Common use of Additional Development Clause in Contracts

Additional Development. If either Party (the “Proposing Party”) desires to conduct Other Global Development or any other additional Development of the Licensed Compound or a Licensed Product in its territory that is not included in any [***] Plan or the then-current Current Global Development Plan or the then-current Territory-Specific Development Plan (including for any New Indication, New Formulation, or any Other Global Development, but excluding any [***], “Additional Development”), then the Proposing Party will present a proposal to the JSC for its [***] pursuant to Section 3.1.5(k) (Specific Responsibilities of the JSC), including a synopsis of the Development activities related to such Additional Development, the potential role of the non-Proposing Party with respect to such Additional Development, the timeline for such Additional Development, and the estimated costs associated with such Additional Development. Notwithstanding the foregoing, if a Regulatory Authority in a country or jurisdiction in the Territory requires a New Formulation for a Licensed Product in order for such Regulatory Authority to grant Regulatory Approval for such Licensed Product in an Initial Indication in such country or jurisdiction, then all Development related to such New Formulation will not be Additional Development and instead will be conducted as Territory-Specific Development pursuant to Section 4.2 (Territory-Specific Development). 4.3.1 [***] Additional Development. (a) JSC [***]; Agreement. If the JSC [***] any Additional Development as Other Global Development and both Parties agree to participate in such Additional Development, then the Parties will enter into a co-development agreement (or an amendment to this Agreement) regarding such Additional Development, including the allocation of costs and responsibilities related to such Additional Development and the reporting of information regarding such Additional Development, and each Party will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated from such Additional Development for the purposes of obtaining Regulatory Approval and Commercializing the Licensed Product in its territory. If the JSC [***] any Additional Development as new Territory-Specific Development and [***] agrees to conduct such Additional Development, then [***] will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated from such Additional Development for the purposes of [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. obtaining Regulatory Approval and Commercializing the Licensed Product outside of the Territory. (b) JSC [***];

Appears in 1 contract

Samples: Collaboration and License Agreement (Akebia Therapeutics, Inc.)

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Additional Development. If either Party (Tenant acknowledges that Landlord, in its reasonable discretion, may from time to time expand, renovate and/or reconfigure the “Proposing Party”) desires to conduct Other Global Development or any other additional Development exterior areas of the Licensed Compound San Diego Facility as the same may exist from time to time and, in connection therewith or a Licensed Product in its territory that is not included in any [***] Plan or addition thereto, as the then-current Current Global Development Plan or the then-current Territory-Specific Development Plan (including for any New Indicationcase may be, New Formulation, or any Other Global Development, but excluding any [***], “Additional Development”), then the Proposing Party will present a proposal from time to the JSC for its [***] pursuant to Section 3.1.5(k) (Specific Responsibilities of the JSC), including a synopsis of the Development activities related to such Additional Development, the potential role of the non-Proposing Party with respect to such Additional Development, the timeline for such Additional Development, and the estimated costs associated with such Additional Development. Notwithstanding the foregoing, if a Regulatory Authority in a country or jurisdiction in the Territory requires a New Formulation for a Licensed Product in order for such Regulatory Authority to grant Regulatory Approval for such Licensed Product in an Initial Indication in such country or jurisdiction, then all Development related to such New Formulation will not be Additional Development and instead will be conducted as Territory-Specific Development pursuant to Section 4.2 (Territory-Specific Development). 4.3.1 [***] Additional Development. time without limitation: (a) JSC [***]change the shape, size, location, number and/or extent of any improvements, structures, entrances, exits, parking and/or parking areas relative to any portion of the San Diego Facility (other than to the Premises, Tenant Improvements or Landlord’s Work, nor shall Landlord construct any new buildings on the Land for the purpose of occupancy or lease to third parties without Tenant’s consent); Agreement. If (b) modify, eliminate and/or add any improvements (other than the JSC [***] any Additional Development as Other Global Development and both Parties agree to participate in such Additional DevelopmentPremises, then the Parties will enter into a co-development agreement (Tenant Improvements or an amendment to this Agreement) regarding such Additional Development, including the allocation of costs and responsibilities related to such Additional Development and the reporting of information regarding such Additional Development, and each Party will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further AssurancesLandlord’s Work) to the data generated San Diego Facility and/or make any other changes thereto affecting the same; and (c) except as otherwise provided herein, make any other changes, additions and/or deletions in any way affecting the exterior areas of the San Diego Facility and/or any portion thereof as Landlord may elect from such Additional Development for the purposes of obtaining Regulatory Approval and Commercializing the Licensed Product in its territory. If the JSC [***] any Additional Development as new Territory-Specific Development and [***] agrees time to conduct such Additional Developmenttime, then [***] will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) including without limitation, additions to the data generated from such Additional Development for land comprising the purposes San Diego Facility. Notwithstanding anything to the contrary contained in this Lease, Tenant shall have no right to seek damages (including abatement of [***] Portions Rent) or to cancel or terminate this Lease because of this exhibit have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. obtaining Regulatory Approval and Commercializing the Licensed Product outside any proposed changes, expansion, renovation or reconfiguration of the Territoryexterior areas of the San Diego Facility permitted by this Section 36 nor shall Tenant have the right to restrict, inhibit or prohibit any such changes, expansion, renovation or reconfiguration; provided, however, (i) Landlord shall not change the size, dimensions or location of the Premises or Tenant’s permitted use of the Premises nor shall the costs of constructing any such development be included as part of Expenses, and (ii) the development described in this Section 36 shall not (x) materially interfere with Tenant’s use and enjoyment of the Premises other than temporarily during any construction, and Landlord shall use reasonable efforts to minimize such interference, and (y) materially increase Tenant’s obligations under this Lease. (b) JSC [***];

Appears in 1 contract

Samples: Lease Agreement (Quidel Corp /De/)

Additional Development. If either Party (In the “Proposing Party”) desires to conduct Other Global Development or any other additional event of a need for Development of a Product beyond the Licensed Compound or a Licensed Product in its territory that is not included in any [***] Plan or scope of the then-current Current Global Development Plan or as mutually agreed solely in the then-current Territory-Specific Development Plan Xxxx Territory (including for any New Indication, New Formulation, or any Other Global Development, but excluding any [***], “Additional Xxxx Development”), then Xxxx shall have the Proposing Party will present a proposal to the JSC right to, and shall be responsible for its [***] pursuant to Section 3.1.5(k) (Specific Responsibilities of the JSC)conducting, including a synopsis of the such Additional Xxxx Development activities and Xxxx shall bear all costs related to such Additional Xxxx Development. The general cost sharing principle provided for in Section 4.3 of this Agreement shall not apply to costs incurred by Xxxx in conducting the Additional Xxxx Development and as such, Xxxx shall be the potential role sole owner of any Intellectual Property or Technology relating to, or derived from such Additional Xxxx Development. In the event of a need for Development of a Product beyond the scope of the non-Proposing Party with respect to Development Plan as mutually agreed solely in the Prometheus Territory (“Additional Prometheus Development”), Prometheus shall have the right to, and shall be responsible for conducting, such Additional Development, the timeline for such Additional Development, and the estimated costs associated with such Additional Development. Notwithstanding the foregoing, if a Regulatory Authority in a country or jurisdiction in the Territory requires a New Formulation for a Licensed Product in order for such Regulatory Authority to grant Regulatory Approval for such Licensed Product in an Initial Indication in such country or jurisdiction, then all Development related to such New Formulation will not be Additional Prometheus Development and instead will be conducted as Territory-Specific Development pursuant to Section 4.2 (Territory-Specific Development). 4.3.1 [***] Additional Development. (a) JSC [***]; Agreement. If the JSC [***] any Additional Development as Other Global Development and both Parties agree to participate in such Additional Development, then the Parties will enter into a co-development agreement (or an amendment to this Agreement) regarding such Additional Development, including the allocation of Prometheus shall bear all costs and responsibilities related to such Additional Prometheus Development. The general cost sharing principle provided for in Section 4.3 of this Agreement shall not apply to costs incurred by Prometheus in conducting the Additional Prometheus Development and as such, Prometheus shall be the reporting sole owner of information regarding such Additional Developmentany Intellectual Property or Technology relating to, and each Party will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated or derived from such Additional Development for Prometheus Development. Each Party may request the purposes right to use the results of obtaining Regulatory Approval and Commercializing the Licensed Product in its territory. If the JSC [***] any other Party’s Additional Development as new Territory-Specific Development and [***] agrees to conduct such Additional Development, then [***] will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) by giving notice to the data generated from other Party and sharing the Out-of-Pocket-Costs of the other Party relating to such results in accordance with the general cost sharing principle forest forth in Section 4.3 of this Agreement. In addition, in the event a request of the right to use the results of the Additional Development for of the purposes of [***] Portions other Party is accepted, all other provisions of this exhibit have been redacted pursuant Agreement relating to a confidential treatment request. An unredacted version the co-funding of Out-of-Pocket-Cost (including but not limited to the reporting, invoicing, etc.) and related to Technology Developed and co-funded under this exhibit has been filed separately with Agreement (including but not limited to the Commission. obtaining Regulatory Approval and Commercializing the Licensed Product outside ownership of the TerritoryIntellectual Property Rights) shall apply. (b) JSC [***];

Appears in 1 contract

Samples: Co Development and Manufacturing Agreement (Prometheus Biosciences, Inc.)

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Additional Development. If either Party (the “Proposing Party”) desires to conduct Other Global Development or any other additional Development of the Licensed Compound or a Licensed Product in its territory Company shall determine that is not included in any [***] Plan or the then-current Current Global Development Plan or the then-current Territory-Specific Development Plan (including for any New Indication, New Formulation, or any Other Global Development, but excluding any [***], “Additional Development”), then the Proposing Party will present a proposal to the JSC for its [***] pursuant to Section 3.1.5(k) (Specific Responsibilities of the JSC), including a synopsis further development of the Development activities related Area following the Term is desirable, Company shall notify Subfranchisor in writing at least [NUMBER OF MONTHS] prior to such Additional Development, the potential role expiration of the non-Proposing Party with respect Term, of Company's intention to such Additional Development, develop additional [FRANCHISED BUSINESSES] in the timeline Development Area and deliver a plan for such Additional Developmentdevelopment over a five-year-period. Subject to the conditions set forth in Section 2.2 of this Agreement, Subfranchisor shall have a prior right to undertake the additional development which Company shall have set forth in its notice to Subfranchisor, which right of additional development shall be exercised only in accordance with Section 2.3. Such right of additional development by Subfranchisor shall arise upon the expiration of each successive Master Franchise agreement between Company and Subfranchisor for so long as Company concludes that development of additional [FRANCHISED BUSINESSES] is commercially appropriate in the estimated costs associated with such Additional DevelopmentDevelopment Area. Notwithstanding Subject to the foregoingrights of first refusal set forth in subparagraph (a) below, if a Regulatory Authority in a country such right of additional development is not exercised by Subfranchisor, Company or jurisdiction its nominee(s) may construct, equip, open and operate additional [FRANCHISED BUSINESSES] in the Territory requires a New Formulation for a Licensed Product in order for such Regulatory Authority to grant Regulatory Approval for such Licensed Product in an Initial Indication in such country or jurisdiction, then all Development related to such New Formulation will not be Additional Development and instead will be conducted as Territory-Specific Development pursuant to Section 4.2 (Territory-Specific Development). 4.3.1 [***] Additional DevelopmentArea upon the expiration of the Term. (a) JSC If Company shall have notified Subfranchisor prior to the expiration of the Term that further development of the Development Area is not then desirable, Company's right to construct, equip, open and operate additional [***FRANCHISED BUSINESSES] in the Development Area, or to license any third party to do so, shall be subject to the Subfranchisor's right of first refusal with respect thereto, which shall be exercised, if at all, in the following manner: (i) In the case any additional [FRANCHISED BUSINESSES] are to be developed by the Company, Company shall serve upon Subfranchisor a written notice setting forth the proposed location of the [FRANCHISED BUSINESS]; , and two (2) copies of the Company's then current form of Franchise Agreement. If the JSC [***] any Additional Development as Other Global Development and both Parties agree Subfranchisor shall have thirty (30) days following Company's service of such notice within which to participate in such Additional Development, then the Parties will enter into a co-lease for the Location and to execute and return both copies of the Franchise Agreement to Company in the manner described in Section 5.4 below, together with the franchise fee payable with respect thereto. If Subfranchisor shall fail to exercise its said right of first refusal, as aforesaid, Company may thereafter open [FRANCHISED BUSINESS] at such location. (ii) With respect to any proposed area development agreement (pursuant to which the Company grants the right to open, but not subfranchise, two (2) or more Franchises within a defined development area), or Master Franchise agreement (pursuant to which the Company grants the right to open, or subfranchise others to open, two (2) or more Franchises within a defined development area), Company shall serve upon Subfranchisor a written notice of its intention to enter into such agreement, together with two copies of the proposed area development or Master Franchise agreement, as applicable. Subfranchisee shall have the right, thirty (30) days following the Company's service of such notice, to execute and return to Company both copies of the proposed area development or Master Franchise agreement, together with any fees payable to Company pursuant to the terms thereof. If Subfranchisor has satisfied the conditions described in Section 2.2, Company shall execute and return one (1) copy of the area development or Master Franchise agreement to Subfranchisor. If Subfranchisor fails to exercise its right of first refusal as aforesaid, or fails to satisfy the conditions described in Section 2.3, Company may thereafter enter into an amendment to this Agreementarea development or Master Franchise agreement, with such third party. (iii) regarding such Additional Development, including the allocation The Subfranchisor's rights of costs and responsibilities related to such Additional Development and the reporting of information regarding such Additional Developmentfirst refusal described herein shall be effective only if, and each Party will receive for so long as, a right of reference management agreement is in effect between Company and Subfranchisor pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated from such Additional Development for the purposes of obtaining Regulatory Approval and Commercializing the Licensed Product in its territory. If the JSC [***] any Additional Development as new Territory-Specific Development and [***] agrees to conduct such Additional Development, then [***] will receive a right of reference pursuant to Section 5.5 (Rights of Reference; Further Assurances) to the data generated from such Additional Development for the purposes of [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. obtaining Regulatory Approval and Commercializing the Licensed Product outside of the Territory6.5 below. (b) JSC [***];

Appears in 1 contract

Samples: Master Franchise Agreement

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