No Harmful Actions. If ADCT or NewCo believes that the other Party is taking or intends to take any action with respect to any Product that could have a material adverse impact upon the regulatory status of any Product outside or inside the Territory (as the case may be), the concerned Party shall have the right to bring the matter to the attention of the 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: (a) NewCo shall not communicate with any Regulatory Authority having jurisdiction outside the Territory, unless so ordered by such Regulatory Authority, in which case NewCo shall immediately notify ADCT of such order; and (b) NewCo shall not submit any Regulatory Documents or seek Regulatory Approvals for any Product outside the Territory and ADCT shall not seek Regulatory Approval for any Product inside the Territory; and (c) ADCT shall not submit Regulatory Documents to any Regulatory Authority having jurisdiction inside the Territory without first providing notice to NewCo and considering in good faith any comments of NewCo in relation thereto.
Appears in 1 contract
Sources: License and Collaboration Agreement (ADC Therapeutics SA)
No Harmful Actions. Each Party shall not, and shall use Commercially Reasonable Efforts to cause its Affiliates, Sublicensees (with respect to Licensee), Third Party Licensees (with respect to Verastem) or its Subcontractors not to, take any action with respect to a Licensed Product that could reasonably be expected to have an adverse impact upon the other Party’s regulatory status of any Licensed Product. If ADCT or NewCo a Party believes that the other Party is (or any of its Affiliates, Sublicensees (with respect to Licensee), Third Party Licensees (with respect to Verastem) or its Subcontractors are) taking or intends to take any action with respect to any a Licensed Product that could have a material an adverse impact upon the other Party’s regulatory status of any Product outside or inside the Territory (as the case may be)Licensed Product, the concerned then such Party shall have the right to bring the matter to the attention of the JSC JCC and the Parties shall promptly meet to discuss in good faith to resolve a resolution of such concern. Without limiting the foregoing, unless the Parties otherwise agree: (a) NewCo Licensee shall not, and shall not permit its Affiliates, Sublicensees or Subcontractors to, communicate with any Regulatory Authority having jurisdiction outside the TerritoryTerritory with respect to any Licensed Product, unless so ordered by such Regulatory Authority, in which case NewCo Licensee shall immediately immediately, but in any event within [* * *] hours, notify ADCT Verastem of such order; and (b) NewCo Licensee shall not, and shall not permit its Affiliates, Sublicensees or Subcontractors to, submit any Regulatory Documents or seek Regulatory Approvals for any Product outside the Territory and ADCT shall not seek Regulatory Approval for any Product inside the Territory; and (c) ADCT shall not submit Regulatory Documents to any Regulatory Authority having jurisdiction inside the Territory without first providing notice to NewCo and considering in good faith any comments of NewCo in relation thereto.
Appears in 1 contract
Sources: License and Collaboration Agreement (Verastem, Inc.)
No Harmful Actions. If ADCT or NewCo either Party reasonably believes that the other Party is taking or intends to take any action with respect to any Product the Licensed Products that could have a material adverse impact upon the regulatory status of any Product outside or inside the Territory (as the case may be)Licensed Products, the concerned such Party shall will have the right to bring the matter to the attention of the JSC and the Parties shall JSC will promptly meet to discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: , (a) NewCo shall [***] GenSci will not communicate with any Regulatory Authority having jurisdiction regarding the Licensed Products in the Field in the Territory, and Yarrow will not communicate with any Regulatory Authority regarding the Licensed Products in the Field outside the Territory, unless so ordered by such Regulatory Authority, in which case NewCo shall immediately such Party will promptly notify ADCT the other Party of such order; order and the Parties will work together in good faith on any potential response, provided that nothing in this clause (a) will prohibit a Party from responding solely to the extent required by Applicable Law, (b) NewCo shall [***] GenSci will not submit any Regulatory Documents or Materials for the Licensed Products in the Field in the Territory, and Yarrow will not submit any Regulatory Materials for the Licensed Products in the Field outside the Territory, and (c) GenSci will not seek Regulatory Approvals for any Product outside the Territory Licensed Products in the Field in the Territory, and ADCT shall Yarrow will not seek Regulatory Approval Approvals for any Product inside the Licensed Products in the Field outside the Territory; and (c) ADCT shall not submit Regulatory Documents to any Regulatory Authority having jurisdiction inside the Territory without first providing notice to NewCo and considering in good faith any comments of NewCo in relation thereto.
Appears in 1 contract
Sources: Exclusive License Agreement (VYNE Therapeutics Inc.)
No Harmful Actions. If ADCT or NewCo either Party reasonably believes that the other Party is taking or intends to take any action with respect to any Product the Licensed Products that could have a material adverse impact upon the regulatory status of any Product outside or inside the Territory (as the case may be)Licensed Products, the concerned such Party shall will have the right to bring the matter to the attention of the JSC and the Parties shall JSC will promptly meet to discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: , (a) NewCo shall [***] GenSci will not communicate with any Regulatory Authority having jurisdiction regarding the Licensed Products in the Field in the Territory, and Yarrow will not communicate with any Regulatory Authority regarding the Licensed Products in the Field outside the Territory, unless so ordered by such Regulatory Authority, in which case NewCo shall immediately such Party will promptly notify ADCT the other Party of such order; order and the Parties will work together in good faith on any potential response, provided that nothing in this clause (a) will prohibit a Party from responding solely to the extent required by Applicable Law, (b) NewCo shall )[***] GenSci will not submit any Regulatory Documents or Materials for the Licensed Products in the Field in the Territory, and Yarrow will not submit any Regulatory Materials for the Licensed Products in the Field outside the Territory, and (c) GenSci will not seek Regulatory Approvals for any Product outside the Territory Licensed Products in the Field in the Territory, and ADCT shall Yarrow will not seek Regulatory Approval Approvals for any Product inside the Licensed Products in the Field outside the Territory; and (c) ADCT shall not submit Regulatory Documents to any Regulatory Authority having jurisdiction inside the Territory without first providing notice to NewCo and considering in good faith any comments of NewCo in relation thereto.
Appears in 1 contract
Sources: Exclusive License Agreement (VYNE Therapeutics Inc.)
No Harmful Actions. If ADCT or NewCo either Party believes that the other Party is taking or intends to take any action with respect to any a Product that could have a material adverse impact upon the regulatory status of any Product outside or inside in the Territory (as in the case may beof Huadong) or outside the Territory (in the case of vTv), the concerned such Party shall have the right to bring the matter to the attention of the JSC JDC and the Parties shall promptly meet to discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (ai) NewCo Huadong shall not communicate with any Regulatory Authority having jurisdiction outside the TerritoryTerritory with respect to a Product, unless (A) so ordered by such Regulatory Authority, in which case NewCo Huadong shall immediately notify ADCT vTv of such orderorder or (B) in connection with the Phase II MRCT pursuant to Section 3.6(b); and (bii) NewCo Huadong shall not submit any Regulatory Documents Filings or seek Regulatory Approvals regulatory approvals for any Product outside the Territory and ADCT Territory; (iii) vTv shall not seek Regulatory Approval for any Product inside the Territory; and (c) ADCT shall not submit Regulatory Documents to communicate with any Regulatory Authority having jurisdiction inside in the Territory without first providing notice with respect to NewCo and considering a Product, unless (A) so ordered by such Regulatory Authority, in good faith which case vTv shall immediately notify Huadong of such order, or (B) in connection with the Phase II MRCT; (d) vTv shall not submit any comments Regulatory Filings or seek regulatory approvals for any Product in the Territory except in connection with the Phase II MRCT. To the extent practicable, vTv shall provide Huadong with any information that reasonably could affect the Development or Commercialization of NewCo the Product in relation theretothe Territory, prior to making such information public.
Appears in 1 contract
No Harmful Actions. If ADCT or NewCo NVCR believes that the other Party Zai is taking or intends to take any action with respect to any the Licensed Product that could have a material adverse impact upon the regulatory status of any the Licensed Product outside or inside the Territory (as the case may be)Territory, the concerned Party shall NVCR will have the right to bring the matter to the attention of the JSC and the Parties shall promptly meet to will discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (a) NewCo shall Zai will not communicate with any Regulatory Authority having jurisdiction outside the Territory, unless so ordered by such Regulatory Authority, in which case NewCo shall Zai will immediately notify ADCT NVCR of such order; and (b) NewCo shall Zai will not submit any Regulatory Documents Submissions or seek Regulatory Approvals regulatory approvals for any the Licensed Product outside the Territory and ADCT shall not seek Regulatory Approval for Territory. To the extent practicable, NVCR will provide Zai with any information that reasonably could CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 24 affect the Development or Commercialization of the Licensed Product inside in the Territory; and (c) ADCT shall not submit Regulatory Documents , prior to any Regulatory Authority having jurisdiction inside the Territory without first providing notice to NewCo and considering in good faith any comments of NewCo in relation theretomaking such information public.
Appears in 1 contract
No Harmful Actions. If ADCT or NewCo Without limiting Section 15.7, if either Party believes in good faith that the other Party is taking or intends to take any action (with respect to any Regeneron’s actions, solely in the Territory) with respect to the Product that could have a material adverse negative impact upon the regulatory status of any the Product outside the Field or inside the Territory (as for Regeneron) or in the case may beField in the Territory (for ZLAB), the concerned such Party shall will have the right to bring the matter to the attention of the JSC and the Parties shall promptly meet to will discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: , (a) NewCo shall ZLAB will not, and will cause its Affiliates and its and their Subdistributors not to, communicate with any Regulatory Authority having jurisdiction outside the TerritoryTerritory regarding the Product, unless so ordered by such Regulatory Authority, in which case NewCo shall ZLAB will immediately notify ADCT Regeneron of such orderorder and if Regeneron is permitted by such Regulatory Authority and applicable Law to respond to such order on behalf of ZLAB, Regeneron shall be responsible for responding thereto and, if such Regulatory Authority or applicable Law requires ZLAB to respond directly, ZLAB shall be responsible for responding thereto and, in either case, ZLAB shall cooperate in good faith with Regeneron to prepare any such communication or response and ZLAB shall […***…]; and (b) NewCo shall ZLAB will not, and will cause its Affiliates and its and their Subdistributors not to, submit any Regulatory Documents Documentation or seek Regulatory Approvals for any the Product outside the Territory and ADCT shall not seek Regulatory Approval for any Product inside the Territory; and (c) ADCT shall not submit Regulatory Documents to any Regulatory Authority having jurisdiction inside Field or the Territory without first providing notice to NewCo and considering in good faith any comments of NewCo in relation theretoor […***…].
Appears in 1 contract