Subject: RE: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)
From: Dhruv Goel <[email-masked]>
To: Tamar Gabunia <[email-masked]>
Cc: Anirudh Deshpande <[email-masked]>, Ekaterine Adamia <[email-masked]>, Irina Gobejishvili <[email-masked]>, "Ron Somers (Contractor)" <[email-masked]>
Date: Tue, 11 Aug 2020 07:40:46 +0000

Hi Dr. Tamar,

As mentioned below, attached is the invoice for shipping purposes.

Regards,

Dhruv

From: Tamar Gabunia

Sent: 10 August, 2020 10:48 PM

To: Dhruv Goel

Cc: Anirudh Deshpande ; Ekaterine Adamia ; Irina Gobejishvili ; Ron Somers (Contractor)

Subject: RE: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

CAUTION:
This email originated from outside of the company. Do not click links or open attachments unless you recognize the sender and know the content is safe.

Well received! Many thanks!

From: Dhruv Goel [mailto:[email-masked]]

Sent: 10 August, 2020 18:41

To: Tamar Gabunia <[email-masked]>

Cc: Anirudh Deshpande <[email-masked]>; Ekaterine Adamia <[email-masked]>; Irina Gobejishvili <[email-masked]>;
Ron Somers (Contractor) <[email-masked]>

Subject: RE: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

Hi Minister Gabunia,

Please find attached the AWB – Flight details and the packing list attached in the email along with
commercial invoice. I will be sending you the nominal value invoice for shipping purposes to you tomorrow.

Please let  me know in case of any concerns.

Thanks

Dhruv

From: Tamar Gabunia <[email-masked]>

Sent: 03 August, 2020 11:43 AM

To: Dhruv Goel <[email-masked]>; Ron Somers (Contractor) <[email-masked]>

Cc: Anirudh Deshpande <[email-masked]>; Ekaterine Adamia <[email-masked]>; Irina Gobejishvili <[email-masked]>

Subject: RE: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

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Dear Dhruv

Many thanks! This is well received. We look forward to receiving other documents.

With kindest regards

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia,
MD, MPH

First Deputy Minister

From: Dhruv Goel [mailto:[email-masked]]

Sent: 29 July, 2020 10:17

To: Tamar Gabunia <[email-masked]>; Ron Somers (Contractor) <[email-masked]>

Cc: Anirudh Deshpande <[email-masked]>; Ekaterine Adamia <[email-masked]>

Subject: RE: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

Hi Minister Gabunia,

Thanks for your consent.

Please find attached the Certificate of Pharmaceutical Product as per your email below (Georgia is mentioned on the last page). We will be sending you the Invoice, packing list and flight details (AWB) as soon as the flights are booked.

Thanks,

Dhruv

From: Tamar Gabunia <[email-masked]>

Sent: 28 July, 2020 11:01 PM

To: Ron Somers (Contractor) <[email-masked]>

Cc: Dhruv Goel <[email-masked]>; Anirudh Deshpande <[email-masked]>; Ekaterine Adamia <[email-masked]>

Subject: RE: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

CAUTION:
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Dear Ron Somers

Many thanks for your e-mail and follow up on our correspondence regarding the next shipment with the Hep C Program. Attached you can find the official order from the ministry. Given the expiry date of drugs we
are quite confident in adequate consumption of current and anticipated amount. As of the regulatory requirements. Ministry will apply the registration waver mechanism as we did for the previous order. In order to process the waiver we will need the following:

Invoice

The certificate of pharmaceutical product (Quality Certificate)

Airway bill

Packing list

Last time we worked with Ben Kamarck
[email-masked]
to have the shipment organized. Our staff member will work with your designee to have all details sorted out as needed.

Should you have additional questions or require clarification please kindly let me know.

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia,
MD, MPH

First Deputy Minister

From: Ron Somers (Contractor) [mailto:[email-masked]]

Sent: 27 July, 2020 22:09

To: Tamar Gabunia <[email-masked]>

Cc: [email-masked];
[email-masked]

Subject: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

Dear Minister Gabunia:

I am interfacing on behalf of Gilead Sciences with Mylan in India to ensure patient access to these viral hepatitis medicines in Georgia. Thank you for your candid appraisal of how Covid-19 has reduced patient numbers.

I spoke with Mylan today regarding MyHepAll shelf life as well as the regulatory issues you have raised.  Dhruv Goel of Mylan has addressed these questions to our satisfaction in the following email.

However, if you are not comfortable accepting this delivery, please let us know.  This is an expensive shipment, and it would be a pity for these medicines to go to waste.

I am relying on your previous mail to Graeme Robertson of Gilead Sciences, wherein during the April time-frame you indicated you had stock of MyHepAll of approx. 9500 bottles. This would provide enough bottles to treat roughly 3000 patients.
You were experiencing at that during the Covid-19 crisis approximately 800 patients per month availing of treatment. Based on your estimates in April, this leaves you with stock on hand.

This next shipment of 10,000 bottles will treat approx. 3500 additional patients – from now and through the end of this year, and into the Spring of 2021.  Please let me know if my estimates are accurate or incorrect.

The bottom line, this shipment being organized is meant to suit your needs and requirements. Accordingly, please do let us know if you are comfortable receiving this shipment of 10,000 bottles.  If so, Mylan’s Dhruv Goel will sort these
other details you have raised and ensure this shipment is timely delivered.

Thank you for your diligence in treating viral hepatitis in Georgia – a goal shared by Gilead Sciences and its Licensee, Mylan Labs.

Sincerely,

Ron Somers for Gilead’s Global Patient Solutions

From: Dhruv Goel <[email-masked]>

Sent: Monday, July 27, 2020 11:37 AM

To: Tamar Gabunia <[email-masked]>; Ekaterine Adamia <[email-masked]>

Cc: Graeme Robertson <[email-masked]>; Ron Somers <[email-masked]>; Anirudh Deshpande <[email-masked]>

Subject: RE: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

Hi Minister Gabunia,

Greetings and Thanks for your kind reply. Please note that the quantity of this shipment is 10,000 bottles of SOF/VELPA with a shelf life of 93% hence it should not be a problem. Given below are the manufacturing and expiry dates of the
stock:

Code

Description

Batch No

Qty

Mfg Date

Exp date

Shelf life

% remaining

400537875

SOFO/VELP TAB 400/100MG 28BT MY EN/FR

3117094

4794

30-May-20

30-Apr-22

93%

3117178

5206

31-May-20

30-Apr-22

93%

Total

10000

Also, as far as registration is concerned, kindly note that it is the same product delivered in the last shipment to you. Can you please let us know who provided you with the below application documents (from Gilead) last time as what I
can understand is that you should already have the import permit. I can recall only providing you the invoice, COAs and flight details.

Please let me know your comfortable date of shipment.

Thanks

Dhruv

From: Tamar Gabunia <[email-masked]>

Sent: 24 July, 2020 10:13 PM

To: Dhruv Goel <[email-masked]>; Ekaterine Adamia <[email-masked]>

Cc: Graeme Robertson <[email-masked]>; Ron Somers <[email-masked]>; Anirudh Deshpande <[email-masked]>

Subject: RE: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

CAUTION:
This email originated from outside of the company. Do not click links or open attachments unless you recognize the sender and know the content is safe.

Dear Dhruv,

Many thanks for your e-mail. I would like to confirm the quantity and the period of the shipment, although would like to double-check that the medication’s shelf-life is not less than 18months, as during the pandemic, number of patients
has decreased, meaning it will take more time to use this quantity;

Also, I’d like to inform you that “MyHep ALL 400mg/100mg”  is not registered in Georgia, therefore we will need several documents from you, like previous shipment;

Those would be as follows:

1. Application.

2. The application should be accompanied with:

a) A request from the donor's representative organization (if the donor organization is importer) and the electronic version of the list of medicines (on CD)

b) A preliminary confirmation assessment document of medicines issued by World Health Organization and/or a document confirming the registration of medicines issued by the country or interstate pharmaceutical product state regulatory authority,
which are recognized by the Georgian Government and/or a document confirming the registration of medicines in the country of manufacture;

c) Distribution timetable of medicines and legal basis of importation of medicines for humanitarian purposes (an agreement, a contract or an official letter, etc.);

d) Patient leaflet of medicine;

e) A copy of the certificate of quality of medicines and/or a document certifying the medicines were manufactured in accordance with international standards, issued by the competent authority (relevant governmental body, recognized international
organizations, special regulatory bodies).

We will send the order on 10K early next week.

With kind regards

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia,
MD, MPH

First Deputy Minister

From: Dhruv Goel [mailto:[email-masked]]

Sent: 22 July, 2020 11:44

To: Tamar Gabunia <[email-masked]>; Ekaterine Adamia <[email-masked]>

Cc: Graeme Robertson <[email-masked]>; Ron Somers <[email-masked]>; Anirudh Deshpande <[email-masked]>

Subject: SOF/VELPA - Next Shipment 10,000 Bottles (Georgia)

Hi Ekaterine and Dr. Tamar,

Greetings from Mylan! Hope you are doing good and staying safe.

We wanted to check and follow up with you with respect to the next lot of shipment of SOF/VELPA bottles to Georgia as part of the donation program. We are ready with supplies of 10K bottles and would like to check if you are fine in receiving
the shipment by end of July / first half of August.

Once you confirm us your acceptance, we will send you the shipment documents and COAs along with the shipping invoice as we did last time.

Please let us know in case of any concerns.

Thanks,

Dhruv Goel

Commercials – Hepatitis Business and Special Projects

Mylan Pharmaceuticals, Bangalore

[email-masked]

Direct: + 91 80 66728875

Mobile: + 91 83904 57715

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