Common use of Development Plan Clause in Contracts

Development Plan. 2.1 ADCT and ADAGENE agree to conduct the Development Plan as set forth in Annex 1 and in accordance with the terms and conditions of this Agreement. The Parties acknowledge and agree that the Development Plan shall divided in up to three proof of concept development programs, namely the [***] PoC, the [***] PoC and [***], as detailed in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 2 contracts

Sources: Material Transfer and Collaboration Agreement (Adagene Inc.), Material Transfer and Collaboration Agreement (Adagene Inc.)

Development Plan. 2.1 ADCT Genentech shall use Commercially Reasonable and ADAGENE agree Diligent Efforts to conduct the create a Development Plan (which shall be attached as set forth in Annex 1 and in accordance with the terms and conditions of this Agreement. The Parties acknowledge and agree that the Development Plan shall divided in up to three proof of concept development programs, namely the [***] PoC, the [***] PoC and [***], as detailed in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCTExhibit E hereto) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days and no later than ninety (90) days from the Effective Date, which may be modified by the JSC (as provided above) from time to time. TolerRx understands that Genentech's performance is dependent in part on the TolerRx's actions, including but not limited to TolerRx providing the detailed description of completion the studies set forth in Section 3.4(b)(i) in a timely manner. TolerRx shall have the opportunity to provide input and suggestions with regard to the Development Plan. The Parties initially agree to develop a Licensed Product related to immune tolerance. Only upon the JSC's written approval shall the Parties perform any activities other than work related to immune tolerance. The Development Plan shall be updated by Genentech for each calendar year and submitted to the JSC for consideration and approval at least three months prior to the beginning of [***] PoC the next calendar year. The Development Plan will include specific tasks, milestones, and estimated timelines. As set forth in Section 3.4(b) and 3.4(f), it is anticipated that the Development Plan may assign specific tasks to TolerRx. TolerRx shall hold in confidence, not use (“[***] PoC Initiation Notice”except to perform its obligations under the Development Plan), and not disclose to anyone any and all information arising out of TolerRx Development Plan Work (as defined in Exhibit A attached hereto), except that TolerRx may disclose such information to Isis only to the extent required under the Isis Agreement and only pursuant to Section 5.3(a)(iii). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1The foregoing confidentiality obligations shall survive any termination of this Agreement by Genentech under Sections 9.3 or 9.4 or expiration of this Agreement. In all events, Genentech shall have final authority regarding the Development Plan and the content thereof. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from Development Plan shall exclude marketing and other commercialization activities. The Development Plan and any modifications thereto shall be approved by the date JSC in the written minutes of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting applicable JSC meeting; anything not approved by the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and JSC in such information written minutes shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either excluded from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this AgreementDevelopment Plan. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 2 contracts

Sources: Collaboration Agreement (Tolerrx Inc), Collaboration Agreement (Tolerrx Inc)

Development Plan. 2.1 ADCT and ADAGENE agree to conduct (a) MONSANTO shall cooperate with D&PL in the Development Plan development activities outlined in the DEVELOPMENT PLAN. (b) D&PL shall not offer for COMMERCIAL SALE or make COMMERCIAL SALES of any LICENSED COMMERCIAL SEED of any particular DELTAPINE ROUNDUP READY(R) CULTIVAR unless D&PL shall have complied with the requirements as set forth in Annex 1 Exhibits F, G and H, and MONSANTO has approved such sales in accordance with the terms and conditions writing. Subject to Section 4.3(d), MONSANTO's approval for COMMERCIAL SALE of this Agreementparticular D&PL ROUNDUP READY(R) CULTIVARS may be withheld if D&PL does not demonstrate that those requirements have been met, but shall not otherwise be withheld. The Parties acknowledge and agree that the Development Plan MONSANTO shall divided in up to three proof of concept development programs, namely the [***] PoC, the [***] PoC and [***], as detailed in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE D&PL in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest decision on approval of a particular DELTAPINE ROUNDUP READY(R) CULTIVAR within sixty thirty (6030) days after D&PL submits a written request for approval of completion that DELTAPINE ROUNDUP READY(R) CULTIVAR with the supporting data for which D&PL is responsible. If MONSANTO does not notify D&PL in writing of [***] PoC its decision on approval within such thirty (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt30) period, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information MONSANTO shall be deemed Confidential Information to have approved the subject DELTAPINE ROUNDUP READY(R) CULTIVAR for COMERCIAL SALE. (c) If in MONSANTO's reasonable business judgment, COMMERCIAL SALES of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, particular DELTAPINE ROUNDUP READY(R) CULTIVAR may result in its reasonable experience, Know-Howproduct complaints which may cause MONSANTO to be liable for significant compensation to growers due to an identifiable product quality or identifiable product performance issue, and considering ADCT’s input as wellMONSANTO gives such notice of same to D&PL not later than November 1 of any year and D&PL makes sales in THE TERRITORY of LICENSED COMMERCIAL SEED of such DELTAPINE ROUNDUP READY(R) CULTIVAR in subsequent years without prior notice (given by labels on the containers of LICENSED COMMERCIAL SEED or by other forms of notice selected by D&PL and approved by MONSANTO, whose approval will present the best engineered structure not be unreasonably withheld or delayed) to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection growers who subsequently purchase LICENSED COMMERCIAL SEED of such DELTAPINE ROUNDUP READY(R) CULTIVAR of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection observation of the masking peptides may be delayedidentifiable product quality or identifiable product performance issue set forth in MONSANTO's notice, then notwithstanding any other provision of this Agreement, MONSANTO shall have no liability to D&PL for any third party claims based on the identifiable product quality or identifiable product performance issue set forth in MONSANTO's notice with respect to LICENSED COMMERCIAL SEED of that DELTAPINE ROUNDUP READY(R) CULTIVAR so sold and D&PL shall indemnify and hold MONSANTO harmless from any third party claims based on the [***] period will be extended by any reasonable delay outside identifiable product quality or identifiable product performance issue set forth in MONSANTO's notice with respect to LICENSED COMMERCIAL SEED of ADAGENE’s control. 2.1.4 [***] initiation. athat DELTAPINE ROUNDUP READY(R) In addition, at any time during the [***] Option Period, ADCT may elect CULTIVAR so sold. MONSANTO shall apply this provision with respect to initiate [***] by sending written notice all notices to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list licensees of the [***] Reserved Targets subject GENE(S) in THE TERRITORY, regarding identifiable product quality or identifiable product performance issues in a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreementsubstantially equal manner. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control."

Appears in 1 contract

Sources: Roundup Ready Gene License and Seed Services Agreement (Delta & Pine Land Co)

Development Plan. 2.1 ADCT Within […***…] days of the delivery of the Exhibit D Documents pursuant to the first sentence of Section 2.1, UroGen shall deliver a copy of its proposed written plan describing in reasonable detail the proposed program of its initial Development for the first therapeutic indication of the Licensed Product(s). The initial Development Plan will focus on anticipated […***…] and ADAGENE agree […***…] (“Early Stage Development”) with an overview of UroGen’s […***…] and […***…] for Licensed Products (“Development Plan”) for Agenus’ review. During Early Stage Development UroGen plans to conduct screen Agenus Antibody for incorporation into or admixture with UroGen’s proprietary sustained release gel formulation(s) known as RTGel™ or other proprietary or licensed technologies. Once a determination has been made by UroGen regarding whether Agenus Antibody is the lead candidate for use in development of the Licensed Product the next Development Plan update shall include the strategy for the initial Clinical Trials and the regulatory plan to support such Clinical Trials for such Licensed Product, as well as a rolling forecast of the quantity of Agenus Antibody that UroGen expects to need for preclinical studies and Clinical Trials (the “Forecast”) of the Licensed Product. The Forecast shall cover the remainder of the calendar year in which the Development Plan as was approved and the […***…] years thereafter. The Forecast shall be divided into […***…] and shall include a delivery 36165924.6 schedule for the first […***…] . Such Forecast shall become effective, along with the associated delivery schedule, following written approval by Agenus of the Forecast or update thereto. Agenus shall have a […***…] to […***…] (or […***…] for) each Development Plan only in connection with (a) matters that present a […***…] of […***…] to the Agenus Antibody or (b) matters that have a […***…] on Agenus’ ability to […***…] the Agenus Antibody set forth in Annex 1 the […***…] (collectively, Agenus’ “[…***…]”). The initial Development Plan shall be updated at least […***…] by UroGen and in accordance with submitted to Agenus for review and […***…] not later than […***…] of each […***…] during the terms and conditions of this AgreementTerm. Each updated Development Plan shall include any proposed modifications to the previously approved Forecast, an overall plan for all major Development tasks remaining to be accomplished prior to Regulatory Approval to the extent such tasks are known or can reasonably be ascertained, as well as a reasonably detailed clinical plan for each proposed Clinical Trial. The Parties acknowledge and agree anticipate that the Development Plan shall divided in up to three proof of concept development programs, namely the will be [***] PoC, the and [***] PoC for near term activities, and will initially be [***], as detailed in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the …] and [***] PoC upon for activities further out in the Effective Date future. Notwithstanding any of this Agreement. ADAGENE shall supply 150 mg of the above with regard to [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the and [***] PoC at any time during the …], Agenus’ [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreementrights shall not be unreasonably withheld or delayed. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 1 contract

Sources: License Agreement (UroGen Pharma Ltd.)

Development Plan. 2.1 ADCT (a) Borrower will prepare and ADAGENE agree submit to conduct Administrative Agent for Approval the initial Development Plan as set forth in Annex 1 (together with AFEs and in accordance with the terms all Supporting Documentation and conditions of this Agreement. The Parties acknowledge and agree that the Development Plan shall divided in up to three proof of concept development programs, namely the [***] PoC, the [***] PoC and [***], as detailed in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCTReimbursement Requests) at least 30 days before requesting an Advance under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree Term Loan to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT fund development activities in accordance with Section 2.2.11.3(b)(ii). For Borrower can propose modifications to the avoidance of doubtDevelopment Plan from time to time, ADCT is under no obligation and those modifications will become effective when Approved (not to initiate the [***] PoC under this Agreementbe unreasonably withheld or delayed) by Administrative Agent. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation Administrative Agent’s Approval of a modification to initiate the [***] under this AgreementDevelopment Plan proposed by Borrower shall be granted in Administrative Agent’s reasonable discretion. b(c) For the purpose In support of [***] Target electioneach Development Plan, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) Borrower will prepare and submit to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can Administrative Agent for Approval(not to be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available unreasonably withheld or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either delayed): (i) already granted exclusive development and commercial rights in the case of costs not yet expended, an AFE (including all Supporting Documentation) at least 15 days before Borrower incurs any costs that it intends to the [***] Alternative Target to a Third Party; fund out of an Advance or (ii) has agreed in the case of costs already expended and to be reimbursed through an Advance, reasonable evidence of a bona fide term sheet request for payment by the applicable Operator and is reasonable evidence of payment by Borrower (collectively, “Reimbursement Request”) at least 5 days before Borrower requests such an Advance. (d) Notwithstanding the Administrative Agent’s Approval of a Development Plan: (i) Borrower must nevertheless satisfy the conditions described in preparation or negotiations for a definitive agreement to grant exclusive development this Article I and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party Section 8.3 prior to the expiration making of each Advance; and (ii) Lenders will have no obligation to make an Advance to fund projects included on the Development Plan: (A) unless the requested Advance relates to an AFE or Reimbursement Request Approved by Administrative Agent; or (B) if the requested Advance (together with all amounts previously Advanced in respect of the [***] Option Periodapplicable AFE or Reimbursement Request) exceeds (1) the cost set forth in the Development Plan for that project, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii2) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that Loan availability remaining under the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option PeriodTerm Loan. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 1 contract

Sources: Credit Agreement (Voyager Oil & Gas, Inc.)

Development Plan. 2.1 ADCT (a) The Development of the Compounds and ADAGENE Collaboration Products under this Agreement (the “Development Program”) shall be conducted pursuant to a comprehensive written Development plan (the “Development Plan”). The Development Plan for each Compound and corresponding Collaboration Products shall set forth the timeline and details of: (i) all preclinical and clinical Development activities to be conducted by the Parties as necessary to generate data sufficient to meet the requirements for Marketing Approval of such Compound and corresponding Collaboration Products for each of the Indications as agreed by the Parties and set forth in the Development Plan; (ii) the protocol synopsis for each clinical trial included in such Development Plan; (iii) a Manufacturing plan; and (iv) any other Development activities that the Parties agree to conduct pursue in collaboration for such Compound and corresponding Collaboration Products. The Parties agree that: (A) the Development Plan as will contain detailed plans for at least [*] covered by the Development Plan, and summary plans for periods thereafter, and (B) the budget associated with such Development Plan shall be subject to the approval process set forth in Annex 1 and in accordance with the terms and conditions of this AgreementSection 6.2(d). The Parties acknowledge Development Plan shall include a coordinated development and agree that regulatory strategy, including the Parties’ respective roles in the development of each Collaboration Product and the countries in which Development of Collaboration Product will occur. The Development Plan shall also set forth: (1) a detailed budget of the Development activities to be [*]; (2) if Cytokinetics has exercised the Cytokinetics Co-Funding Option for a Collaboration Product and [*] for such Collaboration Product, a detailed budget for [*] of such Collaboration Product in the [*] Indications (the [*]); and (3) if [*] Indication [*] the Collaboration and [*] for such [*] Indication, a detailed budget for such [*] Indication Development Work (the “[*] Indication Development Budget”). Upon the other Party’s reasonable request, each Party shall [*] Development activities under the Development Plan. The [*] shall be included in the Development Plan and [*] shall divided be subject to JDC approval. For reference, the Development Plan in up to three proof effect as of concept development programsthe Amendment Effective Date is [*] which was approved by the JDC and signed by the JDC co-chairs in [*]. (b) The initial focus of the Development Program was the conduct of Phase 1 Clinical Trials and Phase 2 readiness activities for the Lead Compound in 2013, namely with the [*] for the Lead Compound [*] (c) The Development Program in 2015 shall include the initial Phase 2 Clinical Trial of the Lead Compound in SMA. As of the Amendment Effective Date, the Parties have agreed on a [*] PoCfor such initial Phase 2 Clinical Trial within the document attached hereto as Exhibit M. Promptly after the Amendment Effective Date, the JDC shall update the Development Plan to include the conduct of such initial Phase 2 Clinical Trial in 2015, consistent with [*] set forth in such exhibit. (d) The JDC shall update the Development Plan (including [*] as applicable) at least annually, with such annual update to be finally approved no later than [*] of the preceding Astellas’ fiscal year, provided that [*] Indication [*] subject to the [***] PoC the JDC (and [**] Indication [*]) after [*] for such Indication. By [*] of each calendar year starting on [*] Development activities are [*] the updated Development Plan, as detailed in Annex 1the JDC shall agree upon a proposed [*] for the following Astellas fiscal year beyond [*]. Prom Astellas shall use good faith efforts to [*]. From time to time during the Term, ADCT the JDC shall prepare amendments, as appropriate, to the then-current Development Plan (including [*] as applicable), including adding additional Compounds and Collaboration Products as well as additional Indications [*] the Collaboration pursuant to Article [*] The JDC shall have the right to modify approve updates and amendments to the Development Plan by written notice to ADAGENE(including [*] as applicable), provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights subject to the [**] the JDC (and [* ]) after [*] Alternative Target to a Third Party; or for such Indication. Once approved by the JDC, such revised Development Plan shall replace the prior Development Plan. (iie) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to If the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration terms of the [***] Option PeriodDevelopment Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE this Agreement shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Periodgovern. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)

Development Plan. 2.1 ADCT 5.1 In each Calendar Year that Development regarding the PIP is occurring, each Party shall at its own cost and ADAGENE agree expense (subject to conduct Section 5.4) use Commercially Reasonable Efforts to carry out the activities specified in the Development Plan in relation to the PIP as the responsibility of such Party so as to meet the timelines set forth out in Annex 1 them. 5.2 During the period of Development regarding the PIP by the Licensor, it shall update the Development Plan on or before November 1st in each year and shall submit the same to the JSC for review and approval. 5.3 The Licensor shall: (a) be responsible for the conduct of the PIP, subject to and in accordance with the terms and conditions of this Agreement. The Parties acknowledge and agree that timelines set out in the Development Plan shall divided and subject to the direction of the JSC; (b) conduct all activities in up relation to three proof of concept development programsthe PIP in compliance with all Legal Requirements, namely ethics committee, informed consent or similar approvals in relation thereto, and in compliance with GCP; (c) provide periodic updates regarding the [***] PoCPIP to the JSC as reasonably requested by the JSC; (d) permit Licensee (at its own cost) and upon reasonable notice to audit, during normal business hours, the [***] PoC trial master file and [***]shall cooperate with any such audit; and (e) promptly provide to the JSC the results of the PIP in the form of a copy of any Interim Report, a Formal Presentation and a copy of the Final Report as detailed these occur, even if between JSC scheduled meetings. 5.4 The Licensee shall reimburse the Licensor for seventy per cent (70%) of the ongoing documented Development Costs reasonably incurred by the Licensor in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify accordance with the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase and the PIP Budget. The Licensee shall reimburse its proportion of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within Costs not later than sixty (60) days following receipt of completion the Licensor's invoices and supporting evidence of [***] PoC such Development Costs having been incurred in connection with the conduct of the PIP, which the Licensor shall submit as and when such Development Costs arise but no more frequently than on a quarterly basis, save where an invoice is for an amount equal to or greater than $100,000 whereupon the Licensor shall be permitted to invoice on a monthly basis. Payment shall be made by the Licensee within thirty (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.130) Business Days of the date of receipt of the Licensor's invoice, into such bank account as the Licensor shall specify from time to time. For the avoidance of doubt, ADCT the Licensor shall be responsible for the remaining thirty per cent (30%) of such Development Costs in connection with the conduct of the PIP. 5.5 During the period in which the PIP is under no obligation ongoing, the Parties may, from time to initiate time, together agree in writing to update the [***] PoC under PIP Budget and where this occurs the proposed changes will be submitted to the JSC for review and discussion. Once agreed by the Parties in writing, the revised PIP Budget shall be the 'PIP Budget' for the purposes of this Agreement. 2.1.3 Within [***] from the date 5.6 Upon a Bankruptcy Event of the [***] PoC Initiation NoticeLicensor, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT Licensee shall have the right, but not the obligation, to elect assume full control of the PIP upon written notice to Licensor. Following any such [***] Alternative Target notice, Licensor shall, to the extent permitted by Law, use its reasonable endeavors to promptly assign to Licensee or its designee all contracts associated with the PIP and shall cooperate with Licensee to ensure a smooth transition of control of the PIP to Licensee, including by executing such documents requested by Licensee as are necessary to enable such transition. Licensee shall thereafter carry out the [***] Target PIP as set forth in lieu the Development Plan on behalf of either Reserved Target itself with respect to the Territory and on behalf of Licensor outside the Territory. Licensee shall pay Licensor's thirty percent (30%) share of the cost and expenses of the PIP as set forth in accordance with the PIP Budget and shall be entitled to deduct all such costs and expenses from any amounts of royalties or milestones owed to Licensor hereunder prior to making any payments to Licensor. 5.7 Except as expressly set forth above in relation to the PIP and subject to Section 2.1.4 5.7 below, each Party shall: (a) above be responsible for the conduct and all associated costs and expenses of the Development activities for the Product in its own territory and for the avoidance of doubt 'territory' shall mean the USA and Canada for the Licensee and the rest of the world for the Licensor; (b) conduct all such Development activities in compliance with all Legal Requirements, ethics committee, informed consent or similar approvals in relation thereto, and in compliance with GCP; (c) provide the JSC with a summary and update in reasonable detail of such Development activities at each meeting of the JSC; and (d) provide the other Party with a copy of a near-final draft of each Clinical Trial protocol or update to a protocol for the Product at least forty-five (45) days prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated in the [***] Initiation Noticedate on which such protocols or updates are provided to any Regulatory Authority or Clinical Trial site, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect permit such other Party to comment on such protocol or update, and shall reasonably consider in good faith any comments thereon provided by such other Party within thirty (30) days following such other Party's receipt of such copy of such protocol or update. 5.8 The Parties agree that where any Development activity of the best [***] SAFEbodies Licensee is, in the Licensor's reasonable opinion, going to have a material adverse impact on the Development, Manufacture or Commercialization of the Product outside of the Territory for the Existing Indications, then the prior written consent of the of the Licensor will be required, such consent not to be unreasonably withheld, delayed or conditioned. 5.9 If Licensee wishes to Develop Product in the [***] SAFEbody Panel. Territory for a New Indication, Licensee shall have the right to do so on the following conditions: (a) the Licensee shall be solely responsible for the costs and expenses of the Development activities; (b) the Licensee shall supply the Licensor with all material Know How, Dossiers and other Licensee IPR Package relating thereto, including a copy of each Final decision relating Report promptly following its preparation; (c) subject to paragraph 5.9(d), the Licensee hereby grants to the selection of Licensor a perpetual, irrevocable, exclusive, sub-licensable, right and license to use the [***] SAFEbody Panel Licensee IPR Package for the Product for such New Indication to Develop, manufacture and Commercialize the Product outside the Territory; and (d) Licensor shall be made by pay royalties to Licensee under such license on the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayedsame payment terms as, and at a rate equal to two percent (2%) less than the [***] period will be extended by any reasonable delay outside rate owed by, Licensee to Licensor for sales of ADAGENE’s controlProducts hereunder, with all applicable definitions and provisions having the Parties reversed, mutatis mutandis.

Appears in 1 contract

Sources: License Agreement (Aeterna Zentaris Inc.)

Development Plan. 2.1 ADCT The development activities, including both preclinical and ADAGENE agree clinical development activities, that Cubist will conduct for Licensed Products shall be covered by a development plan that Cubist shall prepare and submit to conduct the Development Subcommittee for review [ ]* after the Effective Date (such plan, the "Cubist Development Plan"). The Cubist Development Plan as set forth shall include at least the [ ]* in Annex 1 clauses (A), (B) and (C) above in Section 3.1 (a). The Cubist Development Plan shall [ ]*. Subject to its overall diligence obligations contained in this Section 3.1, Cubist reserves the right to change or modify the Cubist Development Plan (except with respect to the [ ]*) or any of the preclinical studies or clinical trials (other than the [ ]*) described in the Cubist Development Plan in response to (i) [ ]*, (ii) [ ]*, (iii) [ ]* or (iv) [ ]*. Cubist additionally reserves the right to change or modify any Core Trial (1) [ ]* such trial in accordance with the terms then-current protocol therefor as a result of [ ]*, or (2) in response to any [ ]*; PROVIDED, HOWEVER, that Cubist recognizes that Gilead's efforts to [ ]* will depend upon [ ]* and conditions of this Agreement. The Parties acknowledge and agree further provided that the foregoing ability to change or modify a Core Trial shall not contravene Cubist's obligations to provide [ ]*. Accordingly, if Cubist has the right to change or modify a Core Trial pursuant to the foregoing sentence, it shall so notify Gilead, the Parties shall discuss any proposed modification to the Core Trial at issue or other alternative arrangement to address the reason giving rise to Cubist's right to change or modify the Core Trial while providing for [ ]* from Cubist to [ ]*, and Cubist shall implement any such proposed modification or alternative arrangement to which the Parties *CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION. mutually agree. Cubist shall modify the Cubist Development Plan shall divided in up to three proof of concept development programs, namely the [***] PoC, the [***] PoC and [***], as detailed in Annex 1. Prom from time to time to reflect timing or protocol changes to the Core Trials or any other trials, and to reflect additional trials that Cubist conducts or trials Cubist terminates for any Licensed Product during the Term. Cubist shall also revise the Cubist Development Plan from time to time to reflect each new indication for or formulation of Licensed Products that Cubist is developing or plans to develop. Additionally, ADCT [ ]*, Cubist shall have update the right Cubist Development Plan no later [ ]* and submit such plan to modify the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this AgreementSubcommittee for review and comment. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT Cubist acknowledges that the generation and selection [ ]*. Accordingly, Cubist shall use Commercially Reasonable Efforts to obtain Regulatory Approval of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated Core IV Products in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriateUnited States. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 1 contract

Sources: Marketing, Distribution and Development Agreement (Cubist Pharmaceuticals Inc)

Development Plan. 2.1 ADCT (a) The Development of the Compounds and ADAGENE Collaboration Products under this Agreement (the “Development Program”) shall be conducted pursuant to a comprehensive written Development plan (the “Development Plan”). The Development Plan for each Compound and corresponding Collaboration Products shall set forth the timeline and details of: (i) all preclinical and clinical Development activities to be conducted by the Parties as necessary to generate data sufficient to meet the requirements for Marketing Approval of such Compound and corresponding Collaboration Products for each of the Indications as agreed by the Parties and set forth in the Development Plan; (ii) the protocol synopsis for each clinical trial included in such Development Plan; (iii) a Manufacturing plan; and (iv) any other Development activities that the Parties agree to conduct pursue in collaboration for such Compound and corresponding Collaboration Products. The Parties agree that: (A) the Development Plan as will contain detailed plans for at least [ * ] covered by the Development Plan, and summary plans for periods thereafter, and (B) the budget associated with such Development Plan shall be subject to the approval process set forth in Annex 1 and in accordance with the terms and conditions of this AgreementSection 6.2(b). The Parties acknowledge Development Plan shall include a coordinated development and agree that regulatory strategy, including the Parties’ respective roles in the development of each Collaboration Product and the countries in which Development of Collaboration Product will occur. The Development Plan shall also set forth: (1) a detailed budget of the Development activities to be [ * ]; (2) if Cytokinetics has exercised the Cytokinetics Co-Funding Option for a Collaboration Product and [ * ] for such Collaboration Product, a detailed budget for [ * ] of such Collaboration Product in the [ * ] Indications (the “[ * ]”); and (3) if [ * ] Indication [ * ] the Collaboration and [ * ] for such [ * ] Indication, a detailed budget for such [ * ] Indication Development Work (the “[ * ] Indication Development Budget”). Upon the other Party’s reasonable request, each Party shall [ * ] Development activities under the Development Plan. The [ * ] shall be included in the Development Plan and [ * ] shall divided be subject to JDC approval. [ * ] = Certain confidential information contained in up to three proof of concept development programsthis document, namely marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. (b) The JDC shall update the [***] PoC, the [***] PoC and [***Development Plan (including [ * ], as detailed in Annex 1applicable) at least annually, with such annual update to be finally approved no later than [ * ] of the preceding Astellas’ fiscal year, provided that [ * ] Indication [ * ] subject to the [ * ] the JDC (and [ * ] Indication [ * ] after [ * ] for such Indication. Prom By [ * ] of each calendar year, [ * ] Development activities are [ * ] the updated Development Plan, the JDC shall agree upon a proposed [ * ] for the following Astellas fiscal year. Astellas shall use good faith efforts to [ * ]. From time to time during the Term, ADCT the JDC shall prepare amendments, as appropriate, to the then-current Development Plan (including [ * ], as applicable), including adding additional Compounds and Collaboration Products as well as additional Indications added to the Collaboration pursuant to Article 4. The JDC shall have the right to modify approve updates and amendments to the Development Plan by written notice to ADAGENE(including [ * ], as applicable), provided that any [ * ] subject to the [ * ] the JDC (and [ * ] for such modification that would result in a material increase Indication. Once approved by the JDC, such revised Development Plan shall replace the prior Development Plan. (c) If the terms of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate contradict, or create inconsistencies or ambiguities with, the [***] PoC upon the Effective Date terms of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE this Agreement shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Periodgovern. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 1 contract

Sources: License and Collaboration Agreement (Cytokinetics Inc)

Development Plan. 2.1 ADCT 2.1.1 If requested by PCYC, the Parties shall undertake a Manufacturing process development project for one or more of the Drug Products to be Manufactured by Contractor hereunder, consisting of the specific research and ADAGENE agree development activities agreed upon by the Parties and detailed in a Development Plan, subject to conduct the Development Plan as set forth in Annex 1 and terms of this Section 2. 1. The Parties shall use good faith, commercially reasonable diligent efforts to complete successfully each such development project in accordance with the terms and conditions of this Agreementapplicable Development Plan. The Parties acknowledge and agree shall conduct each such development project in accordance with a timetable that the Parties shall develop and which shall be set forth in the applicable Development Plan. 2.1.2 The Parties shall undertake a Manufacturing process development project, as described in Section 2.1.1, for the Initial Drug Product. Each Development Plan for the Initial Drug Product shall divided be developed in up accordance with Section 2.1.3, and shall comply with outline of research and development activities set forth in the Drug Product Development Requirements in the Initial Drug Product Appendix. (a) Contractor shall prepare and deliver two (2) copies of the first Development Plan for the Initial Drug Product to three proof PCYC as soon as possible following the Effective Date, but in no event later than thirty (30) days following the Effective Date. (b) For each Drug Product for which PCYC requests Contractor to perform development services hereunder, other than the Initial Drug Product, Contractor shall prepare and deliver two (2) copies of concept each proposed Development Plan to PCYC as soon as possible following its receipt of PCYC's request for development programsservices, namely but in any event, no later than sixty (60) days from the [***] PoCdate that such request was received. (c) Following receipt of Contractor's proposed Development Plan under subsection (a) or (b) above, PCYC shall either sign such Development Plan and return one (1) copy to Contractor or shall return an amended Development Plan acceptable to PCYC, in each case within five (5) business days of receipt of such Development Plan from Contractor. If such amended Development Plan is not acceptable to Contractor, then Contractor shall so notify PCYC within five (5) business days of Contractor's receipt of such amended Development Plan, and the [***] PoC Parties shall promptly meet in order to resolve in good faith any outstanding disagreements with respect to such amended Development Plan. In no event shall Contractor be required to schedule any development activities under this Section 2.1 with respect to any Drug Product until a Development Plan for such Drug Product has been approved in writing by both PCYC and [***]Contractor. Notwithstanding the foregoing, as detailed in Annex 1. Prom time the event that the Parties are unable to time during reach agreement using good-faith efforts with respect to a particular Development Plan within ninety (90) days from the Termdate of request (or ninety (90) days from the Effective Date in the case of the first Development Plan for the Initial Drug Product), ADCT then either Party shall have the right to modify terminate this Agreement with respect to the Drug Product that is the subject of such Development Plan by upon written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriateParty. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 1 contract

Sources: Master Development and Supply Agreement (Pharmacyclics Inc)

Development Plan. 2.1 ADCT and ADAGENE agree Subject to conduct the Development Plan as set forth in Annex 1 and in accordance with this Article 4 (Development), each Party shall be responsible for, and shall use Commercially Reasonable Efforts to, complete the terms and conditions of this Agreement. The Parties acknowledge and agree that Development activities allocated to such Party in the Development Plan shall divided in up to three proof of concept development programsaccordance with the timelines set forth therein. The initial Development Plan, namely attached hereto as Exhibit B (the [***] PoC“Development Plan”), the [***] PoC and [***], as detailed in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify the Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the each subsequent Development Plan shall require ADAGENEinclude (i) a reasonably detailed and written plan for any Development activities and Clinical Trials to be conducted by or on Epirus’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT behalf in order to elect obtain Regulatory Approval to market the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated Licensed Products in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected Field in a harmonized clinical development program for the [***] as well as a plan for regulatory activities in such countries (it deems appropriate. 2.1.5 Within being agreed and understood that (x) the Regulatory Approval timeline under such Plan shall not be adversely impacted as a result of [***] months from being included therein, (y) any separate [***] or otherwise outside of the date Territory shall not be part of the [***] Initiation Notice, ADAGENE hereunder and shall generate and select be solely for [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information (z) Partner shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those entitled to reference to the resulting [***] SAFEbodies within and/or ex-Territory. data solely for use in the Territory) (“Global Development Activities”), (ii) a library of antibodies, that, in its reasonable experience, Know-How, reasonably detailed and considering ADCT’s input as well, will present the best engineered structure written plan for any Development activities and Clinical Trials to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT be conducted in order to elect obtain Regulatory Approval to market the best Licensed Products in the Field in any country in the Territory that are not Global Development Activities as well as a plan for regulatory activities with the EMA and other Regulatory Authorities in the Territory (the “Local Development Activities”) and (iii) a rolling five (5)-year budget for the Global Development Activities and the Local Development Activities (the “Development Budget”). During the Term, the JMC shall review and prepare updates to the Development Plan and Development Budget on an annual basis, or more frequently as determined by the JMC ; provided, however, that any increases to the Development Budget in excess of [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made most recent Development Budget approved by the JSC. ADCT acknowledges that JMC without Epirus’s use of its deciding vote pursuant to Section 3.2.3(c) (Matters Reserved for Epirus) shall require approval of Partner’s representative on the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s controlJMC.

Appears in 1 contract

Sources: Collaboration Agreement (EPIRUS Biopharmaceuticals, Inc.)

Development Plan. 2.1 ADCT The development activities, including both preclinical and ADAGENE agree clinical development activities, that Cubist will conduct for Licensed Products shall be covered by a development plan that Cubist shall prepare and submit to conduct the Development Plan as set forth in Annex 1 and in accordance with Subcommittee for review [*] after the terms and conditions of this AgreementEffective Date (such plan, the "Cubist Development Plan"). The Parties acknowledge and agree that the Cubist Development Plan shall divided in up to three proof of concept development programs, namely include at least the [*] in clauses (A), (B) and (C) above in Section 3.1(a). The Cubist Development Plan shall [**] PoC]. Subject to its overall diligence obligations contained in this Section 3.1, Cubist reserves the right to change or modify the Cubist Development Plan (except with respect to the [***] PoC and [***], as detailed in Annex 1. Prom time to time during the Term, ADCT shall have the right to modify the Development Plan by written notice to ADAGENE, provided that ) or any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the [***] PoC upon the Effective Date of this Agreement. ADAGENE shall supply 150 mg of [***] SAFEbody at no cost to ADCT at such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the [***] PoC at any time during the [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets preclinical studies or a [***] Alternative Target clinical trials (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (]) described in the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target Cubist Development Plan in response to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or ], (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [**], (iii) [*] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the or (iv) [***] Option Period, then ADCT shall have ]. Cubist additionally reserves the right to elect such Target as the change or modify any Core Trial (1) [*] such trial in accordance with the then-current protocol therefor as a result of [*], or (2) in response to any [*]; provided, however, that Cubist recognizes that Gilead's efforts to [*] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such will depend upon [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (further provided that the financial terms of said agreement might be redacted) foregoing ability to change or modify a Core Trial shall not contravene Cubist's obligations to provide ADCT with written evidence that the [**]. Accordingly, if Cubist has the right to change or modify a Core Trial pursuant to the foregoing sentence, it shall so notify Gilead, the Parties shall discuss any proposed modification to the Core Trial at issue or other alternative arrangement to address the reason giving rise to Cubist's right to change or modify the Core Trial while providing for [*] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested from Cubist to [*], and Cubist shall implement any such proposed modification or alternative arrangement to which the Parties mutually agree. Cubist shall modify the Cubist Development Plan from time to time to reflect timing or protocol changes to the Core Trials or any other trials, and to reflect additional trials that Cubist conducts or trials Cubist terminates for any Licensed Product during the Term. Cubist shall also revise the Cubist Development Plan from time to time to reflect each new indication for or formulation of Licensed Products that Cubist is developing or plans to develop. Additionally, [*], Cubist shall update the Cubist Development Plan no later [*] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have and submit such plan to the right, but not the obligation, to elect such Development Subcommittee for review and comment. Cubist acknowledges that [***] Alternative Target as the [***] Target in lieu ]. Accordingly, Cubist shall use Commercially Reasonable Efforts to obtain Regulatory Approval of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated Core IV Products in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriateUnited States. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 1 contract

Sources: Marketing, Distribution and Development Agreement (Gilead Sciences Inc)

Development Plan. 2.1 ADCT and ADAGENE agree to conduct the Development Plan as set forth in Annex 1 and in accordance with the terms and conditions of this Agreement. The Parties acknowledge and agree that the Development Plan shall divided in up to three proof of concept development programs, namely the (a) Within [***] PoCdays following the Exercise Date with respect to a given Collaboration Candidate, ONO will prepare and provide to the JSC an update to its proposed activities under the Joint Development Plan pursuant to which ONO will conduct Research and Development in the ONO Territory, and FATE will prepare and provide to the JSC (i) an update to its proposed activities under the Joint Development Plan pursuant to which FATE will conduct Research and Development in the FATE Territory, for such Collaboration Product on an Indication-by-Indication basis, as applicable and (ii) a process development and manufacturing plan for all non-clinical and clinical Materials of Collaboration Products for use both by ONO in the ONO Territory and by FATE in the FATE Territory. Each Party will prepare and provide a budget and estimated timeline with respect to its proposed activities under the Joint Development Plan. (b) ONO and FATE will discuss in good faith through the JSC, and use Commercially Reasonable Efforts to reach an agreement on, the [***] PoC and Joint Development Plan, including but not limited to: (i) [***], as detailed in Annex 1. Prom time to time during (ii) and (iii) [***]. (c) During each Calendar Year, each Party shall provide its updates on the Term, ADCT shall have the right to modify the Joint Development Plan by written notice to ADAGENE, provided that any such modification that would result in a material increase of ADAGENE’s obligations (including unreimbursed expenses from ADCT) under for the Development Plan shall require ADAGENE’s prior written consent. 2.1.1 The Parties agree to initiate the upcoming year covering activities [***] PoC upon so that the Effective Date of this Agreement. ADAGENE shall supply 150 mg of Parties may agree on such update by [***] SAFEbody at no cost that year, and each Party shall continue to ADCT at provide to the other Party, through the JSC, regular updates from time to time to its proposed activities under the Joint Development Plan, as applicable. Each Party will consider in good faith the other Party's comments on such date as specified in Annex 1. 2.1.2 ADCT may notify ADAGENE in writing of its desire to initiate the proposed activities and any updates thereto. * Confidential Information, indicated by [***] PoC at any time during ], has been omitted from this filing and filed separately with the Securities and Exchange Commission. (d) If the JSC fails to agree, after the use of Commercially Reasonable Efforts in an attempt to reach an agreement between the Parties regarding the Joint Development Plan, notwithstanding the provisions of Article 12 (Dispute Resolution), the decision shall be made in accordance with Section 4.1.8 (Decision-Making; Limitations on JSC), provided however, [***] Option Period but at the latest within sixty (60) days of completion of [***] PoC (“[***] PoC Initiation Notice”). [***] Antibody is hereby exclusively reserved for ADCT in accordance with Section 2.2.1. For the avoidance of doubt, ADCT is under no obligation to initiate the [***] PoC under this Agreement]. 2.1.3 Within [***] from the date of the [***] PoC Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control. 2.1.4 [***] initiation. a) In addition, at any time during the [***] Option Period, ADCT may elect to initiate [***] by sending written notice to ADAGENE identifying the [***] Target elected by ADCT, such elected [***] Target being either from the list of the [***] Reserved Targets or a [***] Alternative Target (as sot forth in Section 2.1.4 (b) below) (“[***] Initiation Notice”), it being however understood and agreed that ADCT is under no obligation to initiate the [***] under this Agreement. b) For the purpose of [***] Target election, no later than [***] days before the expiry date of the [***] Option Period, ADCT may ask ADAGENE in writing (including by email) to confirm if a certain Target named by ADCT, other than the [***] Reserved Targets, (the “[***] Alternative Target”), is available and can be elected by ADCT as a [***] Target under this Agreement. Within [***] business days from the date of ADCT’s request. ADAGENE shall confirm if the [***] Alternative Target is available or not as an Target to the sole and exclusive benefit of ADCT. The [***] Alternative Target shall be deemed available if ADAGENE has not, prior to ADCT’s notice hereunder and as supported by written evidence as set forth below, either (i) already granted exclusive development and commercial rights to the [***] Alternative Target to a Third Party; or (ii) has agreed to a bona fide term sheet and is in preparation or negotiations for a definitive agreement to grant exclusive development and commercial rights to the [***] Alternative Target to a Third Party, provided that in such event, if ADAGENE does not enter into such definitive agreement with such Third Party prior to the expiration of the [***] Option Period, then ADCT shall have the right to elect such Target as the [***] Target under Section 2.1.4(a); or (iii) elected to retain the exclusive rights itself to such [***] Alternative Target and is actively developing its SAFEbody Technology agains such [***] Alternative Target. If ADAGENE claims that the [***] Alternative Target is not available, ADAGENE shall provide ADCT’s outside counsel in confidence with a copy of the exclusive reservation agreement with such Third Party (provided that the financial terms of said agreement might be redacted) or provide ADCT with written evidence that the [***] Alternative Target is being actively developed by ADAGENE as supported by dated pre-clinical or clinical data. If the requested [***] Alternative Target is available, ADAGENE shall immediately notify ADCTand ADCT shall have the right, but not the obligation, to elect such [***] Alternative Target as the [***] Target in lieu of either Reserved Target in accordance with Section 2.1.4 (a) above prior to the expiration of the [***] Option Period. c) Upon election of the [***] Target as stated in the [***] Initiation Notice, ADAGENE shall be free to release the exclusive reservation to the other Target(s) not-elected for the purpose of the [***] (i.e. either one or both [***] Reserved Target(s) or the [***] Alternative Target as the case may be), and ADAGENE shall be free to develop those other Targets which have not been elected for the [***] as it deems appropriate. 2.1.5 Within [***] months from the date of the [***] Initiation Notice, ADAGENE shall generate and select [***] SAFEbodies meeting the Criteria, and supply to ADCT the amino acid sequences of the corresponding masking peptides, and such information shall be deemed Confidential Information of ADCT. For this purpose, ADAGENE shall select those [***] SAFEbodies within a library of antibodies, that, in its reasonable experience, Know-How, and considering ADCT’s input as well, will present the best engineered structure to successfully enable conjugation with the ADCT Materials. During this process, ADAGENE shall fully collaborate with ADCT and work in full transparency with ADCT in order to elect the best [***] SAFEbodies to be the [***] SAFEbody Panel. Final decision relating to the selection of the [***] SAFEbody Panel shall be made by the JSC. ADCT acknowledges that the generation and selection of biomolecules is unpredictable and that the timeline for generation and selection of the masking peptides may be delayed, and the [***] period will be extended by any reasonable delay outside of ADAGENE’s control.

Appears in 1 contract

Sources: Collaboration and Option Agreement (Fate Therapeutics Inc)