Modifications to Equipment and Facility Sample Clauses

Modifications to Equipment and Facility. Duramed shall not modify any parts of the Duramed Facility used for Manufacturing, Packaging or storage of the Product if such modifications impact the DMF or otherwise affect the Product or the NDA, unless approved in advance in writing by Warner. Duramed shall not implement any material changes relating to the Product without obtaining Warner's prior written approval. A material change is defined as any change that (a) impacts the regulatory commitments made to Regulatory Authorities for the Product; (b) may require re-validation; (c) affects the quality, purity, identity or strength of the Raw Materials, Packaging Components or the finished Product; (d) is or may be reportable to the Regulatory Authorities; or (e) would necessarily result in changing or modifying the Specifications, test methods, sampling procedures, standard operating procedures, or the Master Batch Record with respect to the Product. Duramed shall pay for any expenses associated with any modifications and material changes initiated by Duramed.
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Modifications to Equipment and Facility. Oread shall notify Praecis of any significant modifications to parts of the Facility used for Processing, Packaging or storage to the extent such modifications impact or could reasonably be expected to impact the Product . Oread shall not implement any material changes relating to the Product (including modifications to equipment) without obtaining Praecis's prior written approval which approval shall not be unreasonably withheld. A material change is defined as any change that (a) impacts the regulatory commitments made to Regulatory Authorities for the Product; (b) may require re-validation; (c) may affect the quality, purity, identity or strength of the in-process or finished Product; or (d) could reasonably be expected to result in changing or modifying the Praecis or Oread Specifications, test methods, sampling procedures, standard operating procedures, or the Master Batch Record with respect to the Product. The parties to this Agreement shall agree in advance which party will pay for any expenses associated with any modifications and material changes made or proposed to be made under this provision of the Agreement.
Modifications to Equipment and Facility. Xxxxxx shall notify SuperGen of any modifications to parts of the Facility used for Processing or storage if such modifications impact or otherwise could reasonably be expected to affect the API or the Master Production Record. Xxxxxx shall not implement any Material Changes (as defined below) relating to the API without obtaining prior written approval from SuperGen, which approval shall not be unreasonably withheld. As used in this Section 9.4, a “Material Change” shall mean any change that (a) impacts the regulatory commitments made to Regulatory Authorities for the API; or (b) will require revalidation; or (c) could reasonably be expected to affect the quality, purity, identity, strength or yield of the in process or finished API; or (d) would necessarily result in changing or modifying the Specifications; or (e) constitutes a significant change to test methods, sampling procedures, Xxxxxx’x standard operating procedures or the Master Production Record; or (f) would require material modifications to the equipment used in the Facility. Xxxxxx shall pay for any expenses to the extent they are for any modifications and Material Changes made to the Facility initiated by Xxxxxx; such changes may not be the basis of any increase in the Processing Fee. SuperGen shall pay for any expenses to the extent they are for any modifications and material changes made to Processing the Deliverables, or if the changes are in excess of cGMP requirements initiated by SuperGen.

Related to Modifications to Equipment and Facility

  • Additions and Alterations 12 ARTICLE 9

  • Alterations, Modifications and Additions The Grantor will make (or cause to be made) such alterations and modifications in and additions to such Airframe and each such Engine as may be required from time to time to meet the applicable requirements of the FAA or any applicable government of any other jurisdiction in which such Aircraft may then be registered; provided that the Grantor may, in good faith, contest the validity or application of any such requirement in any manner that does not involve any material risk of sale, loss or forfeiture of such Aircraft and does not adversely affect the Trustee’s interest in the Aircraft Collateral. In addition, the Grantor (or any Permitted Lessee), at its own expense, may from time to time add further parts or accessories and make or cause to be made such alterations and modifications in and additions to such Airframe or any such Engine as the Grantor may deem desirable in the proper conduct of its business, including, without limitation, removal (without replacement) of Parts, provided that no such alteration, modification or addition shall materially diminish the value or utility of such Airframe or such Engine below its value or utility, immediately prior to such alteration, modification or addition, assuming that such Airframe or such Engine was then in the condition required to be maintained by the terms of this Aircraft Security Agreement, except that the value (but not the utility) of such Airframe or such Engine may be reduced by the value of any such Parts that shall have been removed that the Grantor deems obsolete or no longer suitable or appropriate for use on such Airframe or such Engine. All Parts incorporated or installed in or attached or added to such Airframe or any such Engine as the result of such alteration, modification or addition shall be free and clear of any Liens, other than Permitted Liens, and shall, without further act, be subject to the Lien of this Aircraft Security Agreement. Notwithstanding the foregoing, the Grantor (or any Permitted Lessee) may, at any time, remove any Part from such Airframe or any such Engine if such Part: (i) is in addition to, and not in replacement of or substitution for, any Part originally incorporated or installed in or attached to such Airframe or such Engine at the time of delivery thereof to the Grantor or any Part in replacement of, or substitution for, any such Part, (ii) is not required to be incorporated or installed in or attached or added to such Airframe or such Engine pursuant to the first sentence of this Section 6.03(c) or Section 6.01(d) and (iii) can be removed from such Airframe or such Engine without materially diminishing the value or utility required to be maintained by the terms of this Aircraft Security Agreement that such Airframe or such Engine would have had had such Part never been installed on such Airframe or such Engine. Upon the removal by the Grantor of any Part as permitted by this Section 6.03(c), such removed Part shall, without further act, be free and clear of the Lien of this Aircraft Security Agreement and of all rights and interests of the Trustee (and the other beneficiaries hereof) and shall no longer be deemed a Part hereunder. Upon request of the Grantor from time to time, the Trustee shall execute and deliver to the Grantor an appropriate instrument confirming the release of any such removed Part from the Lien of this Aircraft Security Agreement.

  • As to Equipment and Inventory The Grantor hereby agrees that it shall

  • Alterations, Additions, and Improvements Subject to the provisions of this Article IV, Lessee may make any alterations, additions, improvements or other changes to the Premises and the Relevant Assets as may be necessary or useful in connection with the operation of the Relevant Assets (collectively, the “Additional Improvements”). If such Additional Improvements require alterations, additions or improvements to the Premises or any of the Shared Access Facilities, Lessee shall notify Lessor in writing in advance and the parties shall negotiate in good faith any increase to the fees paid by Lessee under the Site Services Agreement by Lessee or otherwise provide for reimbursement of any material increase in cost (if any) to Lessor under the Site Services Agreement that results from any modifications to the Premises or the Shared Access Facilities necessary to accommodate the Additional Improvements, or as otherwise mutually agreed by the parties. Any alteration, addition, improvement or other change to the Premises, Relevant Assets or Additional Improvements (and, if agreed by Lessee and Lessor, to the Shared Access Facilities) by Lessee shall be made in a good and workmanlike manner and in accordance with all applicable Laws. The Relevant Assets and all Additional Improvements shall remain the property of Lessee and shall be removed by Lessee within one (1) year after termination of this Lease (provided that such can be removed by Lessee without unreasonable damage or harm to the Premises) or, at Lessee’s option exercisable by notice to Lessor, surrendered to Lessor upon the termination of this Lease. Lessee shall not have the right or power to create or permit any lien of any kind or character on the Premises by reason of repair or construction or other work. In the event any such lien is filed against the Premises, Lessee shall cause such lien to be discharged or bonded within thirty (30) days of the date of filing thereof.

  • ALTERATIONS - ADDITIONS The LESSEE shall not make structural alterations or additions to the leased premises, but may make non-structural alterations provided the LESSOR consents thereto in writing, which consent shall not be unreasonably withheld or delayed. All such allowed alterations shall be at LESSEE's expense and shall be in quality at least equal to the present construction. LESSEE shall not permit any mechanics' liens, or similar liens, to remain upon the leased premises for labor and material furnished to LESSEE or claimed to have been furnished to LESSEE in connection with work of any character performed or claimed to have been performed at the direction of LESSEE and shall cause any such lien to be released of record forthwith without cost to LESSOR. Any alterations or improvements made by the LESSEE shall become the property of the LESSOR at the termination of occupancy as provided herein.

  • Special Covenants With Respect to Equipment and Inventory Each Grantor shall:

  • IMPROVEMENTS AND ALTERATIONS 33. The Lessor agrees to furnish the demised premises to the Lessee at the fixturing date with those improvements set forth as Lessor's Improvements in Schedule "C" attached hereto. The Lessee agrees to be responsible for the installation at the fixturing date at its sole risk, cost and expense of the Lessee's Improvements in accordance with the rules and regulations as set forth in Schedule "D" attached hereto. Should the Lessee require any alterations, improvements, partitions, or changes of whatsoever kind to or in the demised premises after the Lessee has taken possession thereof, the Lessee will make and install the same at its own expense; PROVIDED HOWEVER, that no repairs, alterations, improvements, partitions, or changes of whatsoever kind shall be made without the written consent of the Lessor first had and obtained, such consent not to be unreasonably withheld; PROVIDED FURTHER, that any such repairs, alterations, improvements, partitions, or changes of whatsoever kind shall be made in a good and workmanlike manner with new, first-class materials and shall be carried out and the plans relating thereto shall be prepared by such tradesman, engineers or consultants as are approved by the Lessor. All alterations, improvements, partitions and changes made in or to the demised premises at any time before or after the taking of possession by the Lessee, by the Lessee or the Lessor, shall immediately become the property of the Lessor and form part of the demised premises and the building and shall remain upon the demised premises; PROVIDED ALWAYS that the Lessor may at the expiration or sooner termination of this Lease for any reason whatsoever require that the Lessee restore the demised premises in whole or in part to the same condition in which they were at the time of the entering into of this Lease, the exceptions to the Lessee's repair obligations only excepted. The Lessee shall not remove any furniture, leasehold improvements, fixtures, chattels of any kind from the demised premises without the prior consent of the Lessor and until all rents and other monies due are fully paid. SIGNS

  • Alterations and Repairs Tenant shall not erect any drywall partitions, make any alterations in or additions or changes to the Premises without the Landlord’s prior written approval in each and every instance, which consent shall not be unreasonably withheld or delayed. Unless otherwise provided by written agreement, all Tenant’s Improvements upon the Premises and any replacements therefore, including, but not limited to all air-conditioning or heating systems, decorations, partitions, electrical systems affixed to the Premises, except furniture or movable trade fixtures installed at the expense of Tenant, shall become the property of the Landlord and shall remain upon, and be surrendered with, the Premises as a part thereof and at the termination of this Lease, without compensation to Tenant; unless, however, Landlord, by notice given the Tenant, shall elect to have Tenant remove any or all such Tenant Improvements. Thereupon Tenant shall accomplish such removal at its sole cost, repair any damage caused by such removal, and restore the Premises to their former condition. If Tenant does not remove said additions, decorations, fixtures, hardware, non-trade fixtures and improvements after request to do so by Landlord, Landlord may remove the same and Tenant shall pay the cost of such removal to the Landlord upon demand. Tenant hereby agrees to hold Landlord and Landlord’s beneficiaries, their agents and employees harmless from any and all liabilities of every kind and description which may arise out of or be connected in any way with said alterations or additions. Any mechanic’s lien filed against the Premises, or the Building or the Property, for work claimed to have been furnished to Tenant shall be discharged of record by Tenant within ten (10) days thereafter, at Tenant’s expense, provided however Tenant shall have the right to contest any such lien on the posting of reasonably sufficient security.

  • Alterations and Improvements Tenant shall have the right at any time throughout the term of this Lease and any extensions hereof, to make or cause to be made, any alterations, additions, or improvements, or install or cause to be installed any trade fixture, signs, floor covering, interior or exterior painting or lighting, plumbing fixtures, shades or awnings, as Tenant may deem necessary or suitable with Landlord’s prior written approval, which approval shall not be unreasonably withheld or delayed. Upon the expiration of the Initial Term of this Lease, Tenant shall have the option to remove such alterations, decorations, additions or improvements made by it, provided any damage to Premises resulting from such removal is repaired. Also, upon the expiration of the Initial Term of this Lease, Tenant if requested by Landlord shall remove any signs and repair any damages to the Premises resulting from such removal. During the term, Tenant shall not make any alterations, additions, improvements, non-cosmetic changes or other material changes to the Premises without the prior written approval of Landlord, which approval shall not be unreasonably withheld or delayed. Notwithstanding the foregoing, Tenant shall be permitted to make Minor Alterations (as defined below) without Landlord’s prior written consent. Minor Alterations, as used herein, shall be defined as any alterations, improvements, etc. made to the Premises (excluding the facade thereof) which do not affect the structure of the buildings, their systems or equipment. If Landlord approves any alterations, additions, improvements, etc., Landlord shall notify Tenant, in writing, along with Landlord’s approval notice, of whether Tenant shall, upon termination of this Lease, either: (i) remove any such alterations or additions and repair any damage to the Premises (or the buildings in which the Premises are located) occasioned by their installation or removal and restore the Premises to substantially the same condition as existed prior to the time when any such alterations or additions were made, or (ii) reimburse Landlord for the cost of removing such alterations or additions and the restoration of the Premises.

  • Maintenance Repairs Utility Installations Trade Fixtures and Alterations 7.1 Lessee's Obligations.

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