Post-Marketing Commitments definition

Post-Marketing Commitments means Phase IV Clinical Studies and other preclinical and clinical studies conducted after Marketing Approval (such as, by way of example, carcinogenicity studies, preclinical studies to establish pediatric or other dosing or safety studies, and registries) that are required or requested by a Regulatory Authority to be conducted after Marketing Approval, in connection with obtaining or maintaining such Marketing Approval.
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Post-Marketing Commitments means any item, activity, task, a non‑human study, human clinical study, or other commitment with respect to a product initiated after receipt of Regulatory Approval (other than Pricing Approval) for such product in a country or territory, the completion of which is recommended or required by the Regulatory Authority in such country or territory in connection with the initial grant of, or to support or maintain such, Regulatory Approval for such product in such country or territory.
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Post-Marketing Commitments means any and all items, tasks, activities, studies, trials or other commitments the completion of which is recommended or required by the FDA in connection with the initial grant of Regulatory Approval for the Alkermes 8700 Product in the Initial Indication in the U.S. or to support or maintain such Regulatory Approval.
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Examples of Post-Marketing Commitments in a sentence

  • Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management Steps, if Approvable.

  • Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management Steps, if Approvable Error! Bookmark not defined.

  • Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management Steps, if Approvable None as per this review.

  • Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management Steps, if Approvable We have no Phase 4 CMC recommendations.

  • As between Depomed and Collegium, from and after the Closing, Depomed shall, at its cost and expense, continue to control, direct and maintain control over the Retained Post-Marketing Commitments.

  • Consultation has taken place with Councillor Philip Saxton, Portfolio Holder for Housing and Customer Services and the contents of this report reflect any feedback provided.

  • Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management Steps, if Approvable 7II.

  • Buyer has sufficient financial wherewithal to: (a) perform all of its obligations pursuant to this Agreement, including payment for the Purchase Price; (b) meet the Post-Marketing Commitments outstanding as of the Effective Date as set out in Exhibit E and, to Buyer's Knowledge, all other Post-Marketing Commitments; and (c) meet all of Buyer's obligations that come due in the ordinary course of business.

  • Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management Steps, if ApprovableThe biopharmaceutics reviewer is in negotiations regarding a post-marketing commitment to develop a more discriminating dissolution method and associated acceptance criteria within one year of approval.

  • During the Term, until the earlier of the Transfer Completion Date or an Alkermes Approval Failure, Alkermes shall be responsible for any and all interactions with the FDA in relation to the Initial Development Plan, activities conducted thereunder and the Alkermes 8700 Product 505(b) (2) NDA (other than in connection with any Post-Marketing Commitments, for which Biogen shall be responsible), including any required modifications to such Alkermes 8700 Product 505(b)(2) NDA.


More Definitions of Post-Marketing Commitments

Post-Marketing Commitments means any post-approval commitments required by the FDA in the United States or any other Competent Authority in any other country in the Territory.
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Post-Marketing Commitments means any and all obligations, responsibilities and commitments required by the FDA and/or other Governmental Entity with respect to the Product and/or the Permits, whether outstanding as of Closing or arising thereafter, except the Open Final Study Reports which Seller shall be responsible for completing to the extent and only to the extent set forth in the Transition Period Services Agreement. Buyer acknowledges that attached hereto as Exhibit E is the status of the outstanding Post-Marketing Commitments as of the Effective Date.
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Post-Marketing Commitments means any post-Marketing Approval trials or studies (including a Phase 4 Clinical Trial) or other post-Marketing Approval commitments (including CMC improvement commitments), in each case, that are required by a Regulatory Authority to be conducted or that a Party has committed to a Regulatory Authority to conduct in order to maintain its then-current Marketing Approval for the Licensed Product in a particular country.
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Post-Marketing Commitments. MEANS ANY ITEM, ACTIVITY, TASK, A NON‑HUMAN STUDY, HUMAN CLINICAL STUDY, OR OTHER COMMITMENT WITH RESPECT TO A PRODUCT INITIATED AFTER RECEIPT OF REGULATORY APPROVAL (OTHER THAN PRICING APPROVAL) FOR SUCH PRODUCT IN A COUNTRY OR TERRITORY, THE COMPLETION OF WHICH IS RECOMMENDED OR REQUIRED BY THE REGULATORY AUTHORITY IN SUCH COUNTRY OR TERRITORY IN CONNECTION WITH THE INITIAL GRANT OF, OR TO SUPPORT OR MAINTAIN SUCH, REGULATORY APPROVAL FOR SUCH product in such country or territory.
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Related to Post-Marketing Commitments

  • Total Revolving Commitments at any time, the aggregate amount of the Revolving Commitments then in effect.

  • Initial Term Loan Commitment means, in the case of each Lender that is a Lender on the Closing Date, the amount set forth opposite such Lender’s name on Schedule 1.1(b) as such Lender’s Initial Term Loan Commitment. The aggregate amount of the Initial Term Loan Commitments as of the Closing Date is $820,000,000.

  • Designated Revolving Commitments means the amount or amounts of any commitments to make loans or extend credit on a revolving basis to the Company or any of its Restricted Subsidiaries by any Person other than the Company or any of its Restricted Subsidiaries that has or have been designated (but only to the extent so designated) in an Officers’ Certificate delivered to the Trustee as “Designated Revolving Commitments” until such time as the Company subsequently delivers an Officers’ Certificate to the Trustee to the effect that the amount or amounts of such commitments shall no longer constitute “Designated Revolving Commitments.”

  • Total Revolving Commitment means, at any time, the sum of the Revolving Commitments at such time.

  • Existing Commitment shall have the meaning provided in Section 2.17.

  • Extended Revolving Commitments has the meaning specified in Section 2.16(2).

  • Total Initial Term Loan Commitment means the sum of the Initial Term Loan Commitments of all Lenders.

  • Replacement Revolving Commitments shall have the meaning assigned to such term in Section 2.22.

  • Existing Revolving Commitments has the meaning assigned to such term in Section 2.27(a).

  • Other Revolving Commitments means one or more Classes of revolving credit commitments hereunder or extended Revolving Commitments that result from a Refinancing Amendment or a Loan Modification Agreement.

  • Revolving Commitment Period the period from and including the Closing Date to the Revolving Termination Date.

  • Other Term Loan Commitments means one or more Classes of term loan commitments hereunder that result from a Refinancing Amendment.

  • Initial Term Commitment means, as to each Term Lender, its obligation to make an Initial Term Loan to the Borrower pursuant to Section 2.01(a) in an aggregate principal amount not to exceed the amount set forth opposite such Term Lender’s name in Schedule 1.01A under the caption “Initial Term Commitment.” The initial aggregate principal amount of the Initial Term Commitments as of the Closing Date was $2,670,000,000.

  • Incremental Revolving Commitments has the meaning specified in Section 2.14(a).

  • Other Term Commitments means one or more Classes of term loan commitments hereunder that result from a Refinancing Amendment.

  • Revolving Commitment Termination Date means the earliest of (i) July 31, 2018, (ii) the date on which the Revolving Commitments are terminated pursuant to Section 2.8 and (iii) the date on which all amounts outstanding under this Agreement have been declared or have automatically become due and payable (whether by acceleration or otherwise).

  • Revolving Commitments means such commitments of all Lenders in the aggregate. The amount of each Lender’s Revolving Commitment as of the Closing Date is set forth on Appendix A or in the applicable Assignment Agreement, subject to any adjustment or reduction pursuant to the terms and conditions hereof. The aggregate amount of the Revolving Commitments as of the Closing Date is $75,000,000. The Revolving Commitment of each Lender will be equal to zero on the Revolving Commitment Termination Date.

  • Tranche B Term Loan Commitments means such commitments of all Lenders in the aggregate. The amount of each Lender’s Tranche B Term Loan Commitment, if any, is set forth on Appendix A-2 or in the applicable Assignment Agreement, subject to any adjustment or reduction pursuant to the terms and conditions hereof. The aggregate amount of the Tranche B Term Loan Commitments as of the Third Restatement Date is $600,000,000.

  • New Term Loan Commitments shall have the meaning provided in Section 2.14(a).

  • Extended Revolving Commitment shall have the meaning assigned to such term in Section 2.19(a).

  • Incremental Term Commitments has the meaning set forth in Section 2.14(a).

  • Refinancing Revolving Commitments means one or more Classes of Revolving Loan commitments hereunder that result from a Refinancing Amendment.

  • Initial Term Facility means the Initial Term Loan Commitments and the Initial Term Loans made hereunder.

  • U.S. Revolving Commitment means the commitment of a Lender to make or otherwise fund any U.S. Revolving Loan and to acquire participations in U.S. Letters of Credit and Swing Line Loans hereunder and “U.S. Revolving Commitments” means such commitments of all Lenders in the aggregate. The amount of each Lender’s U.S. Revolving Commitment, if any, is set forth on Schedule 1.01(c) or in the applicable Assignment Agreement or Joinder Agreement, as applicable, subject to any adjustment or reduction pursuant to the terms and conditions hereof. The aggregate amount of the U.S. Revolving Commitments as of the Closing Date is $265,000,000.

  • Incremental Term Loan Commitments has the meaning set forth in Section 2.24.

  • Initial Term Loans means the term loans made by the Lenders on the Closing Date to the Borrower pursuant to Section 2.01(a).