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.
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FILING REQUIREMENTS AND MAINTENANCE. 13 6.6 INSURANCE..........................................................13
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. (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.
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. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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. 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.
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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 Pursuant to Section 10.5 of this Agreement, Developer shall pay the reasonable expenses (including overheads) for the operation, maintenance, repair and replacement of Transmission Owner’s Attachment Facilities and incremental operating and maintenance expenses incurred in association with System Upgrade Facilities, if and to the extent provided for under Attachment S. For Transmission Owner’s Attachment Facilities, such expenses are calculated as follows:

  • 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. When two or more commercial users are simultane- ously using the same road where Forest Service is not requiring maintenance deposits, the commercial users will develop maintenance responsibilities and arrangements for accomplishing the work. Forest Service must agree to this plan. If the commercial users cannot agree on main- tenance responsibilities, Forest Service shall resolve the differences. If Purchaser elects to use different roads than those listed in C5.31, Forest Service shall determine Pur- chaser’s commensurate share of road maintenance and revise road maintenance deposits in C5.32. If Forest Service cannot perform its full commensu- rate share of road maintenance, Forest Service shall make a cash payment to Purchaser for performance of such work. Unless agreed in writing, prehaul maintenance shall be completed on any portion of road prior to hauling on that portion. Maintenance, as used in this contract, does not include road reconstruction or repairs of an extraordi- nary nature.

  • Operation and Maintenance 17.1 O&M obligations of the Concessionaire

  • 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 Sub-Adviser shall maintain such books and records with respect to the Allocated Portion as are required by law, including, without limitation, the 1940 Act (including, without limitation, the investment records and ledgers required by Rule 31a-1) and the Advisers Act, and the rules and regulations thereunder (the “Fund’s Books and Records”). The Sub-Adviser agrees that the Fund’s Books and Records are the Fund’s property and further agrees to surrender promptly to the Trust or the Adviser the Fund’s Books and Records upon the request of the Board or the Adviser; provided, however, that the Sub-Adviser may retain copies of the Fund’s Books and Records at its own cost. The Sub-Adviser shall make the Fund’s Books and Records available for inspection and use by the SEC and other regulatory authorities having authority over the Fund, the Trust, the Adviser or any person retained by the Board at all reasonable times. Where applicable, the Fund’s Books and Records shall be maintained by the Sub-Adviser for the periods and in the places required by Rule 31a-2 under the 1940 Act. In the event of the termination of this Agreement, the Fund’s Books and Records will be returned to the Trust or the Adviser. The Adviser and Fund’s Chief Compliance Officer shall, upon reasonable advance notice, be provided with access to the Sub-Adviser’s documentation and records relating to the Fund and copies of such documentation and records.

  • 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, consistent with Lessee's past practice, 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, (i) in accordance and consistent with (A) 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, consistent with Lessee's past practice, (B) the requirements of all applicable insurance policies, (C) all applicable laws, and (D) 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 (ii) 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; (3) not change the location of any Equipment as specified in the Equipment Schedule without prior written notice to Lessor; (4) not attach or incorporate the Equipment to or in any other item of equipment in such a manner that the Equipment may be deemed to have become an accession to or a part of such other item of equipment; and (5) cause each principal item of the Equipment to be continually marked, in a plain and distinct manner, with the name of Lessor followed by the words "Owner and Lessor," or other appropriate words designated by Lessor on labels furnished by Lessor. (b) Within a reasonable time, Lessee will replace any parts of the Equipment which become worn out, lost, destroyed, damaged beyond repair or otherwise permanently rendered unfit for use, by new or reconditioned replacement parts which are free and clear of all liens, encumbrances or rights of others and have a value, utility and remaining useful life at least equal to the parts replaced. Title to all replacement parts and permanent improvements, or attachments to the Equipment which cannot be removed without damaging the Equipment, immediately shall vest in Lessor, without cost or expense to Lessor or any further action by any other person, and such parts, improvements and additions shall be deemed incorporated in the Equipment and subject to the terms of this Lease as if originally leased hereunder, if such parts are essential to the operation of the Equipment 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 thereof. Lessee shall not make any material alterations to the Equipment without prior written notice to Lessor, provided that such material alterations do not adversely affect the value, utility and remaining useful life which the Equipment would have had without the addition thereof. (c) Upon forty-eight (48) hours' notice, Lessee shall afford Lessor access to the premises where the Equipment is located for the purpose of inspecting such Equipment and all applicable maintenance or other records at any reasonable time during normal business hours; provided, however, if a default or Default shall have occurred and then be continuing, no notice of any inspection by Lessor shall be required.

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