Development and Manufacturing Agreement between Catalyst Pharmaceutical Partners and Pharmaceutics International, Inc. for Vigabatrin Clinical Trial Materials
Catalyst Pharmaceutical Partners (CPP) and Pharmaceutics International, Inc. (PII) have entered into an agreement for PII to develop, scale up, and manufacture film-coated Vigabatrin tablets to support a Phase II clinical trial for the treatment of cocaine addiction. CPP will provide the active pharmaceutical ingredient and technical data, while PII will handle formulation, testing, and production of clinical trial materials. The agreement outlines quality, regulatory, and audit requirements, and specifies that the developed formulation will be owned by CPP. The project supports regulatory submissions and future marketing applications.
to the Manufacture of Clinical Trial Materials to Support a Phase II Study
CPP Contact: | Patrick J. McEnany, Chief Executive Officer | |
Catalyst Pharmaceutical Partners | ||
220 Miracle Mile, Suite 234 | ||
Coral Gables, FL 33134 | ||
Phone: | (305) 529-2522 | |
Fax: | (305) 529-0933 | |
Email: | ***@*** | |
PII Contacts: | Tammy Bryan, Associate Director, Business Development | |
David Fidler, Director Project Management | ||
Pharmaceutics International, Inc. | ||
10819 Gilroy Road | ||
Hunt Valley, MD 21031 | ||
Corporate Phone: | (410) 584-0001 ext. 239 (TB) | |
(410) 584-0001 ext. 156 (DF) | ||
Corporate Fax: | (410) 584-0007 | |
Email: | ***@*** / ***@*** |
(B) Costs
(C) Legal and Signatures
12CAT01.04 | May 10, 2006 | Page 1 of 22 |
| API Vigabatrin with Certificate of Analysis (C of A) and Material Safety Data Sheet (MSDS) | |
| Reference standard and impurities | |
| Technical data package, if any | |
| Quantitative formulation | |
| Product samples of the Sabril 500 mg tablet (10) and 500 mg sachet, C of A, MSDS | |
| Analytical methods for API and drug product with validation package, if available | |
| Safety Information (for NCEs): Investigators Brochure or Summaries of Pre- clinical safety/activity data, where available, including: |
| Safety Pharmacology Studies | ||
| Mutagenicity Studies (eg. AMES test) | ||
| Non-GLP and/or GLP acute and sub-chronic/chronic toxicity trials in any species | ||
| Pharmacology Summary | ||
| Teratogenicity Studies |
| Excipients | |
| Packaging components HPDE bottles | |
| Analytical columns |
12CAT01.04 | May 10,2006 | Page 2 of 22 |
| Tooling |
1. | Materials: PII will order sufficient materials for all activities in this proposal. PII will use stock excipients where possible and will bill for materials and testing at the completion of this contract. |
1.1 | Vigabatrin PII will receive with C of A and perform ID testing. |
1.1.1 | Description. | ||
1.1.2 | Identification by IR (USP <197K>). | ||
API usage table: |
Cleaning method development and validation | 5gm | |
Preformulation activities for dissolution, API characterization and tablet compaction properties | 600 gm | |
Formulation Development 2 prototypes x 10,000 batch sizes | 5.0 Kg | |
Feasibility Batch Size of 100,000 tablets | 50.0 Kg | |
CTM batch size of 100,000 tablets | 50.0 Kg | |
Analytical method development and validation for dissolution, assay and related substance | 5-10gm | |
Subtotal | 105.61 Kg | |
Overage-30% | 33.4 Kg | |
Total | 109.01 Kg * |
* | Based on 500 mg strength |
1.2 | Excipients PII will receive and perform all appropriate testing, including ID testing. |
| Magnesium Stearate (Lubricant) | ||
| Ac-Di-Sol or Sodium Starch Glycolate (Disintegrant) | ||
| Colloidal Silicon Dioxide | ||
| Microcrystalline Cellulose (Avicel PHI01) | ||
| Colorcon Opadry Film Coating Materials (to be confirmed) | ||
| Cab-O-Sil (Glidant) | ||
NOTE: Excipients may be adjusted based on initial studies |
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1.3 | Packaging components PII will receive on C of C and perform ID release testing. |
| HDPE bottles | ||
| Child Resistant Closures |
2. | Pre-formulation |
2.1 | PII will review CPP supplied information including purity profiles, process related degradants, and related substances of API. | ||
2.2 | PII will perform the following studies on the API: |
| Bulk / Tap Density | ||
| Flow | ||
| Screen Analysis | ||
| Appearance | ||
| Hygroscopicity at 25°C/60%RH (6 hours, 24 hours, 48 hours) |
2.3 | Tablet compaction properties (neat API with lubricant) |
3. | Formulation Development Two (2) prototype batch sizes up to 10,000 film- coated tablets (5.0 kg API) |
3.1 | PII will review the technical data package supplied by CPP and prepare a development protocol to be authorized by CPP prior to initiation of formulation activities. CPP will provide quantitative formulation prior to the start of the development activities. | ||
3.2 | PII will develop (2) prototypes (batch sizes of up to 10,000 tablets). | ||
3.3 | The first prototype batch will be a batch of core tablets at the smallest reasonable scale (approximately 3,000 tablets) needed to determine the compression characteristics and compression parameter ranges. (The core tablet formula will be composed of Vigabatrin, Avicel PH101 (or equivalent), Ac-Di-Sol (or equivalent), Cab-O-Sil (or equivalent), and magnesium Stearate. | ||
3.4 | The second prototype batch will be a batch to optimize process and coating parameters. | ||
3.5 | The prototypes will be packaged in HPDE bottles of 100 count. | ||
3.6 | The prototypes will be tested for the following in-process tests: |
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3.6.1 | Tablet properties (hardness, thickness, weight and friability) | ||
3.6.2 | Bulk and Tap Density / Flow | ||
3.6.3 | Sieve Analysis |
3.7 | The prototypes will be tested for the following finished product tests: |
3.7.1 | Physical Appearance | ||
3.7.2 | Assay and related substances | ||
3.7.3 | Dissolution Profile | ||
3.7.4 | Moisture -KF | ||
3.7.5 | Hardness Profile |
3.8 | Prototypes will be placed on accelerated stability at 40°C/75% RH and will be tested at 1, 2 and 3 months for dissolution profile and assay and related substances. |
Condition | Initial | 1 Month | 2 Months | 3 Months | ||||||||||
40°C/75%RH | X | X | X | X | ||||||||||
25°C/60%RH | 0 | 0 | 0 |
4. | Manufacture of Feasibility / Scale-up Batches One (1) active batch size up to 100,000 Vigabatrin 250 mg or 500 mg film-coated tablets (50.0 kg API) and one (1) placebo batch size up to 10,000 tablets |
4.1 | Materials: See Section 1.1 & 1.2 | ||
4.2 | PII will develop a matching placebo based upon the data obtained in Section 3. Per CPP the placebo will be of the same physical dimension as the active tablet. The run weight does not need to match the run weight of the active tablet and is at PIIs discretion. The physical appearance and size are the critical design parameters for the placebo tablets. | ||
4.3 | PII will prepare Batch Records that will be used for the manufacture of the Feasibility Batch. | ||
4.4 | PII will use the following equipment train as needed: |
4.4.1 | V-Blender | ||
4.4.2 | Comil | ||
4.4.3 | Roll Compactor / Mill (if required) | ||
4.4.4 | Tablet Press |
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4.4.5 | Coating Pan |
4.5 | PII will manufacture (1) Feasibility Batch of Vigabatrin 500 mg tablets and one (1) Matching Placebo. | ||
4.6 | Operators will use appropriate personal protective equipment. | ||
4.7 | A portion of the Feasibility Batch will be packaged in HDPE bottles of 100 count to satisfy stability requirements and placed on accelerated stability at 40°C/75% RH and tested at 1, 2, and 3 and at 25°C/60% at 6 months. PII will comply with good documentation practices and that all underlying data will be accurate, complete and suitable for submission to or review by regulatory authorities. |
4.8 | PII will perform the following in process testing for the blend and tablets: |
4.8.1 | Tablet properties (weight, thickness, hardness and friability) | ||
4.8.2 | Bulk and Tap Density / Flow | ||
4.8.3 | Sieve Analysis |
4.9 | PII will perform the following tests on the packaged Feasibility Batches: |
4.9.1 | Physical Appearance | ||
4.9.2 | Dissolution Profile (media and time points to be provided by CPP) | ||
4.9.3 | Assay and Related Substances | ||
4.9.4 | Content Uniformity (calculated based on average tablet weight) | ||
4.9.5 | Moisture (USP<921>) |
Condition | Initial* | 1 Month | 2 Months | 3 Months | 6 Months | |||||||||||||
40°C/75%RH | X | X | X | X | 0 | |||||||||||||
25°C/60%RH | 0 | 0 | 0 | X |
4.10 | After completion of one (1) month accelerated stability, PII will prepare a formulation development report. |
5 | Manufacture of Clinical Trial Materials (CTM) Batch One (1) active batch and one (1) placebo batch of Vigabatrin 500 mg film-coated tablets batch sizes up to 100,000 tablets each |
5.1 | All materials used for the manufacture of the CTM Batches will be fully released by PII unless otherwise specified by CPP. See Materials: Sections 1.1 & 1.2 |
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5.2 | PII will prepare Master Batch Records that will be approved by CPP at least one (1) week prior to manufacture of the CTM Batches. | ||
5.3 | The CTM batches will be manufactured under cGMP conditions as directed in the Master Batch Records. | ||
5.4 | PII will remove periodic samples per the agreed sampling protocols. | ||
5.5 | PII will employ the following equipment train as needed: |
5.5.1 | V-Blender | ||
5.5.2 | Roll Compactor / Mill (if required) | ||
5.5.3 | Tablet Press | ||
5.5.4 | Coating Pan (2 pan loads may be required dependent on final tablet weight) |
5.6 | Operators will wear respirators and Tyvex suits if necessary. | ||
5.7 | Based on the experience gained from manufacture of the Feasibility Batches (See Section 4), PII will manufacture (1) Active CTM Batch (500 mg strength of Vigabatrin film-coated tablets, batch size up to 100,000 tablets). | ||
5.8 | PII will manufacture (1) matching Placebo Batch (batch size of 100,000 tablets). | ||
5.9 | PII will perform the following in-process testing on the Active Batch (to be confirmed by CPP): |
5.9.1 | Weight variation, Hardness, Thickness and Friability | ||
5.9.2 | Bulk and Tap Density | ||
5.9.3 | Sieve Analysis |
5.10 | PII will perform the following finished product testing on the Active Batch or as per mutually agreed upon by CPP and PII (should meet MasterSpecifications): |
5.10.1 | Physical Appearance | ||
5.10.2 | Dissolution Profile (media and time points to be provided by CPP) | ||
5.10.3 | Assay and Related Substances | ||
5.10.4 | Content Uniformity (calculated based on assay and weight) | ||
5.10.5 | Moisture (USP<921>) |
5.11 | PII will perform the following finished product testing on the Placebo Batches or as per mutually agreed upon by CPP and PII (should meet Master Specifications): |
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5.11.1 | Physical Appearance | ||
5.11.2 | Absence of active | ||
5.11.3 | Disintegration |
5.12 | PII will store, monitor and test the stability of CTM Batches per the CPP approved protocols. See Section (7). | ||
5.13 | Once the Batches are released, PII will ship to CPP or CPP designated facility (address to be provided by CPP). |
6. | Packaging and Labeling of CTM Batches to be confirmed with CPP |
6.1 | Materials: See Section 1.3. | ||
6.2 | Packaging and labeling protocols will be prepared by PII and approved by CPP one (1) week prior to the manufacture of the batches. | ||
6.3 | One (1) active batch and one (1) placebo batch will be packaged in HPDE bottles of 100 count per CPP approved packaging protocols. | ||
6.4 | If PII is not labeling, the packaged bottles will have the PII lot number ink jetted on them and shipped to the contract packager for clinical labeling and packaging. | ||
6.5 | Any remaining tablets will be stored in bulk. | ||
6.6 | PII will perform 200% count check on materials going into clinical trials. |
7. | Stability of Clinical Trial Material (CTM) Batches |
7.1 | PII will monitor and test, using CPP approved stability protocol, the stability of the Active and Placebo Batches of Vigabatrin tablets manufactured by PII; the stability program is to be initiated as soon as the Vigabatrin tablets are manufactured and packaged. | ||
7.2 | Stability of the Packaged Product |
7.2.1 | Two (2) batches (1 active and 1 placebo) of 500 mg Vigabatrin tablets packaged in (configuration bottles of 100 count) will be set down on stability. | ||
7.2.2 | Stability protocols will be developed per ICH guidelines. The stability protocols will include a 24 month long term stability at 25°C ±2°C /60% RH ±5% RH (25°C/60% RH) and a 6 month accelerated stability at 40°C ±2°C /75% RH ±5% RH (40°C/75% RH). CPP may elect to include a 12 month intermediate stability |
12CAT01.04 | May 10, 2006 | Page 8 of 22 |
at 30°C ±2°C /65% RH ±5% RH (30°C/65% RH) in the protocol. Sufficient samples will be placed on stability to meet the stability protocol requirements. | |||
7.2.3 | The packaged product on stability will be tested at Initial, 3 and 6 months at 40°C/75% RH and 3, 6, 9, 12, 18, and 24 months at 25°C/60% RH. Samples stored at 30°C/65% RH will be tested if significant change occurs at the accelerated conditions or by CPPs request. |
Initial | 1 | 2 | 3 | 6 | 9 | 12 | 18 | 24 | ||||||||||||||||||||||
Condition | * | Month | Months | Months | Months | Months | Months | Months | Months | |||||||||||||||||||||
25°C/60%RH | X | X | X | X | X | X | ||||||||||||||||||||||||
40°C/75%RH | X | 0 | 0 | X | X | |||||||||||||||||||||||||
30°C/65%RH* | 0 | 0 | 0 | 0 |
Initial | 1 | 2 | 3 | 6 | 9 | 12 | 18 | 24 | ||||||||||||||
Condition | * | Month | Months | Months | Months | Months | Months | Months | Months | |||||||||||||
25°C/60%RH | X | X | X | X | X | X | ||||||||||||||||
40°C/75%RH | X | 0 | 0 | X | X |
7.4 | Stability Tests: |
7.4.1 | The following tests will be performed on the Active Batches if not specified in the approved protocol otherwise: | ||
7.4.1.1 | Physical Appearance | ||
7.4.1.2 | Assay and Related Substances | ||
7.4.1.3 | Dissolution Single Time Point (to be determined by CPP) | ||
7.4.1.4 | Moisture (USP<921>) |
7.4.2 | The following tests will be performed on the Placebo Batches if not specified in the approved protocol otherwise: |
7.4.2.1 | Physical Appearance |
7.5 | General Stability Support: |
12CAT01.04 | May 10, 2006 | Page 9 of 22 |
7.5.1 | PII will prepare stability protocols and CPP will review and approve the stability protocols one (1) week prior to initiation of stability study. | ||
7.5.2 | PII will complete stability testing within thirty (30) calendar days from the scheduled pull date. CPP will be notified in writing of any testing that will not be completed in this time frame. | ||
7.5.3 | PII will provide to CPP test results upon completion at each stability time point and not later than forty-five (45) calendar days from the scheduled pull date. | ||
7.5.4 | CPP will be notified of any Out-of-Specification (OOS) Result within three (3) days of completion of Phase I Investigation when the OOS Result was confirmed. | ||
7.5.5 | PII will provide to CPP an updated stability summary table after each stability time point. |
8. | Analytical Support |
8.1 | PII will develop and validate the following drug product methods: |
| Cleaning | ||
| Dissolution | ||
| HPLC assay and related substances |
NOTE: Method Validation will include the following activities: |
| System Precision | ||
| Accuracy/Recovery | ||
| Method Precision (Repeatability/Intermediate) | ||
| Linearity | ||
| Limit of Quantitation (LOQ) impurities only | ||
| Limit of Detection (LOD) impurities only | ||
| Range | ||
| Specificity (including degradation studies) | ||
| Robustness | ||
| Relative Response Factors (RRF) (impurities only) | ||
| Relative Retention Time (RRT) (impurities only) | ||
| Filter Interference | ||
| Solution Stability |
8.2 | PII will develop and validate the following drug substance methods: |
12CAT01.04 | May 10,2006 | Page l0 of 22 |
| Particle Size PII will subcontract |
8.3 | PII will transfer the following drug substance methods |
| Moisture | ||
| HPLC assay and related substances | ||
| Residual Solvents | ||
| IR Identification |
NOTE: Method Transfer includes the following activities: |
| Validation report/package from API supplier | ||
| Support from the API supplier that validated these methods | ||
| System Precision | ||
| Method Precision (reproducibility) | ||
| Linearity | ||
| Limit of Quantitation (LOQ) impurities only | ||
| Limit of Detection (LOD) impurities only |
9. | Project Management |
9.1 | PII will provide project management including project team meetings, summary status reports, conference calls, project coordination and on site visits. |
10. | General Support |
10.1 | PII will be responsible for report writing and issuance of the final report, as well as approval of the final report. CPP will have the right to review draft reports and all underlying data. | ||
10.2 | Method Validation or Transfer Protocols for the drug product will be prepared by PII and approved by CPP, if required. | ||
10.3 | Waste from the manufacturing process will be incinerated. Any unused excipients will be destroyed after expiry date, as it arises. | ||
10.4 | Dedicated excipients and packaging components will be destroyed six (6) months after completion of the manufacturing campaign. If CPP elects for PII to store the materials longer than six (6) months then there will be a storage charge of $200 per month per pallet. | ||
10.5 | PII will prepare necessary documentation for NDA submission. However, the NDA submission will be the responsibility of CPP. |
12CAT01.04 | May 10, 2006 | Page 11 of 22 |
11 | NDA Documentation |
11.1 | Master Specifications | ||
11.2 | Master and Executed Batch Records | ||
11.3 | Packaging and Labeling Protocols | ||
11.4 | Invalidation Reports for Analytical Methods | ||
11.5 | Master Labels | ||
11.6 | Stability Test Reports |
12CAT01.04 | May 10, 2006 | Page 12 of 22 |
(B) | Cost: |
Activity | Cost | |||||
Section 1: Materials | ||||||
1.1 | API- ID release at $1,500/lot. | $TBC | ||||
1.2 | Excipients full release testing will be charged up to $3,000 / lot; PII will use stock excipients where applicable and may opt to charge on a per Kg basis. | $TBC | ||||
1.3 | Packaging Components release testing will be charged up to $2,500 /lot; PII will use stock components where applicable and may opt to charge on a per bottle basis. | $TBC | ||||
Section 2: Pre-formulation | ||||||
2.2 | API testing | $ | 13,000 | |||
Section 3: Formulation Development | ||||||
3.2 | Prototype Development $20,000 per prototype | $ | 40,000 | |||
3.3 | Accelerated stability testing: (3 pull points x two (2) batches x $2,500) | $ | 15,000 | |||
Section 4: Manufacture of Feasibility Batches | ||||||
4.4 | Development of Matching Placebo | $ | 15,000 | |||
4.5 | Manufacture of two (2) Feasibility Batches one of Vigabatrin Tablets and one of Matching Placebo ($50,000 for active and $25,000 for placebo) | $ | 75,000 | |||
4.6 | Packaging in bottles of 100 to satisfy stability requirements | $ | 10,000 | |||
4.7 | Accelerated stability testing of (1) batch: (4 pull points x 1 batch x 1 packaging configuration x $3,500) | $ | 14,000 | |||
Section 5: Manufacture of CTM Batches / Placebo Batch | ||||||
Manufacture of (1) Active CTM Batch of Vigabatrin tablets (batch size of 100,000 tablets $50,000 per batch). | $ | 50,000 | ||||
Manufacture of (1) Placebo CTM Batch of tablets (batch size of 100,000 tablets $25,000 per batch). | $ | 25,000 | ||||
Section 6: Packaging and Labeling of CTM Batches | ||||||
Two (2) CTM Batches packaged in bottles of 100 count $15,000 per batch | $ | 30,000 | ||||
Section 7: Stability of CTM Batches | ||||||
Stability of Packaged Product | $ | 29,600 | ||||
8 time points x 1 active batch x $3,500 | ||||||
8 time points x 1 placebo batch x $200 | ||||||
Section 8: Analytical Support | ||||||
| Cleaning | $ | 20,000 | |||
| Dissolution for drug product | $ | 27,200 | |||
| HPLC assay and related substances for drug product | $ | 47,600 | |||
| HPLC assay and related substances for drug substance | $ | 10,200 | |||
| IR Identification | $ | 6,400 | |||
12CAT01.04 | May 10, 2006 | Page 13 of 22 |
| Residual solvents for drug substance | $ | 10,200 | |||
| Particle size for drug substance PII to subcontract | $TBC | ||||
Section 9: Project Management | $ | 40,000 | ||||
Section 10: General Support | $ | 15,000 | ||||
Section 11: NDA Documentation | $ | 20,000 | ||||
Total | $ | 513,200 | ||||
Invoice Issue | Section | Activity | Amount Due | Invoice Date and # | ||||||||
Date | Reference | |||||||||||
Mar/April 2006 | 8-10 | Initiation Payment Cleaning, Project Management & General Support | $ | 75,000 | ||||||||
April/May 2006 | 2 | Completion of preformulation activities | $ | 13,000 | ||||||||
May 2006 | 3 | Completion of first prototype | $ | 20,000 | ||||||||
May/June 2006 | 3 | Completion of second prototype | $ | 20,000 | ||||||||
June 2006 | 3 | Initiation of prototype stability (non refundable up to 3 months) | $ | 15000 | ||||||||
TBC | 4 | Completion of matching placebo | $ | 15,000 | ||||||||
TBC | 4 | Initiation of Feasibility Batches (1 active and 1 placebo) | $ | 45,000 | ||||||||
TBC | 4 | Completion of Feasibility Batches Including Packaging (1 active and 1 placebo) | $ | 40,000 | ||||||||
TBC | 4 | Stability initiation of feasibility batches | $ | 14,000 | ||||||||
TBC | 5 | Master Batch Records for Active and Placebo Batches | $ | 40,000 | ||||||||
TBC | 5 | Executed Batch Records for Active and Placebo Batches | $ | 35,000 |
12CAT01.04 | May 10, 2006 | Page 14 of22 |
TBC | 6 | Executed Packaging and Labeling Protocals | $ | 30,000 | ||||||||
TBC | 8 | API reports for IR Identification, Assay and Resdidual Solvents | $ | 26,800 | ||||||||
TBC | 8 | Dissolution Method for the drug product | $ | 17,200 | ||||||||
TBC | 8 | Validation Report for dissolution method for the drug product | $ | 10,000 | ||||||||
TBC | 8 | Validation protocal for assay method for the drug product | $ | 27,600 | ||||||||
TBC | 8 | Validation report for dissolution method for the drug product | $ | 20,000 | ||||||||
TBC | 11 | NDA documentation | $ | 20,000 | ||||||||
TBC | 1 | Materials & Testing | $TBC | |||||||||
Total | $ | 483,600 | ||||||||||
Invoice Issue | Amount Due | Invoice Date | ||||||
Date | and # | |||||||
TBC | Initiation Fee (non-refundable up to three (3) months) | $ | 7,400 | |||||
TBC | 6th month pull points | $ | 7,400 | |||||
TBC | 9th month pull point | $ | 3,700 | |||||
TBC | 12th month pull point | $ | 3,700 | |||||
TBC | 18th month pull point | $ | 3,700 | |||||
TBC | 24th month pull point | $ | 3,700 | |||||
Total | $ | 29,600 | ||||||
12CAT01.04 | May 10, 2006 | Page l5 of 22 |
a) | Shipment requests with three (3) days notice will be charged at $500 plus shipping costs and a 10% service charge on shipping. | |
b) | Shipment requests with two (2) days notice will be charged at $1,000 plus shipping costs and a 10% service charge on shipping. | |
c) | Shipment requests with twenty-four (24) hours notice will be charged at $1,500 plus shipping costs and a 10% service charge on shipping. |
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(C) | Legal and Signatures |
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8. | FORCE MAJEURE |
9. | GOVERNING LAW |
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12CAT01.04 | May 10, 2006 | Page 21 of 22 |
President and CEO
Title CEO
Billing Contact: | E. DIAZ | |
Address: | 220 MIRACLE MILE #234 | |
City, State, Zip: | CORAL GABLES, FL 33134 | |
Phone: | 305 ###-###-#### | |
Fax: | 305 ###-###-#### | |
Email Address: | ***@*** | |
PO Number: | 109 |
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