DRAFT DD MMM YYYY– For Review and Approval Only.

Do not Execute

Safety Data Exchange Agreement

Between

Pfizer Limited

And

Karma Pharmaceuticals and Medical Supplies

For

Multiple Products listed in Attachment 2

In

Bhutan

Confidential PVA ID# XXXX.X Page 1 of 17

 DRAFT DD MMM YYYY– For Review and Approval Only. Do not Execute

Table Of Contents
1 Objective................................................................................................................................................................3
2 Scope.......................................................................................................................................................................3
3 Definitions..............................................................................................................................................................3
4 Safety Database.....................................................................................................................................................3
5 Product Safety Activities......................................................................................................................................4
6 Qualified Person for Pharmacovigilance (“QPPV”).........................................................................................4
7 Pharmacovigilance System Master File (“PSMF”) or Detailed Description of Pharmacovigilance Systems
(“DDPS”).......................................................................................................................................................................4
8 Individual Case Safety Report (“ICSR”) Exchange..........................................................................................4
9 Reconciliation........................................................................................................................................................6
10 Data Privacy..........................................................................................................................................................6
11 Aggregate Reports................................................................................................................................................6
12 Risk Management.................................................................................................................................................7
13 Actions Taken for Safety Reasons.......................................................................................................................7
14 Local Labeling.......................................................................................................................................................8
15 Party Audits and Regulatory Authority Inspections.........................................................................................8
16 Compliance Monitoring........................................................................................................................................9
17 Dispute Resolution................................................................................................................................................9
18 Amendment...........................................................................................................................................................9
19 Term and Termination.........................................................................................................................................9
20 Miscellaneous.......................................................................................................................................................10
Attachment 1 – Definitions.........................................................................................................................................12
Attachment 2 –Product List.......................................................................................................................................13
Attachment 3 – Translation Verification Form.......................................................................................................14
Attachment 4 – Contact Information........................................................................................................................15
Attachment 5 - Pharmacovigilance System Master File (“PSMF”) Reference Number......................................16

Confidential PVA ID# XXXX.X Page 2 of 17

1 Objective

1.1 Pfizer Limited (“Pfizer”) and Karma Pharmaceuticals and Medical Supplies (“Karma”)
are entering into this Safety Data Exchange Agreement (the “Agreement”) to define each
Party’s safety responsibilities with respect to Multiple Products (the “Products”) in
Bhutan (the “Territory”) as shown in Attachment 2 pursuant to the Distribution
Agreement dated June 03, 2021, as may be amended from time to time, (the “Business
Agreement”). Pfizer and Karma are referred to herein individually as a “Party” and
collectively as the “Parties.”

1.2 Under the terms of the Business Agreement, Karma shall be a non-exclusive distributor
for the Products in the Territory. For the purpose of clarity, Karma holds the registration
of the Products and all the necessary marketing approvals on behalf of Pfizer.

1.3 Pfizer is expressly entitled to perform part or all of its safety responsibilities for the
Products through any member of the Pfizer group of companies and exchange of Product
Safety Information shall occur between respective responsible company contacts for each
activity listed in Attachment 4.

1.4 This Agreement replaces and supersedes any prior agreements, whether written or oral,
between the Parties or any of their predecessors-in-interest with respect to the subject
matter of this Agreement.

2 Scope

2.1 This Agreement outlines the exchange procedures for Product Safety Information as
described in the Agreement related to the Product as shown in Attachment 2.

2.2 Medical inquiries (i.e., external information requests) and medicinal product complaints
not associated with an AE or with a special case scenario (“SCS”) including an At Risk
Event Term, as well as non-serious AE reports from interventional clinical trials are not in
scope of this Agreement and are managed out side the scope of the Agreement.

3 Definitions

3.1 Unless specifically defined herein, the capitalized terms shall have the same meanings as
set out in the Business Agreement. The terms used in this Agreement are intended to be
consistent with the corresponding terms used in the finalized International Council for
Harmonisation (“ICH”) guidelines (E2A, E2C, E2D, and E2E), the European Regulations
and Good Pharmacovigilance Practices (“GVP”) guidance modules, United States Food
and Drug Administration (“US FDA”) Code of Federal Regulations (“CFR”), relating to
the collection, maintenance, analysis and reporting of safety information. A list of specific
terms used in this Agreement with definitions is provided in Attachment 1.

Confidential PVA ID# 1972 Page 3 of 17

4 Safety Database

4.1 Pfizer shall maintain the centralized database for the collection and maintenance of all
worldwide Product Safety Information related to the Products received by both Parties
under the scope of this Agreement.

5 Product Safety Activities

5.1 Karma, as holder of Registration Certificate for the Products, shall collect AEs related to
the Products from the Territory. For purpose of clarity, there are no pharmacovigilance
reporting requirements in the Territory at the time of the effectivity of this Agreement. In
the event that pharmacovigilance reporting requirements in the Territory are introduced,
Karma shall inform Pfizer and this Agreement shall be amended to comply to these
requirements.

5.2 Pfizer, as the centralized database holder, shall fulfill all regulatory requirements relating
to the safety of the Products including but not limited to safety monitoring.

5.3 Karma shall cooperate with Pfizer’s requests for information pertaining to safety
activities.

5.4 If required by law or regulation, each Party shall notify the local regulatory authority of
the arrangement stated in this Agreement. A copy of such notification shall be provided
to the other Party upon request.

6 Qualified Person for Pharmacovigilance (“QPPV”)

6.1 Pfizer, as the Party that holds a MA for the Products in the European Economic Area
(“EEA”), shall appoint and have permanently and continuously at its disposal a European
Union QPPV in respect of those MAs.

6.2 Each Party is responsible to appoint, as per applicable legislation, a QPPV or equivalent
(e.g., Responsible Person for Pharmacovigilance or Contact Person for
Pharmacovigilance) in those countries where it holds a MA.

7 Pharmacovigilance System Master File (“PSMF”) or Detailed Description of

Pharmacovigilance Systems (“DDPS”)

7.1 Pfizer, as the Party that holds a MA for a medicinal product in the EEA, shall have in
place a PSMF as required by applicable law. Each Party’s respective PSMF Reference
Number is documented in Attachment 5.

7.2 Outside of the EEA, each Party is responsible to have available, as per applicable
legislation, a documented description of their pharmacovigilance system (e.g., DDPS or
PSMF) in those countries where it holds an MA.

Confidential PVA ID# 1972 Page 4 of 17

8 Individual Case Safety Report (“ICSR”) Exchange

8.1 Product Safety Information Received by Karma. Karma shall forward to Pfizer unassessed
case information (source documents) that are reported (in the Territory) with the use of
the Products from any source (including cases identified from local literature review
defined in section 8.3), with the appropriate contacts in Attachment 4 and in accordance
with the timelines set out in the table below.

Forwarding Timeline Format

Product Safety Information Karma to Pfizer
All valid reports including within one (1) business day or three (3) Source Documents and
 AEs calendar days (whichever is shorter) from Translation Verification
 suspected transmission via the Awareness Date. Form
Product of an infectious agent
 abnormal test results
 exposure during pregnancy
(maternal or paternal) or
exposure during breast feeding
 overdose
 underdose
 medication errors
 misuse
 abuse
 off-label use
 occupational exposure
 unexpected therapeutic effects
 drug interaction
 lack of efficacy
Invalid reports within one (1) business day or three (3) Source Documents
calendar days (whichever is shorter) from
Awareness Date.

 Reports shall contain all available contact details (e.g., email address, phone number or
fax, or full mailing address). In the absence of contact details, the reports shall indicate if
the reporter is contactable.
 Reports where no contact details of the reporter have been provided shall be forwarded.

8.2 Follow-up Investigations. Pfizer shall have primary responsibility for obtaining follow-up
information on reports received by Karma from the Territory. If available, Karma shall
provide sufficient reporter information to facilitate follow-up processes.

If needed, Pfizer may request that Karma, as the Party that initially received the report,
obtain additional follow-up information (including trade name from the source of the
report. These follow-up requests shall be processed on an ad hoc basis. Follow-up
information received by Karma shall be forwarded to Pfizer within the timelines identified
in Section 8.1.

Confidential PVA ID# 1972 Page 5 of 17

 8.3 Literature Review. Pfizer shall be responsible for conducting worldwide literature review
for the Products. Karma shall a conduct a local literature review for the Products in the
Territory where Karma is the holder of Registration Certificate.

9 Reconciliation

9.1 Each Party shall maintain records of all safety information sent to the other Party under
this Agreement.  Forwarding of Product Safety Information via email or fax will be
followed by an acknowledgement of receipt by the receiving Party within no later than
two (2) business days/four (4) calendar days (whichever is the shorter) of receipt. If
acknowledgement is not received, then the sending Party will contact the receiving Party
to determine if the original report needs to be re-sent.  Each Party shall take reasonable
steps to ensure the same does not occur again. This procedure shall ensure all relevant
Product Safety Information have been exchanged.

10 Data Privacy

10.1 In the performance of the safety activities under this Agreement, both Parties shall comply
with all applicable laws and regulations relating to data privacy. “Personal Data” means
information that can be used by itself or in combination with other available information
to identify a specific individual.

10.2 Each Party shall collect, use and disclose any Personal Data obtained in the course of
performing the safety activities under this Agreement solely for the purposes of
complying with the regulatory obligations as described in this Agreement, or as otherwise
required by law or by a court order. Both Parties shall use electronic, physical, and other
safeguards appropriate to the nature of the information to prevent any use or disclosure of
Personal Data other than as provided for by this Agreement and applicable local law.
Both Parties will also take reasonable precautions to protect the Personal Data from
alteration or destruction.

10.3 Each Party shall notify the other Party promptly, in writing, of any accidental,
unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access to, the
Personal Data processed in the performance of this Agreement (“Security Breach”), and
take immediate steps to rectify any Security Breach. 

11 Aggregate Reports

11.1 Pfizer shall prepare aggregate reports, including but not limited to Periodic Safety Update
Reports ("PSURs") for the Products.

11.2 At the time of effectivity of this Agreement, there are no reporting requirements for
aggregate reports in the Territory. In the event that aggregate report requirements are
introduced in the Territory, Karma shall notify Pfizer promptly but no later than one
hundred eighty (180) days before an aggregate report needs to be submitted to a local
regulatory authority.

Confidential PVA ID# 1972 Page 6 of 17

 11.3 Karma shall provide all information needed within the timelines requested for Pfizer to
complete the aggregate report .

12 Risk Management

12.1 If warranted or required by law/regulation, Pfizer shall be responsible for preparing and
maintaining the Risk Management Plan (“RMP”) for the Products, which shall serve as
the reference document for any local RMP.  The RMP shall be consistent with applicable
ICH guidelines and relevant regulatory requirements.

12.2 Pfizer shall notify Karma’s Risk Management contact specified in Attachment 4 of
commitments set forth in the RMP relevant to Karma and changes thereof. Karma shall
comply with such commitments and provide any data needed to support risk management
activities. Karma shall comply with the commitments therein and provide any data needed
to support risk management activities.

12.3 At the time of the effectivity of this Agreement, there is no requirement of local RMP. In
the event that local RMP requirements are introduced in the Territory, Karma shall notify
Pfizer of this requirement. Karma shall consult Pfizer for the development of the local
RMP for the Product for which Karma is the holder of Registration Certificate. Karma
shall forward the local RMP to Pfizer upon completion. Pfizer shall provide any data
needed to support Karma risk management activities.

13 Safety Monitoring

13.1 Pfizer shall be responsible for the on-going review and analysis of all worldwide
information that is pertinent to the safety profile of the Product that is obtained from any
source. Pfizer shall analyze the impact of cumulating safety data on the established safety
profile of the Product.

13.2 Pfizer shall promptly notify Karma of any new risk (identified or potential) related to the
Product to the appropriate Risk Management contact specified in Attachment 4. Karma
shall also promptly notify Pfizer’s Risk Management contact in Attachment 4 of any
safety signals identified in the conduct of its standard surveillance activities.

13.3 Each Party shall promptly notify the other Party’s Risk Management contact in
Attachment 4 of any Emerging Safety Issues identified with the use of the Product.

14 Actions Taken for Safety Reasons

14.1 The Parties shall promptly exchange information, via the specified contacts in Attachment
4, on any regulatory action or pending regulatory action for safety reasons that might
result in a labeling change or market restriction, including but not limited to the
following:

 Refusal to authorize a clinical trial for ethical or safety reasons;

Confidential PVA ID# 1972 Page 7 of 17

  Clinical trial protocol modification, suspension or early termination of an ongoing
clinical trial because of safety findings or lack of efficacy;

 Recall of investigational drug or comparator;

 Failure to apply for or obtain marketing approval for a tested indication, including
voluntary withdrawal of a marketing application;

 Withdrawal or suspension of a marketing approval;

 Suspension of supply by the MAH;

 Risk management activities including:

- Significant restrictions on distribution or introduction of other risk

minimization measures;

- Significant safety-related changes in labeling documents that could

affect the development program, including restrictions on use or
population treated;

- Communications to health care professionals; and

- Plans for new studies to address safety concerns and new post-
marketing study requirement(s) imposed by regulator(s).

14.2 Regulatory correspondence concerning product safety shall be promptly exchanged by the
Parties.

14.3 Each Party shall be responsible for responding to regulatory inquiries for safety
information for the Products that is directed to the Party for their respective MA.  If
necessary, consultation with Pfizer shall occur prior to Karma responding to a local
regulatory authority. Pfizer shall provide worldwide safety information from the
centralized safety database upon Karma’s request.

15 Local Labeling

Pfizer shall provide Karma with a copy of the current local label. Pfizer shall be
responsible for maintaining and updating the local label, and following internal approval
shall promptly forward to Karma the updated local label, for submission by Karma to the
local regulatory authority.
16 Party Audits and Regulatory Authority Inspections

16.1 Pfizer or its authorized representatives shall have the right, at its cost and no more
frequently than on a biennial basis, unless “for cause”, with reasonable advance notice
(not less than 60 calendar days) and agreed upon audit date, plan/scope, during regular
business hours, to:

Confidential PVA ID# 1972 Page 8 of 17

  Audit the facilities used by the Karma in performance of this Agreement.

 Review and audit all documentation relating to the karma’s activities under this
Agreement.

 Interview the key personnel for audit or pre regulatory inspection purposes; and
audit any record keeping, data collection and processing, information and other
electronic and non-electronic systems and business processes used by Karma in
the performance of this Agreement. Karma shall, and shall cause its employees
and representatives to, cooperate with any such activities and shall ensure timely
access to requested facilities and documentation.

16.2 If Pfizer seeks to use the services of an authorized representative for conducting the audit,
the authorized representative must be acceptable to Karma and be willing to comply with
reasonable requirements of Karma, such as signing a confidentiality agreement.

16.3 Pfizer may request confirmation that the observations made during the audit were
addressed.

16.4 Inspection notification: Pfizer and Karma will immediately notify each other’s contact
specified in Attachment 4, about a regulatory authority inspection that relates to the
Product in scope of this Agreement. In the event of unannounced inspections that relate
to the Product in scope of this Agreement, inspection notification will be sent as soon as
practically possible. Pfizer and Karma will also provide each other with the information
necessary to respond to an inspection request in a timely manner, considering any
deadlines the regulatory authority may have set to respond to the request.

17 Compliance Monitoring

17.1 Each Party shall maintain adequate safety quality systems with the capability to
effectively monitor safety activities, compliance with the terms of this Agreement, and
their performance and compliance with their legal obligations.

17.2 Each Party may monitor the conduct of the other Party’s activities under this Agreement
and review compliance with the terms of this Agreement. Where a potential issue with
meeting the terms of this Agreement is identified, either Party may request the other Party
to provide information relating to the area of concern; that upon receipt of such
notification shall respond within fifteen (15) business days. The Parties will jointly
discuss and collaborate on clarifying and resolving the issues. The Party who is alleged to
be performing inadequately will undertake timely good faith efforts to rectify the issues.

17.3 Pfizer may request information related to Karma’s safety system and compliance with this
Agreement via questionnaire, no more frequently than biennially (once every two years).
The other Party shall provide the available information in a mutually agreed format within
thirty (30) business days.

Confidential PVA ID# 1972 Page 9 of 17

18 Dispute Resolution

18.1 With respect to the subject matter of this Agreement, in the event of any conflict between
the Business Agreement and this Agreement, this Agreement shall govern.

18.2 Any dispute between Pfizer and Karma relating to the terms of this Agreement will be
resolved through discussions between the appropriate contacts listed in Attachment 4, or
other individuals authorized by Pfizer and Karma to discuss the matter.  If the dispute
remains unresolved despite such discussions, Pfizer and Karma will escalate the dispute to
the senior leadership of their respective safety organizations for resolution.  

19 Amendment

19.1 No amendment, change or modification of this Agreement shall be valid unless

documented in writing and signed by both Parties (with the exception of Attachment 2 –
Product List (if it does not require a change to the responsibilities set out in this
Agreement) or Attachment 3 – Translation Verification Form, Attachment 4 – Contact
Information and Attachment 5 – PSMF where changes may be initiated by notifying the
appropriate contact in Attachment 4).

20 Term and Termination

20.1 This Agreement shall come into force on the date of the last signature below. 

20.2 This Agreement shall survive termination or assignment of the Business Agreement,
including any amendments thereto, until such time when the Parties agree in writing to
terminate.

21 Miscellaneous

21.1 All data and reports shall be exchanged in the English language. Product Safety
Information when forwarded in a local language including those reports received from
Local Regulatory Authorities should be translated to English and accompanied by the
Translation Verification Form provided as Attachment 3.

21.2 This Agreement is the entire agreement with respect to safety information relating to the
Product. Should either Party enter into business arrangement concerning the Product with
a third party, the Party shall ensure it is able to meet its obligations under this Agreement.

21.3 For Karma employees performing activities defined in the Business Agreement, Pfizer
shall provide Karma with appropriate training material that is developed by Pfizer in
accordance with its Operating Procedures for the purpose of Karma’s Safety Information
reporting training. Pfizer shall also conduct a training session with Karma’s responsible
Party, such as but not limited to, the Medical Director or designee.  Prior to commencing
any activities regarding the Product, Karma shall ensure that all personnel who may
become aware of a Product Safety Information associated with the use of the Product are
fully trained on the requirements for Product Safety Information reporting, as set out in
this Agreement. Karma shall maintain, and shall provide to Pfizerupon request, records of

Confidential PVA ID# 1972 Page 10 of 17

 the names of all personnel who received training and details of the training that was given
to them, including completed knowledge assessments. Karma shall also ensure that if
additional or replacement personnel become responsible for performing activities for
Pfizer, they are also fully trained on Product Safety Information reporting requirements
set out in this agreement before performing the activities.  The training documentation for
karma personnel who are no longer employed by Karma, shall be archived and retained
by Karma

21.4 This Agreement may be executed in two or more counterparts, each of which shall be
deemed an original but all of which taken together shall constitute one and the same
Agreement. The counterparts of this Agreement may be executed and delivered by email
or portable document format (.pdf) by any of the Parties to any other Party and the
receiving Party may rely on the receipt of such document so executed and delivered by
email as if the original had been received.

Signature page(s) follow

Confidential PVA ID# 1972 Page 11 of 17

IN WITNESS WHEREOF, Pfizer Limited and Karma Pharmaceutical and Medical Supplies
hereby approve this Agreement as of the dates set forth below:

Karma Pharmaceutical and Medical

Pfizer Limited Supplies

Sign Sign

Name Name
Title Title

Date Date

Confidential PVA ID# 1972 Page 12 of 17

 Attachment 1 – Definitions

“Awareness Date” means the first date (according to the receiving Party’s time zone) that either
Party or either Party’s agent first becomes aware of information on an AE that is reported with
the use of the Product and meets the Minimum Criteria for exchange and for Invalid Reports
(see Definition below), the Awareness Date shall be the Initial Date of Receipt. The Awareness
Date shall be counted as “Day 0” for safety data exchange.

 An "At Risk Event Term" is an event term that is not a medical event or adverse reaction
per se, but does increase the risk for the patient to experience an AE. An At Risk Event Term
may include exposure during pregnancy or breast feeding, overdose, underdose, misuse, lack
of efficacy, off-label use, * medication error, occupational exposure or unexpected
therapeutic effect.

“Emerging Safety Issues” A safety issue considered by a marketing authorisation holder to

require urgent attention by the competent authority because of the potential major impact on the
risk-benefit balance of the medicinal product and/or on patients' or public health, and the
potential need for prompt regulatory action.

“Invalid Reports” are reports with missing identifiable reporter and/or identifiable patient. In
addition, Invalid Reports may include reports where the reporter indicates that an AE occurred,
but no description of the AE is provided (i.e. the AE is unspecified). NB: Reports of medical
device complaints associated with the medical device constituent of a combination product do
not need to meet the identifiable patient criteria.

“Minimum Criteria” for exchange are defined as presence of the following four (4) validity
elements: identifiable reporter, identifiable patient, AE and suspect product. Reports where no
patient identifiers (e.g., patient ID number, date of birth, or gender or initials) are provided, but
where it is however clear from the case information that a patient exists are valid.
“Minimum Criteria” for medication errors without direct exposure of an individual to the
product (e.g. erroneous dispensing) shall be comprised of an identifiable reporter and a
product.

“Product Safety Information” Any information about the safety of a product received from any
source. This includes potential Adverse Event notifications, reports of certain circumstances that
may increase a patient’s risk of developing an Adverse Event, as well as other reportable
information: Medical Device Complaints and malfunctions, and Unexpected Therapeutic Effects.

“Territory” is Bhutan as per the Business Agreememt

Confidential PVA ID# 1972 Page 13 of 17

 Attachment 2 –Product List

Trade Name Generic Name

1 Dolonex DT Piroxicam

2 Hetrazan Diethylcarbamazine

3 Wysolone DT Prednisolone

Confidential PVA ID# 1972 Page 14 of 17

 Attachment 3 – Translation Verification Form

Document Title:
(Please refer to the
instructions below)

Document Type:
 Email  Journal  Fax  Others:
Translated By:
Name Title Signature Date
Reviewed and
Verified By:
Name Title Signature Date

Forwarding to DSU adverse event reports

By signing this form, I hereby certify that the translation of the document is accurate and
complete.
Instructions:
The document title can be:
- Emails: Subject of the email
- Journals: Name of the journal, volume and date
- Faxes: Subject of the fax
Note. This translation verification form must accompany each document being translated.

Confidential PVA ID# 1972 Page 15 of 17

 Attachment 4 – Contact Information

Pfizer Contact Karma Contact

Forwarding of Product Safety Email: IND.AEReporting@pfizer.com Sonam Tshering
Information Fax: Toll-free (local) 000800100-5961 st@karma.bt
See Section 8 Mobile: + 975-17824617

Aggregate Report Call for Email:

Contribution RSCCVW-REPORTSFROMLI@pfizer.com

See Section 11 cc: SRM-PAM@pfizer.com

cc: IND.AEReporting@pfizer.com
Actions Taken for Safety E-mail: SSRM@pfizer.com
Reasons cc: SRM-PAM@pfizer.com
Regulatory Authority Safety
Queries and Risk Management
Plans

See Section 12, 13

Local Label Email:
IND.AEReporting@pfizer.com
See Section 15 RegulatoryIndia@pfizer.com

cc: SRM-PAM@pfizer.com

Audits or Inspections Email:

MedicalQAInspectionMgmt@pfizer.com

See Section 15 PVInspectionandAuditNotification@pfizer.c

om

cc: SRM-PAM@pfizer.com
SDEAContact Mark Vincent Bandal Sonam Tsherig
All other queries 19F- 8 Rockwell Building st@karma.bt
Rockwell Center Mobile: 00975-17824617
Hidalgo Drive, Makati City 1200,
Philippines
Phone: +63 288417010
Email: markvincent.bandal@pfizer.com
cc: SRM-PAM@pfizer.com

Confidential PVA ID# 1972 Page 16 of 17

 Attachment 5 - Pharmacovigilance System Master File (“PSMF”) Reference Number

In accordance with the requirements of the European Union (“EU”) Good Pharmacovigilance
Practices (“GVP”) Module II - Pharmacovigilance System Master File (“PSMF”), each Party has
prepared and registered with the European Medicines Agency (“EMA”) a description of its
pharmacovigilance system in the form of a PSMF.

The PSMF contains summary details of all safety data exchange agreements which include in
their scope a product which the respective Party holds a marketing authorisation in the [EU/UK]
as applicable (even if the territorial scope of the Agreement is outside of the [EU/UK]).

Pfizer’s PSMF indicates if the partner has a PSMF registered with EMA (with the corresponding
PSMF Reference number), or if the PSMF is not applicable.

The PSMF Reference Number and /or status of the PSMF of both Parties are detailed below.

Pfizer EU PSMF Reference Number MFL 1463

Pfizer UK PSMF Reference Number UKPSMF01184
Karma Holds no marketing authorisations in the EU. Not applicable
Karma Holds no marketing authorisations in the UK. Not applicable

Confidential PVA ID# 1972 Page 17 of 17