Common use of Additional Fields Clause in Contracts

Additional Fields. (a) From time to time scPharma may wish to Develop or commercialize a drug-device combination based on an existing Device for subcutaneous administration based on the SenseCore Technology in fields outside the then-current Field of Use, excluding the Excluded Field (“Additional Field”). In that event, scPharma will provide Sensile written notice of its intentions and the applicable Additional Field. Sensile will respond to such notice within [***] to: (i) if Sensile has an alternate business interest pertaining to a drug/device combination that would preclude scPharma’s development and commercialization plan, Sensile shall so inform scPharma, or (ii) if Sensile does not have such an interest, Sensile will send scPharma a notice of acceptance (“Notice of Acceptance”) and grant scPharma a period of exclusive evaluation and negotiation for [***], during which Sensile and its Affiliates will cooperate in good faith with scPharma with respect to the evaluation of the intended Product. In the event that the Development of any such Product requires additional Development activities, the Parties shall negotiate in good faith a Development Plan for such Product within [***] of the date of the Notice of Acceptance from Sensile and negotiate in good faith reasonable and customary Development charges that may apply. Any such Product shall be subject to the Per-Unit Fee set forth in Section 3.1(a). (b) In the event scPharma desires exclusivity for such Product and/or in an Additional Field, scPharma will notify Sensile in writing the scope of the desired exclusivity (such notice, the “Additional Field Notice”), Such exclusivity may be defined by the applicable Drug, the Drug class, the intended use, or a therapeutic area. If such exclusivity is requested by scPharma, scPharma’s notice will contain certain milestones required to maintain such exclusivity. Such milestones may relate to [***]. Sensile shall respond to such exclusivity request within [***] with acceptance or denial of the request for exclusivity. In the event Sensile accepts such request by written notice to scPharma (the “Exclusivity Acceptance Notice”), scPharma shall pay Sensile a royalty on Net Sales of such Product as set forth in Section 3 below. For each Additional Field granted to scPharma exclusively, the Incremental Disposable Units volume established in Exhibit 2.6(a) will be added to the Minimum Volumes. The following example is to clarify the aggregate minimum volumes: [***]. (c) In the event scPharma has not requested exclusivity by means of an Additional Field Notice, Sensile may elect to grant scPharma exclusivity for the class of therapeutic agents to which the Product belongs, in exchange a royalty on Net Sales of such Product as set forth in Section 3 below.

Appears in 2 contracts

Sources: License Agreement (scPharmaceuticals Inc.), License Agreement (scPharmaceuticals Inc.)

Additional Fields. (a) From time Takeda shall initially conduct Development, Commercialization and Manufacturing activities directed to time scPharma may wish Targets only with respect to Develop or commercialize a drug-device combination based on an existing Device for subcutaneous administration based Indications in the Field. Based on the SenseCore Technology in fields outside the then-current Field results of Use, excluding the Excluded Field (“Additional Field”). In that event, scPharma will provide Sensile written notice of its intentions and the applicable Additional Field. Sensile will respond to such notice within [***] to: with respect to any Licensed Product directed to a specific Target in the Field, Takeda may engage in Development, Commercialization and/or Manufacturing activities directed to such Target for any additional or replacement Indication (each, an “Additional Indication”) in any Additional Field not previously the subject of Takeda’s exercise of a Field Option, without having to pay a Field Option Fee; provided, however, that (i) if Sensile has an alternate business interest pertaining Takeda shall notify Alnylam of its extension of Development, Commercialization and/or Manufacturing activities directed to a drug/device combination that would preclude scPharma’s development such Target for such Additional Indication in such Additional Field, and commercialization plan, Sensile shall so inform scPharma, or (ii) if Sensile does not have Takeda shall pay Alnylam the following amounts (which shall be in addition to any event payments which may be owed under Section 7.2) upon achievement of the following events by Takeda, its Affiliates or sublicensees with respect to each such an interest, Sensile will send scPharma a notice Additional Indication in such Additional Field: With respect to the first Licensed Product for each such Additional Indication in such Additional Field: Initiation of acceptance (“Notice of Acceptance”) and grant scPharma a period of exclusive evaluation and negotiation Phase III for each Additional Indication $ [**] Acceptance of NDA filing in a Major Market for each Additional Indication $ [*], during which Sensile and its Affiliates will cooperate *] First Commercial Sale in good faith with scPharma with a Major Market for each Additional Indication $ [**] With respect to the evaluation second and each subsequent Licensed Product for such Additional Indication in such Additional Field: Initiation of the intended ProductPhase III for each Additional Indication $ [**] Acceptance of NDA filing in a Major Market for each Additional Indication $ [**] First Commercial Sale in a Major Market for each Additional Indication $ [**] The amounts paid under this Section 3.8(a) for Additional Indications within a given Additional Field shall be fully creditable against Field Option Fees which may be paid by Takeda pursuant to Section 7.4 for such Additional Field. In the event that the Development total event payments made under this Section 3.8(a) reach Fifty Million United States dollars ($50,000,000) for a given Additional Field, such Additional Field shall automatically be included in the Field hereunder. Amounts paid under this Section 3.8(a) with respect to Shared Products will be reduced by [**] percent ([**]%); provided that, for purposes of the credit against Field Option Fees described above in this paragraph to which Takeda is entitled with respect to any such reduced payment for a Shared Product, the credit amount shall be the [**] amount of the applicable event payment (i.e., [**] percent ([**]%) of the amount that would have been payable if a Licensed Product requires additional Development activitiesother than a Shared Product had achieved the applicable event) notwithstanding that Takeda only paid [**] percent ([**]%) of such amount. For the avoidance of doubt, in no event shall Takeda conduct Development, Commercialization or Manufacturing activities directed to any Target in any Additional Field other than as permitted in this Section 3.8. In the event that the Parties are unable to agree on whether Takeda’s activities fall within or outside the Primary Fields or any Additional Field in a manner prohibited by this Agreement, the Parties shall negotiate comply with Section 12.2, except that if the dispute is not resolved thereby, then either Party may submit such dispute to a panel (the “Field Definition Panel”) consisting of three (3) independent experts in good faith clinical development, with each Party having the right to select a Development Plan single expert and the two (2) selected experts selecting the third expert by mutual agreement. Such third expert shall serve as the chairperson of the Field Definition Panel. The selection of the experts for such Product the Field Definition Panel shall occur within [***] of following the date of Parties’ decision to submit such dispute to such a panel, and the Notice of Acceptance from Sensile and negotiate in good faith reasonable and customary Development charges that may apply. Any Parties shall consult with such Product shall be subject Field Definition Panel for a period not to the Per-Unit Fee set forth in Section 3.1(a). (b) In the event scPharma desires exclusivity for such Product and/or in an Additional Field, scPharma will notify Sensile in writing the scope of the desired exclusivity (such notice, the “Additional Field Notice”), Such exclusivity may be defined by the applicable Drug, the Drug class, the intended use, or a therapeutic area. If such exclusivity is requested by scPharma, scPharma’s notice will contain certain milestones required to maintain such exclusivity. Such milestones may relate to exceed [***]] from the selection of such experts. Sensile The Field Definition Panel shall respond render a decision with respect to such exclusivity request dispute, based on a majority vote, with each expert having one (1) vote, within [***] with acceptance or denial following the end of such consultation period, which decision shall be binding on the request for exclusivityParties. In the event Sensile accepts such request by written notice to scPharma (that the “Exclusivity Acceptance Notice”)Field Definition Panel determines that Takeda’s Development, scPharma shall pay Sensile a royalty on Net Sales of such Product as set forth Commercialization or Manufacturing activities are being conducted in Section 3 below. For each any Additional Field granted to scPharma exclusivelyin a manner which is prohibited hereunder, the Incremental Disposable Units volume established in Exhibit 2.6(a) will be added to the Minimum Volumes. The following example is to clarify the aggregate minimum volumes: Takeda shall, within [***]. (c) In ] after such determination by the event scPharma has not requested exclusivity by means of an Field Definition Panel, cease such proscribed activity or exercise the Field Option with respect to such Additional Field, if the Field Option is then exercisable as to such Additional Field Notice, Sensile may elect to grant scPharma exclusivity for the class of therapeutic agents to which the Product belongs, in exchange a royalty on Net Sales of and such Product as set forth in Section 3 belowactivity would not be prohibited upon such exercise.

Appears in 1 contract

Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Additional Fields. (a) From time to time scPharma may wish to Develop or commercialize a drug-device combination based on an existing Device for subcutaneous administration based on the SenseCore Technology in fields outside the then-current Field of Use, excluding the Excluded Field (“Additional Field”). In that event, scPharma will provide Sensile written notice of its intentions and the applicable Additional Field. Sensile will respond to such notice within [***] to: : (i) if Sensile has an alternate business interest pertaining to a drug/device combination that would preclude scPharma’s development and commercialization plan, Sensile shall so inform scPharma, or (ii) if Sensile does not have such an interest, Sensile will send scPharma a notice of acceptance (“Notice of Acceptance”) and grant scPharma a period of exclusive evaluation and negotiation for [***], during which Sensile and its Affiliates will cooperate in good faith with scPharma with respect to the evaluation of the intended Product. In the event that the Development of any such Product requires additional Development activities, the Parties shall negotiate in good faith a Development Plan for such Product within [***] of the date of the Notice of Acceptance from Sensile and negotiate in good faith reasonable and customary Development charges that may apply. Any such Product shall be subject to the Per-Unit Fee set forth in Section 3.1(a). (b) In the event scPharma desires exclusivity for such Product and/or in an Additional Field, scPharma will notify Sensile in writing the scope of the desired exclusivity (such notice, the “Additional Field Notice”), Such exclusivity may be defined by the applicable Drug, the Drug class, the intended use, or a therapeutic area. If such exclusivity is requested by scPharma, scPharma’s notice will contain certain milestones required to maintain such exclusivity. Such milestones may relate to [***]. Sensile shall respond to such exclusivity request within [***] with acceptance or denial of the request for exclusivity. In the event Sensile accepts such request by written notice to scPharma (the “Exclusivity Acceptance Notice”), scPharma shall pay Sensile a royalty on Net Sales of such Product as set forth in Section 3 below. For each Additional Field granted to scPharma exclusively, the Incremental Disposable Units volume established in Exhibit 2.6(a) will be added to the Minimum Volumes. The following example is to clarify the aggregate minimum volumes: [***]. (c) In the event scPharma has not requested exclusivity by means of an Additional Field Notice, Sensile may elect to grant scPharma exclusivity for the class of therapeutic agents to which the Product belongs, in exchange a royalty on Net Sales of such Product as set forth in Section 3 below.

Appears in 1 contract

Sources: License Agreement

Additional Fields. (ai) From Licensee shall initially conduct Discovery, Development, Commercialization and Manufacturing activities directed to Targets only with respect to Indications in the Field. After Licensee’s completion of a Phase II Study with respect to any Licensed Product directed to a specific Target in the Field, Licensee may engage in Discovery, Development, and/or Manufacturing activities directed to such Target for any Indication (each, an “Additional Indication”) in any Additional Field (if such Additional Field has not been the subject of Licensee’s exercise of a Field Option) without having to pay a Field Option Fee; provided, however, that (A) Licensee shall notify Alnylam of its extension of Discovery, Development and/or Manufacturing activities directed to such Target for such Additional Indication in such Additional Field, and (B) Licensee shall pay Alnylam the following amounts (which shall be in addition to any event payments which may be owed under Section 5.3 below and except as provided in clause (ii) below) upon achievement of the following events by Licensee, its Affiliates or Licensee Partners with respect to each such Additional Indication: Development Event: Payment for Licensed Products (in [**]): Initiation of Phase III for each Additional Indication $ [**] Filing of an NDA for each Additional Indication $ [**] Regulatory Approval for each Additional Indication $ [**] [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. (ii) Notwithstanding the foregoing provisions of clause (i) above, Licensee shall pay Alnylam the following amounts (which shall be in addition to any event payments which may be owed under Section 5.3 below and in lieu of any amounts which may otherwise be owed under clause (i) above) upon achievement of the following events by Licensee, its Affiliates or Licensee Partners solely with respect to a Licensed Product with respect to which Licensee extends its activities for the first time to time scPharma may wish to Develop or commercialize an Additional Indication in a drug-device combination based on an existing Device for subcutaneous administration based on the SenseCore Technology in fields outside the then-current Field of Use, excluding the Excluded Field (“given Additional Field”). In that event, scPharma will provide Sensile written notice : Development Event: Payment for Licensed Products (in [**]): Initiation of its intentions Phase III for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] Filing of an NDA for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] Regulatory Approval for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] (iii) The amounts paid under subsections (i) and the applicable (ii) of this Section 2.5(a) for Additional Indications within a given Additional Field shall be fully creditable against Field Option Fees which may be paid by Licensee pursuant to Section 5.6 for such Additional Field. Sensile will respond to such notice within In no event shall the total event payments made under this provision exceed $[***] to: for a given Additional Field. (iiv) if Sensile has an alternate business interest pertaining For the avoidance of doubt, in no event shall Licensee conduct Discovery, Development, Commercialization and Manufacturing activities directed to a drug/device combination that would preclude scPharma’s development and commercialization plan, Sensile shall so inform scPharma, or (ii) if Sensile does not have such an interest, Sensile will send scPharma a notice of acceptance (“Notice of Acceptance”) and grant scPharma a period of exclusive evaluation and negotiation for [***], during which Sensile and its Affiliates will cooperate any Target in good faith with scPharma with respect to the evaluation of the intended Productany Additional Field other than as permitted in this Section 2.5. In the event that the Development of Parties are unable to agree on whether or not Licensee’s activities fall within or outside the Primary Field or any such Product requires additional Development activitiesAdditional Field in a manner prohibited by this Agreement, the Parties shall negotiate submit such dispute to a panel (the “Field Definition Panel”) consisting of three (3) independent experts in good faith clinical development, with each Party having the right to select a Development Plan single expert and the two (2) selected experts selecting the third expert by mutual agreement. Such third expert shall serve as the chairperson of the Field Definition Panel. The selection of the experts for the Field Definition Panel shall occur within thirty (30) days following the Parties’ decision to submit such Product dispute to such a panel, and the Parties shall consult with such Field Definition Panel for a period not to exceed thirty (30) days from the selection of such experts. The Field Definition Panel shall render a decision with respect to such dispute, based on a majority vote, with each expert having one (1) vote, within ten (10) days following the end of such consultation period, which [***] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the date of the Notice of Acceptance from Sensile and negotiate in good faith reasonable and customary Development charges that may applyCommission. Any such Product decision shall be subject to binding on the Per-Unit Fee set forth in Section 3.1(a). (b) In the event scPharma desires exclusivity for such Product and/or in an Additional Field, scPharma will notify Sensile in writing the scope of the desired exclusivity (such notice, the “Additional Field Notice”), Such exclusivity may be defined by the applicable Drug, the Drug class, the intended use, or a therapeutic area. If such exclusivity is requested by scPharma, scPharma’s notice will contain certain milestones required to maintain such exclusivity. Such milestones may relate to [***]. Sensile shall respond to such exclusivity request within [***] with acceptance or denial of the request for exclusivityParties. In the event Sensile accepts such request by written notice to scPharma (that the “Exclusivity Acceptance Notice”)Field Definition Panel determines that Licensee’s Discovery, scPharma shall pay Sensile a royalty on Net Sales of such Product as set forth Development, Commercialization or Manufacturing activities are being conducted in Section 3 below. For each any Additional Field granted to scPharma exclusivelyin a manner which is prohibited hereunder, Licensee shall, within ten (10) Business Days after such determination by the Incremental Disposable Units volume established in Exhibit 2.6(a) will be added to the Minimum Volumes. The following example is to clarify the aggregate minimum volumes: [***]Field Definition Panel, cease such proscribed activity. (c) In the event scPharma has not requested exclusivity by means of an Additional Field Notice, Sensile may elect to grant scPharma exclusivity for the class of therapeutic agents to which the Product belongs, in exchange a royalty on Net Sales of such Product as set forth in Section 3 below.

Appears in 1 contract

Sources: License and Collaboration Agreement (Arrowhead Research Corp)

Additional Fields. (ai) From Licensee shall initially conduct Discovery, Development, Commercialization and Manufacturing activities directed to Targets only with respect to Indications in the Field. After Licensee’s completion of a Phase II Study with respect to any Licensed Product directed to a specific Target in the Field, Licensee may engage in Discovery, Development, and/or Manufacturing activities directed to such Target for any Indication (each, an “Additional Indication”) in any Additional Field (if such Additional Field has not been the subject of Licensee’s exercise of a Field Option) without having to pay a Field Option Fee; provided, however, that (A) Licensee shall notify Alnylam of its extension of Discovery, Development and/or Manufacturing activities directed to such Target for such Additional Indication in such Additional Field, and (B) Licensee shall pay Alnylam the following amounts (which shall be in addition to any event payments which may be owed under Section 5.3 below and except as provided in clause (ii) below) upon achievement of the following events by Licensee, its Affiliates or Licensee Partners with respect to each such Additional Indication: Development Event: (in [**]): Initiation of Phase III for each Additional Indication $ [**] Filing of an NDA for each Additional Indication $ [**] Regulatory Approval for each Additional Indication $ [**] (ii) Notwithstanding the foregoing provisions of clause (i) above, Licensee shall pay Alnylam the following amounts (which shall be in addition to any event payments which may be owed under Section 5.3 below and in lieu of any amounts which may otherwise be owed under clause (i) above) upon achievement of the following events by Licensee, its Affiliates or Licensee Partners solely with respect to a Licensed Product with respect to which Licensee extends its activities for the first time to time scPharma may wish to Develop or commercialize an Additional Indication in a drug-device combination based on an existing Device for subcutaneous administration based on the SenseCore Technology in fields outside the then-current Field of Use, excluding the Excluded Field (“given Additional Field”). In that event, scPharma will provide Sensile written notice : Development Event: (in [**]): Initiation of its intentions Phase III for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] Filing of an NDA for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] Regulatory Approval for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] (iii) The amounts paid under subsections (i) and the applicable (ii) of this Section 2.5(a) for Additional Indications within a given Additional Field shall be fully creditable against Field Option Fees which may be paid by Licensee pursuant to Section 5.6 for such Additional Field. Sensile will respond In no event shall the total event payments made under this provision exceed $50 million for a given Additional Field. (iv) For the avoidance of doubt, in no event shall Licensee conduct Discovery, Development, Commercialization and Manufacturing activities directed to such notice within [***] to: (i) if Sensile has an alternate business interest pertaining to a drug/device combination that would preclude scPharma’s development and commercialization plan, Sensile shall so inform scPharma, or (ii) if Sensile does not have such an interest, Sensile will send scPharma a notice of acceptance (“Notice of Acceptance”) and grant scPharma a period of exclusive evaluation and negotiation for [***], during which Sensile and its Affiliates will cooperate any Target in good faith with scPharma with respect to the evaluation of the intended Productany Additional Field other than as permitted in this Section 2.5. In the event that the Development of Parties are unable to agree on whether or not Licensee’s activities fall within or outside the Primary Field or any such Product requires additional Development activitiesAdditional Field in a manner prohibited by this Agreement, the Parties shall negotiate submit such dispute to a panel (the “Field Definition Panel”) consisting of three (3) independent experts in good faith clinical development, with each Party having the right to select a Development Plan for such Product within [***] single expert and the two (2) selected experts selecting the third expert by mutual agreement. Such third expert shall serve as the chairperson of the date Field Definition Panel. The selection of the Notice experts for the Field Definition Panel shall occur within thirty (30) days following the Parties’ decision to submit such dispute to such a panel, and the Parties shall consult with such Field Definition Panel for a period not to exceed thirty (30) days from the selection of Acceptance from Sensile and negotiate in good faith reasonable and customary Development charges that may applysuch experts. Any The Field Definition Panel shall render a decision with respect to such Product dispute, based on a majority vote, with each expert having one (1) vote, within ten (10) days following the end of such consultation period, which decision shall be subject to binding on the Per-Unit Fee set forth in Section 3.1(a). (b) In the event scPharma desires exclusivity for such Product and/or in an Additional Field, scPharma will notify Sensile in writing the scope of the desired exclusivity (such notice, the “Additional Field Notice”), Such exclusivity may be defined by the applicable Drug, the Drug class, the intended use, or a therapeutic area. If such exclusivity is requested by scPharma, scPharma’s notice will contain certain milestones required to maintain such exclusivity. Such milestones may relate to [***]. Sensile shall respond to such exclusivity request within [***] with acceptance or denial of the request for exclusivityParties. In the event Sensile accepts such request by written notice to scPharma (that the “Exclusivity Acceptance Notice”)Field Definition Panel determines that Licensee’s Discovery, scPharma shall pay Sensile a royalty on Net Sales of such Product as set forth Development, Commercialization or Manufacturing activities are being conducted in Section 3 below. For each any Additional Field granted to scPharma exclusivelyin a manner which is prohibited hereunder, Licensee shall, within ten (10) Business Days after such determination by the Incremental Disposable Units volume established in Exhibit 2.6(a) will be added to the Minimum Volumes. The following example is to clarify the aggregate minimum volumes: [***]Field Definition Panel, cease such proscribed activity. (c) In the event scPharma has not requested exclusivity by means of an Additional Field Notice, Sensile may elect to grant scPharma exclusivity for the class of therapeutic agents to which the Product belongs, in exchange a royalty on Net Sales of such Product as set forth in Section 3 below.

Appears in 1 contract

Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Additional Fields. (ai) From Licensee shall initially conduct Discovery, Development, Commercialization and Manufacturing activities directed to Targets only with respect to Indications in the Field. After Licensee’s completion of a Phase II Study with respect to any Licensed Product directed to a specific Target in the Field, Licensee may engage in Discovery, Development, and/or Manufacturing activities directed to such Target for any Indication (each, an “Additional Indication”) in any Additional Field (if such Additional Field has not been the subject of Licensee’s exercise of a Field Option) without having to pay a Field Option Fee; provided, however, that (A) Licensee shall notify Alnylam of its extension of Discovery, Development and/or Manufacturing activities directed to such Target for such Additional Indication in such Additional Field, and (B) Licensee shall pay Alnylam the following amounts (which shall be in addition to any event payments which may be owed under Section 5.3 below and except as provided in clause (ii) below) upon achievement of the following events by Licensee, its Affiliates or Licensee Partners with respect to each such Additional Indication: Development Event: (in [**]): Initiation of Phase III for each Additional Indication $ [**] Filing of an NDA for each Additional Indication $ [**] Regulatory Approval for each Additional Indication $ [**] (ii) Notwithstanding the foregoing provisions of clause (i) above, Licensee shall pay Alnylam the following amounts (which shall be in addition to any event payments which may be owed under Section 5.3 below and in lieu of any amounts which may otherwise be owed under clause (i) above) upon achievement of the following events by Licensee, its Affiliates or Licensee Partners solely with respect to a Licensed Product with respect to which Licensee extends its activities for the first time to time scPharma may wish to Develop or commercialize an Additional Indication in a drug-device combination based on an existing Device for subcutaneous administration based on the SenseCore Technology in fields outside the then-current Field of Use, excluding the Excluded Field (“given Additional Field”). In that event, scPharma will provide Sensile written notice : Development Event: (in [**]): Initiation of its intentions Phase III for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] Filing of an NDA for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] Regulatory Approval for a Licensed Product for the first Additional Indication in a given Additional Field $ [**] (iii) The amounts paid under subsections (i) and the applicable (ii) of this Section 2.5(a) for Additional Indications within a given Additional Field shall be fully creditable against Field Option Fees which may be paid by Licensee pursuant to Section 5.6 for such Additional Field. Sensile will respond to such notice within In no event shall the total event payments made under this provision exceed $[***] to: for a given Additional Field. (iiv) if Sensile has an alternate business interest pertaining For the avoidance of doubt, in no event shall Licensee conduct Discovery, Development, Commercialization and Manufacturing activities directed to a drug/device combination that would preclude scPharma’s development and commercialization plan, Sensile shall so inform scPharma, or (ii) if Sensile does not have such an interest, Sensile will send scPharma a notice of acceptance (“Notice of Acceptance”) and grant scPharma a period of exclusive evaluation and negotiation for [***], during which Sensile and its Affiliates will cooperate any Target in good faith with scPharma with respect to the evaluation of the intended Productany Additional Field other than as permitted in this Section 2.5. In the event that the Development of Parties are unable to agree on whether or not Licensee’s activities fall within or outside the Primary Field or any such Product requires additional Development activitiesAdditional Field in a manner prohibited by this Agreement, the Parties shall negotiate submit such dispute to a panel (the “Field Definition Panel”) consisting of three (3) independent experts in good faith clinical development, with each Party having the right to select a Development Plan for such Product within [***] single expert and the two (2) selected experts selecting the third expert by mutual agreement. Such third expert shall serve as the chairperson of the date Field Definition Panel. The selection of the Notice experts for the Field Definition Panel shall occur within thirty (30) days following the Parties’ decision to submit such dispute to such a panel, and the Parties shall consult with such Field Definition Panel for a period not to exceed thirty (30) days from the selection of Acceptance from Sensile and negotiate in good faith reasonable and customary Development charges that may applysuch experts. Any The Field Definition Panel shall render a decision with respect to such Product dispute, based on a majority vote, with each expert having one (1) vote, within ten (10) days following the end of such consultation period, which decision shall be subject to binding on the Per-Unit Fee set forth in Section 3.1(a). (b) In the event scPharma desires exclusivity for such Product and/or in an Additional Field, scPharma will notify Sensile in writing the scope of the desired exclusivity (such notice, the “Additional Field Notice”), Such exclusivity may be defined by the applicable Drug, the Drug class, the intended use, or a therapeutic area. If such exclusivity is requested by scPharma, scPharma’s notice will contain certain milestones required to maintain such exclusivity. Such milestones may relate to [***]. Sensile shall respond to such exclusivity request within [***] with acceptance or denial of the request for exclusivityParties. In the event Sensile accepts such request by written notice to scPharma (that the “Exclusivity Acceptance Notice”)Field Definition Panel determines that Licensee’s Discovery, scPharma shall pay Sensile a royalty on Net Sales of such Product as set forth Development, Commercialization or Manufacturing activities are being conducted in Section 3 below. For each any Additional Field granted to scPharma exclusivelyin a manner which is prohibited hereunder, Licensee shall, within ten (10) Business Days after such determination by the Incremental Disposable Units volume established in Exhibit 2.6(a) will be added to the Minimum Volumes. The following example is to clarify the aggregate minimum volumes: [***]Field Definition Panel, cease such proscribed activity. (c) In the event scPharma has not requested exclusivity by means of an Additional Field Notice, Sensile may elect to grant scPharma exclusivity for the class of therapeutic agents to which the Product belongs, in exchange a royalty on Net Sales of such Product as set forth in Section 3 below.

Appears in 1 contract

Sources: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)