Post-Approval Research definition

Post-Approval Research means ongoing research and development of a Product after such Product has received Regulatory Approval in a country of the Territory, including, without limitation, Phase IV clinical studies and clinical studies in support of indications within the Field or labeling changes for such Product within the Field in such country during the Term of this Agreement.
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Post-Approval Research. Post-Approval Research shall mean ongoing research and development of a Collaboration Product, pursuant to this Agreement, after such Collaboration Product has received Regulatory Approval in a country of the Territory, including, without limitation, Phase IV Clinical Trials and clinical studies in support of additional indications within the Field or label changes for such Collaboration Product in such country during the term of this Agreement.
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Post-Approval Research means ongoing research and development of a Licensed Product after such Licensed Product has received Regulatory Approval in the Territory, including phase IV clinical studies and clinical studies in support of indications within the Field or labeling changes for such Licensed Product within the Field in the Territory during the Term. Prior CDA has the meaning set forth in Clause 7.1 (Confidentiality Obligations).
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Examples of Post-Approval Research in a sentence

  • For the avoidance of doubt, any Non-Required Studies constitute Post-Approval Research under the Development and Regulatory Plan.

  • Expenses (both internal expenses and out-pocket costs paid to a Third Party) incurred by a Party in performing its regulatory reporting obligations under this Section 5.4 in connection with Regulatory Approvals in the Copromotion Territory shall be charged by such Party to such Party's Marketing Account for such Product as a Post-Approval Research and Regulatory Expense.

  • Other results will be discussed concerning applications of i-BioS to guide the biological screening of a selection of natural products isolated by phytochemistry groups from Brazil.References1 - Anon (2003) Total Cost to Develop a New Prescripton Drug, Including Cost of Post-Approval Research, is $897 Million," The Tufts Center for the Study of Drug Development, Press Release, May 13, 2003.2 - R.

  • For the avoidance of doubt, any Non-Required Studies constitute Post-Approval Research under the Development Plan.

  • Total Cost to Develop a New Prescription Drug, Including Cost of Post-Approval Research, is $897 Million.

  • Expenses (both internal expenses and out-of-pocket costs paid to a Third Party) incurred by a Party in performing its regulatory reporting obligations under this Section in connection with Regulatory Approvals in the Territory shall be charged by such Party to such Party’s Marketing Account for such Product as a Post-Approval Research and Regulatory Expense.

  • Staff members involved in the training included, Administration Secretary, Chief Executive Officer and Senior Administration Officer.

  • See Andrew Powaleny, 3 Things to Know About the Importance of Post-Approval Research and Development, PhRMA (Dec.

  • The Sales and Marketing Expenses, Distribution Expenses, Post-Approval Research and Regulatory Expenses and Working Capital Charges charged by either Party to its Marketing Account in accordance with this Section 6.1.6, shall not be in an amount in excess of *** of the amount included for such expenses in the then current Annual Commercialization Plan, unless the JSC approves such excess expenses.

  • Complaints should be addressed to the Manager at Level 15, Three Pacific Place, 1 Queen’s Road East, Hong Kong.

Related to Post-Approval Research

  • Development approval means any written authorization from a

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • industrial research means the planned research or critical investigation aimed at the acquisition of new knowledge and skills for developing new products, processes or services or for bringing about a significant improvement in existing products, processes or services. It comprises the creation of components parts of complex systems, and may include the construction of prototypes in a laboratory environment or in an environment with simulated interfaces to existing systems as well as of pilot lines, when necessary for the industrial research and notably for generic technology validation;

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Physical therapy licensing board or "licensing board" means the agency of a state that is responsible for the licensing and regulation of physical therapists and physical therapist assistants.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Public research university means Rutgers, The State University