Regulatory Non-Compliance. In addition to its obligations under Section 5.5 and 5.6(a), each Party shall disclose to the other Party any information pertaining to notices from Regulatory Authorities in the Territory of non-compliance with applicable Laws in connection with the Licensed Product including, without limitation, receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Licensed Product.
Regulatory Non-Compliance. Any information pertaining to notices from Regulatory Authorities of non-compliance with laws, regulations, rules or guidance in connection with the Product including, without limitation, receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Product; and
Regulatory Non-Compliance. All material information pertaining to notices from Regulatory Authorities of non-compliance with Applicable Laws in connection with products described in (i) and (ii) above, including without limitation, receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to such products, but only to the extent in each case that such non-compliance pertains specifically to the Device component or the Processed FDKP component of the applicable product;
Regulatory Non-Compliance. All information pertaining to notices from Regulatory Authorities whether inside the Territory or outside the Territory controlled by such Party of non-compliance with Laws in connection with the Bulk Product or Finished Product in the Field, including receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Bulk Product or Finished Product in the Field whether inside the Territory or outside the Territory; provided, however, that a Party shall be entitled to redact those portions thereof to the extent not related to the Bulk Product or Finished Product in the Field.
Regulatory Non-Compliance. Either party may terminate this Agreement immediately if the entity is found to be in non-compliance with other federal and Commonwealth regulations which impose significant risk to one or both parties.
Regulatory Non-Compliance. All information pertaining to notices from Regulatory Authorities whether inside the Territory or outside the Territory controlled by such Party of non-compliance with Laws in connection with the Product in the Field, including receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Product in the Field whether inside the Territory or outside the Territory; provided, however, that a Party shall be entitled to redact those portions thereof to the extent not related to the Product in the Field. ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
Regulatory Non-Compliance. All information Controlled by such Party pertaining to notices from Regulatory Authorities in the Territory of non-compliance with Applicable Laws in connection with a DT Co-Co Product, including receipt of a warning letter or other notice of alleged material non-compliance from any Regulatory Authority relating to a DT Co-Co Product; provided that a Party shall be entitled to redact those portions thereof to the extent not related to a DT Co-Co Product.
Regulatory Non-Compliance. All information Controlled by such Party pertaining to notices from Regulatory Authorities in the Territory of non-compliance with Applicable Law in connection with any Licensed COVID-19 Mono Product, including receipt of a warning letter or other notice of alleged material non- compliance from any Regulatory Authority relating to any Licensed COVID-19 Mono Product; provided that a Party will be entitled to redact those portions thereof to the extent not related to a Licensed COVID-19 Mono Product.
Regulatory Non-Compliance. County may terminate this Agreement immediately upon written notice to Grantor in the event of Grantor's loss of any essential accreditation, license or permit required by law for permissible use of the Space under this Agreement, which may substantially impact the ability of County or the Users to use the Space for intended purposes.
Regulatory Non-Compliance. Failure to maintain, or comply with, all requirements, any and all permits, approvals or licenses required by federal, state or local law, statute or ordinance necessary to CONTRACTOR’s performance of this Agreement.
