Consumption/Loss of API Sample Clauses

Consumption/Loss of API. DSM shall not be responsible for loss of API utilized in the performance of the transfer and development Services except for losses caused by gross negligence or willful misconduct attributable to DSM. For commercial production, the expected loss (the “Expected Loss”) of finished Product per unit of API utilized in the production of the Product hereunder shall not be more than [***] per Batch. If the Expected Loss for the first three (3) Validation Lots run under this Agreement is greater than [***], the parties shall then mutually agree upon a revised Expected Loss based upon the average of the actual loss resulting from the [***] completed commercial lot Batches that return an actual loss of not more than [***] and at such time the revised Expected Loss shall be then established and applied against future Batches. DSM shall provide AMAG with a written report of any production loss of API incurred in connection with the production of each commercial Batch promptly following the delivery of such Batch. For each Batch, DSM shall be responsible for any loss of API greater than the Expected Loss. Within [***] days from the end of each Contract Year hereunder and subject to Limitations of Liability set forth in Section 5.5, DSM shall reimburse AMAG for any loss of API in [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. excess of the Expected Loss during such Contract Year. Notwithstanding anything written to the contrary in this Agreement, DSM shall be responsible for API loss in whole-batch quantities only to the extent such loss results from DSM’s gross negligence or willful misconduct. Further, any consumption or loss of API or Product which exceeds the Expected Loss or the Limitation of Liability set forth in Section 5.5 shall be deemed an incurable material breach by DSM under the Agreement for which AMAG may terminate the Agreement without penalty with [***] days written notice to DSM.
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Consumption/Loss of API. 4.2.7.1. For all Batches other than Validation Batches, the expected yield shall equal the [†] of (a) [†] or (b) [†] (collectively, “Expected Yield”).
Consumption/Loss of API. The expected yield (the “Expected Yield”) of finished Product per unit of API utilized in the production of Product hereunder is set forth in Annex 1. The actual yield of finished Product (the “Average Consumption Ratio”) shall be determined on an annual basis as the average consumption of API per unit of finished Product for all batches produced during the Contract Year. [ *** ] DSM shall, in any case, not be liable for API loss relating to excessive variability in the production processes over which DSM has no control, nor for any losses relating to changes in the Specifications and/or production processes required by Discovery Labs. [ *** ] [ *** ] Denotes that confidential treatment of redacted portions has been requested.

Related to Consumption/Loss of API

  • Allowance for Loan Losses The Company's allowance for loan losses is, and shall be as of the Effective Date, in compliance with the Company's existing methodology for determining the adequacy of its allowance for loan losses as well as the standards established by applicable Governmental Authorities and the Financial Accounting Standards Board and is and shall be adequate under all such standards.

  • Direct Costs Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.

  • Allowance for Possible Loan Losses The allowance for possible loan or credit losses (the “Allowance”) shown on the consolidated balance sheets of each Subsidiary, as applicable, included in the most recent SEC Documents dated prior to the date of this Agreement was, as of the dates thereof, adequate (within the meaning of GAAP and applicable regulatory requirements or guidelines) to provide for all known, reasonably anticipated or probable losses relating to or inherent in the loan and lease portfolios (including accrued interest receivables) of such Subsidiary and other extensions of credit (including letters of credit and commitments to make loans or extend credit) by such Subsidiary as of the date thereof; provided, however, that there can be no assurance that future losses will not exceed the Allowance, or that additional provisions for loan losses will not be required in future periods, and provided, further, that it is understood that the Company’s determination of the Allowance is subject to review by the Company’s bank regulator, which can require the establishment of additional general or specific allowances.

  • Data Loss Prevention Transfer Agent shall implement a data leakage program that is designed to identify, detect, monitor and document Fund Data leaving Transfer Agent’s control without authorization in place.

  • Cost Pools Landlord shall have the right, from time to time, to equitably allocate some or all of the Direct Expenses for the Project among different portions or occupants of the Project (the “Cost Pools”), in Landlord’s reasonable discretion. Such Cost Pools may include, but shall not be limited to, the office space tenants of a building of the Project or of the Project, and the retail space tenants of a building of the Project or of the Project. The Direct Expenses within each such Cost Pool shall be allocated and charged to the tenants within such Cost Pool in an equitable manner.

  • Excess Costs If the sum of the Permitted Costs exceeds the Finish Allowance, then Tenant shall pay all such excess costs (“Excess Costs”), provided, however, Landlord will, prior to the commencement of construction of Tenant’s Improvements, advise Tenant of the Excess Costs, if any, and the Contract Sum. Tenant shall have two (2) business days from and after the receipt of such advice within which to approve or disapprove the Contract Sum and Excess Costs. If Tenant fails to approve same by the expiration of the fourth such business day, then Tenant shall be deemed to have approved the proposed Contract Sum and Excess Costs. If Tenant disapproves the Contract Sum and Excess Costs within such two (2) business day period, then Tenant shall either reduce the scope of Tenant’s Improvements such that there shall be no Excess Costs or, at Tenant’s option, Landlord shall obtain two (2) additional bids, provided that each day beyond a four (4) business day period and until the rebid is accepted by Tenant shall constitute a Tenant Delay hereunder. Subject to the last sentence of this subsection, the foregoing process shall continue until a Contract Sum and resulting Excess Costs, if any, are accepted or deemed accepted by Tenant. Landlord and Tenant must approve (or be deemed to have approved) the Contract Sum for the construction of Tenant’s Improvements in writing prior to the commencement of construction.

  • Cost Allocation For services rendered by MAEM to Project Companies under this Agreement and/or any Direct Contract, each Project Company shall pay MAEM, on a monthly basis, its share of allocated costs including, but not limited to, personnel costs (the “Service Fee”). For purposes of determining Project Company’s share of allocated costs, MAEM shall apply an industry standard methodology which is applied uniformly across the Asset Companies. Each of MAEM and Project Company acknowledges that the monthly allocations may be adjusted from time to time.

  • Property Cash Flow Allocation (a) During any Cash Management Period, all Rents deposited into the Deposit Account during the immediately preceding Interest Period shall be applied on each Payment Date as follows in the following order of priority:

  • Exclusions from Operating Expenses Operating Expenses exclude the following expenditures:

  • Litigation; Loss Contingencies and Violations Other than as identified on Schedule 5.07, there is no action, suit, proceeding, arbitration or, to the Company’s knowledge, investigation before or by any Governmental Authority or private arbitrator pending or, to the Company’s knowledge, threatened against or affecting the Company or any of its Subsidiaries or any property of any of them, including, without limitation, any such actions, suits, proceedings, arbitrations and investigations disclosed in the Company’s SEC Forms 10-K and 10-Q (the “Disclosed Litigation”), which (a) challenges the validity or the enforceability of any material provision of the Loan Documents or (b) has or could reasonably be expected to have a Material Adverse Effect. There is no material loss contingency within the meaning of Agreement Accounting Principles which has not been reflected in the consolidated financial statements of the Company prepared and delivered pursuant to Section 6.01(a) for the fiscal period during which such material loss contingency was incurred. Neither the Company nor any of its Subsidiaries is (i) in violation of any applicable Requirements of Law which violation could reasonably be expected to have a Material Adverse Effect, or (ii) subject to or in default with respect to any final judgment, writ, injunction, restraining order or order of any nature, decree, rule or regulation of any court or Governmental Authority which could reasonably be expected to have a Material Adverse Effect.

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