Common use of No Harmful Actions Clause in Contracts

No Harmful Actions. If either Party believes that the other Party is taking or intends to take any action with respect to a Licensed Product that could have a material adverse impact upon the Regulatory Approval of any Licensed Product in or for the Territory (if such Party is Licensee) or outside the Territory (if such Party is Licensor), then such Party shall have the right to bring the matter to the attention of the other Party and the Parties shall discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (i) Licensee shall not communicate with any Regulatory Authority having jurisdiction only outside the Territory with respect to a Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensee shall immediately notify Licensor of such order; (ii) Licensee shall not submit any regulatory filings or seek Regulatory Approvals for any Licensed Product outside the Territory (unless such regulatory filings or Regulatory Approvals are also for the Territory); (iii) Licensor shall not communicate with any Regulatory Authority having jurisdiction only in or for the Territory with respect to a Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensor shall immediately notify Licensee of such order, and (iv) Licensor shall not submit any regulatory filings or seek Regulatory Approvals for any Licensed Products in or for the Territory. Licensor shall provide Licensee with any information that reasonably could have an adverse effect on the Development or Commercialization of the Licensed Products in or for the Territory, prior to making such information public.

No Harmful Actions. Each Party shall not, and shall not permit its Affiliates, Sublicensees or Subcontractors (with respect to Licensee) to, knowingly take any action with respect to the Licensed Compound or a Licensed Product in the Field in the Territory that could reasonably be expected to have an adverse impact upon the regulatory status of the Licensed Compound or any Licensed Product in the Field inside or outside the Territory. If either a Party believes that the other Party is (or any of its Affiliates, or Sublicensees or its Subcontractors (with respect to Licensee) are) taking or intends to take any action with respect to the Licensed Compound or a Licensed Product that could have a material such an adverse impact upon such Party’s regulatory status of the Regulatory Approval of Licensed Compound or any Licensed Product Product, in or for the case of G1, outside of the Territory (if such Party is and in the case of Licensee) or outside , inside the Territory (if such Party is Licensor)Territory, then such Party shall have the right to bring the matter to the attention of the other Party and the Parties shall discuss in good faith to resolve a resolution of such concern. Without limiting the foregoing, unless the Parties otherwise agree: (ia) Licensee each Party shall not, and shall not permit its Affiliates, or Sublicensees or Subcontractors (with respect to Licensee) or Third Party Licensees (with respect to G1) to, communicate with any Regulatory Authority Authority, in the case of Licensee, having jurisdiction only outside the Territory Territory, and in the case of G1, having jurisdiction within the Territory, in each case with respect to a the Licensed ProductCompound or any Licensed Product in the Field, unless so ordered by such Regulatory Authority, in which case Licensee such Party shall immediately immediately, but in any event within forty-eight (48) hours, notify Licensor the other Party of such order; and (iib) Licensee each Party shall not, and shall not permit its Affiliates, or Sublicensees or Subcontractors (with respect to Licensee) or Third Party Licensees (with respect to G1) to, submit any regulatory filings Regulatory Documents or seek Regulatory Approvals for any Licensed Product outside in the Territory (unless such regulatory filings or Regulatory Approvals are also Field for the Territory); (iii) Licensor shall not communicate with Licensed Compound or any Regulatory Authority having jurisdiction only in or for the Territory with respect to a Licensed Product, unless so ordered by such Regulatory Authority, in which the case Licensor shall immediately notify of Licensee of such order, and (iv) Licensor shall not submit any regulatory filings or seek Regulatory Approvals for any Licensed Products in or for the Territory. Licensor shall provide Licensee with any information that reasonably could have an adverse effect on the Development or Commercialization of the Licensed Products in or for outside the Territory, prior to making such information publicand in the case of G1, within the Territory.

No Harmful Actions. If either Party believes Licensee reasonably determines that the other Party BioLine is taking or intends to take any action with respect to a Licensed Product that could will have a material an adverse impact upon the Regulatory Approval of any Licensed Product in or for the Territory (if such Party is Licensee) or risk outside the Territory (if such Party is Licensor)Territory, then such Party shall have the right to Licensee may bring the matter to the attention of the other Party Steering Committee (or directly to BioLine, following dissolution of the Steering Committee) and the Parties Licensee and BioLine shall discuss in good faith a potential resolution to resolve such concern. Without limiting the foregoing, with respect to each Licensed Product, unless the Parties Licensee and BioLine otherwise agree: (i) BioLine shall not communicate with any Regulatory Agency having jurisdiction within the Territory with respect to any Licensed Product, unless so ordered by such Regulatory Agency, in which case BioLine shall immediately notify Licensee of such order; and (ii) BioLine shall not submit any Regulatory Submissions or seek Marketing Approvals for any Licensed Product in the Territory. If BioLine reasonably determines that Licensee is taking any action with respect to a Licensed Product that will have an adverse risk within the Territory, then BioLine may bring the matter to the attention of the Steering Committee (or directly to Licensee, following dissolution of the Steering Committee) and Licensee and BioLine shall discuss in good faith a potential resolution to such concern. Without limiting the foregoing, (i) Licensee shall not communicate with any Regulatory Authority Agency having jurisdiction only outside the Territory with respect to a any Licensed Product, unless so ordered by such Regulatory AuthorityAgency, in which case Licensee shall immediately notify Licensor BioLine of such order; and (ii) Licensee shall not submit any regulatory filings Regulatory Submissions or seek Regulatory Marketing Approvals for any Licensed Product outside the Territory (unless such regulatory filings or Regulatory Approvals are also for the Territory); (iii) Licensor shall not communicate with any Regulatory Authority having jurisdiction only in or for the Territory with respect to a Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensor shall immediately notify Licensee of such order, and (iv) Licensor shall not submit any regulatory filings or seek Regulatory Approvals for any Licensed Products in or for the Territory. Licensor shall provide Licensee with any information that reasonably could have an adverse effect on the Development or Commercialization of the Licensed Products in or for the Territory, prior to making such information public5.9.6.

No Harmful Actions. Licensee shall not, and shall not permit its Affiliates, Sublicensees or Subcontractors to, take any action with respect to a Licensed Product that could reasonably be expected to have an adverse impact upon the regulatory status of any Licensed Product inside or outside the Territory. If either Party Verastem believes that the other Party Licensee is (or any of its Affiliates, Sublicensees or Subcontractors are) taking or intends to take any action with respect to a Licensed Product that could have a material an adverse impact upon the Regulatory Approval regulatory status of any Licensed Product in or for the Territory (if such Party is Licensee) or outside the Territory (if such Party is Licensor)Product, then such Party Verastem shall have the right to bring the matter to the attention of the other Party JSC and the Parties shall discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (ia) Licensee shall not, and shall not permit its Affiliates, Sublicensees or Subcontractors to, communicate with any Regulatory Authority having jurisdiction only outside the Territory with respect to a any Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensee shall immediately immediately, but in any event within [* * *], notify Licensor Verastem of such order; and (iib) Licensee shall not, and shall not permit its Affiliates, Sublicensees or Subcontractors to, submit any regulatory filings Regulatory Documents or seek Regulatory Approvals regulatory approvals for any Licensed Product outside the Territory (unless such regulatory filings or Regulatory Approvals are also for the Territory); (iii) Licensor shall not communicate with any Regulatory Authority having jurisdiction only in or for the Territory with respect to a Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensor shall immediately notify Licensee of such order, and (iv) Licensor shall not submit any regulatory filings or seek Regulatory Approvals for any Licensed Products in or for the Territory. Licensor shall provide Licensee with any information that reasonably could have an adverse effect on the Development or Commercialization of the Licensed Products in or for the Territory, prior to making such information public.

No Harmful Actions. If either Party Clearside believes that the other Party Bausch Health is taking or intends to take any action with respect to a Licensed Product Products that could have a material adverse impact upon the Regulatory Approval of any Licensed Product in or for the Territory (if such Party is Licensee) or effect on Products outside the Territory (if such Party is Licensor)or in the Territory outside the Field, then such Party shall have the right to Clearside may bring the matter to the attention of the other Party Bausch Health, and the Parties shall discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (ia) Licensee Bausch Health shall not communicate with any Regulatory Authority having jurisdiction only outside the Territory with respect to a Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensee Bausch Health shall immediately notify Licensor Clearside of such order; and (iib) Licensee Bausch Health shall not submit any regulatory filings Regulatory Submissions or seek Regulatory Approvals for any Licensed Product Products outside the Territory (unless such regulatory filings Territory. If Bausch Health believes that Clearside is taking or Regulatory Approvals are also for intends to take any action with respect to Products that could have a material adverse effect on Products inside the Field in the Territory); , Bausch Health may bring the matter to the attention of Clearside, and the Parties shall discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree, unless expressly permitted or required hereunder: (iiia) Licensor Clearside shall not communicate with any Regulatory Authority having jurisdiction only in or for inside the Territory with respect to a Licensed Product, respecting the Product in the Field unless so ordered by such Regulatory Authority, in which case Licensor Clearside shall immediately notify Licensee Bausch Health of such order, ; and (ivb) Licensor Clearside shall not submit any regulatory filings Regulatory Submissions or seek Regulatory Approvals for any Licensed Products inside the Field in or for the Territory. Licensor shall provide Licensee with any information that reasonably could have an adverse effect on the Development or Commercialization of the Licensed Products in or for the Territory, prior to making such information public.

No Harmful Actions. If either Party ReViral or Licensee believes that the other Party is taking or intends to take any action with respect to a any Licensed Product that could have a material adverse impact upon the Regulatory Approval regulatory status of any Licensed Product in outside or for inside the Territory (if such Party is Licensee) or outside as the Territory (if such Party is Licensorcase may be), then such the concerned Party shall have the right to bring the matter to the attention of the other Party JSC and the Parties shall promptly meet to discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (ia) Licensee shall not communicate with any Regulatory Authority having jurisdiction only outside the Territory with respect to a Licensed ProductTerritory, unless so ordered by such Regulatory Authority, in which case Licensee shall immediately notify Licensor ReViral of such order; (iib) Licensee shall not submit any regulatory filings or seek Regulatory Approvals for any Licensed Product outside the Territory (unless such regulatory filings or Regulatory Approvals are also for the Territory); (iii) Licensor requested by Licensee, ReViral shall not communicate with any Regulatory Authority having jurisdiction only in or for within the Territory with respect to a Licensed ProductTerritory, unless so ordered by such Regulatory Authority, in which case Licensor ReViral shall immediately notify Licensee of such order, Licensee; and (ivc) Licensor Licensee shall not submit any regulatory filings Regulatory Documents or seek Regulatory Approvals for any Licensed Products in Product outside the Territory and ReViral shall not submit any Regulatory Documents or seek Regulatory Approval for any Licensed Product inside the Territory. Licensor shall provide Licensee with any information that reasonably could have an adverse effect on the Development or Commercialization of the Licensed Products in or for the Territory, Territory without Licensee’s prior to making such information publicwritten consent.