Summary CMC Section definition

Summary CMC Section means the introductory portion of the CMC section of an NDA, as defined in Title 21, Section 314.50(d)(1) of the Code of Federal Regulations, and analogous regulations in any legal jurisdiction other than the U.S., in each case relating to the Compound and the Product.
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Summary CMC Section means the introductory portion of the chemistry, manufacturing, and controls section of an NDA, as defined in 21 CFR Section 314.50 (1), relating to the Substance and the Finished Product.
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Examples of Summary CMC Section in a sentence

  • To the extent required, Bayer shall either: (i) be responsible for the preparation and delivery to Licensee of the Summary CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in an NDA or NDA Equivalent in accordance with Applicable Laws and as the Parties may mutually agree; or (ii) provide Licensee with all data and information (including, without limitation, all Information) required to complete the Summary CMC Section in accordance with Applicable Laws.

  • Leave under the provisions of this Article shall be limited to four (4) months (nine [9] pay periods [720 hours]) during a twelve (12) month period, regardless of the number of incidents.

  • In the event that there is a deficiency in the Summary CMC Section attributable to Bayer (including as a result of any deficiency in or changes required to be made to the DMF), then Bayer shall be responsible for correcting such deficiency, at Bayer’s expense, and shall use Commercially Reasonable Efforts to do so as soon as practicable.

  • In the event that there is a deficiency in the Summary CMC Section attributable to Bayer (including as a result of any deficiency in or changes required to be made to the DMF), then Bayer shall be responsible for correcting such deficiency, at Bayer’s expense, and shall use Commercially Reasonable Efforts to do so as soon as practicable.*** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED.

  • The results were prepared by the UOA Solvency in the QRT format and sent to the Supervisory Authority within the set deadlines (14 May 2018 QES1).

  • In the event that there is a deficiency in the Summary CMC Section attributable to Schering (including as a result of any deficiency in or changes required to be made to the DMF), then Schering shall be responsible for correcting such deficiency, at Schering’s expense, and shall use Commercially Reasonable Efforts to do so as soon as practicable.

Related to Summary CMC Section

  • Summary Plan Description or "SPD" means the Flexible Benefits Plan SPD and all appendices incorporated into and made a part of the SPD that is adopted by the Employer and attached to this Plan Document as Attachment I, as amended from time to time. The SPD and appendices are incorporated hereto by reference.

  • Tomographic section means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

  • ORSA summary report means a confidential high-level summary of an insurer or insurance group's own risk and solvency assessment.

  • Summary data means statistical records and reports derived from data on individuals but in which individuals are not identified and from which neither their identities nor any other characteristic that could uniquely identify the individual is ascertainable.

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • Multiple Bill/Single Tariff means the billing method used when Switched Exchange Access Services is jointly provided by the Parties. As described in the MECAB document, each Party will render a bill in accordance with its own tariff for that portion of the service it provides. Each Party will bill its own network access service rates.

  • Nominal tomographic section thickness means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.

  • Shift Schedule means a projection of Employees’ shifts with regard to days worked and days off, including shift starting and terminating times.

  • Data Sheet means an integral part of the Instructions to Consultants (ITC) Section2thatisusedtoreflect specific assignment conditions to supplement, but not to over-write, the provisions of the ITC.

  • Service Description means pre-defined descriptions of services found at http://www.sap.com/servicedescriptions current as of the effective date of the Order Form which in conjunction with a Scope Document (if any) defines the Services to be provided and becomes part of the Order Form.

  • Summary report means the year end report containing the summary of a

  • Safety Data Sheet means a safety data sheet within the meaning of regulation 5 of the CHIP Regulations;

  • Summary suspension means the immediate suspension of either a facility's license or program-specific certification or both by the department pending administrative proceedings for suspension, revocation, or other actions deemed necessary by the department.

  • Policy Schedule means a schedule attached to these Terms and Benefits, which sets out, among others, the Policy Effective Date, Renewal Date, the name and the relevant particulars of the Policy Holder and the Insured Person, the eligible benefits, premium and other relevant details in respect of these Terms and Benefits.

  • Service Descriptions means user manuals and other documentation relating to the Services that are made available to Customer by Provider in digital or hardcopy form, as updated from time to time.

  • Compliance schedule means a schedule of events, by date, which will result in compliance with these regulations.

  • Asset adequacy analysis means an analysis that meets the standards and other requirements referred to in 5.34(5)“d.”

  • QAP shall have the meaning set forth in Clause 11.2;

  • Line section means either that portion of an EDU's electric system connected to a customer bounded by automatic sectionalizing devices, the end of the distribution line, or a line segment identified as appropriate for study by a utility engineer.

  • Policy summary means a synopsis describing the elements of a life insurance policy.

  • Emergency Response Plan means the plan constituting the set of procedures developed by the Owner for dealing with an Incident which may impact on the Network or Connecting Infrastructure, including all actions to be taken to minimise or alleviate any threat or danger to any person or property:

  • Basic Comprehensive User Guide means the Ministry document titled Basic Comprehensive Certificates of Approval (Air) User Guide” dated April 2004 as amended.

  • Description Section means the section on page one of the Certificate describing the Company's operations and the

  • Product Description means the description of each Hospitality Package, or series of Hospitality Packages which are the subject of any Confirmation of Purchase.

  • Tariff Schedule means the tariff schedule contained in Annexure B to this Access Arrangement or, if Envestra has published a revised tariff schedule, the tariff schedule in effect from time to time.

  • Departmental Schedule , which means the Public Works Department Schedule of Rates in different district of West Bengal for the working area including up-to-date addenda and corrigenda, if any.