The ANDA Clause Samples

The ANDA clause defines the requirements and obligations related to an Abbreviated New Drug Application (ANDA) within the context of a contract, typically in the pharmaceutical industry. It outlines the responsibilities of the parties regarding the preparation, submission, and maintenance of the ANDA, as well as the handling of regulatory communications and approvals. For example, it may specify which party is responsible for filing the ANDA with the FDA or how information and updates about the application are to be shared. The core function of this clause is to ensure clear allocation of duties and responsibilities concerning the ANDA process, thereby minimizing confusion and potential disputes between the parties.
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The ANDA. The "ANDA" shall mean the Abbreviated New Drug Applications for the Products which has been submitted to the FDA by Lannett, including any amendments or supplements thereto.
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The ANDA. The "ANDA" shall mean the Abbreviated New Drug -------- Application for the Product which has been submitted to the FDA by MOVA, including any amendments or supplements thereto.
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Related to The ANDA

  • Death of the Annuitant If the Annuitant is not an Owner and dies prior to the Annuity Date, Owner 1 will become the new Annuitant unless you designate otherwise. If any Owner is not an individual, we will treat the death of the Annuitant as the death of an Owner.

  • Base Annual Salary “Base Annual Salary” means the greater of (1) the highest annual rate of base salary in effect for the Executive during the 12 month period immediately prior to a Change in Control or, (2) the annual rate of base salary in effect at the time Notice of Termination is given (or on the date employment is terminated if no Notice of Termination is required).

  • Payments Within Twelve Months The Company has not made any direct or indirect payments (in cash, securities or otherwise) (i) to any person, as a finder's fee, consulting fee or otherwise, in consideration of such person raising capital for the Company or introducing to the Company persons who raised or provided capital to the Company, (ii) to any NASD member or (iii) to any person or entity that has any direct or indirect affiliation or association with any NASD member, within the twelve months prior to the Effective Date, other than payments to EBC.

  • NO CONTRACTING OUT 12.01 The Nursing Home shall not contract-out any work usually performed by members of the bargaining unit if, as a result of such contracting-out, a lay-off of any employees other than casual part-time employees results from such contracting-out. Contracting-out to an Employer who is organized and who will employ the employees of the bargaining unit who would otherwise be laid-off with similar terms and conditions of employment is not a breach of this Agreement.

  • Residents In accordance with the provisions of all applicable state and federal statutes, as amended from time to time, the Manager shall use its best efforts to maintain the resident census at the Facility in such numbers and in such a manner as, in the Manager's judgment, will tend to maintain the financial stability of the Facility and will comply with the covenants in any Financing Agreement.