Regulatory Responsible Party definition

Regulatory Responsible Party means [***].

Regulatory Responsible Party means the Party designated under Section 6.1 (Regulatory Responsible Party).

Regulatory Responsible Party means the Party designated under Section 5.7.1 (Regulatory Responsible Party).

Examples of Regulatory Responsible Party in a sentence

• 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.

• At the other Party’s request, the Regulatory Responsible Party will include the other Party in the preparation and strategy for such substantive meeting in the Thera Territory and in any discussions and actions relating to the outcome thereof.

• As between the Parties, Ionis will be the Regulatory Responsible Party for (a) the Licensed Products in the Ionis Territory, and (b) all Manufacturing activities for the Licensed Products for which Ionis is responsible under this Agreement and the Commercial Supply Agreement.

• If the non-Regulatory Responsible Party receives any correspondence or communication from a Regulatory Authority in the Thera Territory regarding the Licensed Products, such Party shall promptly inform the Regulatory Responsible Party and forward copies of all such correspondence as soon as practically possible.

• The non-Regulatory Responsible Party will strictly follow the Regulatory Responsible Party’s instructions with respect to any such meeting that it attends and will not discuss the contents of any such meeting with any Third Party or Regulatory Authority except as required by Applicable Law or authorized by the Regulatory Responsible Party in writing.

• Unless otherwise agreed by the Parties, Thera will be the Regulatory Responsible Party for the Licensed Products in the Thera Territory.

• The applicable Regulatory Responsible Party will invite representatives of the other Party (at such other Party’s expense) to attend all meetings pertaining to Regulatory Submissions for the Licensed Products (to the extent such meetings are scheduled in advance) with HC or any other Regulatory Authority in the Thera Territory to the extent not prohibited by Applicable Law or the applicable Regulatory Authority.

• In addition, at Xxxxx’s reasonable request, Xxxxx will attend (in-person or virtually) and participate in the pre-submission meeting with HC, and Xxxxx has the right to participate in any subsequent meeting with any Regulatory Authority in the Thera Territory for which Thera is the Regulatory Responsible Party.

More Definitions of Regulatory Responsible Party

Regulatory Responsible Party has the meaning set forth in Section 3.5.1.

Regulatory Responsible Party means, with respect to a DT Co-Co Product, on a country-by-country basis in the Territory, (i) the Lead Party prior to any Opt-Out and the Opt-Out Date or (ii) the Primary Party after the Opt-Out Date.

Regulatory Responsible Party has the meaning set forth in Section 6.2.1 (Regulatory Responsibilities).

Regulatory Responsible Party means (a) with respect to the E.U., (i) [***] (or its Affiliates), [***] of Regulatory Approval from the EMA for the Licensed Product for each of the DD-CKD Indication and the NDD-CKD Indication, and (ii) [***] (or its Affiliates [***]), [***] Regulatory Approval from the EMA for the Licensed Product for each of the DD-CKD Indication and the NDD-CKD Indication, and (b) [***] (or its Affiliates [***]), with respect to all other countries within the Territory, in each case ((a) and (b)), subject to Akebia’s ongoing Development obligations in the Territory related to the Licensed Products.

Regulatory Responsible Party means (a) BioCryst until the Regulatory Responsibility Transfer Date and (b) Torii from and after the Regulatory Responsibility Transfer Date; provided that, as between the Parties, BioCryst will remain the Regulatory Responsible Party after the Regulatory Responsibility Transfer Date to the extent that BioCryst is required by Applicable Law or any Regulatory Authority in the Territory with respect to (i) BioCryst’s Manufacture and supply of the Licensed Product for the Territory, and (ii) BioCryst’s conduct of Development activities for the Licensed Product in the Field in the Territory, including the submissions of any CTA.

Regulatory Responsible Party means Partner; provided that, as between the Parties, uniQure will remain the Regulatory Responsible Party to the extent that uniQure is required by Applicable Law or any Regulatory Authority in the Territory [*].