Common use of Quality Assurance Responsibilities Clause in Contracts

Quality Assurance Responsibilities. Supplier agrees that, in order to expedite the acceptance of Products by Distributor’s Quality Assurance and/or Regulatory departments, that Distributor will, at Supplier’s expense, implement Quality Assurance and/or Regulatory programs and/or personnel into the Supplier’s manufacturing facilities. Supplier grants Distributor the right to conduct Quality Assurance and/or Regulatory audits (based on Distributor’s Quality Assurance standards, which at all times shall incorporate applicable FDA and GMP requirements) using Distributor’s personnel, Supplier’s personnel and/or independent consultants on a quarterly basis or more frequent spot basis. Supplier agrees that Supplier will cure any curable deficiencies within ten (10) days of written notice by Distributor of any such Quality Assurance and/or Regulatory audits and commence curing all other curable deficiencies that are curable but not reasonably subject of cure within 10 days. Supplier agrees to credit Distributor’s account in the amount of Five Thousand Dollars (US$5,000.00) per day for every calendar day that any deficiencies remain uncured following the ten (10) day written notice period described above. Similarly, following Clearance Distributor agrees to credit Supplier’s account in the amount of Five Thousand Dollars (US$5,000.00) per day for every calendar day that any deficiencies imposed by the FDA on Distributor and relating to Distributor’s obligations under this Agreement remain uncured following the 10-day period commencing on the later of the date of Distributor’s receipt of notice thereof from the FDA or the date imposed by the FDA for cure or compliance.

Appears in 1 contract

Samples: Non Exclusive Distribution Agreement (Medicor LTD)

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Quality Assurance Responsibilities. Supplier agrees that, in order to expedite the acceptance of Products by Distributor’s Quality Assurance and/or Regulatory departments, that Distributor will, at Supplier’s expense, implement Quality Assurance and/or Regulatory programs and/or personnel into the Supplier’s manufacturing facilities. Supplier grants Distributor the right to conduct Quality Assurance and/or Regulatory audits (based on Distributor’s Quality Assurance standards, which at all times shall incorporate applicable FDA * * * Confidential Treatment Requested and GMP requirements) using Distributor’s personnel, Supplier’s personnel and/or independent consultants on a quarterly basis or more frequent spot basis. Supplier agrees that Supplier will cure any curable deficiencies within ten (10) days * * * of written notice by Distributor of any such Quality Assurance and/or Regulatory audits and commence curing all other curable deficiencies that are curable but not reasonably subject of cure within 10 days* * *. Supplier agrees to credit Distributor’s account in the amount of Five Thousand Dollars (US$5,000.00) per day * * * for every calendar day * * * that any deficiencies remain uncured following the ten (10) day written notice period described above* * *. Similarly, following Clearance Distributor agrees to credit Supplier’s account in the amount of Five Thousand Dollars (US$5,000.00) per day * * * for every calendar day * * * that any deficiencies imposed by the FDA on Distributor and relating to Distributor’s obligations under this Agreement remain uncured following the 10-day period * * * commencing on the later of the date of Distributor’s receipt of notice thereof from the FDA or the date imposed by the FDA for cure or compliance.

Appears in 1 contract

Samples: Non Exclusive Distribution Agreement (Medicor LTD)

Quality Assurance Responsibilities. Supplier agrees that, in order to expedite the acceptance of Products by Distributor’s 's Quality Assurance and/or Regulatory departments, that Distributor will, at Supplier’s 's expense, implement Quality Assurance and/or Regulatory programs and/or personnel into the Supplier’s 's manufacturing facilities. Supplier grants Distributor the right to conduct Quality Assurance and/or Regulatory audits (based on Distributor’s 's Quality Assurance standards, which at all times shall incorporate applicable FDA and GMP requirements) using Distributor’s 's personnel, Supplier’s 's personnel and/or independent consultants on a quarterly basis or more frequent spot basis. Supplier agrees that Supplier will cure any curable deficiencies within ten (10) days of written notice by Distributor of any such Quality Assurance and/or Regulatory audits and commence curing all other curable deficiencies that are curable but not reasonably subject of cure within 10 days. Supplier agrees to credit Distributor’s 's account in the amount of Five Thousand Dollars (US$5,000.00) per day for every calendar day [****]* that any deficiencies remain uncured following the ten (10) day written notice period described above. Similarly, following Clearance Distributor agrees to credit Supplier’s 's account in the amount of Five Thousand Dollars (US$5,000.00) per day for every calendar day [****]* that any deficiencies imposed by the FDA on Distributor and relating to Distributor’s 's obligations under this Agreement remain uncured following the 10-day period commencing on the later of the date of Distributor’s 's receipt of notice thereof from the FDA or the date imposed by the FDA for cure or compliance.

Appears in 1 contract

Samples: Non Exclusive Distribution Agreement (Heritage Worldwide Inc)

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Quality Assurance Responsibilities. Supplier agrees that, in order to expedite the acceptance of Products by Distributor’s Quality Assurance and/or Regulatory departments, that Distributor will, at Supplier’s expense, implement Quality Assurance and/or Regulatory programs and/or personnel into the Supplier’s manufacturing facilities. Supplier grants Distributor the right to conduct Quality Assurance and/or Regulatory audits (based on Distributor’s Quality Assurance standards, which at all times shall incorporate applicable FDA and GMP requirements) using Distributor’s personnel, Supplier’s personnel and/or independent consultants on a quarterly basis or more frequent spot basis. Supplier agrees that Supplier will cure any curable deficiencies within ten (10) days * * * of written notice by Distributor of any such Quality Assurance and/or Regulatory audits and commence curing all other curable deficiencies that are curable but not reasonably subject of cure within 10 days* * *. Supplier agrees to credit Distributor’s account in the amount of Five Thousand Dollars (US$5,000.00) per day * * * for every calendar day * * * that any deficiencies remain uncured following the ten (10) day written notice period described above* * *. Similarly, following Clearance Distributor agrees to credit Supplier’s account in the amount of Five Thousand Dollars (US$5,000.00) per day * * * for every calendar day * * * that any deficiencies imposed by the FDA on Distributor and relating to Distributor’s obligations under this Agreement remain uncured following the 10-day period * * * commencing on the later of the date of Distributor’s receipt of notice thereof from the FDA or the date imposed by the FDA for cure or compliance.

Appears in 1 contract

Samples: Non Exclusive Distribution Agreement (Medicor LTD)

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