Common use of Reassignment of Regulatory Approvals Clause in Contracts

Reassignment of Regulatory Approvals. If this Agreement is early terminated by Can-Fxxx under Section 14.2 because of KDP’s uncured material breach or under Section 14.3 because of KDP’s insolvency, or by Can-Fxxx for KDP’s failure to proceed with Product development pursuant to Section 5.3, KDP shall ensure that all Regulatory Filings and Marketing Authorizations in the Territory relating to the Product are assigned to Can-Fxxx (to the extent legally permissible in the Territory) within a reasonable time after termination of KDP’s rights under this Agreement, subject to Can-Fxxx’x payment to KDP of a two percent (2%) royalty on Net Sales of any Product that is the subject matter of such assigned Regulatory Filings and/or Marketing Authorizations; provided that such royalty payment obligation of Can-Fxxx shall only continue until such time that the total royalty payments delivered by Can-Fxxx equal an amount that reimburses KDP for all of its Non-Clinical Study Costs and Clinical Study Costs and other internal and external costs directly arising from or in connection with preparation and submission of such assigned Regulatory Filings and/or Marketing Authorizations that were reasonably borne by KDP prior to such early termination of this Agreement. Any costs incurred by KDP for such assignment or transfer shall be at KDP’s expense. In the event that no such assignment and/or transfer pursuant to this Section 14.5.5 may legally be made, then, at the request of Can-Fxxx, KDP shall surrender such Regulatory Filings and/or Marketing Authorizations for cancellation. To the extent that such assigned Regulatory Filings and/or Marketing Authorizations are related to the Product, all such data, files, materials, information, filings and approvals shall thereafter be deemed to be Can-Fxxx’x Confidential Information and subject to Article 13 of this Agreement. KDP further agrees to execute and deliver such instruments and take such other actions as Can-Fxxx shall reasonably request in order to carry out this provision.

Appears in 2 contracts

Samples: License Agreement (Can-Fite BioPharma Ltd.), License Agreement (Can-Fite BioPharma Ltd.)

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Reassignment of Regulatory Approvals. If this Agreement is early terminated by Can-Fxxx under Section 14.2 because of KDPSKK’s uncured material breach or under Section 14.3 because of KDPSKK’s insolvency, or by Can-Fxxx for KDPSKK’s failure to proceed with Product development pursuant to Section 5.35.5, KDP SKK shall ensure that all Regulatory Filings and Marketing Authorizations in the Territory relating to the Product are assigned to Can-Fxxx (to the extent legally permissible in the Territory) within a reasonable time after termination of KDPSKK’s rights under this Agreement, subject to Can-Fxxx’x payment to KDP SKK of a two percent (2%) royalty on Net Sales of any Product that is the subject matter of such assigned Regulatory Filings and/or Marketing Authorizations; provided that such royalty payment obligation of Can-Fxxx shall only continue until such time that the total royalty payments delivered by Can-Fxxx equal an amount that reimburses KDP SKK for all of its Non-Clinical Study Costs and Clinical Study Costs and other internal and external costs directly arising from or in connection with preparation and submission of such assigned Regulatory Filings and/or Marketing Authorizations that were reasonably borne by KDP SKK prior to such early termination of this Agreement. Any costs incurred by KDP SKK for such assignment or transfer shall be at KDPSKK’s expense. In the event that no such assignment and/or transfer pursuant to this Section 14.5.5 14.4.5 may legally be made, then, at the request of Can-Fxxx, KDP SKK shall surrender such Regulatory Filings and/or Marketing Authorizations for cancellation. To the extent that such assigned Regulatory Filings and/or Marketing Authorizations are related to the Product, all such data, files, materials, information, filings and approvals shall thereafter be deemed to be Can-Fxxx’x Confidential Information and subject to Article 13 of this Agreement. KDP SKK further agrees to execute and deliver such instruments and take such other actions as Can-Fxxx shall reasonably request in order to carry out this provision.

Appears in 1 contract

Samples: License Agreement (Can-Fite BioPharma Ltd.)

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Reassignment of Regulatory Approvals. If this Agreement is early terminated by Can-Fxxx Xxxx under Section 14.2 because 14.3 for CKD's non-achievement of KDPthe Commercialization Milestones, CKD’s uncured material breach or under Section 14.3 because of KDP14.4, or CKD’s insolvencyinsolvency under Section 14.5, or by Can-Fxxx Xxxx for KDPCKD’s failure to proceed with Product development pursuant to Section 5.3, KDP CKD shall ensure that all Regulatory Filings and Marketing Authorizations in the Territory relating to the Product are assigned to Can-Fxxx Xxxx (to the extent legally permissible in the Territory) within a reasonable time after termination of KDPCKD’s rights under this Agreement, subject to Can-Fxxx’x Xxxx’x payment to KDP CKD of a two percent (2%) royalty on Net Sales of any Product that is the subject matter of such assigned Regulatory Filings and/or Marketing Authorizations; provided that such royalty payment obligation of Can-Fxxx Xxxx shall only continue until such time that the total royalty payments delivered by Can-Fxxx Xxxx equal an amount that reimburses KDP CKD for all of the costs of Clinical Studies and its portion of the costs of the Non-Clinical Study Costs and Clinical Study Costs Studies and other internal and external costs directly arising from or in connection with preparation and submission of such assigned Regulatory Filings and/or Marketing Authorizations that were reasonably borne by KDP CKD prior to such early termination of this Agreement. Any costs incurred by KDP CKD for such assignment or transfer shall be at KDPCKD’s expense. In the event that no such assignment and/or transfer pursuant to this Section 14.5.5 14.6.5 may legally be made, then, at the request of Can-FxxxXxxx, KDP CKD shall surrender such Regulatory Filings and/or Marketing Authorizations for cancellation. To the extent that such assigned Regulatory Filings and/or Marketing Authorizations are related to the Product, all such data, files, materials, information, filings and approvals shall thereafter be deemed to be Can-Fxxx’x Xxxx’x Confidential Information and subject to Article 13 of this Agreement. KDP CKD further agrees to execute and deliver such instruments and take such other actions as Can-Fxxx Xxxx shall reasonably request in order to carry out this provision.

Appears in 1 contract

Samples: Distribution Agreement (Can-Fite BioPharma Ltd.)

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