Exhibit 13 

Case 2:23-cv-00400-JRG-RSP Document 47-13 Filed 12/08/23 Page 1 of 6 PageID #: 1239
Archived: Friday, September 1, 2023 2:46:59 PM

From: Rhoad, Robert

To: 'Lessler, Jay'

Cc: Black, Martin Reilly, Luke

Subject: RE: Mankind Pharma's Varenicline Tartrate Product, ANDA No. 214255

Importance: Normal

Sensitivity: None

Jay,

We wrote to you last Friday (August 25) with minor tweaks to the proposed non-disclosure agreement, and in light of

Mankind’s imminent launch of its generic varenicline tablets, asked you to confirm whether Mankind would commit to producing

the relevant portions of its ANDA and the applicable DMF (i.e., documents sufficient to show how its generic varenicline tablets

and the API contained in them are manufactured) by Monday, specifically noting that time was of the essence. Despite the

urgency of this matter, we have not heard back from you.

If this were a more traditional Hatch-Waxman Act case, then Mankind would have had to give Par notice of any basis on which

it contends that its tablets do not infringe Par’s patents and ordinarily would have also provided Par with confidential access to

the relevant portions of its ANDA, after which Par would have had an opportunity to evaluate a possible infringement claim and,

if filed, have that claim resolved by the court before Mankind was able to launch its tablets and irreversibly disrupt the varenicline

market. Although that statutory regime does not formally apply under the unique circumstances presented here, Par has sought

Mankind’s cooperation in providing, on an expedited basis, the functional equivalent thereof, so as to avoid if possible the need

to commence infringement proceedings unnecessarily. So far, those efforts have not borne fruit.

In light of Mankind’s imminent launch, we need to bring those efforts to a close. Accordingly, Par requests that Mankind either

(a) commit to producing copies of the requested materials on a confidential basis to us this week (i.e., by the close of business on

Friday), or (b) agree not to launch its tablets until at least seven (7) days after it does produce those materials to us.

Please let us know by no later than Thursday if Mankind will comply with that request. If not, Par will have no choice but to file

suit seeking to compel Mankind to produce those materials on an expedited basis and barring Mankind from launching its tablets

until at least seven days thereafter. In any such lawsuit, unless and until Mankind produces those materials, it will bear the burden

of proving non-infringement pursuant to 35 U.S.C. § 295. We hope and trust that that will not be necessary and are available to

meet and confer with you should you wish to discuss the matter further.

Sincerely yours,

Bob

Robert D. Rhoad

Dechert LLP

A Pennsylvania Limited Liability Partnership

+1 609 955 3269 Direct

robert.rhoad@dechert.com

dechert.com

Case 2:23-cv-00400-JRG-RSP Document 47-13 Filed 12/08/23 Page 2 of 6 PageID #: 1240
From: Rhoad, Robert

Sent: Friday, August 25, 2023 4:30 PM

To: Lessler, Jay <jay.lessler@blankrome.com>

Cc: Black, Martin <martin.black@dechert.com>; Reilly, Luke <luke.reilly@dechert.com>

Subject: RE: Mankind Pharma's Varenicline Tartrate Product, ANDA No. 214255

Jay,

Thank you for your email. Par has made a couple of tweaks to the NDA, and I attach clean and redlined versions of the

proposed revised agreement.

Please note that the USPTO has allowed the claims of one of Par’s pending applications – see the attached notice of allowance

and copy of the allowed claims.

Please confirm whether Mankind will produce on Monday the sections of the Mankind ANDA and applicable DMF that

describe the composition of its varenicline tablets and the methods used to manufacture them and the varenicline API contained in

them, as we understand that the launch of Mankind’s tablets is imminent such that time is of the essence. We would prefer to

have access to those materials before any suit is filed, but if Mankind refuses to produce them sufficiently in advance of the launch

to allow us to evaluate whether Mankind is infringing Par’s patents, Par will have no choice but to file suit and seek to halt any

launch until a determination as to infringement can be made.

Regards,

Bob

Robert D. Rhoad

Dechert LLP

A Pennsylvania Limited Liability Partnership

+1 609 955 3269 Direct

robert.rhoad@dechert.com

dechert.com

From: Lessler, Jay <jay.lessler@blankrome.com>

Sent: Thursday, August 24, 2023 5:14 PM

To: Rhoad, Robert <robert.rhoad@dechert.com>

Case 2:23-cv-00400-JRG-RSP Document 47-13 Filed 12/08/23 Page 3 of 6 PageID #: 1241
[EXTERNAL EMAIL]

You don't often get email from robert.rhoad@dechert.com. Learn why this is important

Cc: Black, Martin <martin.black@dechert.com>; Reilly, Luke <luke.reilly@dechert.com>

Subject: RE: Mankind Pharma's Varenicline Tartrate Product, ANDA No. 214255

Dear Bob,

Attached are Mankind’s proposed revisions to the NDA.

Regards,

Jay

Jay P. Lessler | BLANKROME

1271 Avenue of the Americas | New York, NY 10020

O: 212.885.5176 | F: 917.332.3773 | jay.lessler@blankrome.com

From: Rhoad, Robert <robert.rhoad@dechert.com>

Sent: Wednesday, August 23, 2023 2:39 PM

To: Lessler, Jay <jay.lessler@blankrome.com>

Cc: Black, Martin <martin.black@dechert.com>; Reilly, Luke <luke.reilly@dechert.com>

Subject: RE: Mankind Pharma's Varenicline Tartrate Product, ANDA No. 214255

Dear Jay,

Please let us know the status of Mankind’s review of the NDA and when we can expect to receive their response, as time is of

the essence.

Regards,

Bob

Robert D. Rhoad

Dechert LLP

A Pennsylvania Limited Liability Partnership

+1 609 955 3269 Direct

robert.rhoad@dechert.com

dechert.com

Case 2:23-cv-00400-JRG-RSP Document 47-13 Filed 12/08/23 Page 4 of 6 PageID #: 1242
You don't often get email from martin.black@dechert.com. Learn why this is important

[EXTERNAL EMAIL]

From: Lessler, Jay <jay.lessler@blankrome.com>

Sent: Wednesday, August 16, 2023 8:34:01 PM

To: Black, Martin <martin.black@dechert.com>

Cc: Reilly, Luke <luke.reilly@dechert.com>

Subject: RE: Mankind Pharma's Varenicline Tartrate Product, ANDA No. 214255

Dear Mr. Black,

Thank you for your August 15

th

letter.

We are reviewing the non-disclosure agreement provided with your August 11

th

letter and will provide our proposed revisions

next week.

Regards,

Jay

Jay P. Lessler | BLANKROME

1271 Avenue of the Americas | New York, NY 10020

O: 212.885.5176 | F: 917.332.3773 | jay.lessler@blankrome.com

From: Black, Martin <martin.black@dechert.com>

Sent: Tuesday, August 15, 2023 2:34 PM

To: Lessler, Jay <jay.lessler@blankrome.com>

Cc: Reilly, Luke <luke.reilly@dechert.com>

Subject: Mankind Pharma's Varenicline Tartrate Product, ANDA No. 214255

Please see the attached correspondence.

Marty

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Case 2:23-cv-00400-JRG-RSP Document 47-13 Filed 12/08/23 Page 5 of 6 PageID #: 1243
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Case 2:23-cv-00400-JRG-RSP Document 47-13 Filed 12/08/23 Page 6 of 6 PageID #: 1244