From : Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
To : jinming7@sinopharm.com
Subject : Re: RE: Vaccine Cooperation - Georgia
Cc : liyan23 <liyan23@sinopharm.com>; dongjun1 <dongjun1@sinopharm.com>; Gabunia <tgabunia@moh.gov.ge>; Khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>; Kalandia <akalandia@mfa.gov.ge>; dpipinashvili <dpipinashvili@mfa.gov.ge>
Received On : 31.03.2021 19:32
Attachments :

Dear Mr. Ming

 

On behalf of the Ministry of Health, once again I would like to express my deep gratitude for your efforts and very fruitful collaboration. We are glad that the Sinopharm vaccines will soon arrive in Georgia.

 

As I’ve informed you via WeChat, we would like to organize video call with the relevant representatives of the Sinopharm on vaccine administration issues. Topics for discussion is attached.

 

We propose to schedule the meeting through webex platform on April 2 at 11:00/12:00 or April 5 at 12:00, Tbilisi time.

 

The list of participants:

 

Dr. Tamar Gabunia, First Deputy Minister of IDPs from the Occupied Territories, Labour, Health and Social Affairs of Georgia (she is available on April 2, 12:00)

Dr. Amiran Gamkrelidze, Director General of the LEPL National Center for Disease Control and Public Health (NCDC)

Dr. Paata Imnadze, Deputy Director General of NCDC

Dr. Irma Khonelidze, Deputy Director General of NCDC

Dr. Alexandre Turdziladze, Deputy Director General of NCDC

Dr. Khatuna Zakhashvili, Head of Communicable Diseases Department of NCDC

Mr. Kakhaber Shalikadze – Deputy Director of the LEPL National Regulation Agency for Medical and Pharmaceutical Activities;

Mr. Gocha Aladashvili – Head of Department of Drug Registrations and Permits at NRA

 

Please, kindly inform us the preferable date/time for you and the list of participants from your side.

 

In addition, we would much appreciate if you could share the Stability Study by tomorrow.

 

Thank you in advance.

 

Best regards,

 

Maia

 

 

From: Maia Nikoleishvili
Sent: Friday, March 19, 2021 3:32 PM
To: jinming7@sinopharm.com
Cc: liyan23 ; dongjun1 ; Gabunia' ; Khvtisiashvili ; Kalandia ; dpipinashvili ; Khmaladze ; Shorena Okropiridze ; etikaradze@yahoo.de; Zaal Kapanadze
Subject: FW: RE: Vaccine Cooperation - Georgia

 

Dear Mr. Ming,

I would like to kindly inform you that the payment is already completed from our side.

Please see the attached payment order, signed and sealed by the Ministry.

Now we are looking forward to receiving further details on transportation of goods, including delivery date.

Thank you again for your support.

Best regards,

Maia

 

 

 

From: jinming7@sinopharm.com <jinming7@sinopharm.com>
Sent: Thursday, March 18, 2021 7:01:38 AM
To: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Cc: liyan23 <liyan23@sinopharm.com>; dongjun1 <dongjun1@sinopharm.com>; Gabunia' <tgabunia@moh.gov.ge>; Khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>; Kalandia <akalandia@mfa.gov.ge>; dpipinashvili <dpipinashvili@mfa.gov.ge>; Khmaladze <natkhmaladze@moh.gov.ge>; Okropiridze <shokropiridze@moh.gov.ge>; etikaradze@yahoo.de <etikaradze@yahoo.de>; Kapanadze <zkapanadze@moh.gov.ge>
Subject: Re: RE: Vaccine Cooperation - Georgia

 

Ms. Maia,

Well received the final contract.

Please find the proforma invoice in the attachment and kindly arrange the payment at your earliest.

Thank you so much.

Best regards,

Ming

 

 

jinming7@sinopharm.com

 

Dear Mr. Ming,

Georgian Embassy to China provided us with the signed contract and many thanks for all your efforts.

Hereby I am sending a fully executed contract and kindly request you to send us an invoice as well in order to immediately start transaction procedure.

Best regards,

Maia

 

 

From: Maia Nikoleishvili
Sent: Tuesday, March 16, 2021 10:56 PM
To: 'jinming7@sinopharm.com' <jinming7@sinopharm.com>
Cc: 'liyan23' <liyan23@sinopharm.com>; 'dongjun1' <dongjun1@sinopharm.com>; 'Gabunia'' <tgabunia@moh.gov.ge>; 'Khvtisiashvili' <a.khvtisiashvili@mfa.gov.ge>; 'Kalandia' <akalandia@mfa.gov.ge>; 'dpipinashvili' <dpipinashvili@mfa.gov.ge>; 'Khmaladze' <natkhmaladze@moh.gov.ge>; Shorena Okropiridze <shokropiridze@moh.gov.ge>; 'etikaradze@yahoo.de' <etikaradze@yahoo.de>; Zaal Kapanadze <zkapanadze@moh.gov.ge>
Subject: FW: RE: Vaccine Cooperation - Georgia

 

Dear Mr. Ming,

With this e-mail I would like to kindly send you Emergency Use Authorization submitted by the National Regulation Agency and look forward to move to the next stage of the negotiations.

Thank you again for continued and fruitful collaboration.

Best regards,

Maia

 

From: jinming7@sinopharm.com <jinming7@sinopharm.com>
Sent: Tuesday, March 16, 2021 7:22:55 AM
To: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Cc: liyan23 <liyan23@sinopharm.com>; dongjun1 <dongjun1@sinopharm.com>; Gabunia' <tgabunia@moh.gov.ge>; Khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>; Kalandia <akalandia@mfa.gov.ge>; dpipinashvili <dpipinashvili@mfa.gov.ge>; Khmaladze <natkhmaladze@moh.gov.ge>; Okropiridze <shokropiridze@moh.gov.ge>; etikaradze@yahoo.de <etikaradze@yahoo.de>; Kapanadze <zkapanadze@moh.gov.ge>
Subject: Re: RE: Vaccine Cooperation - Georgia

 

Ms. Maia,

Thanks for your email.

Here I have to inform you that there is some problem when we are applying for the export of our product. Our legal indicated that the EUA or formal registration from destination on our product must be required, which means that only import permit from Georgia is not enough for the shipment. So here we are asking the possibility of issuing the EUA or formal registration on our product in Georgia. The EUL from WHO seems to be issued within March or April.

Sorry to inform you above issue, but these 100,000 vials are always available for Georgia.

Just let us discuss on the EUA or formal registration in Georgia at first.

By the way, the contract is still in the process of signature by CNBG, will deliver it to your side soon after get the signed contract.

Thank you.

Best regards,

Ming

 

 

 

Dear Mr. Ming,

With this e-mail I would like to kindly inform you that the Government approval has been received today. Hereby, I am sending the signed LoC along with a letter submitted by the NRA on expressing regulatory readiness to issue an import permit immediately upon receiving the shipping documents.

We kindly ask you to send the signed contract tomorrow and we will send you back the countersigned one.   

As for the transportation issues, I will get in touch with you soon, after clarifying the details.

Thank you again for all your support and fruitful collaboration.

Best regards,

Maia

 

 

From: Maia Nikoleishvili
Sent: Thursday, March 4, 2021 10:24 PM
To: 'jinming7@sinopharm.com' <jinming7@sinopharm.com>
Cc: '李燕' <liyan23@sinopharm.com>; 'Tamar Gabunia' <tgabunia@moh.gov.ge>; 'Khvtisiashvili' <a.khvtisiashvili@mfa.gov.ge>; 'Kalandia' <akalandia@mfa.gov.ge>; 'dpipinashvili' <dpipinashvili@mfa.gov.ge>; 'Natia Khmaladze' <natkhmaladze@moh.gov.ge>; Shorena Okropiridze <shokropiridze@moh.gov.ge>
Subject: Fw: Re: Vaccine Cooperation - Georgia

 

 

 

Dear Mr. Ming,

Many thanks for your prompt reply.

Per your advice, we propose to amend the Article 2.10 of the Purchase Contract and Article 3 of the Letter of Commitment in the following manner:

 

Purchuse Contract

2.10 Insurance

2.10.1 The Buyer will have in place and maintain with a reputable insurance company insurance policies which will provide cover against potential liabilities arising out of the use of the Product and which would normally be insured against by a prudent market entity, to an extent and to limits that would be reasonably expected under legal requirements and the standards of good industry practice and prudent risk judgment, and will maintain the validity of such insurance policies during the use of Product and for one year thereafter.

The Buyer, in case of damage (side effects/complications) caused by use of the purchased product will cover medical expenses within the State Health Care program and will insure manufacturer against potential liabilities and will maintain the validity of such condition during the use of the Vaccine and for one year thereafter.

2.10.2 Upon the written request of the Supplier or Seller, the Buyer shall provide the copies of the insurance policies certificates and full particulars of such insurance cover.

2.10.3 The Buyer will bear all costs, fees, and expenses in connection with putting in place and maintaining the insurance mentioned in this clause.

 

Letter of Commitment

3. Insurance

3.1 We will insure the use of Vaccines with reputable insurance companies. The insurance coverage should cover the types of insurance that would usually be insured against by a prudent market entity. The limit of compensation should reach the level that can be reasonably expected in accordance with legal requirements, good industry practices and prudent risk judgments. In addition, we will maintain the validity of such insurance during the use of the Vaccine and for one year thereafter.

We will cover the medical expenses within the State Health Care program in case of damage (side effects/complications) caused by use of the purchased product and will insure manufacturer against potential liabilities. We will maintain the validity of such condition during the use of the Vaccine and for one year thereafter.

3.2 Upon Sinopharm’s request, we shall immediately provide Sinopharm with the copies of the insurance certificates and full particulars of such insurance and other relevant supporting documents.

3.3 We will bear all costs, fees, and expenses in connection with the insurance mentioned in this clause.

 

Hereby, I am sending fully executed NDA and look forward to receiving your feedback regarding the proposed amendments.

Thank you again for fruitful collaboration.

Best regards,

Maia

 

 

---------- Forwarded message ---------
From: jinming7@sinopharm.com <jinming7@sinopharm.com>
Date: Thu, Mar 4, 2021 at 11:58 AM
Subject: Fw: Re: Vaccine Cooperation - Georgia
To: nikoleishvilim <nikoleishvilim@gmail.com>
Cc: Nikoleishvili <mnikoleishvili@moh.gov.ge>, liyan23 <liyan23@sinopharm.com>, Gabunia' <tgabunia@moh.gov.ge>, Khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>, Kalandia <akalandia@mfa.gov.ge>, dpipinashvili <dpipinashvili@mfa.gov.ge>, Khmaladze <nkhmaladze@moh.gov.ge>, Okropiridze <shokropiridze@moh.gov.ge>

 

Dear Ms. Maia,

I am fowarding the emails to you.

Below includes 2 emails, 1 for the response on 3rd March, another for the final NDA on 4th March which requests your stamp and signature (please find in the attachment).

Best regards,

Ming

 

 

 

 

Date: 2021-03-04 11:10

Subject: Re: Re: Vaccine Cooperation - Georgia

Ms. Maia,

Good day.

Here please check the attached NDA with our stamp and signature.

Due to the exact signature date on NDA, we have to request you to sign & stamp on the NDA again. Sorry for the inconvenience, and please note we need the stamp as well, not only signature.

Thank you so much.

Regards,

Miles

 

 

Date: 2021-03-03 11:12

Subject: Re: FW: Vaccine Cooperation - Georgia

Ms. Maia,
Thank you for your email. Please find below response on your opinion:

 

1. In the article 2.10 of the Purchase Contract and Article 3 of the Letter of Commitment is indicated that the Buyer is obliged to have in place and maintain with a reputable insurance company insurance policies to cover against potential liabilities arising out of the use of the product. According to the recently enacted amendment to the law of Georgia on “Public Health” (https://matsne.gov.ge/en/document/view/21784?publication=33 Article 455 – The temporary liability rule related to the pharmaceutical product against the infection (COVID-19)), the manufacturer is indemnified from the liabilities refer to those vaccines which have emergency use authorization or prequalification by the WHO or a stringent regulatory authority (SRA). Hereby, it should be mentioned that Article 9 of the Purchase Contract and Article 4 of the Letter of Commitment also refers to the indemnification of the manufacturer from the liabilities. Therefore, would you be kind to consider exclusion of the provisions related to the insurance, since according to the national legislation, Universal Health Care State program will cover against potential liabilities arising out of the use of the product and in addition introducing private insurance packages is not relevant.

---This insurance clause cannot be deleted. If this kind of insurance is not applicable in Georgia, it needs to be replaced by other alternative insurance or medical insurance fund to guarantee liability and compensation here. 

 

Additionally, we are aware, that you are in the process of obtaining WHO authorization, however to complete formal procedures ASAP, please inform us is if any of the listed SRA https://www.who.int/medicines/regulation/sras/en/ have granted emergency use authorization to the Sinopharm vaccine.

---I found that Hungary is one of the members listed in SRA, which has granted EUA for our product.

 

2.We Kindly request you to exclude Covid-19 pandemic as force major event in the Article 9.4 of the Purchase Contract and Article 4.5 of the Letter of Commitment, considering current epidemiological situation in the worldwide.

---The clause of force major event can not exclude the COVID-19 pandemic.

 

3.In the Article 10.5 of the Purchase Contract and Article 5 of the Letter of Commitment is indicated that the contract is made in both Chinese and English languages. We kindly request you to indicate English as a prevailing language instead of Chinese one.

---Sorry but we can just indicate the Chinese language as a prevailing language.

 

4.Would it be possible to indicate International Court of Arbitration (ICC/Paris Arbitration) instead of China International Economic and Trade Arbitration Commission in Beijing in the Article 8.2 of the Purchase Contract?

---The Arbitration place must be China International Economic and Trade Arbitration Commission in Beijing.

 

5.And the last, the date of delivery of the product should be updated.

---Of course, we will revise it.

 

I have to say that due to the unique requirement of our Group as well as the higher level, it is really difficult for us to revise these clauses. 

Please accept our apologies, and hope your side can agree on the original clauses.

Thank you and look forward to the news for the NRA approval.

Best regards,

Ming

 

 

 

Date: 2021-03-03 00:33

Subject: FW: RE: Vaccine Cooperation - Georgia

Dear Mr. Ming,

Many thanks for your e-mail.

The provided documents have been reviewed by the national regulation agency. To submit an import permit, we need to proceed with the formalities set forth under the national legislation. The NRA has already addressed with request to the WHO to provide an access to the Sinopharm vaccine dossier through the WHO secure platform. 

In parallel, our legal team reviewed the draft contract and letter of commitment and kindly request your feedback on the following provisions:

 

1.      In the article 2.10 of the Purchase Contract and Article 3 of the Letter of Commitment is indicated that the Buyer is obliged to have in place and maintain with a reputable insurance company insurance policies to cover against potential liabilities arising out of the use of the product. According to the recently enacted amendment to the law of Georgia on “Public Health” (https://matsne.gov.ge/en/document/view/21784?publication=33 Article 455 – The temporary liability rule related to the pharmaceutical product against the infection (COVID-19)), the manufacturer is indemnified from the liabilities refer to those vaccines which have emergency use authorization or prequalification by the WHO or a stringent regulatory authority (SRA). Hereby, it should be mentioned that Article 9 of the Purchase Contract and Article 4 of the Letter of Commitment also refers to the indemnification of the manufacturer from the liabilities. Therefore, would you be kind to consider exclusion of the provisions related to the insurance, since according to the national legislation, Universal Health Care State program will cover against potential liabilities arising out of the use of the product and in addition introducing private insurance packages is not relevant.

 

Additionally, we are aware, that you are in the process of obtaining WHO authorization, however to complete formal procedures ASAP, please inform us is if any of the listed SRA https://www.who.int/medicines/regulation/sras/en/ have granted emergency use authorization to the Sinopharm vaccine.

 

2.      We Kindly request you to exclude Covid-19 pandemic as force major event in the Article 9.4 of the Purchase Contract and Article 4.5 of the Letter of Commitment, considering current epidemiological situation in the worldwide.

3.      In the Article 10.5 of the Purchase Contract and Article 5 of the Letter of Commitment is indicated that the contract is made in both Chinese and English languages. We kindly request you to indicate English as a prevailing language instead of Chinese one.

4.      Would it be possible to indicate International Court of Arbitration (ICC/Paris Arbitration) instead of China International Economic and Trade Arbitration Commission in Beijing in the Article 8.2 of the Purchase Contract?

5.      And the last, the date of delivery of the product should be updated.

 

We remain at your disposal to discuss further details related to this contract.

 

Thank you in advance for consideration and looking forward to receiving your feedback as early as possible.

 

Best regards,

 

Maia

 

 

 

From: jinming7@sinopharm.com [mailto:jinming7@sinopharm.com]
Sent: 2 March, 2021 06:41
To: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Cc: 李燕 <liyan23@sinopharm.com>; Tamar Gabunia <tgabunia@moh.gov.ge>; Khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>; Kalandia <akalandia@mfa.gov.ge>; dpipinashvili <dpipinashvili@mfa.gov.ge>
Subject: Re: RE: Vaccine Cooperation - Georgia

 

Ms. Maia,

Thanks for your email. The NDA is still in our internal process of review, will send it after our stamp and signature. 

 

Here I am attaching the data for pre-clinical trial and Phase I&II clinical trial, as well as the neutrilization test on South Africa variants.

Please advise us on the official registration or EUA of our product in Georgia. The approval in Georgia is priority for us.

 

By the way, I think you have also received the draft of contract and Letter of Committment, please kindly let us know whether they are OK beforehand.

Thank you.

Regards,

Ming

 

 

 

Date: 2021-02-27 01:56

To: 金明

Subject: RE: Vaccine Cooperation - Georgia

Dear Mr. Miles,

First of all, please accept our sincere apologies for the delayed response.

We much appreciate your commitment to support our country at this very special and challenging time of the global pandemic.

The provided Nondisclosure Agreement is acceptable for the Ministry. All provisions remained unchanged, only MFA of Georgia was included as the signatory party together with the Ministry of Health, since the MFA is also engaged in the negotiations.

With this e-mail I would like to kindly send you the signed NDA and look forward to receiving the countersigned one in order to proceed with the next steps.

Thank you once again for your support and fruitful collaboration.

Kind regards,

 

Maia Nikoleishvili MPA

 

Head of International Relations and Protocol Division of Administration

Ministry of IDPs from the Occupied Territories, Labour, Health and Social Affairs of Georgia

Address: 144 Tsereteli ave., 0159 Tbilisi, Georgia

Tel.: +995 32 2510034 (0803)

Cell phone: +995 577272713

E-mail: mnikoleishvili@moh.gov.ge

–

 

From: 金明 [mailto:jinming7@sinopharm.com]
Sent: Tuesday, February 9, 2021 9:05 AM
To: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Cc: 李燕 <liyan23@sinopharm.com>
Subject: Vaccine Cooperation - Georgia

 

Dear Ms. Maia,

Nice to contact with you through email.

Here I am attaching the draft of NDA according to the infomation you provided.

Please confirm and look forward to your reply.

Thank you.

Best regards,

Miles
 
 

 

Attach/image001(03-03-10-31-47).png