Additional Development. If either Party proposes to conduct additional Development of a Product in the Field beyond the Initial Indication Development performed pursuant to Section 4.1(a), including Development of Product for any Additional Indication or label expansion or modification (“Additional Development”) for (a) the purpose of seeking Regulatory Approval both in and outside the Territory (“Global Additional Development”) or (b) the purpose of seeking Regulatory Approval solely in the Territory (“Territory Additional Development”), then the proposing Party shall provide the other Party with a written proposal of such Additional Development (the “Additional Development Proposal”), 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 anticipated timeline for such Additional Development, the proposed clinical trial protocols or designs, if applicable, the estimated costs associated with such Additional Development, and, in the case of Global Additional Development, the proposed cost allocation between each Party’s territory taking into account the respective value of such Development to each Party’s territory (including, with respect to an Additional Indication, the anticipated market value of such Additional Indication using sales data provided by IQVIA or similar Third Party provider) (“Cost Allocation”). For clarity, Global Additional Development does not include any Additional Clinical Trial or other Development that is required solely by a Regulatory Authority or Applicable Laws for obtaining Regulatory Approval in one Party’s territory and is not required by Regulatory Authorities or Applicable Laws for obtaining Regulatory Approvals both within and outside the Territory. (i) Within thirty (30) days of receipt of an Additional Development Proposal, the JSC shall meet to review the Additional Development Proposal and to permit the non-proposing Party an opportunity to ask questions and request additional information from the proposing Party related to the Additional Development Proposal, including whether such Proposal is reasonably likely to have a material adverse effect on obtaining or maintaining Regulatory Approval of any Product or Commercializing any Product, in either case, in the non-proposing Party’s territory. The non-proposing Party shall be given the opportunity to (a) comment on the Additional Development Proposal to ensure the study design for a Global Additional Development meets the regulatory requirements of respective Regulatory Authorities, and (b) seek appropriate scientific advice from relevant Regulatory Authorities to ensure the results of the Additional Development Proposal would be sufficient for purposes of a Regulatory Filing in relevant territories.
Appears in 1 contract
Samples: License and Collaboration Agreement (Catalyst Pharmaceuticals, Inc.)
Additional Development. If either (i) Either Party proposes may at any time submit to conduct additional the Development Committee a written proposal for Additional Development, including development of an Additional Indication or Improvement. Such proposal shall contain, at a minimum, commercially reasonable information supporting the rationale for such development from a scientific, regulatory and commercial standpoint, as well as an estimated developmental critical path and an estimate of the time, cost and economic or other benefit of such efforts. In considering whether to recommend to the Steering Committee approval of such proposal for Additional Development, the Development Committee shall evaluate whether the proposed program has scientific and technical merit and is likely to result in the approval of a new indication or dosage amount of Product, or is advisable to address safety or efficacy issues and/or, in concert with the Marketing Committee, whether the commercial return from sales of Product in the Field beyond Territory that may result from such development can reasonably be expected to offset the Initial Indication cost of development within a reasonable period of time, and shall evaluate which Party should conduct such development. If any such Additional Development performed pursuant is approved by the Steering Committee, the Development Committee shall promptly determine a development plan and budget for such development including, without limitation the estimated cost and scope of work necessary for obtaining any required FDA Approval and the Parties shall promptly meet to Section 4.1(adetermine whether the Parties can reach mutually acceptable terms for such development, taking into consideration the provisions of the following subsections 4.1 (c) (ii), including (iii) and (iv).
(ii) It is currently the expectation of the Parties that:
(1) with respect to any Additional Development under section 4.1(c) approved by the Steering Committee and conducted during the Copromotion Period, the costs and expenses associated with such development shall be deemed Product Expenses; provided, however, that (A) if the Launch Date of any Product for resulting from such development occurs during the Copromotion Period, the provisions of Section 6.3 shall apply to such Product, and (B) if the Launch Date of any Product resulting from such development occurs during the License Period, Indevus shall be entitled to reimbursement from Odyssey of costs and expenses associated with such development and included in the budget established by the Development Committee, and the provisions of Section 6.4 shall apply to such Product; and
(2) subject to an agreement by the Parties to the contrary, with respect to any Additional Development relating to an Additional Indication or label expansion Improvement approved by both Parties and conducted during the License Period, the costs and expenses associated with such Additional Indication or modification Improvement shall be the responsibility of and be paid by Odyssey and the provisions of Section 6.4 shall apply to any Product resulting from such Additional Indication or Improvement.
(“iii) Notwithstanding any provision of this Agreement, Indevus and Odyssey each shall have unilateral discretion to determine if it wants to participate in the funding of any Additional Development”, provided, however, that if the Parties cannot reach mutually acceptable terms for any such Additional Development then (A) for if such Additional Development was presented to the Development Committee during the Copromotion Period, neither Party may develop or pursue such Additional Indication, and (aB) if such Additional Development was presented to the purpose Development Committee during the License Period, Indevus (but not Odyssey) may exclusively so develop and/or commercialize any Product resulting from such development and any such Product shall not be subject to the terms of seeking Regulatory Approval both in and outside this Agreement, subject to the Territory provisions of subsection 4.1 (“Global c) (iv).
(iv) In the event that (A) any Additional Development”Development is presented to the Development Committee; (B) or (b) the purpose of seeking Regulatory Approval solely Odyssey does not elect to participate in the Territory (“Territory Additional Development”), then the proposing Party shall provide the other Party with a written proposal funding of such Additional Development within sixty (60) days after such proposal is presented to the “Development Committee; and (C) Indevus funds such development, then as soon as reasonably practicable after additional material information or data supporting the proof of concept for the Additional Development Proposal”)is available, including Indevus shall submit such data to Odyssey and Odyssey shall have a synopsis subsequent option to participate in the funding of and obtain rights to any product resulting from such Additional Development on terms and conditions to be negotiated in good faith by the Development activities related Parties within ninety (90) days after providing such additional information or data. Such terms shall include provisions for financial compensation to Indevus, which may include reimbursement of development expenses, milestones and royalties, and such other financial and other material terms relating to the development and commercialization of any product subject to such Additional Development, Development as may be negotiated between the potential role of the non-Proposing Party with respect to such Additional Development, the anticipated timeline for such Additional Development, the proposed clinical trial protocols or designs, if applicable, the estimated costs associated with such Additional Development, and, in the case of Global Additional Development, the proposed cost allocation between each Party’s territory taking into account the respective value of such Development to each Party’s territory (including, with respect to an Additional Indication, the anticipated market value of such Additional Indication using sales data provided by IQVIA or similar Third Party provider) (“Cost Allocation”). For clarity, Global Additional Development does not include any Additional Clinical Trial or other Development that is required solely by a Regulatory Authority or Applicable Laws for obtaining Regulatory Approval in one Party’s territory and is not required by Regulatory Authorities or Applicable Laws for obtaining Regulatory Approvals both within and outside the Territory. (i) Within thirty (30) days of receipt of an Additional Development Proposal, the JSC shall meet to review the Additional Development Proposal and to permit the non-proposing Party an opportunity to ask questions and request additional information from the proposing Party related to the Additional Development Proposal, including whether such Proposal is reasonably likely to have a material adverse effect on obtaining or maintaining Regulatory Approval of any Product or Commercializing any Product, in either case, in the non-proposing Party’s territory. The non-proposing Party shall be given the opportunity to (a) comment on the Additional Development Proposal to ensure the study design for a Global Additional Development meets the regulatory requirements of respective Regulatory Authorities, and (b) seek appropriate scientific advice from relevant Regulatory Authorities to ensure the results of the Additional Development Proposal would be sufficient for purposes of a Regulatory Filing in relevant territoriesParties.
Appears in 1 contract
Additional Development. If either (a) Either Party proposes may at any time submit to conduct additional Development the Oversight Committee a written proposal for Additional Development. Such proposal shall contain, at a minimum, commercially reasonable information supporting the rationale for such development from a scientific, regulatory and commercial standpoint, as well as an estimated developmental critical path and an estimate of a the time, cost and economic or other benefit of such efforts. In considering whether to recommend approval of such proposal for Additional Development, the Oversight Committee shall evaluate factors whether the proposed program (i) relates to an Additional Indication or an Improvement to an Additional indication; (ii) has scientific and technical merit and is likely to result in the approval at least by the FDA and Regulatory Authorities in the Major European Countries of such Improvement to Additional Indication or Additional Indication, (iii) is advisable to address safety or efficacy issues, (iv) whether the commercial return from sales of Licensed Product in the Field beyond in the Initial Indication Territory that may result from such proposed Additional Development performed pursuant can reasonably be expected to Section 4.1(a)offset the cost of development within a reasonable period of time, including Development of Product for and (v) any Additional Indication or label expansion or modification (“other factors relevant to a determination as to whether to pursue such Additional Development”) for (a) the purpose of seeking Regulatory Approval both in and outside the Territory (“Global Additional Development”) or .
(b) the purpose of seeking Regulatory Approval solely in the Territory (“Territory Additional Development”), then the proposing Party shall provide the other Party with a written proposal of If any such Additional Development is approved by the Oversight Committee, the Oversight Committee shall promptly determine a development plan and budget for such development including the estimated cost and scope of work necessary for obtaining any required approval by the FDA in the United States and/or approval by Regulatory Authorities in the Territory. Upon receipt of such plan and budget, the Parties shall promptly meet to determine whether the Parties can reach mutually acceptable terms for (i) conducting, administering and funding such development (taking into consideration the “provisions of the following subsections 3.1.3 (c) and (d)); (ii) if such Additional Development Proposal”), 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 anticipated timeline for such Additional Development, the proposed clinical trial protocols or designs, if applicable, the estimated costs associated with such Additional Development, and, in the case of Global Additional Development, the proposed cost allocation between each Party’s territory taking into account the respective value of such Development to each Party’s territory (including, with respect relates to an Additional Indication, and Orion desires to obtain rights under this Agreement in the anticipated market value Territory to any product resulting therefrom or for use in such Additional Indication, financial compensation to Indevus, if any, which may include milestone payments associated with the development and commercialization of any product for an Additional Indication; (iii) a new supply price for the supply of Bulk Drug Product and/or Insertion Tools associated with clinical development and commercial use of any product incorporating or resulting from such Additional Development; and/or (iv) such other financial and other material terms relating to the development and commercialization of any product incorporating or resulting from such Additional Development as may be negotiated between the Parties.
(c) Notwithstanding any provision of this Agreement, Indevus and Orion each shall have unilateral discretion to determine if it wants to participate in the funding of any Additional Development; provided, however, that (i) if the Parties cannot reach mutually acceptable terms for the funding of any such Additional Development then Indevus (but not Orion) may exclusively so develop and/or commercialize any product resulting from such development and, unless such product incorporates an Improvement to an Additional Indication that has previously been agreed by the Parties to be a Licensed Product, any such product shall not be deemed a Licensed Product or otherwise included in the license granted to Orion under this Agreement, and such indication shall not be deemed an Additional Indication, subject to the provisions of subsection 3.1.3(d); and (ii) Orion’s share of development costs for any Additional Development, if Orion has decided to participate in the funding, shall be calculated based on the Territory’s [***] of Licensed Product for the Additional Indication.
(d) In the event that (i) any Additional Development is presented to the Oversight Committee; (ii) Orion does not elect to participate in the funding of such Additional Indication using sales Development within [***] days after such proposal is presented to the Oversight Committee; and (iii) Indevus funds such development, then as soon as reasonably practicable after additional material information or data provided by IQVIA or similar Third Party provider) (“Cost Allocation”). For clarity, Global Additional Development does not include any Additional Clinical Trial or other Development that is required solely by a Regulatory Authority or Applicable Laws supporting the proof of concept for obtaining Regulatory Approval in one Party’s territory and is not required by Regulatory Authorities or Applicable Laws for obtaining Regulatory Approvals both within and outside the Territory. (i) Within thirty (30) days of receipt of an Additional Development Proposal, the JSC shall meet to review the Additional Development Proposal is available, Indevus shall submit such data to Orion and Orion shall have a subsequent option to permit participate in the non-proposing Party an opportunity funding of and obtain rights under this Agreement in the Territory to ask questions any product resulting from such Additional Development on terms and request conditions to be negotiated in good faith by the Parties within [***] days after providing such additional information from or data or until a mutually agreed extension of said deadline. Such terms shall include provisions for financial compensation to Indevus, if any, which may include participation in and/or reimbursement of development expenses, milestone payments associated with the proposing Party related development and commercialization of any such product for an Additional Indication, a new supply price for the supply of such product, and/or such other financial and other material terms relating to the Additional Development Proposal, including whether such Proposal is reasonably likely to have a material adverse effect on obtaining or maintaining Regulatory Approval development and commercialization of any Product or Commercializing any Product, in either case, in the non-proposing Party’s territory. The non-proposing Party shall be given the opportunity to (a) comment on the Additional Development Proposal to ensure the study design for a Global Additional Development meets the regulatory requirements of respective Regulatory Authorities, and (b) seek appropriate scientific advice from relevant Regulatory Authorities to ensure the results of the Additional Development Proposal would be sufficient for purposes of a Regulatory Filing in relevant territoriesproduct.
Appears in 1 contract
Samples: License, Supply and Distribution Agreement (Indevus Pharmaceuticals Inc)
Additional Development. If either Party proposes to conduct additional Development of a Product in the Field beyond the Initial Indication Development performed pursuant to Section 4.1(a), including Development of Product for any Additional Indication or label expansion or modification (“Additional Development”) for (a) the purpose of seeking Regulatory PMDA or the MHLW requires any Additional First Approval both in and outside the Territory (“Global Additional Development”) , or (b) either Party desires that BioCryst conduct any Additional Essential Element Expansion Development or Additional Label Expansion Development, then, in each case ((a) and (b)), the purpose Parties will discuss such activities at the JSC and Torii will have the right to elect, in its sole discretion, by providing written notice to BioCryst no later than [***] after Torii receives from BioCryst the estimated internal costs (at the FTE Rate) and external expenses to be incurred by or on behalf of seeking Regulatory Approval solely BioCryst in the Territory (“Territory performance of such required Additional Development”, to either: (i) terminate this Agreement pursuant to Section 13.2.1(a), or (ii) to have BioCryst conduct such activities in accordance with the terms of this Agreement and to reimburse BioCryst for the applicable share of the Additional Development Costs set forth in this Section 4.1.3 (Additional Development) such that Torii would reimburse BioCryst for (A) [***] of all Additional First Approval Costs or Additional Essential Element Expansion Cost and (B) [***] of all Additional Label Expansion Costs, in each case ((A) and (B)), subject to Section 8.3.3(c) (Reductions for Additional Development). If Torii does not provide such notice to BioCryst within such [***] period, then Torii will be deemed to have elected to share the applicable Additional Development Costs as set forth in this Section 4.1.3 (Additional Development) and Section 8.3.3(c) (Reductions for Additional Development). If Torii elects (or is deemed to have elected) to share the Additional Development Costs with BioCryst pursuant to the foregoing clause (b), then the proposing Party shall provide the other Party with a written proposal of such Additional Development (the “Additional Development Proposal”), 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 anticipated timeline BioCryst will invoice Torii for such Additional Development, the proposed clinical trial protocols or designs, if applicable, the estimated costs associated with such Additional Development[***], and, in each case, Torii will pay the case undisputed invoiced amounts within [***] after the date of Global the invoice. Torii may deduct from future Transfer Price Payments payable to BioCryst pursuant to Section 8.3 (Transfer Price Payments to BioCryst) amounts reimbursed to BioCryst as Additional Development Costs in accordance with Section 8.3.3(c) (Reductions for Additional Development, the proposed cost allocation between each Party’s territory taking into account the respective value of such Development to each Party’s territory (including, with respect to an Additional Indication, the anticipated market value of such Additional Indication using sales data provided by IQVIA or similar Third Party provider) (“Cost Allocation”). For clarity, Global Additional Development does not include any Additional Clinical Trial or other Development that is required solely by a Regulatory Authority or Applicable Laws for obtaining Regulatory Approval in one Party’s territory and is not required by Regulatory Authorities or Applicable Laws for obtaining Regulatory Approvals both within and outside the Territory. (i) Within thirty (30) days of receipt of an Additional Development Proposal, the JSC shall meet to review the Additional Development Proposal and to permit the non-proposing Party an opportunity to ask questions and request additional information from the proposing Party related to the Additional Development Proposal, including whether such Proposal is reasonably likely to have a material adverse effect on obtaining or maintaining Regulatory Approval of any Product or Commercializing any Product, in either case, in the non-proposing Party’s territory. The non-proposing Party shall be given the opportunity to (a) comment on the Additional Development Proposal to ensure the study design for a Global Additional Development meets the regulatory requirements of respective Regulatory Authorities, and (b) seek appropriate scientific advice from relevant Regulatory Authorities to ensure the results of the Additional Development Proposal would be sufficient for purposes of a Regulatory Filing in relevant territories.
Appears in 1 contract
Samples: Commercialization and License Agreement (Biocryst Pharmaceuticals Inc)
Additional Development. If either (a) Either Party proposes may at any time submit to conduct additional Development the Oversight Committee a written proposal for Additional Development. Such proposal shall contain, at a minimum, commercially reasonable information supporting the rationale for such development from a scientific, regulatory and commercial standpoint, as well as an estimated developmental critical path and an estimate of a the time, cost and economic or other benefit of such efforts. In considering whether to recommend approval of such proposal for Additional Development, the Oversight Committee shall evaluate factors whether the proposed program (i) relates to an Additional Indication or an Improvement to an Additional indication; (ii) has scientific and technical merit and is likely to result in the approval at least by the FDA and Regulatory Authorities in the Major European Countries of such Improvement to Additional Indication or Additional Indication, (iii) is advisable to address safety or efficacy issues, (iv) whether the commercial return from sales of Licensed Product in the Field beyond in the Initial Indication Territory that may result from such proposed Additional Development performed pursuant can reasonably be expected to Section 4.1(a)offset the cost of development within a reasonable period of time, including Development of Product for and (v) any Additional Indication or label expansion or modification (“other factors relevant to a determination as to whether to pursue such Additional Development”) for (a) the purpose of seeking Regulatory Approval both in and outside the Territory (“Global Additional Development”) or .
(b) the purpose of seeking Regulatory Approval solely in the Territory (“Territory Additional Development”), then the proposing Party shall provide the other Party with a written proposal of If any such Additional Development is approved by the Oversight Committee, the Oversight Committee shall promptly determine a development plan and budget for such development including the estimated cost and scope of work necessary for obtaining any required approval by the FDA in the United States and/or approval by Regulatory Authorities in the Territory. Upon receipt of such plan and budget, the Parties shall promptly meet to determine whether the Parties can reach mutually acceptable terms for (i) conducting, administering and funding *** CONFIDENTIAL TREATMENT REQUESTED such development (taking into consideration the “provisions of the following subsections 3.1.3 (c) and (d)); (ii) if such Additional Development Proposal”), 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 anticipated timeline for such Additional Development, the proposed clinical trial protocols or designs, if applicable, the estimated costs associated with such Additional Development, and, in the case of Global Additional Development, the proposed cost allocation between each Party’s territory taking into account the respective value of such Development to each Party’s territory (including, with respect relates to an Additional Indication, and Orion desires to obtain rights under this Agreement in the anticipated market value Territory to any product resulting therefrom or for use in such Additional Indication, financial compensation to Indevus, if any, which may include milestone payments associated with the development and commercialization of any product for an Additional Indication; (iii) a new supply price for the supply of Bulk Drug Product and/or Insertion Tools associated with clinical development and commercial use of any product incorporating or resulting from such Additional Development; and/or (iv) such other financial and other material terms relating to the development and commercialization of any product incorporating or resulting from such Additional Development as may be negotiated between the Parties.
(c) Notwithstanding any provision of this Agreement, Indevus and Orion each shall have unilateral discretion to determine if it wants to participate in the funding of any Additional Development; provided, however, that (i) if the Parties cannot reach mutually acceptable terms for the funding of any such Additional Development then Indevus (but not Orion) may exclusively so develop and/or commercialize any product resulting from such development and, unless such product incorporates an Improvement to an Additional Indication that has previously been agreed by the Parties to be a Licensed Product, any such product shall not be deemed a Licensed Product or otherwise included in the license granted to Orion under this Agreement, and such indication shall not be deemed an Additional Indication, subject to the provisions of subsection 3.1.3(d); and (ii) Orion’s share of development costs for any Additional Development, if Orion has decided to participate in the funding, shall be calculated based on the Territory’s [***] of Licensed Product for the Additional Indication.
(d) In the event that (i) any Additional Development is presented to the Oversight Committee; (ii) Orion does not elect to participate in the funding of such Additional Indication using sales Development within [***] days after such proposal is presented to the Oversight Committee; and (iii) Indevus funds such development, then as soon as reasonably practicable after additional material information or data provided by IQVIA or similar Third Party provider) (“Cost Allocation”). For clarity, Global Additional Development does not include any Additional Clinical Trial or other Development that is required solely by a Regulatory Authority or Applicable Laws supporting the proof of concept for obtaining Regulatory Approval in one Party’s territory and is not required by Regulatory Authorities or Applicable Laws for obtaining Regulatory Approvals both within and outside the Territory. (i) Within thirty (30) days of receipt of an Additional Development Proposal, the JSC shall meet to review the Additional Development Proposal is available, Indevus shall submit such data to Orion and Orion shall have a subsequent option to permit participate in the non-proposing Party an opportunity funding of and obtain rights under this Agreement in the Territory to ask questions any product resulting from such Additional Development on terms and request conditions to be negotiated in good faith by the Parties within [***] days after providing such additional information from or data or until a mutually agreed extension of said deadline. Such terms shall include provisions for financial compensation to Indevus, if any, which may include *** CONFIDENTIAL TREATMENT REQUESTED participation in and/or reimbursement of development expenses, milestone payments associated with the proposing Party related development and commercialization of any such product for an Additional Indication, a new supply price for the supply of such product, and/or such other financial and other material terms relating to the Additional Development Proposal, including whether such Proposal is reasonably likely to have a material adverse effect on obtaining or maintaining Regulatory Approval development and commercialization of any Product or Commercializing any Product, in either case, in the non-proposing Party’s territory. The non-proposing Party shall be given the opportunity to (a) comment on the Additional Development Proposal to ensure the study design for a Global Additional Development meets the regulatory requirements of respective Regulatory Authorities, and (b) seek appropriate scientific advice from relevant Regulatory Authorities to ensure the results of the Additional Development Proposal would be sufficient for purposes of a Regulatory Filing in relevant territoriesproduct.
Appears in 1 contract
