SAFETY DATA EXCHANGE AGREEMENT

“SDEA”

Between

Al Debeiky Pharmaceutical Company

“DBK”

And

Effective Guide

And

Ceutico Consulting Services

Pharmacovigilance Agreement Regarding

Manufacturing

Version 0.0

This is a confidential Agreement and shall not be distributed by any of parties without written
permission or will subject to legal accountability
 SAFETY DATA EXCHANGE AGREEMENT

1. Introduction
This Safety Data Exchange Agreement is made by and between:

First party Second party Third party

Company Al Debeiky Pharmaceutical Effective Guide Ceutico Consulting
name Company (DBK) Services
Address Obour city, Second Abd Rabo Street, Khadra 14 Ali Tawfek Shousha,
industrial zone, Cairo, Abdel Rahman Abdo, from Tayaran Street,
Egypt. Abo Kbeer, Al Sharkia Nasr city
Representativ Eng., Hamdy El- Debeiky Hatem Salah Ali Amany Abo Al Haggag
e Mohamed Mahmoud Abdel Allah
Title CEO CEO CEO
Commercial 364133 12468 147721
registry
number:
Tax card (+2) 02-44891407- 407-754-253 579-565-998
number: 44891408-44891409
Third party “Ceutico Consulting Services” shall be the PV representative of the second party
“Effective Guide” in all pharmacovigilance activities according to their agreement.
Al Debeiky Pharmaceutical Company (DBK), Effective Guide and Ceutico Consulting Services may
hereinafter jointly be referred to as the "Parties" or individually as a "Party"

2. Purpose
The purpose of this SDEA is to allow the best transmission of the data related to safety and quality of the
products owned by the second party “Effective Guide” and its PV representative “Ceutico Consulting
Services” and manufactured by the first party Al Debeiky Pharmaceutical Company (DBK), resulting
from spontaneous notifications made between the Parties' pharmacovigilance structures during the
therapeutic use, through periodic report, whatever the origin may be.

3. Scope
This SDEA describes procedures and time frames, and defines responsibilities of the Parties in order to
protect patients and promote their well-being.
The requirements set forth in this SDEA will also:
 Facilitate compliance with regulatory safety reporting requirements and guidelines, for Adverse Events
reported in association with the use of the Product(s).
 Help and ensure the completeness and accuracy of the safety information as found in each Company’s
Core Data Sheet (CCDS), Company Core Safety Information (CCSI) and/or product labelling (e.g.,
Investigator Brochure, Summary of Product Characteristic, Local Prescribing Information), as
appropriate.
 Ensure harmonisation and consistency of safety information.
 Prevent premature dissemination of non-validated or unapproved safety information.
 Optimise the decision making process in the event that an adverse event is likely to have an impact on
the benefit/risk ratio of the product(s).
 The products to which this SDEA applies are defined in Annex 1., And any change in this product list
will not affect the terms of this agreement.

4. Definitions:
o Adverse Event is defined as any untoward medical occurrence in a patient or clinical trial subject
administered a medicinal product and which does not necessarily have to have a causal relationship with
this treatment. An adverse event can therefore be any unfavourable and unintended sign (e.g. an
abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal
  use outside the terms of the marketing authorisation, including overdose, misuse,
abuse and medication errors.
 occupational exposure.
o“Reportable Adverse Reaction”, “Required Information” or “Minimum Information” will specify
a reportable adverse drug reaction (ADR) with the following minimum information:
1. An identifiable reporter: The reporter can be identified by either name or initials, or address or
qualification (e.g., physician, dentist, pharmacist, nurse, consumer, etc.).
2. An identifiable patient: The patient can be identified by patient’s initials, date of birth (or age
information if date of birth not available), or gender. Note: Patient and reporter identity is
important to avoid duplication, detect fraud, and facilitate follow-up of appropriate cases. The term
“identifiable” in this context only refers to the verification of the existence of an actual patient and
an actual reporter. Local data privacy laws regarding patient and reporter identity might apply.
3. At least one suspected medicinal product.
4. At least one suspected adverse reaction or the outcome of death.

o Serious adverse reaction

An adverse reaction which results in death, is life-threatening, requires in-patient hospitalization or
prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a
congenital anomaly/birth defect.
Life-threatening in this context refers to a reaction in which the patient was at risk of death at the time of
the reaction; it does not refer to a reaction that hypothetically might have caused death if more severe

5. Responsibilities:

5.1 Al Debeiky Pharmaceutical Company (DBK)’s reporting obligations to Ceutico

Consulting Services and commits to the following:
 To collect all Adverse Events (AE) / Adverse Drug Reaction (ADR) reports and any other Safety
Information deriving from special situations even if no AE / ADR occurred such as: drug exposure of
embryo or fetus either through maternal exposure, breastfeeding, overdose, abuse, drug misuse,
medication error, off-label use/unapproved use, occupational exposure, lack of efficacy, suspected
transmission of an infectious disease via Product, un intended beneficial effect and drug-drug-
interaction that DBK’s personnel becomes aware of.
 To document all Adverse Event / Adverse Drug Reaction reports or Other Safety Information
(hereinafter referred to as “Reports”) in writing if received verbally and indicate the date of receipt on
the telephone reports or other documentation which DBK’s personnel became aware of.
 To forward all received Reports including source documents (by fax, e-mail, phone or other means)
to Ceutico Consulting Services (dedicated safety person QPPV) immediately but not later than 24
hours of receipt to the contact address specified below.
 To forward a valid report to Ceutico Consulting Services with minimum information, which is the
smallest amount of information, required for the submission of a Report and every attempt should be
made to obtain and submit further information when it becomes available. If after completion of
adequate attempts to obtain all four minimum information, the report remains invalid, will however
forward this report.
 DBK shall use all reasonable effort to obtain additional or follow-up a previously ADR report upon
request from Ceutico Consulting Services.
 To inform Ceutico Consulting Services (QPPV) immediately but not later than 24 hours of receipt
of cases where a pharmaceutical technical complaint may cause or may have caused potential medicinal
problems.
 To keep Ceutico Consulting Services (QPPV) timely informed on all safety matters related to the
products.
 To notify Ceutico Consulting Services (QPPV) promptly in writing in case of there is any safety-
related action, decision or request.
 To inform Ceutico Consulting Services (QPPV) immediately, not later than 24 hours of any safety
related recall situation concerning the products and to consult with Ceutico Consulting Services on
measures to be taken prior their implementation.
 To ensure that the information exchanged under this Letter of Commitment is confidential and shall
not be disclosed to any party other than for the purposes described herein.
 Ceutico Consulting Services is responsible for PSUR compilation as per current regulation of drug
authorities.
 Ceutico Consulting Services shall fulfil all regulatory requirements relating to the safety of
the Product including collecting and assessing AEs , reporting safety information such as
Individual Case Safety Reports (ICSRs) and aggregate reports to the regulatory authorities, and
conducting pharmacovigilance for the product, which shall include safety monitoring ,risk
management activities ,and preparation of aggregate reports.
 Ceutico Consulting Services will prepare Risk Management Plans for the product(s) (if required in
the EPVC).
 Ceutico Consulting Services is responsible for the submission of PSURs and RMPs to Egyptian
Pharmacovigilance Centre (EPVC) or any other relevant local authorities.
 Ceutico Consulting Services Is responsible to Follow-up investigations and obtain follow-up
information on the reports received by DBK. If available, DBK shall provide sufficient reporter
information to facilitate follow-up processes.
 Ceutico Consulting Services is responsible for literature screening and searching in all publishing all
over the world to collect all safety signals both companies shall be responsible for conducting
worldwide and local literature review for the products.

6. Reconciliation
 On a quarterly basis, DBK shall make a reconciliation report for Adverse Event reports / Adverse Drug
Reaction reports or Other Safety Information sent by DBK to Ceutico Consulting Services, even if no
Adverse event, Adverse Drug Reaction or Other Safety Information was exchanged .

 The reconciliation report shall be sent through the mail provided in the contact details in the
annex of this agreement.

7. Audits
Ceutico Consulting Services may request an audit of DBK’s activities outlined in this Letter of
Commitment. Audit announcements are to be given in advance and a mutually acceptable timing sought.
Both Parties should be in agreement as to the designated auditor(s). The results of the audit may not be
shared outside the two Parties involved without written permission, with the exceptions as needed to be
compliant with PV System Master File regulation, applicable laws and regulations and/or permitted
request by a competent governmental authority. All documents pertinent to the corresponding
pharmacovigilance services and access to DBK facilities will be provided for such audit/inspection after
an adequate announcement. All documents, information, and services provided hereunder shall comply
with applicable data protection laws.

8. Termination and Validity

This Agreement shall come into force on the date of the last signature below and shall remain in full force
and effect for so long as the Business Agreement is valid, including any amendments there to, remain in
full force and effect.
This Agreement shall survive termination or assignment of the Business Agreement until such time when
the Parties agree in writing to terminate.

9. Miscellaneous
This Letter of Commitment enters into force on the date of last signature. and shall continue in full force
and effect until formal revision, expiration or termination of the Commercial Agreement. However,
reporting requirements accrued up to the termination date shall outlast termination until all regulatory
obligations are met (e.g. for Effective Guide’s stock remaining in the marketplace).

10. Signatures

Al Debeiky Effective Guide Ceutico Consulting

Pharmaceutical Services
 Signature / Date: Signature / Date Signature / Date

Name of the CEO:

Eng., Hamdy El- Debeiky

Signature / Date
Annex 1: Products and territory
This Letter of Commitment applies to Effective Guide products for which Al Debeiky Pharmaceutical
Company (DBK) is responsible for Production and Ceutico Consulting Services is a PV representative
in the Territory of Egypt:
This list may be changed with time without any effect on the agreement.

Active Dosage Registratio Marketing

Product Name
constituents Form n no. status
Ofloxacin 400 Film Coated Not marketed yet
OFLOGUIDE 25447/2018
mg Tablet

CITROFLEXOGUID Ciprofloxacin Film Coated 31104/2015(T) Not marketed yet

E 500 mg FCT 500 mg Tablet

CITROFLEXOGUID Ciprofloxacin Film Coated 31105/2015(T) Not marketed yet

E 750 mg FCT 750 mg Tablet
Annex 2: Pharmacovigilance contact details:
Contact details of DBK’s QPPV
Dr. Eman I. Mubarak
Zone 11 block 12014 Obour City Industrial Zone
01002633674
01127252221/ 01002633674
pharamcisteman_mubarak@yahoo.com
Contact details of Effective Guide safety contact person:
Name Mr. Hatem Salah Ali Mohamed
Address Abd Rabo Street, Khadra Abdel Rahman Abdo, Abo Kbeer, Al Sharkia
Mob. No 0 114 969 6078
E-mail effective.guide@gmail.com
Contact details of Ceutico Consulting Services QPPV:
Dr. Hebatalla Ahmed Mohamed Ismail
14 Ali Tawfek Shousha, from Tayaran Street, Nasr city
01022485015
022625014
pv@ceutico-eg.com