Example ContractsClausesHolder of Regulatory Approvals and Regulatory Submissions
Holder of Regulatory Approvals and Regulatory Submissions
Holder of Regulatory Approvals and Regulatory Submissions contract clause examples

Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, # the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and # the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions.

Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, # the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and # the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory Approval in the Territory submitted by Zai, in each case ((a) or (b)), to the extent permitted by Applicable Law and in accordance therewith. If agreed by the Parties, NVCR shall reasonably cooperate with Zai, at Zai’s expense, to enable Zai to hold any or all such Regulatory Approvals and Regulatory Submissions.

Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, # the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and # the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory

Holder of Regulatory Approvals and Regulatory Submissions. NVCR shall initially be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Territory. At Zai’s request during the Term, # the JSC will discuss in good faith whether to transfer manufacturing responsibilities for Licensed Products for the Territory to Zai, and # the Parties will discuss in good faith whether to enable Zai to hold Regulatory Approvals and Regulatory Submissions in the Territory, including any pricing or reimbursement approvals, whether by transfer to Zai of such Regulatory Approvals and Regulatory Submissions or through the submission of a new application for Regulatory

Regulatory Submissions. Upon NVCR’s written request, Zai shall provide NVCR with copies of all Regulatory Submissions for Licensed Products. To the extent Zai has obtained any ownership interest in a Regulatory Submission, and to the extent permissible under Applicable Law and commercially feasible, Zai shall assign to NVCR or shall provide NVCR with a right of reference with respect to such Regulatory Submissions, as NVCR determines at its reasonable discretion, at ​ cost and expense. In addition, upon NVCR’s written request, Zai shall, at ​ cost and expense, provide to NVCR copies of all material related documentation, including material non-clinical, preclinical and clinical data that are held by or reasonably available to Zai, its Affiliates or sublicensees. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange, provided that NVCR will assume all safety and safety database activities no later than ​ months after termination.

Regulatory Submissions. Upon NVCR’s written request, Zai shall provide NVCR with copies of all Regulatory Submissions for Licensed Products. To the extent Zai has obtained any ownership interest in a Regulatory Submission, and to the extent permissible under Applicable Law and commercially feasible, Zai shall assign to NVCR or

Regulatory Submissions. Upon NVCR’s written request, Zai shall provide NVCR with copies of all Regulatory Submissions for Licensed Products. To the extent Zai has obtained any ownership interest in a Regulatory Submission, and to the extent permissible under Applicable Law and commercially feasible, Zai shall assign to NVCR or shall provide NVCR with a right of reference with respect to such Regulatory Submissions, as NVCR determines at its reasonable discretion, at ​ cost and expense. In addition, upon NVCR’s written request, Zai shall, at ​ cost and expense, provide to NVCR copies of all material related documentation, including material non-clinical, preclinical and clinical data that are held by or reasonably available to Zai, its Affiliates or sublicensees. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange, provided that NVCR will assume all safety and safety database activities no later than ​ months after termination.

Regulatory Submissions. Upon NVCR’s written request, Zai shall provide NVCR with copies of all Regulatory Submissions for Licensed Products. To the extent Zai has obtained any ownership interest in a Regulatory Submission, and to the extent permissible under Applicable Law and commercially feasible, Zai shall assign to NVCR or shall provide NVCR with a right of reference with respect to such Regulatory Submissions, as NVCR determines at its reasonable discretion, at ​ cost and expense. In addition, upon NVCR’s written request, Zai shall, at ​ cost and expense, provide to NVCR copies of all material related documentation, including material non-clinical, preclinical and clinical data that are held by or reasonably available to Zai, its Affiliates or sublicensees. The Parties shall discuss and establish appropriate arrangements with respect to safety data exchange, provided that NVCR will assume all safety and safety database activities no later than ​ months after termination.

Holder of Regulatory Approvals. QIAGEN will be the holder of any Regulatory Approval of the Product.

Regulatory Approvals. Any redemption pursuant to this Section 4 shall be subject to receipt of any and all required federal and state regulatory approvals or non-objections, including, but not limited to, the consent of the Federal Reserve. In the case of any redemption of this Subordinated Note pursuant to paragraph # of this Section 4 (Redemption), the Company will give the holder hereof notice of redemption, which notice shall indicate the aggregate principal

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