Regulatory Controls. 11.1 The Parties acknowledge and agree that the relevant MNO and the UK Office of Communications (Ofcom) have the right, (a) to access such Equipment to ensure it is being used in accordance with the licence under which the MNO is authorised to provide radio coverage solutions, (b) if there is a breach of such licence, or if the Equipment or the Services cause or contribute to undue interference with other radio equipment, or in times of national or local states of emergency: (i) require the MNO's Equipment to be modified, (ii) temporarily or permanently stop use of the MNO's Equipment, and/or (iii) deactivate any affected part of the Service, in its sole discretion. Where any such modification or deactivation is required:
a. Freshwave shall have no liability to the extent of any such modification or deactivation, but shall not be otherwise relieved from its obligations under this Agreement; and
b. where there is a material change to the Services or Freshwave's ability to provide the Services in accordance with this Agreement, the event shall be considered an MNO Event.
Regulatory Controls. 11.1. The Parties acknowledge and agree that the relevant MNO and the UK Office of Communications (Ofcom) have the right, (a) to access such Equipment to ensure it is being used in accordance with the licence under which the MNO is authorised to provide radio coverage solutions, (b) if there is a breach of such licence, or if the Equipment or the Services cause or contribute to undue interference with other radio equipment, or in times of national or local states of emergency: (i) require the MNO's Equipment to be modified,
Regulatory Controls. 9.1 The Parties acknowledge and agree that the UK Office of Communications (Ofcom) have the right, (a) to access such Equipment to ensure it is being used in accordance with the licence under which Freshwave is authorised to provide radio coverage solutions, (b) if there is a breach of such licence, or if the Equipment or the Services cause or contribute to undue interference with other radio equipment, or in times of national or local states of emergency: (i) require the Equipment to be modified, (ii) temporarily or permanently stop use of the Equipment, and/or
Regulatory Controls. Transferee covenants and agrees that it shall take all appropriate action to obtain such consents, exceptions, exemptions or approvals of governmental -,-, authorities as may be necessary to permit it to comply fully with -... = -6,-.- all of its covenants, stipulations, obligations and agreements :.•L'A-J. contained in this Agreement. Transferor covenants to cooperate reasonably with Transferee in this regard. • .'''.:' SECTION
Regulatory Controls. The Parties acknowledge and agree that the relevant MNO and the UK Office of Communications (Ofcom) have the right, (a) to access such Equipment to ensure it is being used in accordance with the licence under which the MNO is authorised to provide radio coverage solutions, (b) if there is a breach of such licence, or if the Equipment or the Services cause or contribute to undue interference with other radio equipment, or in times of national or local states of emergency: (i) require the MNO's Equipment to be modified, (ii) temporarily or permanently stop use of the MNO's Equipment, and/or (iii) deactivate any affected part of the Service, in its sole discretion. Where any such modification or deactivation is required:
Regulatory Controls. 9.1 The Parties acknowledge and agree that the UK Office of Communications (Ofcom) have the right,
Regulatory Controls. 7.1. Filing/Registration Change Control CYTOVANCE and CLIENT QA shall jointly notify one another of any proposed change that might, in reasonable judgment, affect regulatory filing/registrations. These changes may include, but are not limited to, formulation change to Product or components, changes in manufacturing/packaging/testing site, equipment, batch size or process, test methods, etc. Prior approval from CLIENT QA/Regulatory Affairs is required prior to implementation of the changes that may impact the filing/registration. Any changes to CYTOVANCE documents and information contained in CLIENT’S regulatory Filings must be reviewed and approved by CLIENT QA/Regulatory Affairs prior to implementation at CYTOVANCE.
7.2. Regulatory Filings CLIENT is responsible for all Product Regulatory Filings and for providing CYTOVANCE with portions of any filings related to CYTOVANCE activities as described in this Agreement. At the request of CLIENT, CYTOVANCE may be requested to review CYTOVANCE-related submission information for accuracy to current operations.
7.3. Government Agency Communication and Inspections
7.3.1. CLIENT will be responsible for all FDA (and other regulatory agency) communications regarding CLIENT Product with the exception of regulatory inspections of the CYTOVANCE facility. CYTOVANCE will assist and provide appropriate documentation as reasonably required in support of agency inquiries.
7.3.2. Any regulatory authority inspections of CYTOVANCE facilities will be managed by CYTOVANCE. CYTOVANCE will notify CLIENT within twenty-four (24) hours after the initiation of any general regulatory inspection. A redacted copy of any inspection observations will be provided to CLIENT within 3 business days after issuance to CYTOVANCE. Redacted copies of written responses to regulatory inspections will be provided within 3 business days after being finalized.
7.3.3. CYTOVANCE will notify CLIENT the same day the inspection is initiated of any regulatory inspections directly involving CLIENT product. If desired by CLIENT, a Quality Representative may be on site during any regulatory inspection that applies to CLIENT product and reasonable consideration will be given to requests for direct participation in the inspection during product-related inspection activities. A redacted copy of any inspection observations will be provided to CLIENT 3 days after they are issued to CYTOVANCE. Unredacted copies of written responses to regulatory inspections directly invo...
Regulatory Controls. 9.1 The Parties acknowledge and agree that the UK Office of Communications (Ofcom) have the right, (a) to access such Equipment to ensure it is being used in accordance with the licence under which Freshwave is authorised to provide radio coverage solutions, (b) if there is a breach of such licence, or if the Equipment or the Services cause or contribute to undue interference with other radio equipment, or in times of national or local states of emergency:
(i) require the Equipment to be modified, (ii) temporarily or permanently stop use of the Equipment, and/or (iii) deactivate any affected part of the Services, in its sole discretion. Where any such modification or deactivation is required: Freshwave shall have no liability to the extent of any such modification or deactivation, but shall not be otherwise relieved from its obligations under this Agreement; and where there is a material change to the Services or Freshwave's ability to provide the Services in accordance with this Agreement, the event shall be considered a Licensing Event.
Regulatory Controls. Except as disclosed on the DISCLOSURE SCHEDULE, no Loan Party has received any notices concerning, and there are no existing orders of, proceedings pending before or other requirements of any Governmental Authority, expressly including the Bureau of Land Management, Minerals Management Service, or the Federal Energy Regulatory Commission and the comparable Governmental Authority for the States of Alabama, Colorado, Louisiana, Mississippi, Oklahoma, Texas and Utah, other than as may affect the oil and gas industry in general, which (a) could or will materially interfere with such Loan Party's development, production, operation, transportation and/or marketing of the such Loan Party's Oil and Gas Interests or (b) could or will require such Loan Party to refund any portion of the proceeds received or to be received from the sale of Hydrocarbons from such Loan Party's Oil and Gas Interests.
Regulatory Controls. 46 SECTION 5.20. Engineering Report..................................... 46 SECTION 5.21.
