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MEMORANDUM OF AGREEMENT

KNOW ALL MEN BY THIS PRESENT:


ADIP Quality Control, Product Research and Development Cooperative (ADIP QC
COOP), duly organized by the laws of the Philippines with office at Unit 380-F Jacinto
Bldg., Quezon Ave., cor. Scout Reyes, Quezon City, represented by its Technical Director,
FRANCES EVELYN ROBLES (herein referred to as first party)
and
ABC COMPANY INC duly organized by laws of the Philippines with office at 123
Scout Tobias Quezon City; represented herein by its President, JUAN DE LA CRUZ
(herein referred to as second party).
WITNESSETH THAT:
WHEREAS, Food and Drug Administration (FDA) requires all person and entity
engaged in the manufacture of pharmaceutical products for commercial purposes to retain
the services of, among others, a licensed chemist and a quality control laboratory duly
recognized by the FDA as an analyst, to determine the quality of the raw materials used
in the manufacture of drugs and the conformity of manufactured drugs with their
respective formulas;
WHEREAS, in the compliance with the FDAs requirements, the SECOND PARTY is
in need of the services of a recognized analyst to determine the conformity of its
products;
WHEREAS, SECOND PARTY hereby engage the services of the FIRST PARTY and
the latter hereby accept the engagement;
WHEREAS, FIRST PARTY operates an analytical laboratory manned by experienced
analysts to analyze and test pharmaceutical products;
NOW, THEREFORE, for and in consideration of the foregoing premises and the terms
and condition hereafter set forth, the parties have agreed as follows;
1. SECOND PARTY shall pay for the analysis conducted by the FIRST PARTY,
based on the price list and in accordance with the guidelines attached hereto as
ANNEX A and B respectively, subjected to adjustment by prior written
notice.
2. FIRST PARTY shall analyze the raw materials, ingredients and finished product
submitted by the SECOND PARTY, thereafter, FIRST PARTY shall issue to
the SECOND PARTY the approximate (why approximate? Hindi ba exact ang
results natin?) analysis report duly certified by the FIRST PARTYS chemist
(dont our Technical Director sign official documents like this?). I understand
FDA accepts RESULTS from our QC Lab. Are our chemists identified and
recognized as sole signatories of our Technical documents?
3. SECOND PARTY shall submit to FIRST PARTY for analysis at least
_________ samples per year. This can be part of the Guidelines in Annex A or B
4. SECOND PARTY shall pay the FIRST PARTY the amount of
_________________ per year as retainers fee starting on _______________ until
this contract is terminated and/or expired, payable one year advance. Is this MOA
not a per transaction basis? Why is there a retainers fee? When the Retainers
Fee is paid, does this mean that the client can submit as many samples he wants
for testing for FREE?

5. Whenever necessary, the FIRST PARTY and SECOND PARTY shall enter into
Supplementary Agreements concerning specific programs and one year in
advance (What is one year in advance? The implementation, payment or
preparation? Or whatever.).
6. This agreement shall take effect upon signing and shall be effective and valid for
a period of one (1) year therefrom unless sooner terminated by either party upon
thirty (30) days prior written notice provided however, that all monetary
obligation to either party is settled satisfactorily.

IN WITNESS WHEREOF, the parties have hereunder affixed their signature this
___________day of _________________ 2010

____________________________
FRANCES EVELYN ROBLES
Technical Director
ADIP QC COOP
(FIRST PARTY)

____________________________
JUAN DELA CRUZ
President
ABC, INC
(SECOND PARTY)

SIGNED IN THE PRESENCE OF


_____________________________
WITNESS
(Signature over Printed Name)

______________________________
WITNESS
(Signature over Printed Name)

REPUBLIC OF THE PHILIPPINES


IN THE CITY OF _______________

)
) S.S

SUBSCRIBED AND SWORN to before me this _______ day of ___________,


2010 at ______________, Philippines, personally appeared.
Name

Res. Cert No.

Date

Place

FRANCES EVELYN ROBLES


JUAN DE LA CRUZ
Known to me the persons who executed the above instrument, and they acknowledge to
me that the same is their free act and deed.
IN WITNESS WHEREOF, I have hereunto set my hand and affixed my hand
and affixed my notarial seal, the day, the year, and place above written.

Notary Public
Doc. No.: __________
Page No.: __________
Book No.: __________

Series of 2010
ADIP Quality Control, Product Research and Development Cooperative
(ADIP QC COOP)
Unit 380-F Jacinto Bldg., Quezon Ave., cor. Scout Reyes, Quezon City
Telefax: 410-0930 / 799-2257
ANNEX A
Test
Identification

Water
Assay
Dissolution

Stability
Studies

Method Used
TLC
IR
HPLC
Spectrophotometer
KF
HPLC
GC
Spectrophotometer
Dissolution Apparatus to
Spectrophotometer
Dissolution Apparatus to
HPLC

Regular Lead
Time

Lead time for


RUSH
Testing

14 working days
14 working days
14 working days
14 working days
14 working days
14 working days
14 working days
14 working days
14 working days

3 working days
3 working days
3 working days
2 working days
2 working days
3 working days
3 working days
3 working days
5 working days

Cost per
Test
(in Php)
1650.00
1100.00
2420.00
1650.00
1100.00
2420.00
2100.00
1650.00
3300.00

18 working days

7 working days

16500.00

Depends on the Active Component. A separate Annex for each type of


product will be made.

ANNEX B
GUIDELINES IN OF THE LABORATORY SERVICES
1. Down payment of 50% of the total cost will be required upon receipt of the
samples. (Checks must be payable in favor of ADIP QC Cooperative)
2. Samples given must be enough (determined by ADIP QC) to have a retain
quantity for further reference.
3. Samples must bear proper information for ease of identification. (sample name,
batch or lot number or any identifying number) Dont we require Technical
Document from Sample manufacturer? Dont we do just Confirmation Testing?
4. Samples must be in closed containers upon receipt. Samples given must be
enough to have a retain quantity for further reference which will be kept for a
period of one year (1) after which it will be disposed of by ADIP QC Coop.
unless there is a written request that it be kept for more than one (1) year but not
to exceed three (3) years. This is the same as Item 2 above.
5. Results and Certificate of Analysis (CA) will be given only upon the full payment
of the testing charges and the CA shall not be reproduced except in full and
without the written approval of the ADIP QC Coop. Management. The CA should
not be accepted without the signed AQCPRDC dry seal on all its pages.
Suggested revision:
5. Certificate of Analysis (CA) where testing results are stated including
pertinent attachments like chromatograms, if applicable, shall be issued to
the client only upon full payment of the testing charges. The original and
authentic copy of the CA shall bear a signed AQCPRDC Dry Seal on all pages.
6. Any reproduction made by clients on the issued CA must be submitted to
ADIP QC for dry sealing if clients wants the document for official use and may
need confirmation of the results from ADIP QC in the future.
6. All pertinent attachments (like chromatograms) to the CA will be given to the
client without any additional charges. This may be deleted if such attachments is
mentioned in the price list.
7. Reference/Calibrated working standards should be provided by the client
including the reference drug samples.
8. The result(s) apply only to the samples submitted to ADIP QC Coop.
9. Lead time for the rush testing will be three (3) working days upon receipt of the
sample with additional rush testing fee of twenty five (25%) of the regular fee.
10. It is the responsibility of ADIP QC to test the sample/s given as per quoted and it
is the responsibility of the Client to give the final disposition for the sample/s for
whatever purpose it may be.
11. All results will be held in confidence by ADIP QC Cooperative and NO
RESULTS SHALL BE STATED VERBALLY TO CLIENTS BY ADIP QC.
12. For out of Metro Manila samples, all courier cost will be shouldered by the client.

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