Regulatory Submissions definition

Regulatory Submissions means any filing, application, or submission with any Regulatory Authority in support of the Development, Manufacture, Commercialization, or other Exploitation of a pharmaceutical or biologic product (including to obtain, support, or maintain Regulatory Approval from that Regulatory Authority), and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences, or discussions with the relevant Regulatory Authority. Regulatory Submissions include all INDs, ▇▇▇▇, and other applications for Regulatory Approval and their equivalents.

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Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

Examples of Regulatory Submissions in a sentence

• Kissei may use such right of reference to Viridian’s Regulatory Submissions solely for the purpose of performing Development activities for the Licensed Products in accordance with this Agreement and the Territory Development Plans and to seek, obtain, support, and maintain Regulatory Approvals and any Reimbursement Approvals, as applicable, for the Licensed Products in the Territory Development Indications in the Field in the Territory, [***].

• If Kissei is unable to mitigate the deficiencies or replace any Deficient Site with a Replacement Site or Deficient Sublicensee with a replacement Sublicensee, as applicable, or, as agreed by the Parties in writing, is unable to do so in a timely manner so as not to jeopardize the Parties’ ability to meet the timelines for Regulatory Submissions set forth in the Territory Development Plans, as applicable, [***].

• Kissei will provide to Viridian (through the JSC, the Alliance Managers, or their designees) for review and comment drafts of all material Regulatory Submissions (including all INDs and ▇▇▇▇) and all proposed Approved Labeling in the Field in the Territory for each Licensed Product in each Territory Development Indication, and [***].

• All INDs, MAAs, Approved Labeling, and other Regulatory Submissions for the Licensed Products in the Field in the Territory will be consistent with the then-current regulatory strategy.

• Viridian may use such right of reference to Kissei’s Regulatory Submissions, if any, solely for the purpose of Developing the Licensed Products and to seek, obtain, support, and maintain Regulatory Approval and any Reimbursement Approvals for the Licensed Products outside of the Territory.

More Definitions of Regulatory Submissions

Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Collaboration Product in the Field in a particular country, whether obtained before or after a Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigational new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Collaboration Product in a particular country.

Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including INDs, Regulatory Approvals and Regulatory Approval Applications, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to the Licensed Product.

Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Product in the Field in a particular country, whether obtained before or after Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigational new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Product in a particular country.

Regulatory Submissions means any submission by a Person to a Regulatory Authority in connection with the Product.

Regulatory Submissions means all Regulatory Materials submitted to a Regulatory Authority in support of the Development, Manufacture or Commercialization of a pharmaceutical or biological product.

Regulatory Submissions has the meaning set forth in Section 4.6b).

Regulatory Submissions means all applications, filings, dossiers and the like submitted to the FDA and associated with NDA #205488, including any internal records, minutes or informal communications (e-mails and letters) related to discussions with the FDA, as set forth on Schedule 1.121.