Boxed Warning definition
Boxed Warning means labeling requirements, as may be required by the FDA as set forth in 21 C.F.R. § 201.57(c)(1).
Boxed Warning means a contraindication or serious warning required by the FDA to be presented in a box within the approved labeling of a drug product, as set forth in 21 C.F.R. Sections 201.57(a)(4) and 201.57(c)(1). “Business Day” shall mean a day (other than a Saturday or Sunday) on which commercial banks are not authorized or required to close in New York City, Toronto, Canada, or London, England. “Call Option” shall have the meaning set forth in Section 5.05(a). “Call Option Closing Date” shall have the meaning set forth in Section 5.05(a). “Call Price” shall mean, as of any date of determination, an amount sufficient, that, after giving effect to the payment of the Assigned Interests Payments made by the Company to the Purchasers pursuant to Section 2.02(a), (i) the MOIC equals 1.20x, if such date is on or before the one-year anniversary of the Tranche A Funding Date, (ii) the MOIC equals 1.40x, if such date is after the one-year anniversary of the Tranche A Funding Date and on or before the two-year anniversary of the Tranche A Funding Date, (iii) the MOIC equals 1.55x if such date is after the two-year anniversary of the Tranche A Funding Date and on or before the three-year anniversary of the Tranche A Funding Date, and (iv) the MOIC equals 1.75x if such date is after the three-year anniversary of the Tranche A Funding Date. “Capital Lease Obligations” shall mean, as to any Person, the obligations of such Person to pay rent or other amounts under a lease of (or other agreement conveying the right to use) any property by such Person as lessee, which obligations are required to be classified and accounted for as a capital lease or finance lease on a balance sheet of such Person under GAAP, and for the purposes of this Agreement, the amount of such obligations shall be the capitalized amount thereof, determined in accordance with GAAP. “Capital Lease Obligations” shall not include any obligations under a straight-line or operating lease (including any lease that would not have been a capital lease under GAAP prior to giving effect to Accounting Standards Codification 842, Leases). “Change of Control” shall mean an event or series of events (i) as a result of which any “person” or “group” (as such terms are used in Sections 13(d) and 14(d) of the Securities Act, but excluding any of such person or its Subsidiaries, and any Person acting in its capacity as trustee, agent or other fiduciary or administrator of any such Plan) becomes the “beneficial owner”, directly or...
Boxed Warning means a contraindication or serious warning required by the FDA to be presented in a box within the approved labeling of a drug product, as set forth in 21 C.F.R. Sections 201.57(a)(4) and 201.57(c)(1).
Examples of Boxed Warning in a sentence
Please see full prescribing information, including Boxed Warning, at ▇▇▇.▇▇▇▇▇▇▇▇.▇▇▇.
Full Prescribing Information, including Boxed Warning and Medication Guide in the U.S., is available at ▇▇▇.▇▇▇▇▇▇▇.▇▇▇.
Prescribing Information has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.
More Definitions of Boxed Warning
Boxed Warning means a contraindication or serious warning required by the FDA to be presented in a box within the approved labeling of a drug product, as set forth in 21 C.F.R. Sections 201.57(a)(4) and 201.57(c)(1). Oaktree-TCDRS Strategic Credit, LLC [***] Oaktree-▇▇▇▇▇▇▇ Multi-Strategy, LLC [***] Oaktree-TBMR Strategic Credit Fund C, LLC [***] Oaktree-TBMR Strategic Credit Fund F, LLC [***] Oaktree-TBMR Strategic Credit Fund G, LLC [***] Oaktree-TSE 16 Strategic Credit, LLC [***] INPRS Strategic Credit Holdings, LLC [***] Oaktree Specialty Lending Corporation [***] Oaktree Strategic Credit Fund [***] Oaktree AZ Strategic Lending Fund, L.P. [***] Oaktree LSL Fund Delaware Holdings EURRC, L.P. [***] Oaktree Direct Lending Fund Delaware Holdings Non-EURRC, L.P [***] Oaktree Direct Lending Fund Unlevered Delaware Holdings Non-EURRC, L.P. [***] Oaktree Direct Lending Fund VCOC Delaware Holdings Non-EURRC, L.P. [***] Oaktree Loan Acquisition Fund, L.P. [***] Oaktree Jalapeno Investment Fund, L.P. [***] OCM Life Sciences Portfolio LP [***]
Boxed Warning means any notice required by Health Canada or by any foreign equivalent of such. A Boxed Warning is deemed to be a Circumstance and is subject to the reporting requirements of Clause XII.
Boxed Warning means a contraindication or serious warning required by the FDA to be presented in a box within the approved labeling of a drug product, as set forth in 21 C.F.R. Sections 201.57(a)(4) and 201.57(c)(1). Tranche C Term Loans Lenders and their respective Applicable Commitments: Lender Applicable Commitment Oaktree-TCDRS Strategic Credit, LLC [***] Oaktree-▇▇▇▇▇▇▇ Multi-Strategy, LLC [***] Oaktree-TBMR Strategic Credit Fund C, LLC [***] Oaktree-TBMR Strategic Credit Fund F, LLC [***] Oaktree-TBMR Strategic Credit Fund G, LLC [***]