Selection of Accepted Fcab Targets. Denali has the right to nominate up to three Targets for approval as Accepted Fcab Targets. Prior to the Effective Date, TfR has been accepted by the Parties as the first such Accepted Fcab Target. Denali may nominate up to two further Accepted Fcab Targets as follows: 3.1.1 The second and third Fcab are both to be directed against Targets which have been selected with the aim to facilitate transcytosis of the resulting mAb2 across the blood-brain barrier. 3.1.2 The second and third Fcab Targets shall be nominated no later than thirty-six (36) months after the Effective Date provided always that if Licensor is requested to commence work on an Fcab Discovery Plan within [***] of the commencement of work on a prior Fcab Discovery Plan it’s obligation shall be subject to Licensor and/or F-star Ltd having the resources available to undertake such work. 3.1.3 Denali shall nominate a proposed Accepted Fcab Target by providing a notice to Licensor (an “Fcab Target Nomination Notice”). Such notice must include the Entrez Gene ID, HUGO or official symbol and common synonyms (if available) for such Target. On receipt of such notice Licensor shall submit the Fcab to the Gatekeeper. Within ten (10) Business Days following the Gatekeeper’s receipt of the Fcab Target Nomination Notice with respect to a particular Target, the Gatekeeper shall verify whether such Target is on the list of Unavailable Fcab Targets and notify Licensor in writing. On receipt of a response from the Gatekeeper, Licensor shall notify Denali whether the Proposed Fcab Target is an Available Fcab Target. An Available Fcab Target is a Target in respect of which the Licensor is entitled to exercise the rights set out in the Gamma IP License to nominate as an Accepted Fcab Target and which is not an Unavailable Fcab Target. The Gatekeeper shall maintain an up-to-date list of Unavailable Fcab Targets (“Unavailable Fcab Targets”). An Unavailable Fcab Target shall only be a Target that is: (a) the subject of a pre-existing and bona fide internal Fcab program of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. on which Licensor, F-star GmbH, F-star Ltd or their respective Affiliates are then expending resources to the active research, Development or Commercialization of such program and have committed resources to the continued research, Development or Commercialization of such program in the upcoming twelve (12) months, (b) under an active, executed written agreement between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party that would preclude the grant of a license or exclusivity to such Target, or (c) the subject of bona fide, ongoing negotiations between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party where such negotiations specifically contemplate that a license or exclusivity would be granted to such Target and a written term sheet (or other written statement (including by email) of the scope and corresponding financial terms of such potential agreement) has been received or delivered by or to Licensor, F-star GmbH, F-star Ltd or their respective Affiliates. 3.1.4 If the Fcab Target is an Unavailable Fcab Target then, subject to Section 3.1.2, Denali shall be entitled to nominate a different Target as a proposed Accepted Fcab Target and the provisions of this Section 3.1 shall apply to such proposed Accepted Fcab Target. 3.1.5 If the Fcab Target is an Available Fcab Target then Licensor shall prepare an Fcab Discovery Plan for such proposed Accepted Fcab Target and shall submit such plan to Denali. If, based on the Fcab Discovery Plan, Licensor considers that the Fcab Target is not suitable for the generation of Fcabs and mAb2 it shall inform Denali and, the JSC shall meet within thirty (30) days of such Licensor informing Denali to consider the suitability of such Fcab Target for the generation of Fcabs. If the JSC agrees with Licensor then Denali shall be entitled to nominate a different Target as a proposed Accepted Fcab Target and the provisions of this Section 3.1 shall apply to such proposed Accepted Fcab Target. 3.1.6 Within thirty (30) days of submission of an Fcab Discovery Plan by Licensor to Denali the JSC shall meet to agree on the Fcab Discovery Plan; and on such agreement, the proposed Accepted Fcab Target shall become an Accepted Fcab Target. If the Parties are unable to agree upon the terms of the Fcab Discovery Plan, then provided a new Fcab Discovery Plan is substantially similar in scope to the TfR Fcab Discovery Plan (attached hereto as Exhibit 1.51), requires similar resources from Licensor and the Fcab Delivery Criteria have been agreed by both Parties (such agreement not to be unreasonably withheld or delayed), Licensor shall agree to such new Fcab Discovery Plan.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Denali Therapeutics Inc.), License and Collaboration Agreement (Denali Therapeutics Inc.)
Selection of Accepted Fcab Targets. Denali has the right to nominate up to three Targets for approval as Accepted Fcab Targets. Prior to the Effective Date, TfR has been accepted by the Parties as the first such Accepted Fcab Target. Denali may nominate up to two further Accepted Fcab Targets as follows:
3.1.1 The second and third Fcab are both to be directed against Targets which have been selected with the aim to facilitate transcytosis of the resulting mAb2 across the blood-brain barrier.
3.1.2 The second and third Fcab Targets shall be nominated no later than thirty-six (36) months after the Effective Date provided always that if Licensor is requested to commence work on an Fcab Discovery Plan within [***] of the commencement of work on a prior Fcab Discovery Plan it’s obligation shall be subject to Licensor and/or F-star Ltd having the resources available to undertake such work.
3.1.3 Denali shall nominate a proposed Accepted Fcab Target by providing a notice to Licensor (an “Fcab Target Nomination Notice”). Such notice must include the Entrez Gene ID, HUGO or official symbol and common synonyms (if available) for such Target. On receipt of such notice Licensor shall submit the Fcab to the Gatekeeper. Within ten (10) Business Days following the Gatekeeper’s receipt of the Fcab Target Nomination Notice with respect to a particular Target, the Gatekeeper shall verify whether such Target is on the list of Unavailable Fcab Targets and notify Licensor in writing. On receipt of a response from the Gatekeeper, Licensor shall notify Denali whether the Proposed Fcab Target is an Available Fcab Target. An Available Fcab Target is a Target in respect of which the Licensor is entitled to exercise the rights set out in the Gamma IP License to nominate as an Accepted Fcab Target and which is not an Unavailable Fcab Target. The Gatekeeper shall maintain an up-to-date list of Unavailable Fcab Targets (“Unavailable Fcab Targets”). An Unavailable Fcab Target shall only be a Target that is:
(a) the subject of a pre-existing and bona fide internal Fcab program of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. on which Licensor, F-star GmbH, F-star Ltd or their respective Affiliates are then expending resources to the active research, Development or Commercialization of such program and have committed resources to the continued research, Development or Commercialization of such program in the upcoming twelve (12) months,
(b) under an active, executed written agreement between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party that would preclude the grant of a license or exclusivity to such Target, or
(c) the subject of bona fide, ongoing negotiations between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party where such negotiations specifically contemplate that a license or exclusivity would be granted to such Target and a written term sheet (or other written statement (including by email) of the scope and corresponding financial terms of such potential agreement) has been received or delivered by or to Licensor, F-star GmbH, F-star Ltd or their respective Affiliates. *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
3.1.4 If the Fcab Target is an Unavailable Fcab Target then, subject to Section 3.1.2, Denali shall be entitled to nominate a different Target as a proposed Accepted Fcab Target and the provisions of this Section 3.1 shall apply to such proposed Accepted Fcab Target.
3.1.5 If the Fcab Target is an Available Fcab Target then Licensor shall prepare an Fcab Discovery Plan for such proposed Accepted Fcab Target and shall submit such plan to Denali. If, based on the Fcab Discovery Plan, Licensor considers that the Fcab Target is not suitable for the generation of Fcabs and mAb2 it shall inform Denali and, the JSC shall meet within thirty (30) days of such Licensor informing Denali to consider the suitability of such Fcab Target for the generation of Fcabs. If the JSC agrees with Licensor then Denali shall be entitled to nominate a different Target as a proposed Accepted Fcab Target and the provisions of this Section 3.1 shall apply to such proposed Accepted Fcab Target.
3.1.6 Within thirty (30) days of submission of an Fcab Discovery Plan by Licensor to Denali the JSC shall meet to agree on the Fcab Discovery Plan; and on such agreement, the proposed Accepted Fcab Target shall become an Accepted Fcab Target. If the Parties are unable to agree upon the terms of the Fcab Discovery Plan, then provided a new Fcab Discovery Plan is substantially similar in scope to the TfR Fcab Discovery Plan (attached hereto as Exhibit 1.51), requires similar resources from Licensor and the Fcab Delivery Criteria have been agreed by both Parties (such agreement not to be unreasonably withheld or delayed), Licensor shall agree to such new Fcab Discovery Plan.
Appears in 1 contract
Samples: License and Collaboration Agreement (Spring Bank Pharmaceuticals, Inc.)
Selection of Accepted Fcab Targets. Denali Gamma has the right to nominate up to three (3) Targets for approval as Accepted Fcab Targets. Prior to the Effective Date, TfR has been accepted by the Parties as the first such Accepted Fcab Target. Denali Gamma may nominate up to two further Accepted Fcab Targets as follows:
3.1.1 The second and third Fcab are both to be directed against Targets which have been selected with the aim to facilitate transcytosis of the resulting mAb2 across the blood-brain barrier.
3.1.2 The second and third Fcab Targets shall be nominated no later than thirty-six (36) months after the Effective Date provided always that if Licensor is requested to commence work on an Fcab Discovery Plan within [***] of the commencement of work on a prior Fcab Discovery Plan it’s obligation shall be subject to Licensor and/or F-star Ltd having the resources available to undertake such workDate.
3.1.3 Denali Gamma shall nominate a proposed Accepted Fcab Target by providing a notice to Licensor F-star and the Gatekeeper simultaneously (an “Fcab Target Nomination Notice”). Such notice must include the Entrez Gene ID, HUGO or official symbol and common synonyms (if available) for such Target. On receipt of such notice Licensor F-star shall submit the Fcab to the Gatekeeper. Within ten (10) Business Days following the Gatekeeper’s receipt of the Fcab Target Nomination Notice with respect to a particular Target, the Gatekeeper shall verify whether such Target is on the list of Unavailable Fcab Targets and notify Licensor F-star in writing. On receipt of a response from the Gatekeeper, Licensor F-star shall notify Denali Gamma whether the Proposed proposed Fcab Target is an Available Fcab Target. An “Available Fcab Target Target” is a Target Target, in respect of which the Licensor F-star is entitled to exercise the rights set out in the Gamma IP License pursuant to this Agreement, to nominate as an Accepted Fcab Target and which is not an Unavailable Fcab Target. The Gatekeeper shall maintain an up-to-date list of Unavailable Fcab Targets (“Unavailable Fcab Targets”). An Unavailable Fcab Target shall only be a Target that is:
(a) the subject of a pre-existing and bona fide internal Fcab program of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. on which Licensor, F-star GmbH, F-star Ltd or their respective Affiliates are then expending resources to the active research, Development or Commercialization of such program and have committed resources to the continued research, Development or Commercialization of such program in the upcoming twelve (12) months,
(b) under an active, executed written agreement between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party that would preclude the grant of a license or exclusivity to such Target, or
(c) the subject of bona fide, ongoing negotiations between one or more of Licensor, F-star GmbH, F-star Ltd or their respective Affiliates and a Third Party where such negotiations specifically contemplate that a license or exclusivity would be granted to such Target and a written term sheet (or other written statement (including by email) of the scope and corresponding financial terms of such potential agreement) has been received or delivered by or to LicensorF-star, F-star GmbH, F-star Ltd GmbH or their respective Affiliates.
3.1.4 If the Fcab Target is an Unavailable Fcab Target then, subject to Section 3.1.2, Denali Gamma shall be entitled to nominate a different Target as a proposed Accepted Fcab Target and the provisions of this Section 3.1 shall apply to such proposed Accepted Fcab Target.
3.1.5 If the Fcab Target is an Available Fcab Target then Licensor shall prepare an Fcab Discovery Plan for such proposed Accepted Fcab Target and shall submit such plan to Denali. If, based on the Fcab Discovery Plan, Licensor considers that the Fcab Target is not suitable for the generation of Fcabs and mAb2 it shall inform Denali and, the JSC shall meet within thirty (30) days of such Licensor informing Denali to consider the suitability of such Fcab Target for the generation of Fcabs. If the JSC agrees with Licensor then Denali shall be entitled to nominate a different Target as a proposed Accepted Fcab Target and the provisions of this Section 3.1 shall apply to such proposed Accepted Fcab Target.
3.1.6 Within thirty (30) days of submission of an Fcab Discovery Plan by Licensor to Denali the JSC shall meet to agree on the Fcab Discovery Plan; and on such agreement, the proposed Accepted Fcab Target shall become an Accepted Fcab Target. If the Parties are unable to agree upon the terms of the Fcab Discovery Plan, then provided a new Fcab Discovery Plan is substantially similar in scope to the TfR Fcab Discovery Plan (attached hereto as Exhibit 1.51), requires similar resources from Licensor and the Fcab Delivery Criteria have been agreed by both Parties (such agreement not to be unreasonably withheld or delayed), Licensor shall agree to such new Fcab Discovery Plan.
Appears in 1 contract
Samples: Gamma Ip Licence Agreement (Denali Therapeutics Inc.)