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Quality Agreement
This AGREEMENT, made and entered into this ________________, 2011 at Canlubang Industrial Estate, Calamba, Laguna, Philippines by and between: BAYER PHILIPPINES, INC. a corporation duly organized and existing by virtue of the laws of the Republic of the Philippines with principal office address located at Bayer House, Canlubang Industrial Estate, Calamba City, Laguna 4028, Philippines and herein represented by its General Manager-Animal Health Division, Mr. Andrew Mantek, and Ms. Cynthia Miravite, QA & QC Officer and hereinafter referred to as BAYER PHILIPPINES, INC.; -andInphilco, Inc., a corporation duly organized and existing by virtue of the laws of the Philippines_________ with principal office address located at 7th Floor Ave Maria Bldg. 1517 Quezon Ave. , Quezon City________ and herein represented by its ________ , ________________________ and hereinafter referred to as ______________ ; together referred to as the PARTIES. Witnesseth that : Preliminary Remarks In the Pharmaceutical industry, contract manufacturing means the production, processing, packaging and quality control of materials or pharmaceuticals with a division of responsibilities. WHEREAS , the purpose of this Agreement is to define and establish the obligations and responsibilities of BAYER PHILIPPINES, INC. and Inphilco, Inc._ relating to the Quality requirements of the PRODUCTS manufactured by Finnfeeds Finland Oy and supplied to BAYER PHILIPPINES, INC. in accordance with cGMPs. WHEREAS , Finnfeeds Finland Oy manufactures, processes, packages and tests the products on its own responsibility, in accordance with its formulae or instructions. WHEREAS , Inphilco, Inc. is willing to supply BAYER PHILIPPINES,INC. with PRODUCTS as specified in ANNEX 2- RELEVANT PRODUCTS. WHEREAS , BAYER PHILIPPINES,INC. is willing to buy from Inphilco, Inc. the following products : a. Betafin S1 WHEREAS ,the responsibility of distributing the product is borne by BAYER PHILIPPINES,INC. or the company in the name of which the product is being distributed.
NOW THEREFORE, in consideration of the mutual covenants expressed, the parties agree as follows: 1. Where Regulatory Inspections or BAYER PHILIPPINES,INC. audits identify quality and compliance issues, Finnfeeds Finland Oy should submit a GMP improvement plan, with timings, and shall inform BAYER PHILIPPINES,INC. regularly on the progress in the implementation of this plan. 2. Inphilco, Inc. shall notify BAYER PHILIPPINE,INC. of any regulatory inspections that may directly or indirectly impact on the PRODUCTS supplied to BAYER PHILIPPINES,INC.. Inphilco, Inc. shall inform BAYER PHILIPPINES,INC. of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to BAYER PHILIPPINES,INC.. 3. Inphilco, Inc. shall, where required, develop internal control limits in coordination with BAYER PHILIPPINES,INC. including limits, which support the expiry period of the PRODUCTS in the Registered Details. Where these internal control limits are set, batches failing the internal control limits shall not be shipped to BAYER PHILIPPINES,INC. until Inphilco, Inc. conducts an appropriate investigation and the outcome acceptable to BAYER PHILIPPINES,INC.. 4. Inphilco, Inc. shall supply an agreed Certificate of Analysis as defined in ANNEX 3 . indicating that the batch complies with all agreed specifications and cGMPs. 5. BAYER PHILIPPINES,INC. shall undertake any additional tests, as BAYER PHILIPPINES,INC. deems appropriate. 6.Inphilco, Inc. shall investigate all out of specification (OOS) results in accordance with cGMPs and shall inform the BAYER PHILIPPINES,INC. of the outcome of all investigations. 7..Inphilco, Inc. shall retain batch documentation for 5 years. 8. Inphilco, Inc. shall retain reference samples from each batch of the PRODUCTS and starting materials in accordance with cGMPs. For the batches that are produced at BAYER PHILIPPINES'S facility, BAYER PHILIPPINES,INC. shall retain reference samples from each batch of the resultant products in accordance with cGMPs. 9. Inphilco, Inc. shall investigate all complaints relative to the PRODUCTS supplied to BAYER PHILIPPINES, INC. and shall communicate the data to BAYER PHILIPPINES, INC. within reasonable time. Definition of Functions and Responsibilities Article 1
1.
The PARTIES follow the Quality Assurance System defined in the current version of the WHO GMP Guidelines.
The contacts and responsible persons are established as set forth in ANNEX 1CONTACTS AND RESPONSIBLE PERSONS. All functions and responsibilities are in accordance with the rules of Good Manufacturing Practices and Local Requirements (if any; to be defined in ANNEX 3DEFINITION OF PHARMACEUTICAL RESPONSIBILITIES.) . The PRODUCTS are as specified in ANNEX 2- RELEVANT PRODUCTS.. Starting materials and packaging materials shall be purchased only from approved suppliers. Inphilco, Inc. agrees to allow BAYER PHILIPPINES to conduct site inspections.
3.
4. 5.
6.
Article 2
1.
This agreement shall become effective with the signatures of both PARTIES. It is concluded for an unlimited period of time and may be cancelled with six (6) month's prior written notice. Both PARTIES may cancel the Agreement with immediate effect if just good cause is existing. Changes and amendments to this Agreement and its Annexes require both PARTIES' mutual consent and shall be made in writing. Should individual provisions in this Agreement be or become legally invalid or should the Agreement contain a gap, then this shall not affect the validity of the remaining provisions. The PARTIES agree to replace an invalid provision of a gap with a provision that is as close as possible to the intended economic effect of the Agreement and which meets legal requirements. All annexes as listed below form part of the Agreement. By the moment, there are: Annex 1: Annex 2: Annex 3 Contacts and Responsible Persons Relevant Products Definition of Pharmaceutical Responsibilities
2.
3.
4.
Bayer Philippines, Inc. __________________ Andrew Mantek General Manager Animal Health Division __________________ Ms. Cynthia Miravite QA & QC Officer
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____________________ President
ACKNOWLEDGMENT Republic of the Philippines ) City of ____________ ) S.S. Before me a Notary Public of _____________, ___________, 2011, personally appeared: Name Bayer Philippines Inc. Andrew Mantek Cercado Danilo _______________ ________________ Comm. Tax Cert. No. at the above locality, on
Date/Place of Issue
____________________ _________________ Passport No.________ Valid up to ____ _ _________ ________________ __________________ _________________ __________________ _________________
known to me and to me known to be the same persons who executed the foregoing QUALITY AGREEMENT , and they acknowledged to me that the same is their own free and voluntary act and deed and the free and voluntary act and deed of the corporations they represent. IN WITNESS WHEREOF, I have hereunto set my hand and affixed my notarial seal at the place and on the date first above written. Doc. No. _____ Page No. _____ Book No. _____ Series of 2011 Notary Public
Phone/Fax 632 450 3560 632 450 5479 632 450 5479
Technical Operations Manager QA/QC Officer Responsible persons Responsible for storage and distribution Responsible for QA/QC Responsible for Regulatory Affairs
632 450 3760 6349 549 2950 632 450 3764 6349 549 2950
632 450 3773 632 450 5491 632 450 3764 6349 549 2950 632 450 3770 6349 549 2950
Contacts President/Executive VicePresident Responsible for Marketing/Distribution Responsible for Quality Assurance/Quality Control Responsible for Regulatory Affairs /Accounting Officer
Name Gregorio B. Abreu Cristina A. Dator Delfin A. Anareta William Roger Uy Norma E. Florencio Lorenza B. Camus
Holder of the marketing authorization Manufacturing and testing in compliance with the marketing authorization
A. Product Materials Primary packaging components Secondary packaging components Packaging Quality Control Process Validation and Validation of analytical methods Release for Dispatch Final Release for Sale or Supply Stability/Follow-up stability testing of finished product Annual Product Review X X X X X X X X X
X X X X X X
Quality Agreement
This AGREEMENT, made and entered into this ________________, 2011 at Canlubang Industrial Estate, Calamba, Laguna, Philippines by and between: BAYER PHILIPPINES, INC. a corporation duly organized and existing by virtue of the laws of the Republic of the Philippines with principal office address located at Bayer House, Canlubang Industrial Estate, Calamba City, Laguna 4028, Philippines and herein represented by its General Manager-Animal Health Division, Mr. Andrew Mantek, and Ms. Cynthia Miravite, QA & QC Officer and hereinafter referred to as BAYER PHILIPPINES, INC.; -andInphilco, Inc., a corporation duly organized and existing by virtue of the laws of the Philippines_________ with principal office address located at 7th Floor Ave Maria Bldg. 1517 Quezon Ave. , Quezon City________ and herein represented by its ________ , ________________________ and hereinafter referred to as ______________ ; together referred to as the PARTIES. Witnesseth that : Preliminary Remarks In the Pharmaceutical industry, contract manufacturing means the production, processing, packaging and quality control of materials or pharmaceuticals with a division of responsibilities. WHEREAS , the purpose of this Agreement is to define and establish the obligations and responsibilities of BAYER PHILIPPINES, INC. and Inphilco, Inc._ relating to the Quality requirements of the PRODUCTS manufactured by Lican Paraguay S.A. and supplied to BAYER PHILIPPINES, INC. in accordance with cGMPs. WHEREAS , Lican Paraguay S.A. manufactures, processes, packages and tests the products on its own responsibility, in accordance with its formulae or instructions. WHEREAS , Inphilco, Inc. is willing to supply BAYER PHILIPPINES,INC. with PRODUCTS as specified in ANNEX 2- RELEVANT PRODUCTS. WHEREAS , BAYER PHILIPPINES,INC. is willing to buy from Inphilco, Inc. the following products : a. Prolechon WHEREAS ,the responsibility of distributing the product is borne by BAYER PHILIPPINES,INC. or the company in the name of which the product is being distributed.
NOW THEREFORE, in consideration of the mutual covenants expressed, the parties agree as follows: 1. Where Regulatory Inspections or BAYER PHILIPPINES,INC. audits identify quality and compliance issues, Lican Paraguay S.A. should submit a GMP improvement plan, with timings, and shall inform BAYER PHILIPPINES,INC. regularly on the progress in the implementation of this plan. 2. Inphilco, Inc. shall notify BAYER PHILIPPINE,INC. of any regulatory inspections that may directly or indirectly impact on the PRODUCTS supplied to BAYER PHILIPPINES,INC.. Inphilco, Inc. shall inform BAYER PHILIPPINES,INC. of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to BAYER PHILIPPINES,INC.. 3. Inphilco, Inc. shall, where required, develop internal control limits in coordination with BAYER PHILIPPINES,INC. including limits, which support the expiry period of the PRODUCTS in the Registered Details. Where these internal control limits are set, batches failing the internal control limits shall not be shipped to BAYER PHILIPPINES,INC. until Inphilco, Inc. conducts an appropriate investigation and the outcome acceptable to BAYER PHILIPPINES,INC.. 4. Inphilco, Inc. shall supply an agreed Certificate of Analysis as defined in ANNEX 3 . indicating that the batch complies with all agreed specifications and cGMPs. 5. BAYER PHILIPPINES,INC. shall undertake any additional tests, as BAYER PHILIPPINES,INC. deems appropriate. 6.Inphilco, Inc. shall investigate all out of specification (OOS) results in accordance with cGMPs and shall inform the BAYER PHILIPPINES,INC. of the outcome of all investigations. 7..Inphilco, Inc. shall retain batch documentation for 5 years. 8. Inphilco, Inc. shall retain reference samples from each batch of the PRODUCTS and starting materials in accordance with cGMPs. For the batches that are produced at BAYER PHILIPPINES'S facility, BAYER PHILIPPINES,INC. shall retain reference samples from each batch of the resultant products in accordance with cGMPs. 9. Inphilco, Inc. shall investigate all complaints relative to the PRODUCTS supplied to BAYER PHILIPPINES, INC. and shall communicate the data to BAYER PHILIPPINES, INC. within reasonable time. Definition of Functions and Responsibilities Article 1 The PARTIES follow the Quality Assurance System defined in the current version of the WHO GMP Guidelines.
1.
10
The contacts and responsible persons are established as set forth in ANNEX 1CONTACTS AND RESPONSIBLE PERSONS.
2.
All functions and responsibilities are in accordance with the rules of Good Manufacturing Practices and Local Requirements (if any; to be defined in ANNEX 3DEFINITION OF PHARMACEUTICAL RESPONSIBILITIES.) .
3. 4. 5.
Starting materials and packaging materials shall be purchased only from approved suppliers. 6. Inphilco, Inc. agrees to allow BAYER PHILIPPINES to conduct site inspections.
Article 2 This agreement shall become effective with the signatures of both PARTIES. It is concluded for an unlimited period of time and may be cancelled with six (6) month's prior written notice. Both PARTIES may cancel the Agreement with immediate effect if just good cause is existing.
1.
Changes and amendments to this Agreement and its Annexes require both PARTIES' mutual consent and shall be made in writing.
2.
Should individual provisions in this Agreement be or become legally invalid or should the Agreement contain a gap, then this shall not affect the validity of the remaining provisions. The PARTIES agree to replace an invalid provision of a gap with a provision that is as close as possible to the intended economic effect of the Agreement and which meets legal requirements.
3.
4. All annexes as listed below form part of the Agreement. By the moment, there are: Annex 1: Annex 2: Annex 3 Contacts and Responsible Persons Relevant Products Definition of Pharmaceutical Responsibilities
Bayer Philippines, Inc. __________________ Andrew Mantek General Manager Animal Health Division __________________ Ms. Cynthia Miravite QA & QC Officer
11
____________________ President
ACKNOWLEDGMENT Republic of the Philippines ) City of ____________ ) S.S. Before me a Notary Public of _____________, ___________, 2011, personally appeared: Name Bayer Philippines Inc. Andrew Mantek Cercado Danilo _______________ ________________ Comm. Tax Cert. No. at the above locality, on
Date/Place of Issue
____________________ _________________ Passport No.________ Valid up to ____ _ _________ ________________ __________________ _________________ __________________ _________________
known to me and to me known to be the same persons who executed the foregoing QUALITY AGREEMENT , and they acknowledged to me that the same is their own free and voluntary act and deed and the free and voluntary act and deed of the corporations they represent. IN WITNESS WHEREOF, I have hereunto set my hand and affixed my notarial seal at the place and on the date first above written. Doc. No. _____ Page No. _____ Book No. _____ Series of 2011 Notary Public
12
Phone/Fax 632 450 3560 632 450 5479 632 450 5479
Technical Operations Manager QA/QC Officer Responsible persons Responsible for storage and distribution Responsible for QA/QC Responsible for Regulatory Affairs
632 450 3760 6349 549 2950 632 450 3764 6349 549 2950
632 450 3773 632 450 5491 632 450 3764 6349 549 2950 632 450 3770 6349 549 2950
13
Contacts President/Executive VicePresident Responsible for Marketing/Distribution Responsible for Quality Assurance/Quality Control Responsible for Regulatory Affairs /Accounting Officer
Name Gregorio B. Abreu Cristina A. Dator Delfin A. Anareta William Roger Uy Norma E. Florencio Lorenza B. Camus
14
Holder of the marketing authorization Manufacturing and testing in compliance with the marketing authorization
A. Product Materials Primary packaging components Secondary packaging components Packaging Quality Control Process Validation and Validation of analytical methods Release for Dispatch Final Release for Sale or Supply Stability/Follow-up stability testing of finished product Annual Product Review X X X X X X X X X
15
X X X X X X
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