Examples of Regulatory Responsible Party in a sentence
If the Parties’ Executive Officers are unable to reach agreement on the content of such Jointly-Agreed Regulatory Submission within a period of [***], then the Regulatory Responsible Party will have final decision-making authority with respect to the content of such Jointly-Agreed Regulatory Submission.
If the Parties cannot come to a mutual agreement through the Regulatory Sub-Committee on an issue related to regulatory matters, then the Regulatory Responsible Party for the applicable Product at such time will have the final decision-making authority over such matter, except as otherwise set forth in Section 3.5.6 with respect to decisions regarding the label for a Product and class generic claims included in any regulatory filings for a Product.
The non-Regulatory Responsible Party will assist the Regulatory Responsible Party, as is reasonably necessary, in [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request.
Ionis will be the Regulatory Responsible Party for the Licensed Products in the Ionis Territory.
The Parties shall reasonably cooperate with and assist each other in complying with regulatory obligations and communications, including by providing to the applicable Regulatory Responsible Party, within two (2) Business Days after a request, such information and documentation that is in the other Party’s possession as may be necessary or helpful for such Regulatory Responsible Party to prepare a response to an inquiry from a Regulatory Authority in the Territory with respect to a DT Co-Co Product.
The Regulatory Responsible Party will not be required to delay any submission, correspondence, or communication with any Regulatory Authorities in a manner that affects such Regulatory Responsible Party’s ability to comply with any Regulatory Authority requirement or deadline or Applicable Law in such jurisdiction.
The non-Regulatory Responsible Party will cooperate fully and in a timely manner to reasonably assist the Regulatory Responsible Party in its efforts to prepare and submit those Regulatory Submissions required to obtain, support, or maintain any Regulatory Approvals or Reimbursement Approvals for the Licensed Product in the Field in the Territory.
Subject to the obligations in this Article 5 (Regulatory Affairs), the Regulatory Responsible Party will be responsible for, and [***] all Regulatory Submissions, communications, and other dealings with the Regulatory Authorities relating to the Licensed Products in the applicable Territory, and for seeking and maintaining all Regulatory Approvals with respect to the Licensed Product in the applicable Territory.
Notwithstanding the foregoing, in all cases the Regulatory Responsible Party for a Licensed Product in a given jurisdiction will determine whether to initiate any recall, withdrawal, or field alert of such Licensed Product or applicable Sarepta Diagnostic Product in such jurisdiction, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or field alert.
The Regulatory Responsible Party will also be responsible for the quality control and quality assurance, release, and distribution of such Licensed Product, at the Regulatory Responsible Party’s cost and expense.