Gatekeeper Procedures. At the Signing Date Dicerna shall provide to the Gatekeeper the list of Blocked Targets for the Dicerna Excluded Programs and from time to time thereafter (including at least [* * *], including in response to inquiries hereunder), (a) Dicerna will provide the Gatekeeper with a current list adding up to [* * *] Dicerna Reserved Orphan Liver Targets which shall be Blocked Targets (where it is understood that [* * *] such Targets is all Dicerna may designate during the R&D Collaboration Term pursuant to this Agreement) (the “Blocked Target List”), and (b) Novo will be entitled, acting in good faith as reasonably necessary to identify Hepatocyte Targets as permitted under Section 2.1.1, to submit inquiries to the Gatekeeper as to whether or not a proposed Target is a Blocked Target. Upon receipt of an inquiry, the Gatekeeper will notify Dicerna of such inquiry by Novo without disclosing the proposed Target, after which Dicerna will have [* * *] to provide the Gatekeeper with any updates on requests made to Dicerna for reservations, substitutions or eliminations to the Blocked Target List with supporting evidence of such changes having been requested in writing prior to the Novo inquiry. The Gatekeeper will inform Novo in writing whether the proposed Target is a Blocked Target within [* * *] of receipt of the associated inquiry and, if the proposed Target is a Target as to which Dicerna can still grant rights to Novo, the Gatekeeper will inform Novo of the availability of such Target and what rights Dicerna can grant and any associated restrictions. Upon the Effective Date, the Pre-Reserved Targets will automatically be designated as Collaboration Targets and after the Effective Date upon notification of Novo by the Gatekeeper of availability, each subsequent proposed Target will be automatically designated as Collaboration Targets. If the Gatekeeper notifies Novo in response to an inquiry (or Dicerna notifies Novo, in the case of direct contact between the Parties) that a proposed Target is a Blocked Target, Novo will not have exhausted any of its rights to reserve or select Targets as a result of the inquiry, and if the status of any Blocked Target changes and it is no longer a Blocked Target, Dicerna shall promptly notify the Gatekeeper; and if such a change relates to a Target which was previously submitted by Novo and rejected by the Gatekeeper, the Gatekeeper shall be under an obligation to notify Novo of such change as soon as practicable. Dicerna may from time to time inquire as to whether any Hepatocyte Target with respect to which Dicerna intends to engage in activities that may be restricted under Sections 3.1 and 3.2 is a Collaboration Target. Upon receipt of such an inquiry from Dicerna, the Gatekeeper will inform Dicerna in writing whether the proposed Target is a Collaboration Target within [* * *] of receipt of the associated inquiry.
Appears in 1 contract
Sources: Collaboration and License Agreement (Dicerna Pharmaceuticals Inc)
Gatekeeper Procedures. At the Signing Date Dicerna shall provide to the Gatekeeper the list of Blocked Targets for the Dicerna Excluded Programs and from time to time thereafter (including at least [* * *], including in response to inquiries hereunder), (a) Dicerna will provide During the Gatekeeper with a current list adding up to [* * *] Dicerna Reserved Orphan Liver Targets which shall be Blocked Targets (where it is understood that [* * *] such Targets is all Dicerna may designate during the R&D Collaboration Term pursuant to this Agreement) (the “Blocked Target List”)Research Term, and (b) Novo will be entitledGSK may, acting in good faith as reasonably necessary to identify Hepatocyte Targets as permitted under Section 2.1.1at its discretion, to submit written inquiries to the Gatekeeper as to whether or not determine if a proposed Target is available for inclusion as a Blocked Target [***] under this Agreement (each, a “Proposed Target”); provided, for clarity, that (i) GSK will comply with the parameters on Targets as set forth in Section 3.4.2 (Parameters for Target Validation Programs); and (ii) Targets may not be added [***] after the Execution Date. GSK’s written inquiry to the Gatekeeper for each Proposed Target will include the following information (each, a “Proposed Target Notice”): (1) the identity of such Proposed Target (which includes the NCBI Gene ID for known targets), and if no such NCBI Gene ID exists then an unequivocal identifier of such target, and, if applicable, whether such Proposed Target is a[***].
(b) Upon receipt of an inquirya Proposed Target Notice, the Gatekeeper will notify Dicerna Wave as soon as practicable of such inquiry by Novo GSK without disclosing the proposed identity of the Proposed Target, after which Dicerna Wave will have [* * ***] to provide the Gatekeeper with any updates on requests made to Dicerna a then-current list of Unavailable Targets, [***] (which includes the NCBI Gene ID for reservationsknown targets), substitutions or eliminations to the Blocked Target List with supporting evidence and if no such NCBI Gene ID exists then an unequivocal identifier of such changes having been requested in writing prior to the Novo inquirytarget. The Gatekeeper will inform Novo in writing whether the proposed Target is a Blocked Target within Within [* * ***] of receipt of the associated inquiry and, if the proposed Target is a Target as to which Dicerna can still grant rights to Novolist of Unavailable Targets from Wave, the Gatekeeper will inform Novo of the availability of such Target and what rights Dicerna can grant and any associated restrictions. Upon the Effective Date, the Pre-Reserved Targets will automatically be designated as Collaboration Targets and after the Effective Date upon notification of Novo by the Gatekeeper of availability, each subsequent proposed Target will be automatically designated as Collaboration Targets. If the Gatekeeper notifies Novo in response to an inquiry (or Dicerna notifies Novo, in the case of direct contact between the Parties) that a proposed Target is a Blocked Target, Novo will not have exhausted any of its rights to reserve or select Targets as a result of the inquiry, and if the status of any Blocked Target changes and it is no longer a Blocked Target, Dicerna shall promptly notify the Gatekeeper; and if such a change relates to a Target which was previously submitted by Novo and rejected by the Gatekeeper, the Gatekeeper shall be under an obligation to notify Novo of such change as soon as practicable. Dicerna may from time to time inquire as to whether any Hepatocyte Target with respect to which Dicerna intends to engage in activities that may be restricted under Sections 3.1 and 3.2 is a Collaboration Target. Upon receipt of such an inquiry from Dicerna, the Gatekeeper will inform Dicerna GSK in writing whether the proposed Proposed Target is available.
(i) If the Gatekeeper informs GSK that a Collaboration Proposed Target within is an Unavailable Target, then such Proposed Target will not become a Target on the Target List, and the Parties will have no further obligations under this Agreement with respect to such Target.
(ii) If the Gatekeeper confirms that a Proposed Target is available for inclusion on the Target List (i.e., not an Unavailable Target) (an “Available Proposed Target”), then the Gatekeeper will provide written notice to both Parties, specifying all of the information that was included in the Proposed Target Notice (such notice, the “Available Proposed Target Notice”). Following the Parties’ receipt of an Available Proposed Target Notice from the ‑35‑ Gatekeeper, the Parties will update [* * ***] Target List[***] to include the new Target and its identity (including the NCBI Gene ID for known targets), and if no such NCBI Gene ID exists then an unequivocal identifier of receipt of the associated inquirysuch target, and, [***].
Appears in 1 contract
Sources: Collaboration and License Agreement (Wave Life Sciences Ltd.)