Pharmascience Inc. v. Meda AB et al - Nov 16, 2021 - Part 4

6:29PM Nov 16, 2021

Speakers:

MR. de SOUSA

JUSTICE ZINN

Keywords:

batches

validation

manufacture

fc

purchase order

science

exhibit

document

api

invoice

abrams

pharma

product

record

validate

sap

martinez

supplier

date

milligram strength

Test CHECK AUDIO test check 123 Transcript test 123 And it's already too late resume

Thank you

recording in progress.

It is now resumed.

More questions of this witness Mr. Maher.

So I reviewed my notes and I think I am done with Miss Chang

I heard God or not Miss Chang, but Mr. Maher has no more questions for you

Yeah. Thank you for your time and and apologies for keeping you over lunch.

No problem. Okay.

Anyway, examination Mr. Growling

are not from us. Thank you, Miss Chang.

Thank you very much, Miss Jane. Where are you're finished with us. Feel free to sign off.

Perfect. Have a good day.

Bye. Thank you. And just as in we have we have a further witness coming for pharma science. It is Miss Paola Martinez, but I'm going to turn the screen over to Mr. stainsby. Who's waiting this witness.

Thank you.

Thank you. And we've we instructed her to join at 145 But I'll just tell her to join right away.

She's already been done. Yeah.

I think we're ready to go.

My name is Martinez. Good afternoon. Can you hear me I believe your microphone.

Oh, no. To hear me.

Yesterday, very quickly. Thank you. Perfect. Okay, are you ready to be sworn in? Yes, I am. Okay, perfect. According to what I have here you had wanted to swear on didn't have any more details on that I'm bipedal or Okay, perfect. In that case, I will ask you to state your name, occupation and professional address please.

My name is Paula Martinez. I work for pharma science and the procurement team as the manager of the direct procurement team. And my address is 26 channel go down not down Delhi pareho and the postal code J seven vs Victor zero why five?

Okay, so I'll ask you to place your left hand on the Bible that you have with you Yep. And do you swear that the evidence to be given to you, by you to the court shall be the truth, the whole truth and nothing but the truth? So help you guide please say aye. Aye.

Thank you, Mr. stainsby.

It's good. Afternoon, Miss Martinez. When did you begin working at pharma science.

I started working at pharma science in 2011.

And what was your first position?

I was an analyst in the laboratory for the analysis of raw materials purchased by pharma science for the r&d Center.

Here you you say you have a different role. Now, where did you move after your first role as a raw materials analyst?

I moved to the procurement team for the r&d department at Pharmascience. In 2012,

he said procurement what was being procured

it's the team responsible for buying the active pharmaceutical ingredients that I normally refer to as API's for the r&d Center.

Thank you, and what were your responsibilities in that role?

I was responsible for translating the requirements of material into purchase orders that would ensure that the materials would come with the quality and timely manner to Farmer science.

And did you move to a different role farmer science after that?

Yes, I was later promoted to strategic sourcing specialists within the same team

and what were your responsibilities is strategic sourcing sourcing specialist.

It was a little bit more of a strategic role in one of my functions. Comprised supervising and overseeing and training the person that took over the position that I left open.

And did you move on after that from that role at pharmacists?

Yes, in 2017, I was promoted to the manager position for the team responsible for buying APIs excipients and packaging components for both r&d and commercial operations.

Now it means Martinez, you've been with Pharmascience continuously since 2011.

No, I left from science in 2016 and came back in 2017. And he also hard to majority Leafs won in 2018 And one last year in 2020.

Now I'm gonna switch topics no Mr. Martinez and talk to you about the general process for ordering materials at farmer's science. And if someone determined that a material was needed for manufacturing a particular product, what was the first step in acquiring that material?

There is a requisition that is generated that requisition is transformed into a purchase order. And that purchase order follows a process to receive goods at Pharmascience

and who would initiate the creation of a purchase order?

There is either a team or a person we normally refer to in general as the buyer. So the buyer is responsible for generating that purchase order and making sure that the material comes at the right time the right quantities and with the right quality.

Once the purchase order had was prepared, what would happen

it has to be sent to the supplier

How would it be sent?

It sent electronically?

Great Oh, would you record the fact that an order had been placed?

Our purchase orders are generating in a system called an ERP that is called SAP and that system generates a record and automatically sends the peel to the supplier

and what sort of information would you enter in the ASAP system in respect of a given order? The

purchase order, you need to input the supplier name, the substance name, the quantity, the date for which you require the material to be received. And I suppose the price and the price of course yes.

Was it part of the usual and ordinary course of business to record financial traction? IQ transactions in SAP? Yes, Farmer science rely on the information in SAP for any purpose and if so, what?

Yes, we relied for inventory management for financial recording and reporting among many others,

and who would that data be reported to are used by

it's used by the functional teams? It's reported to management and management and upper management.

Once the data has been entered into SAP, can it be altered?

No, those records are permanent.

And the time you worked at for our science, could anyone enter information into SAP SAP?

No, there are specific people in the company that have access and specific functions have different levels of access and permissions.

Once an order was received by a supplier with anything additional we recorded in SAP

Yes, the supplier needs to acknowledge the order and the buyer is responsible for inputting that information in the system, the date of the acknowledgement.

And if you want to dated retrieve an invoice or purchase order for a product, is that something you would use SAP for? Yes. Can you put up a FC 153 Please? Do you recognize this document as murkiness?

Yes, that is an invoice sent by Glenmark for a purchase order of zolpidem. tartrate, an API active pharmaceutical ingredient and I was responsible for the purchase order at that time.

I'd like to walk through this to help the court understand how this record was created and stored. Can you explain what it relates to?

It's the invoice for an order. If you see on the upper right corner there is a buyer's order number that is pharma sciences. Purchase Order Number. The date is the date where the purchase order was issued. It tells you also ABC in the middle tells you what the substance is. So it's so bid intertrade, the quantity six kilos. It gives you the budget number and if you see a little bit lower, you have information such as the export authorization number, and the import permit. All those refer to documents and details of that specific purchase order.

micelle as Ms. Martinez saw the process for ordering this particular shipment absorbed the domain API commenced.

So for this one formulator scientist raised the need for this product. There was a requisition that was sent to me, I would receive it coordinate the duration of the purchase order, I would get a copy of that. Talk to the cubic recall the cubic is a qualified person in charge for her to request the import permit. I will send the electronic version of this purchase order to the supplier and ask them to confirm that you know they received it

or you mentioned the cubic the qualified person in charge. Who is that? Who is that person and what is their job their duty?

The qualified qualified person in charge is a person appointed by former science and recognized or approved by Health Canada that has the knowledge of what we call what Canada calls the controlled substance act and is responsible for overseeing all the activities related to management and utilization of the controlled substances within pharma science.

And what's the import permit? The import

permit is a document that tells the service border agency that Pharmascience is authorized by Health Canada to import that specific product that is a controlled substance under the regulations and laws of Canada.

So once you give the purchase order to this cubic person what happens then

the cubic needs to sign the purchase order that purchase order sign is sent to the supplier so that the supplier knows that we have the authorization by the cubic to you know, start the operation of purchasing the material. Then the cubic will talk to Health Canada there is a protocol that is followed and then we'll apply for an import permit. And then we would receive an import permit. The import permit, I would send that point I would send the import permit a copy of the original plus a copy of the PO original signed by the Kubik to the supplier for the supplier to be able to apply for an export permit.

And can you briefly explain what an export permit is?

So the export permit under the regulation of India zolpidem was also a controlled substance over there. So for the suppliers Glenmark to be able to export that substance they needed to have an export permit issued by the Indian government and the quantity that they would export needs to match the quantity that I requested and that was authorized by Canada with the import permit.

So once the import permit and export permit have been obtained and all the necessary paperwork is assembled, what happens then

the supplier prepares everything for shipment since the buyer in this case me the documentation telling you that the shipping, the shipment is going to come and then the buyer follows up on all the transit

tickets. What further documentation did they send you?

You normally receive this invoice you receive an electronic copy of the invoice you receive the certificate of analysis the packing list and the shipping details and then the supplier at the same time since the purchase sorry, the invoice to our accounts payable team,

our copy of copies of those documents or are they kept by a foreign science?

Yes, they are stored in SAP

and why do you keep copies? Why does farmer science keep copies of these documents?

Well, it's part of good documentation practices to standard in the industry.

Now this document we're looking at which is FC 153 Where did you retrieve this from from SAP just as just before I forget we mark this as the next exhibit please exhibit 36 Thank you very much. And does this document accurately record the quantities of materials and dates that the device and when did Pharmascience placed the order for this quantity of zolpidem

as you see in the top right corner? Date 26 03 2013 reflects that the purchase order number finishing 72 419 was placed on March 26 2013.

What are the details? Where are the details? Of the export import permit?

If you go to the middle part you will see export authorization number p dash e x p 7x Six slash 2013 That is the Indian export permit and then two rows below you will see import permit number i 1129 Dash 13

Okay thank you and now we're gonna like to turn to a new document this will be SC 179. Can you identify this document for the court?

Yes, that is the import permit that was granted by Health Canada for the purchase order for which the invoice we just saw on the screen.

Receive the permit number in the first box at the top there I went 129 Guys 13 Yes. Where's this document started from a science data store by the cubic the mark this is the next exhibit please just just send

exhibit 37

Thank you. We turn up FC 154 Please. And I'm turning up this document you recognize this.

This is another invoice from Glenmark for any other purchase order of zolpidem tartrate. API.

And with this all of the evidence you've given a with regard to the first invoice we looked at and apply to this as well. Yes. And is the data any accurate in the same way as universe we just looked at? Yes it is. And just to say I'd like to mark this as the next exhibit.

Exhibit 38.

Now we have a series of other exhibits invoices. There's seven or eight of them and I can give you the FC numbers just to sin and if my friends don't, don't object, I would propose to just mark them as as a bundle as the next exhibit because we're going to go through the same thing on each of them if otherwise.

I hear from

if that's fine with us, Your Honor,

rather than do it as a bundle let's do them each individually Mr.

That's that's fine. We've got FC 95 through 96. Give me the okay FC 152 and FC 155 5156 and 157.

Okay, so for the record UFC 95 is exhibit 39. I've seen it sixes exhibit 40 FC 152 is exhibit 41 FC 155 is exhibit 42. FC 156 is exhibit 43 and FC 157 is exhibit 44.

Thank you Now Miss Martinez you've looked at these prior to giving your testimony today and we've talked about doing that. I take it you'd agree that they you recognize them all that they're created in the same way and have the same qualities and characteristics as the other invoices we looked at. Yes. Thank you. Now I'd like to turn up FC 97 Please can you identify this document?

Yes, that is an invoice for the procurement of one Excipient called sodium saccharin.

And how does the purchasing process work for an Excipient such as sodium saccharin that's shown on this invoice.

The principle is exactly the same as for active pharmaceutical ingredients.

Except I suppose you don't need them import and export permits?

No, because they are in a controlled substance. You're right. Yeah.

And do these, how are these created in much the same way as the other?

Yes, there is a requirement the requirements translating into a purchase order, there is a purchase order being said follow up in reception,

and do these it does this invoice accurately reflect record the price that was paid for the material and the data was shipped? Yes. And where are these documents maintained it from a science and SAP as well. Like the mark this is the next exhibit please? Just the same will be exhibit 45. And just as before we've got a series of others it's FC 98 through 110. So FC 9899 100 101102103104105 and a six one a seven when we went on nine 110. So you could write it down. And you've looked at these again, Miss Martinez and they're the same Yes, same and they're kept in SAP and they accurately record what they were what they purport to record. Yes. I'd like to mark these as exhibits.

Any objection Miss Teuns No,

thank you.

Thank you very much. Okay. So I've seen 98 will be exhibit 46 And the line will be exhibit 47 100 will be exhibit 48 101 will be exhibit 49. One or two will be exhibit 5103 will be exhibit 51 104 will be exhibit 52 105 is marked exhibit 53 106 is exhibit 54 107 is exhibit 55 108 is exhibit 56 109 is exhibit 57 and 110 is exhibit 58

For sure much. Miss Martinez. His job is to keep these records.

The invoices it's the responsibility of accounts payable.

Alright, and now we have a series of documents. Maybe we can bring up the first one of these just so that everyone has seen one. FC 111 If we've made that available. Can you tell us what this document is?

Yes, that is an invoice for packaging. component that was procured by farmers science or the manufacturing of zolpidem tartrate finished goods.

And what's the process for preparing for generating the these invoices and purchasing packaging materials a farmer science

made goes through the same process of the excipients our requirement triggers a purchase order and then a purchase order triggers an invoice.

Where are these documents maintained at

pharma science they are also stored in SAP

and whose job is it to maintain these records.

Accounts Payable maintains all the invoices of the company.

The information on these documents complete and accurate. Yes it is. Now, I shudder to do this justice in but we've got documents 111 through 124 which you could mark those as the next series of exhibits unless Mr. On says in any objection. Oh, thank you.

Okay, so give it 111. Sorry, FC 111 is exhibit 59. He said to 124 accounts,

I'm afraid so.

I'm beginning to regret not doing these as a bundle. But I think we're almost done justice. I thought it would be easier for the registrar.

I think ultimately you're correct that it is easier to deal with it but I was just trying to be expeditious getting

there enough. Okay. So FC 112 is exhibit 661 61 114 is exhibit 62 115 is exhibit 63 116 is exhibit 64 117 is exhibit 65 118 is exhibit 66 119 is exhibit 67 120 is exhibit 68 121 is exhibit 69 122 is exhibit 7123 is exhibit 71 in 124 is exhibit 72

Thank you very much. Now, I'd like to turn up FC 262 If we could Can you tell us Do you recognize this document Miss Martinez? Yes I do. You tell us what it is.

It is an extract from SAP that contains the purchase orders placed by farmer science with Glenmark for the raw material API sold within tartrate

and the stock was used it was retrieved from SAP is that correct? Yes. Make the mark this is the next exhibit please. Just as in

exhibit 73.

Thank you very much. Now where does the data in column B purchase order number what does that what does that signify?

That is the unique identifier issued by SAP when you generate a purchase order. So it's the number of the purchase order.

Or any of these purchase orders on this spreadsheet. Ms. Martinez for the API voices we saw previously.

Yes, I'm sorry, line 11. You see the PIO number that finishes in 72419. Yes, I do. And then this is the one for which we saw the first invoice and we went in detail through it.

And we talked about how that information got inputted into SAP while moving through that

and

there's a column labeled original item delivery date that's a column I can you tell us what that this is?

That is the date for which the material was requested once a purchase order was placed.

There is a purchase order here in row 11 for an order where the purchase date is the same as the original delivery date. Row 11. Yeah, it's June 21. Sorry, they're not the same date.

That is the invoice date

numbers. ie the

purchase or delivery

date is 2603 and the delivery date is 2603 Both of 2013 Why are those dates the same

and indicates that the material is needed as soon as possible. Urgently immediately. You know as the process allows.

Okay. Now, looking at row eight for purchase order number four or 500093456. When was that order placed?

Or the replace was in February. 26th 2014.

And what was the original item delivery date specified to be?

It was requested for the 26th of June 2014.

And when did that order arrive at Pharmascience?

Sorry, I'm just removing the the picture review from zoom. The received date marks may 5 2015.

Why did it not arrive in June of 2014 and not then why was the arrival delayed until May of 2015.

There was a change made in SAP but I do not have the details as to why.

When you placed orders within Mark Frizzle the domain API Did you run into situations that caused you to be concerned about whether whether they would be able to provide the quantity requested

and no PVC they were able to supply the product within the you know 90 days roughly. Timeline

Alright, can we pull up please FC 187 Tell me whether you recognize this. Yes. Oh, sorry. Did I mark that last one did I not?

Yes, you did. It was exhibit 73.

Thank you. Now FC 187. Can you tell us what this is please?

Yes, that is the bill of materials. So that list all the components that go in the finished products will be the entire trade. Five milligram and then the second page you will see the 10 milligram

can we mark that as the exhibit the next exhibit please justice in

Yes, we can. But what is the next page she's talking about?

Yeah. Can we go down to this page to please. And you see that that says in the box in the middle at the top 10 milligrams. So the first is five second is 1074. Thank you very much. And if you could pull up a SC 244. Now please. And do you recognize this document?

Yes, that is the list of the packaging components that go into making the finished goods sold within tartaric.

This first page again is five and the second page is 10. Who does 10 for the 10 milligrams is that right? Yes. Mark that is the next exhibit please just send it 75 Thank you, Miss Martinez. Those are all the questions I have for you today. I'm assuming as Torrance May I have a few questions for you and thank you.

Thank you, Mr. Lawrence.

Thank you, Stephanie. Miss Martinez.

Good afternoon. Miss Taurus.

My friend Mr. Stains me took you to a couple invoices. But I'm going to take you to a few more and even though they are repeat I think it makes sense to go in chronological order. So if we could please pull up what I believe is now exhibit 41. It's FC 152.

So we didn't go to this one, but we did mark it and I just wanted to see if you as you did with the other ones recognize this document, Miss Martinez.

Well, it's an invoice for a purchase order of zolpidem. tartrate the purchase order was issued on May 5, not sorry, May 9 2012.

Thank you. And so that was going to be one of my questions. The order date was May 9 2012. Correct? Yes. And if we look at the manufacture date is August 10 2012.

manufacturing date of the batch Yes.

And that's the date that Glenmark was manufacturing the product, correct? Yes. As opposed to the date that Pharmascience received it.

Yes, that is the date we're seeing more manufacture that a specific patch that we received.

And so from May 9 2012 to August 10 2012. That's about a four month delay from order to manufacture date Correct.

May June, July, August, three and a half, three and

a half. That's that's fair. Thank you. And I see here that it is for three kilograms of zolpidem. Yes. And the cost is per kilogram. It's $800. Yes. And that is in US dollars. Yes. And so that would mean that firma science as a Canadian company when it was purchasing this would then have to convert the amount that it was paying over into Canadian dollars

well, we pay in US dollars to that specific supplier. i Sorry, I don't understand the question.

That's fair. I might have confused you. I was merely just saying that. US dollars and Canadian dollars were different. And so it would not equate equipment like it wouldn't be 100 Canadian.

Yes, it was 10 minutes, correct. It's not the same. Thank you.

And if we could then pull up what is what was made exhibit 36. It's also FC 153. And if we could scroll down a touch so we can see that this was for six kilograms of zolpidem. You see that yes. And back up if we may, the order date on this one I have as March 26 2013. Yes. Yes, this is marked as exhibit 36 and the manufacture date if we can scroll down once more. This is June 18 2013. Yes. So again, probably more properly two and a half but around a three month delay from the order to the manufacturer date.

In this specific case, yes. And

yet again, we see the cost is 800 USD per kilogram. Yes. And if we can now pull up exhibit 38, which is FC 154. And if we could scroll down. And so this is for quite a small amount of API here. This is 4.5 kilograms of zolpidem. Yes, and if we scroll back up, the order date is December 24 2013. Yes. And the manufacture date was May 3 2014.

Sorry, I'm just

no problem. Let us I don't see. Yes. Great. Thank you. And so then that would be about a five month delay between the order date to the manufacture date.

For that specific order. Yes. And

again, the manufacture date is not the date where farm science has this in hand, but instead you told me that this is when Glenmark is manufacturing this this batch? Yes. And again, we see the rate at 800 USD per kilogram.

Yes.

If we could pull up exhibit 42, which is FC 155. If we scroll down, you can see that this is for six kilograms of soap Edem Yes. And back up. The order date was December 30 2013. Yes. And the manufacturer date was May 14 2014. Yes. And again a five months away from order to manufacture delay. Sorry, from a five month delay for border to the manufacture date.

or month and a half actually. But yes, thank you.

And so just to recap, at this time from a science, if we were to calculate all of those numbers that we just went through the three kilograms the six kilograms the point five, and the fix has purchased 15.5 kilograms of API.

Correct. I didn't do the math myself right now. So I will assume that your calculation is correct.

Thank you. And the two most recent orders that we saw, so one, 4.5 kilograms, and 146 kilograms. We looked at the dates of the manufacturer, and we understood that they would actually be provided to a firm science afterwards. So those would be arriving sometime after May 2014.

Yes.

And overall, I we were you know, sometimes off a bit in the half months, but there was a delay of about two and a half to perhaps four and a half month delay from order date to when a tie was was actually manufactured.

Yes.

And if we could pull up exhibit 43, please. It's FC a 156. And this order we see now is from February 26 2014. Correct? Yes. And this was not manufactured until April 24 and 25th. In 2015, correct? Yes. And so that's over a year from when the API was ordered to when it was manufactured. Yes. And this amount was for quite a large This order was for quite a large amount of API it says 43 kilograms. Yes. So in the real world, Pharmascience did not receive this 43 kilograms until at least after April 2015.

Could you please scroll up and then I'll see well, yes. After April 2015. Yes.

And we do see here there is a change in cost. At this point there, the cost for the API is now $650 per per kilogram.

Yes.

If we could go to exhibit 44, please. That's FC 157. Thank you. And we see this is from April 14 2016. Yes. And if we scroll down, it was not manufactured until July 19 2016.

Yes.

And again, another three months between the time that it was ordered and manufactured. Yes. And the amount here is is 16 kilograms.

Sorry, and the amount is 16 kilograms. Yes.

And so I believe, and certainly you can correct me if I am wrong, but this was the last invoice for API that that we see before farmer farmer science launched in the real world.

I am actually not sure. I don't know for sure. And I prefer not to respond if I don't know.

I respect that. If we could please flip to exhibit 26 which is SC 209. So this we saw earlier today, our friends took both Miss Chang and Miss ship to this this gate document. And we heard this morning that additional API was needed to be ordered in order to launch in the real world and to orient you I will I will scroll down or have my friends go scroll down to the project history section if we could. And perhaps move it a little bit over. I am also missing part of it. So we we heard earlier. You see at the last sentence it says therefore an additional quantity of API needs to be ordered in order to have sufficient API to complete the validation at Royal Mt. Is it reasonable to assume then, that this order that needed to be placed was the one that we just saw from from April 2016.

Can you scroll down again and can I please read? Oh,

apologies yes, certainly take your time.

If you allow me can you say just a moment? Nope. Yeah. Okay,

and then can I see you again the date please, if you don't mind. Okay, so that is dated March 29 2016. And the date that we saw in the last I'm actually not sure if that is the case.

Do you have any reason to believe that that is not the case?

No, just not sure. But I'm also not sure so I'd rather not comment. It's something that I'm not completely sure about.

And if we go back to that 209 that exhibit 44. And scroll down. We can see that I did the additional API was needed to be ordered, whether it's from that that order that we were looking at or otherwise additional API needed to be ordered. Correct?

Yes, there was an issue. Maybe I don't need it to be or the recording to that document.

And for all the invoices that we we looked at here today. They were all from Glenmark. Correct?

Yes. The API invoices. Yes, they are.

Thank you for that correction. Yes. Regarding the API. They were all from Glenmark because in the real world Pharmascience only obtained API from Glenmark Correct?

No. There is no

there was no

sorry. clarify your question.

My question was that in the real world, during the time that we looked at the invoices, we looked at the that firm science only obtained ABI from Glenmark.

From the invoices you saw, yes. I'm not absolutely sure that there was never any other sample or material acquired.

And there was no agreement between Glenmark and pharma science in writing that memorialize any of the terms between them correct.

Which kind of terms sorry, I would appreciate if you can clarify.

Well, there was no requirement on Glenmark that agreed to the price of the API, for example. It was farm science put in an order for at the at that one price, but presumably, the next week Glenmark could change their price for API to something else. Correct.

Once the purchase order is acknowledge the purchase price remains the one that is in the purchase order. But for

future orders, if they weren't in yet. Glenmark could change the price of the API.

It is always a possibility, not necessarily something that happens in the real world.

And there's no requirement that Glenmark had to supply API to firm science Correct.

What do you mean by requirement?

So once a purchase order is in they are agreeing to supply that purchase order. Yes. But going forward, there was no overarching agreement that Glenmark always had to supply the API that was requested by Pharmascience.

Correct. Like a contract signed for that. Do you mean? Yes. No, besides the purchase order, which is a contract itself, no one knows something.

And you don't know what other obligations then mark might have had to supply zolpidem, zolpidem or other drugs to its to its other customers.

Know that I don't know that. Is there a confidential information?

And you don't know Glenn marks production schedule for soap soap Edem API.

Right now I don't know. The buyer is responsible. So I don't recall exactly the data, but the buyer responsible for being aware of that.

femicides does not own Glenmark No, it does not control Glenmark.

No No to do something that I'll let you know.

And so other than the quantities of API that Pharmascience actually received, which we can see in the documents, you cannot say that Glenmark could have or would have supplied more correct.

I cannot say that it could have been I cannot say that they couldn't have I don't have information for responding to that question.

Those are my questions. Thank you.

Thank you very much.

And you read the examination Mr. stainsby.

Nothing whatsoever. Thank you justice.

Thank you very much. Yeah, Miss Martinez. You can log off now. Thank you very much.

Thank you Miss McKenna's. Justice in it'll be madam boy a next time we'll have to get her lined up. So if we make it get 10 minutes just to make sure everything's all in order. That could be our afternoon break and I don't think her testimony is going to take any longer than this last one.

Okay, we will take a 10 minute afternoon break. Thank you. We'll resume at 230

Thank you.

Thank you

recording stopped Live transcription test live transcription Test Nothing is late.

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Yes I can hear you.

I can see you well. Should I do a few tests? Any questions or concerns? Before starting Cooper currently on break? We'll be back in a few minutes.

No, it's okay. I think I have to remove my background. Right?

Yes, ideally.

In that case, I will just transfer you to the waiting room temporarily until the judge joins us back and we're will be ready and again at that point.

Okay. Thank you.

It's ready to resume. I am

recording in progress

resumed I will bring this way you back

Good afternoon this way. You're doing well.

Good afternoon. Yes. Thank you.

Um, are you ready to be sworn in? Yeah. Okay, excellent. According to the information I have hearing you chosen to make a solemn affirmation. Is that correct? Yeah. Correct. Perfect. So first, I'll ask you to state your name, occupation and professional address, please.

Yeah, so my name is Annie way. I'm a Technical Service Director at Pharmascience and the address is 6111 where Mahtab new at Montreal.

That's professional address. Yeah. Okay. Um,

is

you solemnly affirm that the evidence to be given by you to the court shall be the truth, the whole truth and nothing but the truth please? Say I do.

I do. Thank you.

stainsby.

Thank you justice. Good afternoon, Madam boy. Yeah. When did you join Pharmascience

and the 2000 over 20 years ago,

and what was your role at the time? You joined?

I was validation specialists. I was responsible to write and execute validation protocol and report. And how long did you have that role? Until 2003? Then I became validation supervisor.

And how did your role change? So

I was responsible to supervise the validation team to approve validation protocol and report to train new employee and to assure that the validation schedule is respected.

And how long did you remain a validation supervisor

until 2009 Then I became validation manager

and what were your responsibilities on that changing?

So I was responsible of process validation and cleaning validation. And I was the expert validation during regulatory audits. I also participated actively to a new product launch and I was responsible to manage validation procedure and validation master plan.

And how long did you remain in that position? I've employee

until 2013. Then I became tech transfer and process validation manager.

And how did your responsibilities change at that time?

So it's signs responsibility as previous except the addition of the technology transfer a team responsibility. So the tech transfer team respond is responsible to optimize and transfer product from r&d to commercial facilities. And my team was also responsible to write the manufacturing instruction for a new product.

I forgot to ask at the outset, apologize to everyone. You're alone in the room and I take it you have no no documents in front of

you. Yes, I confirm.

What was your next role after becoming a technology transfer and process validation manager?

So in 2015, I became entering entering Technical Service Director, so I became permanent in that role in 2017. And I'm still in that role.

And what are your responsibilities as technical services director,

so still process and cleaning validation and technical service support? And so the technical service support is the is the technical support for a commercial product manufacturer internally and externally. And for processes improvement as the batch size change, API change or a site change? And then starting from 2019. I had an additional responsibility. So is the production department of OSD product at Candiac facility?

ca n di AC caveat. Yeah. Now you mentioned validation. Can you explain for the court what that involves? What it means?

Yeah, so is the data collection and evaluation through a process design stage to a commercial plant, which established scientifically that the process is capable of consistently delivering quality products? Usually, we perform validation after submission batches and before the regulatory approval.

Could you explain for the court what some submission batches are please man and boy, yeah,

yeah. So submission batches are batches used to do their work to submit the product to health authorities to get the approval. We use these batches to do the stability studies and also the beer week well and study and also these batches are used to prove that the product can meet all the analytical tests required as per finished product and stability specification

and how does Pharmascience approach value validation for its products?

So once the validation or the sorry the submission batches are manufacture and the validation protocol is approved, and the validation can start so we validate each product and then with three lot so we manufacture the batch, we analyze them and we issue a report. Once the report is issued, the batches can be released on the market.

And how does validation of packaging work?

It's smart streamline. It's a metric thing approach meaning that we don't have to validate on a product base, but it's more on the depending of bottle format, format and tablet shape.

And you mentioned validation requiring three batches of each product. How does that work when you have more than one strength of the product?

When we have more than one strength? We have to validate three batches of each strength.

Thank you. What's the general timeline for validation? And here I'm talking about of the strength rather than the package. Yeah,

so the first batch is you usually manufacture in nine months before getting the approval. So the launch date, and the two other batches are a manufacturer closer to the launch date, because we want to avoid destruction risks related to the expiry of the product.

No matter boy is validation only required on product launch.

Now it's also require uncommercial product when we make a change as the batch size change API or site change Exeter

turning to zolpidem. You're familiar with the pharma sense of the DEM product.

Yes, my team was responsible to validate this product.

Now I'd like to pull up a document which is SC two to four. Recognize this document?

Yes, it's an email change. That's sent out if regarding the launch of the zolpidem. So I was the CC on this email and Catherine who are from my team attend the meeting. And I remember discussing this with her

no stepping away from the document for a moment. What was the validation the original validation plan for zolpidem.

Zolpidem that the original plan was to validate first at the smaller facility Abrams, and then transfer the product of well mount and validate the product also at wire Knotfest.

Going back to the document if we start the email the bottom of the second page, what is being discussed here in this email from us or that

so that the launch date as the dam is planned for January 2017. So a year away and we had following issue that we had for the 10 milligrams train to Abrams for validation the timeline, get getting tight to achieve that launch is why Sakonnet called the meeting.

And do you recall why the validation for zolpidem had begun so far in advance of the anticipated launch date? Yes,

because we plan enough time to validate the product at each site, Abrams and

now looking at the first page of this document, can you tell us what was being discussed here?

Yeah, it was success to manufacture the engineering batch of the 10 milligrams trained at the same times as this the validation batch of the five milligram strength at weigh on Mount. An engineering batch is the batch manufacturer to confirm critical process pyrometer before starting a validation study, and I suggest the holding of the transfer of the 10 milligram strength at Hawaiian mount and until we manufacture the batches of the second validation study of the telegram straight at a bronze because from a regulatory standpoint, the principal manufacturing site for a brand for them was a brand

that's designed I like to mark this document as the next exhibit. XFC 224.

That's exhibit 75. Can you confirm that?

Sorry, that's Jonathan drew all the speaking. I believe that may have been marked this morning. As exhibit 27 with Ms. Chang. Sara Chang. Okay, yes.

47.

All right, we don't need to remarket them. Now, Ms. Boyer, you mentioned the Abrams site. Can you explain what that site was and how it was used?

Yes, so it was a separate facility. It was it was mainly an r&d facility and we also manufacture a few commercial product from there, and the site was closed when we transfer all the production to cantact site and this site was managed a bit differently regarding the planning, meaning that it was not true SAP, but it was a manual planning of the manual of the manufacturing.

Alright, can we put up FC 267 Do you recognize this document?

Yeah, is the manufacturing schedule from Abrams for January 6 to 10 2014.

What do we see on this page?

So we see every room so at the left and every day of the week, and for each each of them we can see the name of the product and the lot that will be manufactured.

And how does work did work at sheduled at Abrams

so the commercial lead got priority. And then after to fill in the capacity. We had the r&d Lots. If there is some priority or emergency for production, we move the r&d Lots and then also we can use the weekend to manufacture as needed.

Just as in I like to mark this as the next exhibit this being FC 267.

Exhibit 76

Thank you. Turning to page five of seven in this document. What does this page show us, Madam boy?

So it's the it's the same schedule but it's for the weekend. It's the same principle so it's for the weekend of January 25 26th 2014. So we can see that for that we can we plan work on some room?

No, I'd like to mark this as an exhibit. There are a number of other documents similar to this showing the utilization at this facility and Madam way you've looked at those documents and they take it they reflect and record the same kind of information for different time periods.

Yes, exactly.

And barring a an objection from my friend, Mr. Mara proposed to mark those documents which are pharma size productions, sorry, FC two six to 683 to seven eight as the next exhibits

no infection

I mean your hands just as if you want to do them one by one or as a bundle.

No, I'll do them by when I started that process. The last seven ages.

That's correct.

Okay, so, FC 268 is exhibit 77 269 is exhibit 78 to 70 is exhibit 79 to 71 is exhibit 8272 is exhibit 81 273 is exhibit 82 274 is exhibit 83 275 is exhibit 84 276 is exhibit 85 277 is exhibit 86 and 278 is exhibit 87.

I take you're aware of these documents, and boy can you confirm that they cover off the activity of Abraham's for the calendar year 2014.

Yes, exactly.

I could put up FC ad to please. And, Madam boy, can you tell us what this document is?

So yes, it's the manufacturing record the batch record for this epidemic five milligrams train at Walmart. It was a validation lab. And we can see on the first page the yield of this batch. So roughly 447,000 tablets

and how what was the purpose of this batch and how do we understand the yield?

So the purpose of the batch was to validate the product and the yield is the so we start with the quantity and the yield is the quantity that left at the end of the batch. For that because it's a validation batch. We took a lot of sample during process. So usually the yield and commercial batches are much much higher than for validation batches.

Mark this is the next exhibit SC 82 is justice.

Yes

now where you got on the screen FC 83 Can you tell us what this document is is matter way

Yeah, so it's a batch record also for the five milligrams training at wellmont.

In the free go to PDF page 33. And what do we see here? It's just a wealth Yeah,

so at step 12 We can see the the compression yield, so it's 93%. For this let

me explain to the for the benefit of the court what compression yield is. Yeah,

so it's the same as the last process step of the product is the final yield of the product. So isn't the tablet that left available for sale?

Mark FC 83 is the next exhibit please justice in the bid

89

Thank you and will you pull up SC 85 Tell us what this is.

So is the manufacturing batch record for this that then 10 milligrams trained at Walmart. And it's a it's also a validation batch. And here we can see that the yield for this lot was roughly 463,000 tablets

marked the CFC 85 as the next exhibit please just just know to pull up SC 136. With this has already been marked as exhibit 32. So I want to change topics now and talk ask you a few questions about Val about the validation for zolpidem. Do you recognize this document?

Yes. Is there a final process validation report for the five milligram strength at a Bronze

Age sorry, go ahead.

No so the date is the early February 2007. Six things so we can see from the last session that you're there. And the viola Nickleby when catkin were bought from my team and signed off on this document.

Turning to page seven of the PDF and which patches are manufactured naturalize as reflected in this report?

Yes, so the batches were at section 1.4. The three batches are there they were manufacture in May and June 2015.

Turning to page PDF page 26 What was the conclusion of this report?

The conclusion is that the process for the five grams strength at Abrams was successfully validated.

And what was the batch size for the five milligram dosage of Abrams

120,000 tablets?

Is that reflected in this document somewhere?

Yes, in the head editor.

You scroll up to the top of the page.

Just hear you can see it Yeah.

So then I'd like to put up FC 137 which has been marked as exhibit 34 In this trial. Do you recognize this document?

Yes is the Validation Report. For the 10 milligram strength that they brands. It is they from December 2016. And both Aviva Nick and kept him from my thing, sign off on the document

during the PDF page 16 Can you tell us when the batch is just

is that's

PDF page six. I think we're Page five one more page because when these batches are manufactured,

yeah, so they were a manufacturer in June 2015

and two pages further in PDF eight. Down at the bottom. What's the conclusion?

The conclusion is that the product is not validated for the 10 milligram strength at Abrams because we got the other spec result for dissolution profile.

And how significant with this conclusion in terms of the development of the zolpidem product, the pharma science.

So the failure app in there from time to time so we were used to manage and deal with this kind of situation.

Okay, now I'd like to put up SC 138. This is marked as exhibit 35. Can you do you recognize this document

Yes, it's the Validation Report for the second validation study of the 10 milligram strength at a bronze.

It's dated. It says it's

December 2016. And veronik and Catherine as well. Both from my team sign up on the document.

And if we go to PDF seven, when were the batches is subject to this report manufactured

from March to May 2016.

And if we go to PDF 28 What's the conclusion?

The conclusion is that the product was successfully validated the app a brand site

and the batch size is shown at the top again.

Yeah 120,000 tablets

SC 140, please this is marked as exhibit 33. Already justice then Do you recognize this document medically?

Yes, is the final process validation report for the five milligram strength at wellmont site. It is data from November 2016

and returned a PDF page five. You tell us when the batches are manufactured.

They were manufacture in July to August 2016.

Drilling to PDF 21. Can you tell us what the conclusion of this report is?

Yeah, that the process for the five milligram strength at wellmont site is successfully validated.

And the batch size for the five milligrams that rolled out was

500,000 tablets

Thank you. Keep it up. FC 142. Recognize this document.

Yes the final process validation report for the 10 milligram strength atonement site. Its date from December 2018.

And we signed off on this one

yeah. So Gina boy if you and Melanie Burnham both from my teams to sign off on the document

and would you have seen this at around the time it was issued?

Yeah, this was part of my regular duty

training to PDF six. Can you tell us when the batches were prepared or manufactured?

Yeah, just a little bit. So from September to November 2018.

And turning to PDS 17. What were the conclusions of this report?

So the conclusion is that the process is successfully validated for the 10 milligram strength at home at home on site.

Okay, Mark, this is the next exhibit this being FC 142 justice

in exhibit 91.

Thank you very much now just to recap what we've seen Medavoy Abrams, we saw that the validation batches for the five milligram dose were manufactured in May in June 2015. And the report was completed in February 2016. Yeah, for the 10 milligram dose at Abrams successful validation batches. Were prepared in May 26. Keen sorry. Report was completed in December of that year. 2016. Yes, that's right. And that royal mount the five milligram for the five milligrams of validation batches for prepared in the summer of 2016 and the validation report is completed in November of 2016. Yes, the 10 milligram at rollout the validation batches were prepared by November 2018. The Validation Report was completed in December 2018 Exact so pharma science was able to prepare validations batches of both sites. Yes, and so could have manufactured at both sites. Yes. I want to ask you a hypothetical question. Anyway, someone had come to you in mid 2014 and said that PMS was expected to get lunch approval for January 2015. Would you have have had enough time to complete validation? Yes. And what ability was there to expedite timing in this hypothetical?

Yeah, we can validate a product within a timeframe of three months.

In your experience, converse as a validated Zopa tender support a launch on January 12 2015.

Yeah, that that that's the plan for a new product launch. So to be ready for release at the date of regulatory approval.

Validation dashes to be sold. Yes. Now pharma science had validated three batches of five milligram the five milligram product that Abrams how many tablets would have had available for from the validation batches,

so roughly 260,000 tablets.

And the pharmacist said validated three batches of the 10 milligram product that Abrams how many tablets would ever had available for lunch?

Yeah, the same thing. So roughly 360,000 tablets.

Now I'm going to ask you to assume that pharma science would need approximately 800,000 tablets of the 10 milligram zolpidem for the first six months of sale would that present a problem in terms of manufacturing capacity?

No, it was about this seven batches to be manufacture at Abrams

and we're gonna ask you this in the fire science would need approximately 500,005 milligram tablets for the first six months of sale would that present a problem in terms of manufacturing capacity?

No, it's represent four batches at the Abrams.

Thank you, Madam Boy, those are all my questions. Sure that Mr. Maher will have some questions for you.

Thank you, Mr. Maher. Thank you,

Madam boy. Yes. Got a few questions about the validation batches. And maybe I'll start with Oh, FC? I think 142 Was that the last exhibit we went to?

It is exhibit 91

She's gonna ask Miss Torrance to pull it up just loading. So my friend Mr. stainsby took you to this document. I just want to confirm that this was this issued to pharma science in December of 2018. Correct? Yep. So this batch was not available to pharma science in December 2016.

Exact okay.

I'm turning now to exhibit 32, which is FC 136.

I think

Mr. stainsby took you to sort of the same questions I was going to I just like to confirm that if we go down to page seven. These batches were manufactured in June of 2015. Yes. And are you aware that pharmacy science received its notice of compliance for zolpidem in December of 2016

Yes.

So this is about 18 months in advance of receiving notice of compliance. Next I'm just going to move to FC 140. which I understand is already an exhibit

exhibit 33.

So this is a again, validation batch for the five milligram dosage form.

Yes. Acquire on Mount site.

Okay. And we go down to page two section 1.4. These were manufactured in July and August of 2016. Yes, and there's a batch for 91610. I think if we scroll down that one was rejected. Because a footnote

Yeah, maybe just scroll down a bit.

Much. Yeah.

So that was a situation where the five milligram dosage form was rejected during the validation process.

Yeah, the first batch. Okay.

I'm moving to exhibit 34. FC 137. This is the first validation report, I believe for the 10 milligram dose or it's dated December 19 2016.

This one is the second one. Okay. The first validation report was shown and this one is the second one so the successful one

okay, if Can we just scroll to 1.9?

Sorry, my mistake. Not Know it my mistakes was the first one the one that was not successful.

Okay. And I think this was actually manufactured prior to the second one. It just might be dated after the fact. I think that might be the confusion.

Yeah, so the batches were manufactured before the second study, but the report was done approximately at the same time.

Okay. So this validation batch was rejected. Yes. And if we go to just for completeness, FC 138. So I think this is the validation batch that you were referring to this is the second one. And that one was a successful one.

Yes, exactly. Okay.

Just for the record. That's the 35

Yes, thank you Justus. So, just to recap, I think Mr. stainsby did a similar recap for you. In the real world. Pharma science, manufactured a validation batch 18 months prior to launching PMS, zolpidem?

Yes, because we want to have enough time to validate the product on both sides.

Okay. And then a second validation batch was manufactured I think in May or June of 2016.

You're talking about the 10 milligram strength? Yep. Yes.

And that's because in the real world Pharmascience began validating their the validation manufacturing process 18 months in advance of launching. And this allowed pharma science to maneuver some issues with the manufacturing validation batches such as the issues with the 10 milligram dosage form.

Yeah, but we didn't need 18 months to resolve the issue. So it's possible to resolve this kind of issue faster than that.

Okay, but in the real world, that's the time that it took.

Yes.

And this also, there was additional time in perhaps I believe we heard that there was additional API that had to get ordered.

For that for the API. I don't I don't know the details about it.

Okay. In any event, additional tablets had to be manufactured. And these were steps that were necessary for pharma science to take in order to launch in December 2016.

Yeah, so we, we we can learn lunch, only from a brand's it was not mandatory to launch from both sides. So with the W that we the lot that we manufacture at a bronze, it could be possible to launch from there. Only.

The supply would be less though without having both sides.

It was the capacity that we had that Abraham it suppose it was possible, you know, to manufacture the number of batches require to support the six month the first six month forecast. So we talked about element batches to manufacture at Abrams well string together

and he's trying to look at exhibit 76. Maybe we can pull that up briefly. Sorry, it's FC 267267

Please.

I just have a couple of questions for you is my boy on this mic correct correction that this is a schedule the Abrams plant. So it's predicting into the future.

It's four to this per year from January 6 to 10 2014 we have separate the schedule is is done every week.

Okay. This was created prior to January six.

Yeah, we usually it's the week before. Okay.

But we don't know what actually occurred at the Abrams plant.

This this schedule was most of the time was follow at 90% of the time. So we don't have the all the information exactly. But I can say that as per my experience, the schedule is far lower, at least at 90 90% of the time. Okay.

But this doesn't tell us anything about whether all the machines were functioning properly.

And if the if I mention it does not work properly, and you will see a maintenance in one of the you know the that time so you for some of them you you can see and maintenance on the mesh on the equipment so it's what you will see on the schedule. If one equipment needs to be a repair.

We don't know if there's anything unexpected that happened that would prevent farmer science from being able to follow this schedule.

If something happened usually is resolved very fast. So it within a day if we had a major issue with an equipment and it will be written in the schedule as I made a mention but most of the time equipment that downtime are low. And it's it's resolved with them that they are a maximum to if if we have an issue with equipment that the Abrahms at that

time. I'd like to go now to FC two to four and I believe it was exhibit

27 Maybe. Yeah, yeah. Exhibit 27. I think this was an email that you were copied on from Miss Chang. And if we can go down to page two my friend Mr. stainsby took you to this as well.

So this email is dated January 2016. Yeah. And so at this stage Pharmascience had manufactured a validation batch for both the five milligram and the 10 milligram zolpidem product.

Yes. As a brand site. Yeah. Okay.

And you noted I believe that to launch in January 2017 timelines were very tight.

Yeah. It's why thema need to be aligned. To to reach the target date.

Okay, so so for this product for zolpidem, and pharma sciences plan 12 months was a tight timeline to obtain sort of all of the steps that you needed to go through in order to be able to launch in January 2017.

It was very tight, validate both sides, not to validate only a bronze. So it's because after a bronze we have to move the product environment and to validate also worthwhile it's why it's very tight to redo only the 10 milligrams training that a bronze and we did you know in 2016

Okay. And that's to follow the plan that pharma science had in the real world. Yeah. Just as engrave maybe five minutes to collect myself and we can come back,

they will take a five minute German.

Thank you. And I'm way you can turn off your video and your audio for the five minutes.

Okay. Thanks.

adjourned until 318

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resumed

Thank you, Madam boy. Those are my questions.

Nothing arising.

Thank you very much. Merci beaucoup, Madame boiI and sign off.

Thank you very much. Bye bye.

I see we have four relatively short witnesses tomorrow.

Yeah, and I expect tomorrow will be as efficient yesterday. And so again, it'll probably be a slightly shorter day than the trials which suggests and so we're not gonna have any trouble finishing but we're doing very well in terms of timing. So

okay. Then we'll adjourn until tomorrow. It's Friday. We're starting early, right. Yes,

we know it's Thursday. Thursday. We were going to start at nine because of Matt.

Oh, yes, you're right. Sorry. I can't read my own handwriting here. 930. Tomorrow morning, then Council. We're adjourned until then.

Thank you. Justice isn't

just a firm that Mr. Justice and we'll be beginning at nine o'clock on Thursday.

Yes. Beginning at nine o'clock on Thursday. Okay, perfect. The witness from India

okay. For the Glenmark witness. Can I just confirm that I will be getting the contact information for the Glenmark witness from the plaintiffs shortly with?

Yes, we'll send we'll send what we have to you.

Okay, perfect and an updated updated trial schedule as well. Please, if possible

yes, we can do that. Thank you.

Thank you all.

Thank you for

the court stands adjourned until tomorrow. November 17. At 9:30am

recording stopped