Common use of Notice of Regulatory Action Clause in Contracts

Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of BeiGene relating to the Licensed Product, then BeiGene shall notify Leap of such notice within [***] of its receipt thereof. Leap shall have the right to review and comment on any responses to Regulatory Authorities that pertain to a Licensed Product promptly and in any event [***] of receipt of such proposed response. BeiGene will [***] to a Licensed Product in the Territory if BeiGene is the holder of Regulatory Approvals and Regulatory Submissions for such Licensed Product in the Territory and will [***]. The costs and expenses of any regulatory action in the Territory will be borne by BeiGene. In addition, each Party shall promptly notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from a Third Party that, in the case of notice to Leap, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products, and in the case of notice to BeiGene, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products in the Field in the Territory.54

Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of BeiGene relating to the Licensed Product, then BeiGene shall notify Leap Zymeworks of such notice within […***…] of its receipt thereof. Leap Zymeworks shall have the right to review and comment on any responses to 58 Competitive Information – Commercially Sensitive Terms. 59 Competitive Information – Commercially Sensitive Terms. 60 Competitive Information – Commercially Sensitive Terms. Regulatory Authorities that pertain to a Licensed Product promptly and in any event within […***…] of receipt of such proposed response. BeiGene will […***…] to a Licensed Product in the Territory if BeiGene is the holder of Regulatory Approvals and Regulatory Submissions for such Licensed Product in the Territory and will […***…]. The costs and expenses of any regulatory action in the Territory will be borne by BeiGene. In addition, each Party shall promptly notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from a Third Party that, in the case of notice to LeapZymeworks, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products, and in the case of notice to BeiGene, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products in the Field in the Territory.54Territory.61

Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of BeiGene relating to the Licensed Product, then BeiGene shall notify Leap AssemblyBio of such notice within [*** * *] of its receipt thereof. Leap AssemblyBio shall have the right to review and comment on any responses to Regulatory Authorities that pertain to a Licensed Product promptly and in any event within [*** * *] of receipt of such proposed response. BeiGene will [*** * *] to a Licensed Product in the Territory if BeiGene is the holder of Regulatory Approvals and Regulatory Submissions for such will [* * *]. AssemblyBio will [* * *] to a Licensed Product in outside of the Territory and will [*** * *]. The costs and expenses of any regulatory action in the Territory will be borne by BeiGeneincluded among the Development and Regulatory Costs and shared in accordance with Section 5.4. In addition, each Party shall promptly notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from a Third Party that, in the case of notice to LeapAssemblyBio, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products, and in the case of notice to BeiGene, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products in the Field in the Territory.54Territory.

Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of BeiGene relating to the Licensed Product, then BeiGene shall notify Leap Zymeworks of such notice within […***…] of its receipt thereof. Leap Zymeworks shall have the right to review and comment on any responses to Regulatory Authorities that pertain to a Licensed Product promptly and in any event within […***…] of receipt of such proposed response. BeiGene will […***…] to a Licensed Product in the Territory if BeiGene is the holder of Regulatory Approvals and Regulatory Submissions for such Licensed Product in the Territory and will […***…]. The costs and expenses of any regulatory action in the Territory will be borne by BeiGene. In addition, each Party shall promptly notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from a Third Party that, in the case of notice to LeapZymeworks, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products, and in the case of notice to BeiGene, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products in the Field in the Territory.54Territory.61