Proposal Nº:7475 /2006 Date: 06/28/06 1

ANALI - 024
Analytical Laboratory Qualified by ANVISA

Visit ANVISA’s website for the scope:

http://www.anvisa.gov.br/reblas/bio/anali/index.htm

RESEARCH PROPOSAL

SPF DETERMINATION – FDA MONOGRAPH

Products: 02 products

protector solar en gel factor de protección superior a 30

protector solar en crema protección superior a 50 o igual

Company: Quifarma ltda

calle 61 Nº51d-53
Medellín, Colômbia
Inquirer: Fabio Arboleda Torres
Phone: 574 511 95 35
E-mail: compras@quifarma.com

PROTOCOL SUMMARY

Our tests follow CTFA and JCIA international standard for methodology and
number of volunteers.
All tests comply with Brazilian Health Department Guiding Lines.

Test begins with two volunteers. If the found result complies with the expected
we will proceed test. Otherwise (below or far above the expected) we stop
testing and get in touch with the company. In case of a reformulation is needed,
the company will pay for additional the volunteers involved at the beginning.

SPF Determination Test

• Test runs with 20 volunteers, both sexes, phototype I, II and III, aging
from 18 to 60 years old and approved by the exclusion criteria.
• All volunteers subjected to interview and dermatological exams.
• In each volunteer is determined its MED (Minimal Erythemal Dose)
and then submitted to UVB radiation to determine SPF.

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• 24 H after radiation the tested areas are evaluated by the erythema.

• Statistical analysis.
• Comprehensive Report.
• The methodology will follows FDA standards according to FDA Final
monograph 1999

STUDY LASTING

SPF Determination Test :

Volunteer selection: 1 week
Test run: 3 weeks
Report elaboration: 1 week
Total Lasting: 5 weeks

This timeframe is valid for a normal test situation. Please check terms for
samples delivery.

NECESSARY MATERIAL

SPF 01 sample of 50 ml or grams per product/version

The sample is representative to the end product to be introduced into the

market

Please also send:

9 official product name to report
9 product directions ( if applicable )
9 qualitative product formulation – INCI names /batch number (it will
be attached to report)

sample’s shipping address to be informed

Please send us all billing information (company name, address) to send the
invoice

SAFETY OF THE TEST

• VOLUNTEERS :
o Must fill Consent Form and will be clinically evaluated at the
beginning and in the end of the test.

• EVALUATION:
o Follows the Declaration of Helsinki Rules for tests in humans.

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o Obeys Law 196/96 from Heath Dept. of Brazil and Organization

for Economic Co-operation and Development (OECD ) directions
for tests in humans.
o General protocols approved by Independent Ethic Committee.
o Follows the principles of Clinical Good Practices.
• UNDISCLOSURE:
We guarantee total secrecy of presented information, if necessary a Non-
Disclosure Agreement could be signed.

COST OF THE TEST

Test Sample Test cost No. Total Cost
for one Products USD
SPF range product
in USD

SPF FDA
(static) SPF30 + (<= 50) 2,900 02 5,800

VAT/fee 60
Total 02 5,860

Remarks :
• Report in English
• SPF higher than 30 : according to FDA, product should be labeled
as 30+

• in case of re-sending sample (reformulation ) : to be included

additional of US$ 145/per voluntary involved at the beginning or
according to SPF range/test cost plus VAT (US$ 60 ).

PAYMENT CONDITIONS:
TWO INSTALLMENTS: 50% at the approval
50% + additional value (by additional voluntary
involved in case of re-sending sample ) on the
report delivery or after tests conclusion in case of
being waiting for the formula or official product name.

We would appreciate your payments through wire transfer to our bank account
as follow . Please be aware that all wire transfer fees (remittance) to be
paid by sender.

Beneficiary name: Allergisa Pesquisa Dermato Cosmética Ltda

Bank name: ITAU Bank S/A
Bank address: Av. Santa Isabel, 126

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Bank city: CAMPINAS-SP

Bank country: BRASIL
Account number: 10180-9
Branch number: 1619
SWIFT CODE: ITAUBRSPCAS

Intermediate Bank (if ITAU Bank is not directly available)

Bank name: CITIBANK

Bank city: New York
Bank country: USA
Account number: 10960953
SWIFT CODE: CITIUS33

After test approval, in case of cancellation, the amount paid will cover the
expenses of the initial phases of the test foreseen on the protocol.

Thanks for choosing Allergisa and do not hesitate to contact us in

case of any additional information.

Truly Yours,

Gilvanice Carvalho

International Technical Sales Dept.

Allergisa Pesquisa Dermato-Cosmética Ltda.
Phone:+55 11 8315.95.56
g.carvalho@allergisa.com.br

I hereby approve this proposal and accept the herein payment conditions.

Signature

Name:
Position:
Date :

Please send the approval by fax number + 55 (19) 3289-3956

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