ADIP+QC

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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 FDA’s 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.

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Transcript of ADIP+QC

Page 1: ADIP+QC

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 FDA’s 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 PARTY’S chemist (don’t 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 retainer’s 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 retainer’s fee? When the Retainer’s Fee is paid, does this mean that the client can submit as many samples he wants for testing for FREE?

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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 JUAN DELA CRUZ Technical Director President ADIP QC COOP ABC, INC

(FIRST PARTY) (SECOND PARTY)

SIGNED IN THE PRESENCE OF

_____________________________ ______________________________ WITNESS WITNESS

(Signature over Printed Name) (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 ROBLESJUAN 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.: __________

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Series of 2010ADIP 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 Method Used Regular Lead Time

Lead time for “RUSH” Testing

Cost per Test

(in Php)Identification TLC 14 working days 3 working days 1650.00

IR 14 working days 3 working days 1100.00HPLC 14 working days 3 working days 2420.00Spectrophotometer 14 working days 2 working days 1650.00

Water KF 14 working days 2 working days 1100.00Assay HPLC 14 working days 3 working days 2420.00

GC 14 working days 3 working days 2100.00Spectrophotometer 14 working days 3 working days 1650.00

Dissolution Dissolution Apparatus toSpectrophotometer

14 working days 5 working days 3300.00

Dissolution Apparatus toHPLC

18 working days 7 working days 16500.00

Stability Studies

Depends on the Active Component. A separate Annex for each type of product will be made.

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“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) Don’t we require Technical Document from Sample manufacturer? Don’t 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.