Common use of Quality Control; Regulatory Compliance Clause in Contracts

Quality Control; Regulatory Compliance. Licensee agrees that the Licensed Product sold by it and the processes for manufacturing, storage and handling of such Licensed Product shall strictly comply with all Applicable Law (including cGMP) and Licensee's manufacturing standards (such standards to be no less stringent than industry standards used by companies that manufacture similar products for sales in countries that are regulated by SRAs) relating to any operations involved in the manufacture, packaging, labeling, quality control, testing, receipt, storage of, warehousing, and shipping, of Licensed Product, including but not limited to regulations for protection of worker health and safety. Licensee shall immediately notify MPP in writing of any action (including any official notifications or communications) taken by any Agency in the Territory in connection with Licensee's failure to meet the standards set forth in this Section 9.1 for the manufacture and handling of the Licensed Product (Agency Action), such notice to set forth in reasonable detail all such failures and observations made by such Agency. If at any time, during the term of this Agreement, MPP is made aware of any Agency Action other than by Licensee pursuant to the preceding sentence, MPP shall promptly provide Licensee with a notice of the same. Licensee shall within a period of 30 days from becoming aware of an Agency Action provide MPP with a plan for remedying the same within a timeline to be mutually agreed by the Parties, such agreement by either Party not to be unreasonably withheld or delayed. If Licensee is unable to remedy the same within the mutually agreed timeline (or, in the absence of such a mutually agreed timeline, within a reasonable period of time not to exceed 90 days), MPP may, after giving Licensee written notice, terminate this Agreement at its sole discretion and without prejudice to any other remedies that may be available to MPP; provided however, that in the event that Licensee has already received a prior notice of any such violation, then MPP shall have the right to terminate this Agreement immediately without any notice.

Quality Control; Regulatory Compliance. Licensee agrees that the Licensed Product sold by it and the processes for manufacturing, storage and handling of such Licensed Product shall strictly comply with all Applicable Law (( including cGMP) and Licensee's ’ s manufacturing standards (( such standards to be no less stringent than industry standards used by companies that manufacture similar products for sales in countries that are regulated by SRAs) relating to any operations involved in the manufacture, packaging, labeling, quality control, testing, receipt, storage of, warehousing, and shipping, of Licensed Product, including but not limited to regulations for protection of worker health and safety. Licensee shall immediately notify MPP in writing of any action (( including any official notifications or communications) taken by any Agency in the Territory in connection with Licensee's ’ s failure to meet the standards set forth in this Section 9.1 for the manufacture and handling of the Licensed Product (“Agency Action”), such notice to set forth in reasonable detail all such failures and observations made by such Agency. If at any time, during the term of this Agreement, MPP is made aware of any Agency Action other than by Licensee pursuant to the preceding sentence, MPP shall promptly provide Licensee with a notice of the same. Licensee shall within a period of 30 thirty (30) days from becoming aware of an Agency Action provide MPP with a plan for remedying the same within a timeline to be mutually agreed by the Parties, such agreement by either Party not to be unreasonably withheld or delayed. If Licensee is unable to remedy the same within the mutually agreed timeline (( or, in the absence of such a mutually agreed timeline, within a reasonable period of time not to exceed 90 ninety (90) days), MPP may, after giving Licensee written notice, terminate this Agreement at its sole discretion and without prejudice to any other remedies that may be available to MPP; provided however, that in the event that Licensee has already received a prior notice of any such violation, then MPP shall have the right to terminate this Agreement immediately without any notice.

Quality Control; Regulatory Compliance. Licensee agrees that the Licensed Product sold by it and the processes for manufacturing, storage and handling of such Licensed Product shall strictly comply with all Applicable Law (including cGMP) and Licensee's manufacturing standards (such standards to be no less stringent than industry standards used by companies that manufacture similar products for sales in countries that are regulated by SRAs) relating to any operations involved in the manufacture, packaging, labeling, quality control, testing, receipt, storage of, warehousing, and shipping, of Licensed Product, including but not limited to regulations for protection of worker health and safety. Licensee shall immediately notify MPP in writing of any action (including any official notifications or communications) taken by any Agency in the Territory in connection with Licensee's failure to meet the standards set forth in this Section 9.1 for the manufacture and handling of the Licensed Product (Agency Action), such notice to set forth in reasonable detail all such failures and observations made by such Agency. If at any time, during the term of this Agreement, MPP is made aware of any Agency Action other than by Licensee pursuant to the preceding sentence, MPP shall promptly provide Licensee with a notice of the same. Licensee shall within a period of 30 days from becoming aware of an Agency Action provide MPP with a plan DocuSign Envelope ID: CA69B741-C435-4DB2-9D40-D4529C9174DE for remedying the same within a timeline to be mutually agreed by the Parties, such agreement by either Party not to be unreasonably withheld or delayed. If Licensee is unable to remedy the same within the mutually agreed timeline (or, in the absence of such a mutually agreed timeline, within a reasonable period of time not to exceed 90 days), MPP may, after giving Licensee written notice, terminate this Agreement at its sole discretion and without prejudice to any other remedies that may be available to MPP; provided however, that in the event that Licensee has already received a prior notice of any such violation, then MPP shall have the right to terminate this Agreement immediately without any notice.