Regulatory Package definition

Regulatory Package means all of Insmed’s intellectual property relating to Masoprocal, including without limitation, all of the masoprocal-related pre-clinical and clinical research dossier associated with the Endocrine IND and modifications, variations, amendments and any regulatory documents filed with the FDA or any other regulatory agency associated with the Endocrine IND, as set forth on Exhibit A attached.
View Source
Regulatory Package means, with respect to each Oncology Product, all INDs and other regulatory applications submitted to any Agency, Product Approvals, pre-clinical and clinical data and information, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. 314.420 (or any non-United States equivalent thereof)), and any other reports, records regulatory correspondence and other materials
View Source
Regulatory Package means, with respect to each Otezla Product, all INDs and other regulatory applications submitted to any Agency, Product Approvals, pre-clinical and
View Source

Examples of Regulatory Package in a sentence

  • On or prior to March 9, 2007, Insmed shall have delivered to Napo, at Napo’s expense, a copy of all files relating to the Regulatory Package and the Existing Patents.

  • Any successor-in-interest to Insmed’s rights in either or both the Existing Patents and/or the Regulatory Package shall receive such rights subject to the License and the terms of this Agreement.

  • Both Parties acknowledge (i) that the Regulatory Package contains reports, data, summaries, compilations and other information that has not been publicly filed and (ii) that it is in the best interests of both Parties and their respective development activities to treat such contents as proprietary and confidential.

  • All Representatives of both Napo and Insmed that have access to any contents of the Regulatory Package will be bound by the foregoing restrictions and each party will take such steps as are necessary to ensure that its Representatives are bound by this provision and are aware of their obligations.

  • Insmed agrees to provide Napo a right of reference to all applicable components of the Regulatory Package, and to any clinical safety data, developed under the Endocrine IND, as necessary and appropriate to permit the development, marketing and commercialization of Masoprocal by Napo.

  • After Insmed has (i) amended the Endocrine IND to include, and incorporate, the safety data from the Prostate Cancer Study and (ii) delivered such Endocrine IND Amendment to Napo, such delivery to be no later than March 9, 2007, and all other components of the Regulatory Package, Napo will remit to Insmed another [***]dollars ($[***]) by wire transfer in immediately available funds.

  • Neither party anticipates the exchange of any information that either considers to be proprietary or confidential, other than the contents of the Regulatory Package.

  • Upon termination of the license, Developer will be prohibited from, and will refrain from, using or incorporating any portion of the Regulatory Package in Developer’s filing with the SFDA.

  • Developer will remit the remaining one-half (50%) upon the receipt from the Licensor of the Regulatory Package and Proprietary Information reasonably required to conduct the Activities pursuant to this Agreement.

  • Developer understands and agrees that it will not attempt to transfer or sublicense this license, the Regulatory Package or any Improvements or other information relating to the Regulatory Package without Licensor’s express written approval.


More Definitions of Regulatory Package

Regulatory Package means the entire documentary apparatus consisting
View Source
Regulatory Package means all of the investigational new drug applications and amendments for acute infectious diarrhea, pediatric diarrhea, and HIV-related diarrhea filed with the FDA (according to FDA standards) with respect to crofelemer. All future filings submitted to the FDA and/or the EMEA, or the applicable regulatory agency in the Reserved Territory, including NDAs, with respect to Licensed Product(s) will be considered part of the Regulatory Package.
View Source
Regulatory Package means the entire documentary apparatus composed of the Code of Ethics, the Code of Conduct and the Corporate Governance Model adopted by INSO S.p.A.
View Source

Related to Regulatory Package

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

  • Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.

  • Regulatory Problem means any set of facts or circumstance wherein it has been asserted by any governmental regulatory agency (or a Regulated Stockholder reasonably believes that there is a risk of such assertion) that such Regulated Stockholder is not entitled to acquire, own, hold or control, or exercise any significant right (including the right to vote) with respect to, any Equity Securities of the Company or any subsidiary of the Company.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all clinical studies and tests, including the manufacturing batch records, relating to the Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.