Facility Compliance and Related Matters Sample Clauses

Facility Compliance and Related Matters. Supplier shall maintain the Facilities in compliance with all applicable Regulatory Requirements, and with the provisions of this Agreement, at all times during the term hereof. Supplier shall be responsible under this Agreement for all costs and expenses related to the compliance of the Facilities with such Regulatory Requirements. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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Facility Compliance and Related Matters. Impax shall maintain the Approved Facility and shall conduct all Manufacturing in compliance with all applicable laws, rules and regulations, including cGMPs, and the Impax Know-How at all times during the term of this Agreement. Impax shall be responsible for all costs and expenses related to the compliance of the Approved Facility with such laws, rules and regulations and with the Impax Know-How. Impax agrees to Manufacture the Product at the Approved Facility, and not to change the location thereof without Schering's prior written consent.
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Facility Compliance and Related Matters. RIBI [*] maintain the Approved Facility in compliance with all applicable laws, rules and regulations, including GMPs, at all times during the term of this Agreement. RIBI shall be responsible for all costs and expenses related to the compliance of the Approved Facility with such laws, rules and regulations. RIBI agrees to Manufacture the Product at an Approved Facility.
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Facility Compliance and Related Matters. Genchem Pharma shall cause Sicor to maintain the Sicor Facility in compliance with all applicable laws, rules and regulations relating to the Manufacture of the Validation Batches and AD32, including without limitation the Regulatory Guidelines and Requirements, and with the provisions of this Agreement, at all times during the term hereof. Genchem Pharma shall be responsible for all costs and expenses related to the compliance of the Sicor Facility with such laws, rules and regulations. The AD32 supplied to Anthra by Genchem Pharma pursuant to this Agreement shall be Manufactured at the Sicor Facility.
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Facility Compliance and Related Matters. 17 8.5 Quality Control Program............................................................ 17 8.6 Approval for Manufacturing Changes; Third Party Manufacturing...................... 17 8.7
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Facility Compliance and Related Matters. 3.1.1 GalaGen covenants that the Approved Facility shall be in compliance with all applicable laws, rules and regulations, including cGMP, at all times during the term of this Agreement. GalaGen shall be responsible for all costs and expenses related to the compliance of the Approved Facility with such laws, rules and regulations related to the Manufacture of the Ingredient in accordance with the Specifications. The Ingredient shall be Manufactured at the Approved Facility and the location thereof shall not be changed without Wyeth-Ayerst's written consent, which consent shall not be unreasonably withheld.
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Facility Compliance and Related Matters. CIMA shall maintain the Approved Facility and shall conduct the Development Program and all Manufacturing in compliance with all Laws, including but not limited to GMPs, the Specifications, and any written instructions provided by Schering, at all times during the Term of this Agreement. CIMA shall be responsible for all costs and expenses related to the compliance of the Approved Facility with such Laws, Specifications, and any written instructions provided by Schering. CIMA agrees to manufacture the Licensed Product at the Approved Facility, and not to change the location thereof without Schering's prior written consent, which consent shall not be unreasonably withheld or delayed. In the event CIMA gains access to a second manufacturing facility and Schering desires that CIMA Manufacture Licensed Product at the second manufacturing facility as well as at the Approved Facility, Schering will reimburse CIMA for all reasonable expenses associated with establishing the second manufacturing facility to Manufacture Licensed Product. The parties shall agree in advance in writing to the costs reimbursable to CIMA under this Section.
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Facility Compliance and Related Matters 
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Related to Facility Compliance and Related Matters

  • Environmental Compliance and Conditions Except as set forth on Schedule 3.16:

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower's part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower's part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Existence and Compliance Maintain its existence, good standing and qualification to do business, where required and comply with all laws, regulations and governmental requirements including, without limitation, environmental laws applicable to it or to any of its property, business operations and transactions.

  • Title to Properties and Related Matters (a) Except as set forth on Schedule 3.10(a), the Company has good and valid title to all material personal property, tangible or intangible, which the Company purports to own, including the properties reflected on the Balance Sheet or acquired after the date thereof (other than properties and assets sold or otherwise disposed of in the ordinary course of business and consistent with past practice since June 30, 1999), free and clear of any claims, liens, pledges, security interests or encumbrances of any kind whatsoever (other than (i) purchase money security interests and common law vendor's liens, in each case for goods purchased on open account in the ordinary course of business and having a fair market value of less than $5,000 in each individual case), (ii) liens for Taxes not yet due and payable, and (iii) such imperfections of title and encumbrances, if any, that are not material in character, amount or extent and that do not materially detract from the value, or materially interfere with the use of, the property subject thereto or affected thereby.

  • Compliance with Legal and Insurance Requirements, etc Subject to Section 8.3(b) below and Section 12.2 (relating to permitted contests), Lessee, at its expense, will promptly (a) comply with all applicable Legal Requirements and Insurance Requirements in respect of the use, operation, maintenance, repair and restoration of the Leased Property, and (b) procure, maintain and comply with all appropriate Licenses and other authorizations required for any use of the Leased Property and Lessee’s Personal Property then being made, and for the proper erection, installation, operation and maintenance of the Leased Property or any part thereof.

  • Authority; Compliance With Other Agreements and Instruments and Government Regulations The execution and delivery by Borrower of the Loan Documents to which it is a Party and payment of the Obligations have been duly authorized by all necessary corporate or company action, as applicable, and do not and will not:

  • Compliance with Legal and Insurance Requirements Subject to Article XII relating to permitted contests, Lessee, at its expense, (a) shall comply, in all material respects with all Legal Requirements and Insurance Requirements applicable to Lessee and the use, operation, maintenance, repair and restoration of the Facilities and the Leased Property, whether or not compliance therewith shall require structural change in any of the Leased Improvements or interfere with the use and enjoyment of the Leased Property; (b) shall not use the Leased Property and Lessee’s Personal Property for any unlawful purpose; (c) shall procure, maintain and comply with all material Licenses and any other licenses, certificates, certifications, consents, permits, governmental approvals, and authorizations required under the Legal Requirements for any use of the Leased Property and Lessee’s Personal Property then being made, and for the proper erection, installation, operation and maintenance of the Leased Property or any part thereof, including, without limitation, any Capital Additions; and (d) shall use its commercially reasonable efforts to require under the Tenant Leases that all Tenants acquire and maintain all material Licenses necessary to operate any portion of the Leased Property subleased to them for any appropriate and permitted uses conducted on the Leased Property as may be permitted from time to time hereunder, it being acknowledged by Lessor that any failure by any Tenant under this clause (d) shall not cause (or be deemed to cause) a breach by Lessee of this Section 8.1 unless Lessee has so failed to use commercially reasonable efforts. Lessee’s use of the Leased Property, the use of all Lessee’s Personal Property used in connection with the Leased Property, and the maintenance, alteration, and operation of the same, and all parts thereof, shall at all times conform in all material respects to all Legal Requirements. Upon Lessor’s request, Lessee shall deliver to Lessor copies of all such Licenses that are currently held by Lessee or its Affiliates to the extent applicable to the Leased Property. Lessee shall indemnify and defend, at Lessee’s sole cost and expense, and hold Lessor, its Affiliates and their respective successors and assigns harmless from and against and agrees to reimburse Lessor, its Affiliates and their respective successors and assigns with respect to any and all claims, demands, actions, causes of action, losses, damages, liabilities, reasonable, out-of-pocket costs and expenses (including, without limitation, reasonable attorneys’ fees and court costs) of any and every kind or character, known or unknown, fixed or contingent, asserted against or incurred by Lessor, its Affiliates and their respective successors and assigns, at any time and from time to time by reason or arising out of any breach by Lessee of any of the provisions of this Article VIII or any breach or violation by Lessee of any Legal Requirements, including any and all such claims, demands, liabilities, damages, costs and expenses relating to immaterial violations or breaches of the Legal requirements, except to the extent arising solely as a result of the gross negligence or willful misconduct of Lessor or its Affiliates. All such damages and reasonable out-of-pocket costs and expenses payable to Lessor under this Section 8.1 shall be due and payable by Lessee within thirty (30) days after delivery of written demand from Lessor, its Affiliates or their respective successors and assigns.

  • Performance and Compliance Purchaser shall have performed all of the covenants and complied, in all material respects, with all the provisions required by this Agreement to be performed or complied with by it on or before the Closing.

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