Regulatory Responsibility definition
Examples of Regulatory Responsibility in a sentence
Notwithstanding the foregoing, Dermira acknowledges that, as sponsor, UCB may delegate to Dermira certain of its responsibilities, as set forth in the Regulatory Responsibility Matrix.
Dyax shall therefore consult with ▇▇▇▇▇▇▇▇▇▇ in relation to the Chemistry, Manufacturing and Controls (CMC) section of any submissions to Regulatory Authorities before submission to such Regulatory Authorities and Dyax shall not make any change to its regulatory filings, which may have an impact on any ▇▇▇▇▇▇▇▇▇▇ Regulatory Responsibility without prior agreement with ▇▇▇▇▇▇▇▇▇▇.
Dyax shall therefore consult with ▇▇▇▇ in relation to the Chemistry, Manufacturing and Controls (CMC) section of any submissions to Regulatory Authorities before submission to such Regulatory Authorities and Dyax shall not make any change to its regulatory filings, which may have an impact on any ▇▇▇▇ Regulatory Responsibility without prior agreement with ▇▇▇▇.
Subject to this Section 6.1 (Regulatory Responsible Party), effective from and after each Regulatory Responsibility Transfer Date, all Regulatory Submissions and Regulatory Approvals in the Sanofi Territory with respect to the relevant Licensed Product after the Regulatory Responsibility Transfer Date will be owned by and held in the name of Sanofi.
To reduce the red tape and regulatory interventions that are reducing investment and depriving New Zealanders of jobs, National and ACT agree that the government will establish a task force to carry forward work on the Regulatory Responsibility ▇▇▇▇ considered by the Commerce Committee of Parliament in 2008.
Prior to the Regulatory Responsibility Transfer Date, as the holder of the Regulatory Approval for the Licensed Product in the Field in the Territory, BioCryst or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, practices, or records of Torii or its Controlled Affiliates or Sublicensees relating to the Licensed Product.
Upon Torii’s request at the appropriate time prior to the Regulatory Responsibility Transfer Date, the JSC will discuss in good faith and determine whether Torii will directly retain one or more CMOs in the Territory to conduct Territory-Specific Packaging and Labeling.
After the Regulatory Responsibility Transfer Date, Torii will have the final decision-making authority with respect to such responses to the extent relating solely to the Commercialization of a Licensed Product in the Field in the Territory and BioCryst will have the right to review and comment on any such response.
Until the Regulatory Responsibility Transfer Date, BioCryst will have the final decision-making authority with respect to the content of any responses to Regulatory Authorities or other Governmental Authorities that relate to a Licensed Product in the Field in the Territory and will consider Torii’s reasonable comments to such responses.
Dyax shall therefore consult with Fujifilm in relation to the Chemistry, Manufacturing and Controls (CMC) section of any submissions to Regulatory Authorities before submission to such Regulatory Authorities and Dyax shall not make any change to its regulatory filings, which may have an impact on any Fujifilm Regulatory Responsibility without prior agreement with Fujifilm.