FILING REQUIREMENTS AND MAINTENANCE Sample Clauses

FILING REQUIREMENTS AND MAINTENANCE. (a) Impax shall promptly comply with all FDA filing and reporting requirements with respect to the Product, including, without limitation, all filing and reporting necessary to maintain the ANDA. Impax shall be responsible for all stability studies as may be necessary or advisable regarding storage of the Product in bulk containers or blisters. (b) Leiner shall be responsible for compliance with all FDA and other rexxxxxxry requirements concerning its labeling, packaging and marketing activities including, without limitation, all stability studies relating to Product packaged by it, except as stated on the bulk packaging of the Product or as otherwise approved in writing by Impax.
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FILING REQUIREMENTS AND MAINTENANCE. Ampio shall promptly comply with all filing and reporting requirements with respect to the Product, including general reporting requirements necessary to keep and maintain the Regulatory Documentation for the Regulatory Approval current with the Regulatory Authority and any applicable clinical study. Ampio shall be responsible for conducting all stability studies at its own cost and expense that may be required for ongoing marketing and sale of the Product during the Term and such stability studies shall be conducted in compliance with the Regulatory Documentation, the Regulatory Approval and other Regulatory Authorities requirements.
FILING REQUIREMENTS AND MAINTENANCE. 13 6.4 INSURANCE..................................................13 6.5
FILING REQUIREMENTS AND MAINTENANCE. The ANDA Holder shall promptly comply with all FDA requirements with respect to the Generic Product, including all filing and reporting requirements necessary to keep such ANDA current with the FDA and all payment obligations with respect to required fees and costs associated with such ANDA and any other regulatory approvals; provided, that Par shall be responsible for (a) drug listings, formulary submissions and Par’s NDC number and (b) such compliance with other FDA, DEA and all other regulations applicable only to a distributor of the Generic Product as can be achieved by Par, given regulatory requirements. As reasonably requested by Xxxxxxx, if Xxxxxxx is the ANDA Holder, Par shall supply to Xxxxxxx samples of finished labeled units of the Generic Product and otherwise reasonably assist Xxxxxxx with such filing and reporting requirements. Par shall be responsible for all stability studies that may be required for ongoing marketing and sale of the Generic Product and shall conduct such stability studies in compliance with the ANDAs.
FILING REQUIREMENTS AND MAINTENANCE. NovaDel (prior to its transfer of the NDA to Par) and Par (after NovaDel's transfer of the NDA to it) shall promptly comply with all FDA filing and reporting requirements with respect to the Product and similar filing and reporting requirements of equivalent governmental agencies in jurisdictions outside the United States, including, without limitation, all filing and reporting requirements necessary to keep the NDA current with the FDA. NovaDel shall be responsible for all stability studies as may be required for ongoing marketing and sale of the Product and shall, or shall cause its designee(s) to, conduct such stability studies in compliance with the NDA and FDA requirements.
FILING REQUIREMENTS AND MAINTENANCE. (a) Genpharm shall cause the Manufacturer to promptly comply with all FDA filing and reporting requirements with respect to the Product, including, without limitation, all filing and reporting necessary to keep the ANDA current with the FDA. Genpharm shall cause the Manufacturer to be responsible for all stability studies as may be required for the Product in bulk containers. (b) Leiner shall be responsible for compliance with all FDA requirements concerning its repackaging, labeling, and marketing activities, including, but not limited to, stability of the Product in Leiner's contaxxxx-xxxsure system.

Related to FILING REQUIREMENTS AND MAINTENANCE

  • Listing and Maintenance Requirements The Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration. The Company has not, in the 12 months preceding the date hereof, received notice from any Trading Market on which the Common Stock is or has been listed or quoted to the effect that the Company is not in compliance with the listing or maintenance requirements of such Trading Market. The Company is, and has no reason to believe that it will not in the foreseeable future continue to be, in compliance with all such listing and maintenance requirements.

  • Listing and Maintenance Requirements Compliance The Company has not in the two years preceding the date hereof received written notice from any stock exchange, market or trading facility on which the Common Stock is or has been listed or quoted to the effect that the Company is not in compliance with the listing, maintenance or other requirements of such exchange, market, trading or quotation facility. The Company has no reason to believe that it does not now or will not in the future meet any such requirements.

  • Operations and Maintenance Seller shall not during the months of June through September inclusive schedule any non-emergency maintenance that reduces the energy generating capability of the Facility by more than ten percent (10%), unless (i) such outage is required to avoid damage to the Facility, (ii) such maintenance is necessary to maintain equipment warranties and cannot be scheduled outside the months of June through September, (iii) such outage is required in accordance with prudent electrical practices, or (iv) the Parties agree otherwise in writing.

  • Repairs and Maintenance It is the responsibility of the Tenant(s) to notify the Landlord immediately of any needed repair or unsafe condition existing around or in the Premises including but not limited to cracks in the foundation, cracks in plaster, moisture in walls and ceiling, buckling sheetrock or siding, or any leaks. If Xxxxxx(s) fails to immediately notify Landlord of visible problems, which result in damage to the unit, then Tenant(s) becomes liable for cost of resultant damage. All repairs necessary to maintain premises shall be done by or under the direction of the Landlord, at the Landlord’s expense, except those caused by negligence or acts of Tenant(s), Tenant’s agents, or invitees, which repairs shall be made at the sole cost of the Tenant(s). Such repairs shall be made to conform to the original condition of the Premises at the time the Tenant(s) took possession. Although the Landlord repairs normal wear and tear items, the adage “you broke it you pay to fix it” applies to the Tenant(s) and it applies during tenancy as well as at the end of tenancy. In addition, if a Tenant(s) calls for maintenance for which no such maintenance is needed (false call), Tenant(s) will be charged for the service call. Any repairs, including labor, material, and parts used, which are the responsibility of the Tenant(s), must be pre-approved in writing by the Landlord. Landlord shall be the sole judge as to what repairs are necessary. Landlord shall have no obligation to repair any defective condition, nor shall any defense or remedy be available to the Tenant(s), where the defective condition complained of was caused by the Tenant, Xxxxxx’s family, invitee, licensee, or other person acting under the control or direction of the Tenant(s), or where the Tenant unreasonably fails to notify the Landlord of the condition or allow the Landlord access to the Premises for purposes of the repair. Before exercising any of the remedies in accordance with the Landlord-Tenant Act, Tenant(s) must be current in rent. Tenant(s) shall be responsible for all broken glass. Tenant(s) shall not paint, re-wallpaper, or otherwise redecorate or make alterations to the Premises without the written consent of the Landlord. If written consent is given, such alterations shall be at the expense of the Tenant(s) and shall become part of the Premises and the Owner’s property upon termination of this Lease and tenancy. Tenant(s) shall not permit any act or thing deemed hazardous by Landlord due to potential risk of fire or which will increase the rate of insurance on said Premises. In case the Premises or surrounding areas shall be damaged by fire, rain, wind, or other cause beyond the control of the Landlord or the Tenant, then the Premises or surrounding areas shall be repaired within a reasonable time at the expense of the Landlord; and in case the damage is so extensive as to render the Premises unfit for human habitation, the rent shall cease until such time as the Premises will be put in repair. In case of total destruction, the rent shall be paid until the time of such destruction and from thenceforth this Lease Agreement shall cease and come to an end. In the event, the damage is caused by the act of the Tenant(s), or someone in or on the Premises by reason of Tenant’s permission or consent, there shall be no reduction of rent and Tenant(s) shall be liable for all costs of repair. Should Landlord notify Tenant(s) of intent to clean, replace carpets or paint the Premises, moving furniture and wall hangings shall be the duty and expense of the Tenant(s). Tenant(s) understands there will be no rent reductions, adjustments, or other compensation due to repairs or interruptions of service except as provided by law.

  • Road Maintenance Purchaser shall maintain roads, commensurate with Purchaser’s use, in accor- dance with Road Maintenance Requirements in C5.31 and the Road Maintenance Specifications. Performance of road maintenance work by Purchaser may be required prior to, during, or after each period of use. The timing of work accomplishment shall be based on Purchaser’s Op- erating Schedule under B6.31.

  • Operation and Maintenance 17.1 O&M obligations of the Concessionaire 17.1.1 During the Operation Period, the Concessionaire shall operate and maintain the Bus Terminal in accordance with this Agreement either by itself, or through the O&M Contractor and if required, modify, repair or otherwise make improvements to the Bus Terminal to comply with the provisions of this Agreement, Applicable Laws and Applicable Permits, and conform to Specifications and Standards and Good Industry Practice. The obligations of the Concessionaire hereunder shall include: (a) permitting safe, smooth and uninterrupted flow of traffic on the Bus Terminal during normal operating conditions. Buses of other state road transport corporations shall be parked inside the Bus Terminal for which no charges shall be payable to the Concessionaire and if any charges are applicable for such parking then it shall be realized by Authority only; (b) minimising incidents affecting the safety and use of the Bus Terminal by providing a rapid and effective response and maintaining liaison with emergency services of the State; (c) carrying out periodic preventive maintenance of the Bus Terminal; (d) undertaking routine maintenance including prompt repairs of ticket counters, Workshops, Authority's Office and other infrastructure as mentioned in the Operation and Maintenance Schedule; (e) undertaking major maintenance such as per the Maintenance Schedule of the major infrastructure in the Bus Terminal; (f) preventing, with the assistance of the concerned law enforcement agencies, any encroachments on the Bus Terminal; (g) protection of the environment and provision of equipment and materials therefor; (h) operation and maintenance of all communication, control and administrative systems necessary for the efficient operation of the Bus Terminal; (i) maintaining a public relations unit to interface with and attend to suggestions from the Users, passengers, government agencies, media and other agencies; (j) complying with Safety Requirements in accordance with Article 18; (k) operation and maintenance of all Project Assets diligently and efficiently and in accordance with Good Industry Practice; (l) maintaining punctuality and reliability in operating the Bus Terminal; and (m) maintaining a high standard of cleanliness and hygiene in the Bus Terminal. 17.1.2 The Concessionaire shall remove promptly from the Bus Terminal all surplus construction machinery and materials, waste materials (including hazardous materials and waste water), rubbish and other debris (including, without limitation, accident debris) and keep the Bus Terminal in a clean, tidy and orderly condition,

  • Construction and Maintenance There are on-going maintenance, renovation and construction projects taking place in and around the residences. The work typically takes place during regular business hours, but may begin earlier or extend into evenings or weekends. On-going construction or renovation projects will continue through midterm and final exam periods. The University will take measures to ensure that prudent construction practices are followed, but there may be noise, dust and temporary interruption of some services. Residents may be required to temporarily or permanently relocate to facilitate construction or renovation to their residence area. There will be no compensation or reduction to your residence fees due to disruption and/or relocation.

  • Maintenance Requirements The Contractor shall ensure and procure that at all times during the Maintenance Period, the Project Highway conforms to the maintenance requirements set forth in Schedule-E (the “Maintenance Requirements”).

  • Operations and Maintenance Notice Each Party shall notify the other Parties in writing of the identity of the person(s) that it designates as the point(s) of contact with respect to the implementation of Articles 9 and 10.

  • USE AND MAINTENANCE (a) Lessee shall (1) use the Equipment solely in the continental United States and in the conduct of its business, for the purpose for which the Equipment was designed, in a careful and proper manner, and shall not permanently discontinue use of the Equipment; (2) operate, maintain, service and repair the Equipment, and maintain all records and other materials relating thereto, (A) in accordance and consistent with (i) the Supplier’s recommendations and all maintenance and operating manuals or service agreements, whenever furnished or entered into, including any subsequent amendments or replacements thereof, issued by the Supplier or service provider, (ii) the requirements of all applicable insurance policies, (iii) the Supply Contract, so as to preserve all of Lessee's and Lessor's rights thereunder, including all rights to any warranties, indemnities or other rights or remedies, (iv) all applicable laws, and (v) the prudent practice of other similar companies in the same business as Lessee, but in any event, to no lesser standard than that employed by Lessee for comparable equipment owned or leased by it; and (B) without limiting the foregoing, so as to cause the Equipment to be in good repair and operating condition and in at least the same condition as when delivered to Lessee hereunder, except for ordinary wear and tear resulting despite Lessee's full compliance with the terms hereof; (3) provide written notice to Lessor not less than thirty (30) days after any change of the location of any Equipment (or the location of the principal garage of any Equipment, to the extent that such Equipment is mobile equipment) as specified in the Schedule; and (4) not attach or incorporate the Equipment to or in any other property in such a manner that the Equipment may be deemed to have become an accession to or a part of such other property. (b) Within a reasonable time, Lessee will replace any parts of the Equipment which become worn out, lost, destroyed, damaged beyond repair or otherwise unfit for use, by new or reconditioned replacement parts which are free and clear of all Liens and have a value, utility and remaining useful life at least equal to the parts replaced (assuming that they were in the condition required by this Lease). Any modification or addition to the Equipment that is required by this Lease shall be made by Lessee. Title to all such parts, modifications and additions to the Equipment immediately shall vest in Lessor, without any further action by Lessor or any other person, and they shall be deemed incorporated in the Equipment for all purposes of the related Schedule. Unless replaced in accordance with this Section, Lessee shall not remove any parts originally or from time to time attached to the Equipment, if such parts are essential to the operation of the Equipment, are required by any other provision of this Lease or cannot be detached from the Equipment without materially interfering with the operation of the Equipment or adversely affecting the value, utility and remaining useful life which the Equipment would have had without the addition of such parts. Except as permitted in this Section, Lessee shall not make any material alterations to the Equipment that diminishes its use or value. (c) Upon forty-eight (48) hours' notice, Lessee shall afford Lessor and/or its designated representatives access to the premises where the Equipment is located for the purpose of inspecting such Equipment and all applicable maintenance or other records relating thereto at any reasonable time during normal business hours; provided, however, if a Default or Event of Default shall have occurred and then be continuing, no notice of any inspection by Lessor shall be required. If any discrepancies are found as they pertain to the general condition of the Equipment, Lessor will communicate these discrepancies to Lessee in writing. Lessee shall then have thirty (30) days to rectify these discrepancies at its sole expense. Lessee shall pay all expenses of a re-inspection by Lessor’s appointed representative, if corrective measures were required.

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