Common use of Additional Development Clause in Contracts

Additional Development. (i) Either Party may at any time submit to 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 Territory that may result from such development can reasonably be expected to offset the cost of development within a reasonable period of time, and shall evaluate which Party should conduct such development. If any such Additional Development 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 determine whether the Parties can reach mutually acceptable terms for such development, taking into consideration the provisions of the following subsections 4.1 (c) (ii), (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 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 Improvement approved by both Parties and conducted during the License Period, the costs and expenses associated with such Additional Indication or 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) if such Additional Development was presented to the Development Committee during the Copromotion Period, neither Party may develop or pursue such Additional Indication, and (B) if such Additional Development was presented to the 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 this Agreement, subject to the provisions of subsection 4.1 (c) (iv). (iv) In the event that (A) any Additional Development is presented to the Development Committee; (B) Odyssey does not elect to participate in the 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 is available, Indevus shall submit such data to Odyssey and Odyssey shall have a 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 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 as may be negotiated between the Parties.

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 (i“Additional Development”) Either 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 may at any time submit to shall provide the Development Committee other Party with a written proposal for of such Additional DevelopmentDevelopment (the “Additional Development Proposal”), 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 synopsis of the time, cost and economic or other benefit of Development activities related to 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 Territory that may result from such development can reasonably be expected to offset the cost of development within a reasonable period of time, and shall evaluate which Party should conduct such development. If any such Additional Development 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 determine whether the Parties can reach mutually acceptable terms for such development, taking into consideration the provisions potential role of the following subsections 4.1 (c) (ii), (iii) and (iv). (ii) It is currently the expectation of the Parties that: (1) non-Proposing Party with respect to any such Additional Development under section 4.1(c) approved by the Steering Committee and conducted during the Copromotion PeriodDevelopment, the anticipated timeline for such Additional Development, the proposed clinical trial protocols or designs, if applicable, the estimated costs and expenses associated with such development shall be deemed Product Expenses; providedAdditional Development, howeverand, that (A) if in the Launch Date case of any Product resulting from such development occurs during the Copromotion PeriodGlobal Additional Development, the provisions proposed cost allocation between each Party’s territory taking into account the respective value of Section 6.3 shall apply such Development to such Product, and each Party’s territory (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 contraryincluding, with respect to any Additional Development relating to an Additional Indication or Improvement approved by both Parties and conducted during the License PeriodIndication, the costs and expenses associated with anticipated market value of such Additional Indication using sales data provided by IQVIA or Improvement 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 responsibility of and be paid by Odyssey and opportunity to (a) comment on 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) if such Proposal to ensure the study design for a Global Additional Development was presented to meets the Development Committee during the Copromotion Period, neither Party may develop or pursue such Additional Indicationregulatory requirements of respective Regulatory Authorities, and (Bb) if such Additional Development was presented seek appropriate scientific advice from relevant Regulatory Authorities to ensure the 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 results of this Agreement, subject to the provisions of subsection 4.1 (c) (iv). (iv) In the event that (A) any Additional Development is presented to the Development Committee; (B) Odyssey does not elect to participate in the 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 is available, Indevus shall submit such data to Odyssey and Odyssey shall have Proposal would be sufficient for purposes of a subsequent option to participate Regulatory Filing 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 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 as may be negotiated between the Partiesrelevant territories.

Additional Development. (ia) Either Party may at any time submit to the Development Oversight 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 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 a new indication such Improvement to Additional Indication or dosage amount of ProductAdditional Indication, or (iii) is advisable to address safety or efficacy issues and/orissues, in concert with the Marketing Committee, (iv) whether the commercial return from sales of Licensed Product in the Field in the Territory that may result from such development proposed Additional Development can reasonably be expected to offset the cost of development within a reasonable period of time, and shall evaluate which Party should conduct (v) any other factors relevant to a determination as to whether to pursue such development. Additional Development. (b) If any such Additional Development is approved by the Steering Oversight Committee, the Development Oversight Committee shall promptly determine a development plan and budget for such development including, without limitation including the estimated cost and scope of work necessary for obtaining any required approval by the FDA Approval 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, development (taking into consideration the provisions of the following subsections 4.1 3.1.3 (c) and (d)); (ii)) if such Additional Development relates to an Additional Indication, and Orion desires to obtain rights under this Agreement in the 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) and (iv). (ii) It is currently a new supply price for the expectation supply 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 Bulk Drug Product and/or Insertion Tools associated with such clinical development shall be deemed Product Expenses; provided, however, that (A) if the Launch Date and commercial use of any Product 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 product incorporating or Improvement approved by both Parties and conducted during the License Period, the costs and expenses associated with such Additional Indication or 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 Development; and/or (iv) such other financial and other material terms relating to the development and commercialization of any product incorporating or Improvementresulting from such Additional Development as may be negotiated between the Parties. (iiic) Notwithstanding any provision of this Agreement, Indevus and Odyssey 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 (A) if such Additional Development was presented to the Development Committee during the Copromotion Period, neither Party may develop or pursue such Additional Indication, and (B) if such Additional Development was presented to the Development Committee during the License Period, Indevus (but not OdysseyOrion) may exclusively so develop and/or commercialize any Product product resulting from such development and 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 product shall not be subject deemed a Licensed Product or otherwise included in the license granted to the terms of Orion under this Agreement, and such indication shall not be deemed an Additional Indication, subject to the provisions of subsection 4.1 3.1.3(d); and (cii) (iv)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. (ivd) In the event that (Ai) any Additional Development is presented to the Development Oversight Committee; (Bii) Odyssey Orion does not elect to participate in the funding of such Additional Development within sixty (60) [***] days after such proposal is presented to the Development Oversight Committee; and (Ciii) 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 is available, Indevus shall submit such data to Odyssey Orion and Odyssey Orion shall have a subsequent option to participate in the funding of and obtain rights under this Agreement in the Territory to any product resulting from such Additional Development on terms and conditions to be negotiated in good faith by the Parties within ninety (90) [***] days after providing such additional information or datadata 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, milestones milestone payments associated with the development and royaltiescommercialization of any such product for an Additional Indication, and a new supply price for the supply of such product, and/or such other financial and other material terms relating to the development and commercialization of any product subject to such Additional Development as may be negotiated between the Partiesproduct.

Additional Development. If either Party (ithe “Proposing Party”) Either 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 may at any time submit 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 Committee 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 written proposal 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 development the allocation of an costs and responsibilities related to such Additional Indication or Improvement. Such proposal shall contain, at a minimum, commercially reasonable Development and the reporting of information supporting the rationale for regarding 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 each Party will receive a right of reference pursuant to result in the approval Section 5.5 (Rights 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 Territory that may result from such development can reasonably be expected to offset the cost of development within a reasonable period of time, and shall evaluate which Party should conduct such development. If any such Additional Development 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 determine whether the Parties can reach mutually acceptable terms for such development, taking into consideration the provisions of the following subsections 4.1 (cReference; Further Assurances) (ii), (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 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 Improvement approved by both Parties and conducted during the License Period, the costs and expenses associated with such Additional Indication or 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) if such Additional Development was presented to the Development Committee during the Copromotion Period, neither Party may develop or pursue such Additional Indication, and (B) if such Additional Development was presented to the 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 this Agreement, subject to the provisions of subsection 4.1 (c) (iv). (iv) In the event that (A) any Additional Development is presented to the Development Committee; (B) Odyssey does not elect to participate in the 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 is available, Indevus shall submit such data to Odyssey and Odyssey shall have a subsequent option to participate in the funding of and obtain rights to any product resulting generated from such Additional Development on terms for the purposes of obtaining Regulatory Approval and conditions Commercializing the Licensed Product in its territory. If the JSC [***] any Additional Development as new Territory-Specific Development and [***] agrees to be negotiated in good faith by the Parties within ninety conduct such Additional Development, then [***] will receive a right of reference pursuant to Section 5.5 (90Rights of Reference; Further Assurances) 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 data generated from such Additional Development as may be negotiated between for the Partiespurposes 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 [***];