

It was about one year that's correct.

Okay. And Pharmascience had manufactured validation batches for the 10 and five milligram dose at that at that point.

So according to the other presentation that was included in the email, the validation was initiated and At that time, okay.

And then there would be the further validation for this 10 milligram, the second validation manufactured batch that had to occur. That was fun. Yes. Okay. You can scroll the page to

scroll down a little bit more. That's good. So this the, I think this is an email from you. You just want to review that for me and confirm that.

Yes. So it is signed by me. Okay, email. Yes.

And at this point, it seems that you're planning on launching January 15 2017.

That's what's indicated in this email. Yes.

Okay. And the timelines there were very tight.

That's what's also indicated in the email. Okay.

And this is despite having already manufactured some validation badges.

And, yes. As presented in the presentation, there was an attachment to this email. There was a plan to launch from the oil on site.

Okay. And just, again, reframe ourselves. We're to Google back to February 2014. That's when pharma science was planning on launching in March or April 2015. I think we've talked about that sort of being a 14 month runway.

That's correct. That's what was indicated on that document. Yes.

Okay. And but at that point, there hadn't been any validation batches manufactured.

In February 2014. Not that I am aware of.

Okay. And so, those timelines like, would have been tight as well, you would agree.

I cannot, I cannot make a judgement on on those timelines.

Okay. But in January 2016, when validation batches had been manufactured, the 12 month, projected launch was a very tight timeline.

Yes, this was what I have set in my email to to the activities and how the strategy was planned at that time.

Okay, so. So at that point, there was sort of a 12 month window to launch. And you had indicated that that timeline was very tight. And so as of February 2014, if we wanted to take the same steps to launch in 14 months, would you agree that that was very tight?

I'm not aware about the strategy at that time, and 2014. So I cannot make a judgment call on that. Okay.

Would you agree that a 12 month timeline in February 2014 would be very tight?

Again, I cannot make a judgment call on that. Since I was not involved about the strategy that was decided at that time. That's fine. Okay,

I'll move on. Let's go to exhibit 30. FC 217. I think this is another document that or email that you received.

It seems to Yes. Can we just scroll down a little bit just for me to put myself back in the background?

Okay. And if we go to page two we see you received an email from Sylvia on December 5 2016.

That's what's indicated Yes.

And there's four batches listed.

That's correct. That's four batches listed on there.

I think those are all the five milligram batch

and we can re verify with the table that I have built in another email.

Let's go back to that. That's exhibit 29 FC 216216 news there key so and maybe I don't know if we can split the screen FC 217

Okay, that's fine

Can you see those that? Okay, yeah, that's going to the left, we have exhibit 29. And on the right, we have a screenshot of exhibit 30. And so, this email was informing you what batches were okay for release in which we're not.

So, you're asking about the email from Sylvia? Yeah. Basically, she is mentioning the status of each slot, either whether they were packaged or not package.

Okay, and why don't we go back to the full version of it just to confirm these are all the five milligram

That's right. So they seem to be all the five milligrams okay.

217 So the first 1491611 That was okay for release.

That is what is indicated by Sylvia. Yeah.

And the one ending Oh, eight five that required retesting.

So only the bulk needed retesting the package slot did not need retesting.

So the bulk validation lot required retesting,

if we wanted to package it.

Okay, and that was required to use commercially

that step. So, basically what I've explained earlier was that the fault 496085 There was a certain quantity that was packaged into 600838. So that's okay. However, the remaining bulk if ever we wanted to use it would need to be retested before before being packaged.

Okay, that makes sense. The one ending 609 That was rejected.

And this is what is indicated in the email.

Okay, and likewise 600144 As with oh eight, five required, retesting.

If we would want to package it, it would need to be retested prior to being packaged. That's what it's indicated.

Okay. So, in order for you to use that badge, it needed to be retested.

If we want to use it for packaging, yes.

If you want to use it commercially.

At that time, it would need to be retested. Yes. On that date of December 5 2016.

Okay, so you couldn't use that batch at that time without retesting.

That's correct.

You can pull back to one six, maybe have a screenshot again. Yeah, if we can pull them side by side and it's difficult

So there was three batches in that chart that we looked at. And I think based on the chart that you had indicated that all of these would be available at launch, but indeed, the one ending 144 would not have been available at launch without retesting.

That's correct, it has not been packaged.

Okay, so not all of the batches in this chart would have been available, as indicated.

And so basically, what I have indicated was only the bulk a lot and not the package lot, if ever they were package that would be assigned another lot numbers. For commercial.

Okay, the bulk lot numbers in this chart 600144 It indicates that it is available at launch. But in that later email, we see that it wasn't available at launch without retesting. That fair?

So I wouldn't say that it is available is that it could be used for lunch. The purpose of the table was more to indicate which one was short dated, and which one were not and could be used for launch.

Okay, so the ones that you indicate could, you would need to do additional tests, though, to make sure that they were okay. from a commercial standpoint,

if we wanted to package them or if they were not packaged. Okay.

And that would have taken some extra time.

And, yes, so there are normal testing time.

Okay. And just maybe to recap. I think we saw throughout the documents that we went to that there's some issues that arise either short dating or lots being out of scope. Correct. validation requirements

not being met. So we did encounter and awareness during validation from a brand side. And once we were ready to launch based on a more firm date of launch, then yes, there was some batches that were considered short dated at that time.

And this might limit perhaps pharma sciences ability to supply the market at the relevant time. If not all lots were available.

And I don't have the demand numbers and I think this was evaluated at the time. Someone probably could. Someone else from one of my colleagues can probably confirm that though.

Generally speaking, if not all of the validation badges are available at launch. That's going to limit what was sort of anticipated to be available

I cannot confirm this as it really depends on the launch quantity and the demand that was planned by the marketing team. To go

to one other document, and it's at FC 294. And are you familiar with the website drug shortages.ca?

And no, I am not.

Yeah. Okay.

So I take it that you haven't seen this document before.

I have not seen this document before.

Were you involved with from a commercial aspect? And zolpidem in 2018?

No, I was not.

Okay. Are you aware of there being a drug shortage for PMS, zolpidem in February 2018.

No, I was not.

Justice and I think I'm, and maybe I could mark this for identification. It's not in the giant book of documents. I may put it to another witness.

Mark is exhibit one for identification.

And I think I'm nearly done, but maybe we could take the lunch break now. That's okay.

Let's take an hour in 15 minutes for lunch. And that brings us back here at 135, I believe. Thank you.

And your honor. And I just asked something to it, which is just I understood from the trial protocol at parties would be providing each other with copies of documents that they intended to put to the witness. It's just to be of assistance. So we have the matter. Fingertips can pull them up as witnesses are looking at them. And we didn't actually didn't get anything from my friends in advance of midships testimony or miss Chang's testimony. Just wondering if my friends could do that for any witnesses in the afternoon.

Yep, and I can send you that document as well. I think it's should be on the trial toolkit but it might be private or something.

Miss Jang is still under examination and this point you should not discuss your evidence with anyone from pharma science or its counsel. Feel free to discuss it with the cats and dogs that you must maintain silence and we'll come back then at 135 Perfect you. Thank you

for watching five was changed. You can stay logged in. I will put you in the waiting room in the meantime, that way you don't have to worry about reconnecting Okay, perfect. Thank you. recording stopped