DEVIATION AND DEFECTS Sample Clauses

DEVIATION AND DEFECTS. In the event of procedural deviation or other deviation from the Production Batch Record or an Out-of-Specification test result noted in the Raw Materials, Packaging Components, or finished Product or during Manufacturing or Packaging, Duramed will notify Warner within twenty-four (24) hours. Unless otherwise obligated by Law or impractical due to the requirement of an immediate response, Duramed shall consult with Warner before taking action in connection with these events. Duramed shall, at its sole expense, identify and correct any Product defects, or adverse conditions (such as a spill), that are caused by Duramed's failure to perform its responsibilities under this Agreement. During the term of this Agreement and for a period of five (5) years following the Batch Release Date for each Batch, Duramed shall notify Warner, in writing, within one (1) business day in the event Duramed discovers or has reason to believe there are any cGMP violations by Duramed or any vendor that might have impacted the Product, which violations may be reportable to the Regulatory Authorities or if there are any defects in the Production Batch Records or the Batch.
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Related to DEVIATION AND DEFECTS

  • Remedies for Environmental Defects Subject to Seller’s continuing right to dispute the existence of a Environmental Defect and/or the Remediation Amount asserted with respect thereto, in the event that any Environmental Defect timely asserted by Buyer in accordance with Section 12.1(a) is not waived in writing by Buyer or cured on or before Closing, Seller shall, at its sole option, elect to:

  • Latent Defects Seller has no actual knowledge of any latent defects on, in, under or above the Land, the Lots or the Improvements (to the extent completed as of the date of this Agreement). For purposes of this representation, the actual knowledge of Seller shall mean the actual knowledge of only Xxxxxxxx X. Xxxx and no other person. 7.2

  • REMEDY OF DEFECTS (a) The BUILDER shall remedy, at its expense, any Defect against which the VESSEL is guaranteed under this Article, by making all necessary repairs or replacements at the Shipyard.

  • Defects To Borrower’s knowledge, there are no defects, facts or conditions affecting the Project which would make it unsuitable for its present use and operation as a medical/commercial office buildings.

  • WAIVER AND CUMULATIVE REMEDIES One or more waivers by Landlord or Tenant of any breach of any term, covenant or condition contained in this Lease shall not be a waiver of any subsequent breach of the same or any other term, covenant or condition. Consent to any act by one of the parties shall not be deemed to render unnecessary the obtaining of that party's consent to any subsequent act. No breach by Tenant of this Lease shall be deemed to have been waived by Landlord unless the waiver is in a writing signed by Landlord. The rights and remedies of Landlord under this Lease shall be cumulative and in addition to any and all other rights and remedies which Landlord may have.

  • No Waiver by Course of Conduct; Cumulative Remedies No Secured Party shall by any act (except by a written instrument pursuant to Section 8.1), delay, indulgence, omission or otherwise be deemed to have waived any right or remedy hereunder or to have acquiesced in any Default or Event of Default. No failure to exercise, nor any delay in exercising, on the part of any Secured Party, any right, power or privilege hereunder shall operate as a waiver thereof. No single or partial exercise of any right, power or privilege hereunder shall preclude any other or further exercise thereof or the exercise of any other right, power or privilege. A waiver by any Secured Party of any right or remedy hereunder on any one occasion shall not be construed as a bar to any right or remedy which such Secured Party would otherwise have on any future occasion. The rights and remedies herein provided are cumulative, may be exercised singly or concurrently and are not exclusive of any other rights or remedies provided by law.

  • Environmental Conditions A Phase I environmental site assessment (or update of a previous Phase I and or Phase II environmental site assessment) and, with respect to certain Mortgage Loans, a Phase II environmental site assessment (collectively, an “ESA”) meeting ASTM requirements conducted by a reputable environmental consultant in connection with such Mortgage Loan within 12 months prior to its origination date (or an update of a previous ESA was prepared), and such ESA (i) did not identify the existence of Recognized Environmental Conditions (as such term is defined in ASTM E1527-05 or its successor, hereinafter “Environmental Condition”) at the related Mortgaged Property or the need for further investigation, or (ii) if the existence of an Environmental Condition or need for further investigation was indicated in any such ESA, then at least one of the following statements is true: (A) an amount reasonably estimated by a reputable environmental consultant to be sufficient to cover the estimated cost to cure any material noncompliance with applicable Environmental Laws or the Environmental Condition has been escrowed by the related Mortgagor and is held or controlled by the related lender; (B) if the only Environmental Condition relates to the presence of asbestos-containing materials, radon in indoor air, lead based paint or lead in drinking water, the only recommended action in the ESA is the institution of such a plan, an operations or maintenance plan has been required to be instituted by the related Mortgagor that can reasonably be expected to mitigate the identified risk; (C) the Environmental Condition identified in the related environmental report was remediated, abated or contained in all material respects prior to the date hereof, and, if and as appropriate, a no further action, completion or closure letter or its equivalent, was obtained from the applicable governmental regulatory authority (or the Environmental Condition affecting the related Mortgaged Property was otherwise listed by such governmental authority as “closed” or a reputable environmental consultant has concluded that no further action or investigation is required); (D) an environmental policy or a lender’s pollution legal liability insurance policy that covers liability for the Environmental Condition was obtained from an insurer rated no less than “A-” (or the equivalent) by Xxxxx’x, S&P and/or Fitch; (E) a party not related to the Mortgagor was identified as the responsible party for the Environmental Condition and such responsible party has financial resources reasonably estimated to be adequate to address the situation; or (F) a party related to the Mortgagor having financial resources reasonably estimated to be adequate to address the situation is required to take action. To Seller’s knowledge, except as set forth in the ESA, there is no Environmental Condition at the related Mortgaged Property.

  • Modification and Waiver of Breach No waiver or modification of this Agreement shall be binding unless it is in writing signed by the parties hereto. No waiver of a breach hereof shall be deemed to constitute a waiver of a future breach, whether of a similar or dissimilar nature.

  • Title Defects If on the Closing Date the Sellers shall be unable to cause title to the Property to be free and clear of all exceptions to title other than Permitted Encumbrances, then the Sellers shall be entitled, but shall not be obligated, to adjourn the Closing for one or more periods not to exceed ninety (90) days in the aggregate for the purpose of causing title to be placed in the condition called for by this Agreement. If on the Closing Date, as the same may be adjourned as above provided, title to the Property is not free and clear of all exceptions to title other than Permitted Encumbrances, Purchaser may terminate this Agreement by notice to the Sellers delivered on or prior to the Closing Date, as the same may have been extended, in which event this Agreement shall be terminated and of no further force or effect, and neither party shall have any obligations of any nature to the other hereunder or by reason hereof, except as to those obligations hereunder that are specifically stated to survive such termination, and the Deposit shall be distributed by Escrow Agent in accordance with Section 3.2.2 (and the Sellers shall join with Purchaser in executing a written instruction to Escrow Agent to do so); provided, however, that in the event that title to the Property is not free and clear of all exceptions to title other than Permitted Encumbrances due to a breach of the proviso clause of the next sentence, Purchaser shall have the rights set forth in Section 16.2. Neither the Sellers nor Owner shall be under any obligation to take any steps or to institute or prosecute any action or proceedings, or expend any sums of money, to remove from title to the Property any defect, encumbrance or objection to title; provided, however, that the Sellers shall be responsible for discharging (and at or prior to the Closing shall discharge) any liens, encumbrances or other title defects which do not constitute Permitted Encumbrances, which can be discharged solely by the payment of a sum of money and which arise solely on account of actions or failures to act by Owner or VCR. The Sellers may use any part of the Purchase Price to discharge the same, provided that the Sellers shall deliver to Purchaser at the Closing instruments in recordable form sufficient to discharge such liens and encumbrances of record. Except for the Sellers' failure to discharge such monetary liens or encumbrances as aforesaid, the Sellers shall not be deemed in default of this Agreement, and Purchaser shall not be entitled to damages of any kind, if the Sellers shall fail or be unable to cause title to the Property to be in the condition called for by this Agreement, nor shall Purchaser, in such circumstances, be entitled to specific performance of this Agreement (unless the same is due to a default by the Sellers under this Agreement). In no event shall the Sellers or Owner be obligated to discharge any mechanic's or similar lien created by a Tenant in occupancy at the Closing whose Lease is in full force and effect, but the Sellers shall cause Owner (or VCR, as applicable) to use reasonable efforts to cause such Tenant to do so. For purposes of this Section 14.2, the Sellers shall be deemed to have cured or removed any title exception if the Title Company or any other reputable title insurance company shall be prepared to issue to Owner an owner's policy of title insurance for the Property (at standard rates or with the Sellers paying any additional premium in connection with such exception) dated as of the Closing Date insuring over such exception, or providing affirmative coverage or an endorsement with respect thereto that is reasonably satisfactory to Purchaser.

  • Notice and Effect of Material Events The Company will immediately notify each Initial Purchaser, and confirm such notice in writing, of (x) any filing made by the Company of information relating to the offering of the Securities with any securities exchange or any other regulatory body in the United States or any other jurisdiction, and (y) prior to the completion of the placement of the Securities by the Initial Purchasers as evidenced by a notice in writing from the Initial Purchasers to the Company, any material changes in or affecting the earnings, business affairs or business prospects of the Company and its subsidiaries which (i) make any statement in the Offering Memorandum false or misleading or (ii) are not disclosed in the Offering Memorandum. In such event or if during such time any event shall occur as a result of which it is necessary, in the reasonable opinion of the Company, its counsel, the Initial Purchasers or counsel for the Initial Purchasers, to amend or supplement the Final Offering Memorandum in order that the Final Offering Memorandum not include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein not misleading in the light of the circumstances then existing, the Company will forthwith amend or supplement the Final Offering Memorandum by preparing and furnishing to each Initial Purchaser an amendment or amendments of, or a supplement or supplements to, the Final Offering Memorandum (in form and substance satisfactory in the reasonable opinion of counsel for the Initial Purchasers) so that, as so amended or supplemented, the Final Offering Memorandum will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at the time it is delivered to a Subsequent Purchaser, not misleading.

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