Directing that the Product be recalled. If, within *** of the receipt of notice under clause 11.1, the parties are unable to agree on the need to undertake a recall (including after HPPI discusses the issue with the Relevant Regulatory Authority), then either party may direct that the Product be recalled, with or without the agreement of the other party, if it reasonably determines that such recall is necessary to protect the public health or is necessary to ensure compliance with applicable laws, rules and regulations.
Appears in 5 contracts
Samples: Supply and License Agreement (HedgePath Pharmaceuticals, Inc.), Supply and License Agreement, Supply and License Agreement (HedgePath Pharmaceuticals, Inc.)