Miscellaneous Data Submissions Sample Clauses

Miscellaneous Data Submissions. If applicable, the Awardee must submit to the Government all Point Papers, Briefings, Technical Performance Plans (TPP), Program Development Plans (PDP), Regulatory Strategy, Technology Transfer Report and Gap Analysis, Formulation Development, Feasibility and Optimization Reports, United States Army Medical Research and Material Command Animal Care and Use Review Office (USAMRMC ACURO) Approvals, Human Resources Operations Branch (HROB) Approvals, Technical Presentations and Publications, and any formal technical reports that have been prepared for eventual submission to FDA or other regulatory agencies. Examples include the following reports related to: pharmaceutical development, manufacturing development, manufacturing validation, completed batch records, certificates of analysis, analytical development and validation, drug substance and product stability, nonclinical testing, and clinical testing. Examples include clinical performance and clinical quality documentation.
Sample 1
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Miscellaneous Data Submissions. If applicable, as required by the OTA and requested by HJF, Redhill shall submit to HJF and the Government all point papers, briefings, technical performance plans, program development plans, regulatory strategy, technology transfer report and gap analysis, formulation development, feasibility and optimization Reports, United States Army Medical Research and Material Command Animal Care and Use Review Office (USAMRMC ACURO) approvals, Human Resources Operations Branch (HROB) approvals, technical presentations and publications, and any formal technical reports that have been prepared for eventual submission to FDA or other regulatory agencies. Examples include the following reports related to: pharmaceutical development, manufacturing development, manufacturing validation, completed batch records, certificates of analysis, analytical development and validation, drug substance and product stability, nonclinical testing, and clinical testing.
Sample 1

Related to Miscellaneous Data Submissions

  • Miscellaneous Terms The term "or" is disjunctive; the term "and" is conjunctive. The term "shall" is mandatory; the term "may" is permissive. Masculine terms also apply to females; feminine terms also apply to males. The term "including" is by way of example and not limitation.

  • Miscellaneous Provisions Section 11.01

  • Miscellaneous Expenses Board members may seek reimbursement for other expenses incurred while attending a meeting sponsored by organizations described herein by fully describing the expenses on the expense form, attaching receipts.

  • Miscellaneous Amendments Notwithstanding anything contained herein to the contrary, whenever any of the terms “Leased Premises”, “Demised Premises” or “Premises” (and whether or not capitalized) is used herein, it shall be understood to mean the “premises leased hereby”; and whenever the term “Entire Premises” is used herein (and whether or not capitalized), it shall be understood to mean all of the contiguous land and buildings owned by Landlord at this location, which include the premises leased hereby. The term “Non-leased Premises” shall mean the Entire Premises less the Leased Premises.

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