Common use of Amendments to the Development Plan Clause in Contracts

Amendments to the Development Plan. (i) On an annual basis (no later than October 31st of the preceding Calendar Year), or more often as the Parties deem appropriate, the JDC shall prepare amendments to the then-current Development Plan and Development Budget for approval of the JSC. Each such amended Development Plan shall specify, with a reasonable level of detail, the items described in Section 3.2(a). Such amended Development Plan shall cover the next Calendar Year (and additional periods as reasonably determined by the Parties) and shall contain a corresponding budget for U.S. activities. Such updated and amended Development Plan shall reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to the then-current Development Plan. In addition, the JDC may prepare amendments for approval of the JSC to the Development Plan and corresponding Development Budget from time to time during the Calendar Year in order to reflect changes in such plan and budget for such Calendar Year, in each case, in accordance with the foregoing. At the request of either Party, but no more frequently than quarterly, the JDC shall review the Development Budget and propose any necessary amendments to the JSC for approval. Once approved by the JSC, the amended annual Development Plan and Development Budget shall become effective for the applicable period on the date approved by the JSC (or such other date as the JSC shall specify). Any JSC-approved amended Development Plan and Development Budget shall supersede the previous Development Plan and Development Budget for the applicable period. (ii) Each Party shall notify the other Party promptly upon becoming aware that it is likely to exceed, or has exceeded, the budget for a particular activity for U.S. Development of the Product allocated to such Party in the Development Plan. Thereafter, the JDC shall promptly meet and determine whether to amend the Development Plan or Development Budget accordingly, provided that the JDC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control or that the Parties agree includes expenses reasonably incurred in the performance of the Development Plan. Any such amendment proposed by the JDC shall not be subject to the JSC’s review and will be deemed automatically approved by the JSC, unless such amendment would cause the total Development Costs incurred by a Party in any Calendar Year to exceed [*] percent ([*]%) of the budgeted Development Costs for such Party in such Calendar Year, in which event JSC approval will be required; provided that the JSC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control and that the Parties agree includes expenses reasonably incurred in the performance of the Development Plan.

Amendments to the Development Plan. (iA) On an annual basis (no later than October 31st of the preceding Once per Calendar Year)Quarter, or more often as the Parties deem Board deems appropriate, the JDC shall Product Development Subcommittee will review the then-current Development Plan (including the Development Budget) and if deemed appropriate prepare amendments to the then-current Development Plan and the corresponding Development Budget and submit such amendments for approval of the JSCBoard. Each Once approved by the Board, such amended Development Plan shall specify, with a reasonable level of detail, will cover the items described in Section 3.2(a). Such amended Development Plan shall cover remaining current Calendar Year and the next Calendar Year (and additional periods as reasonably determined by or such period that the PartiesBoard will determine) and shall will contain a corresponding budget Development Budget, which will appropriately itemize the costs separately for U.S. activitieseach Product. Such updated and amended Development Plan shall will reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to the then-current Development Plan. In addition, the JDC may Product Development Subcommittee may, of its own accord, prepare amendments for approval of the JSC to the Development Plan and corresponding (including amendments to the Development Budget therein) for the Board’s approval from time to time during the a Calendar Year in order to reflect changes in such plan and budget for such Calendar Year and the next Calendar Year, in each case, in accordance with the foregoing. At the request of either Party, but no more frequently than quarterly, the JDC shall review the Development Budget and propose any necessary amendments to the JSC for approval. Once approved by the JSCBoard, the amended annual Development Plan and (including amendments to the Development Budget shall therein) will become effective for the applicable period on the date approved by the JSC Board (or such other date as the JSC shall Board will specify). Any JSCBoard-approved amended Development Plan and (including the Development Budget shall therein) will supersede the previous Development Plan and Development Budget for the applicable period. (iiB) Each Party shall notify Subject to Section 3.2.5(iv), in the other Party promptly upon becoming aware event that it is likely to exceed, or has exceeded, the budget for a particular activity for U.S. Development of the Product allocated Development Subcommittee cannot reach agreement on an amended Development Plan to such Party be submitted to the Board in accordance with this Section 3.2.5(iii), it will inform the Board of its inability to make a decision and the Board will proceed with finalizing the Development Plan without the Product Development Subcommittee’s recommendation. If the Board is unable to agree on amendments to the Development Plan. Thereafter, the JDC shall promptly meet and determine whether to amend the then-current Development Plan or Development Budget accordinglywill remain in force until such time as an amended plan is adopted in accordance with the terms of this Agreement and, provided that the JDC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control or that the Parties agree includes expenses reasonably incurred in the performance of the Development Plan. Any such amendment proposed by the JDC shall not be subject to the JSC’s review and extent applicable, the provisions of Section 7.6 will be deemed automatically approved by the JSC, unless such amendment would cause the total Development Costs incurred by a Party in any Calendar Year to exceed [*] percent ([*]%) of the budgeted Development Costs for such Party in such Calendar Year, in which event JSC approval will be required; provided that the JSC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control and that the Parties agree includes expenses reasonably incurred in the performance of the Development Planapply.

Amendments to the Development Plan. (iA) On an annual basis (no later than October 31st of the preceding Once per Calendar Year)Quarter, or more often as the Parties deem Board deems appropriate, the JDC shall Product Development Subcommittee will review the then-current Development Plan (including the Development Budget) and if deemed appropriate prepare amendments to the then-current Development Plan and the [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. corresponding Development Budget and submit such amendments for approval of the JSCBoard. Each Once approved by the Board, such amended Development Plan shall specify, with a reasonable level of detail, will cover the items described in Section 3.2(a). Such amended Development Plan shall cover remaining current Calendar Year and the next Calendar Year (and additional periods as reasonably determined by or such period that the PartiesBoard will determine) and shall will contain a corresponding budget Development Budget, which will appropriately itemize the costs separately for U.S. activitieseach Product. Such updated and amended Development Plan shall will reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to the then-current Development Plan. In addition, the JDC may Product Development Subcommittee may, of its own accord, prepare amendments for approval of the JSC to the Development Plan and corresponding (including amendments to the Development Budget therein) for the Board’s approval from time to time during the a Calendar Year in order to reflect changes in such plan and budget for such Calendar Year and the next Calendar Year, in each case, in accordance with the foregoing. At the request of either Party, but no more frequently than quarterly, the JDC shall review the Development Budget and propose any necessary amendments to the JSC for approval. Once approved by the JSCBoard, the amended annual Development Plan and (including amendments to the Development Budget shall therein) will become effective for the applicable period on the date approved by the JSC Board (or such other date as the JSC shall Board will specify). Any JSCBoard-approved amended Development Plan and (including the Development Budget shall therein) will supersede the previous Development Plan and Development Budget for the applicable period. (iiB) Each Party shall notify Subject to Section 3.2.5(iv), in the other Party promptly upon becoming aware event that it is likely to exceed, or has exceeded, the budget for a particular activity for U.S. Development of the Product allocated Development Subcommittee cannot reach agreement on an amended Development Plan to such Party be submitted to the Board in accordance with this Section 3.2.5(iii), it will inform the Board of its inability to make a decision and the Board will proceed with finalizing the Development Plan without the Product Development Subcommittee’s recommendation. If the Board is unable to agree on amendments to the Development Plan. Thereafter, the JDC shall promptly meet and determine whether to amend the then-current Development Plan or Development Budget accordinglywill remain in force until such time as an amended plan is adopted in accordance with the terms of this Agreement and, provided that the JDC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control or that the Parties agree includes expenses reasonably incurred in the performance of the Development Plan. Any such amendment proposed by the JDC shall not be subject to the JSC’s review and extent applicable, the provisions of Section 7.6 will be deemed automatically approved by the JSC, unless such amendment would cause the total Development Costs incurred by a Party in any Calendar Year to exceed [*] percent ([*]%) of the budgeted Development Costs for such Party in such Calendar Year, in which event JSC approval will be required; provided that the JSC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control and that the Parties agree includes expenses reasonably incurred in the performance of the Development Planapply.

Amendments to the Development Plan. (i) On an annual basis (no later than October 31st of the preceding Calendar Year), or more often as the Parties deem appropriate, the JDC shall prepare amendments to the then-current Development Plan and Development Budget for approval of the JSC. Each such amended Development Plan shall specify, with a reasonable level of detail, the items described in Section 3.2(a). Such amended Development Plan shall cover the next Calendar Year (and additional periods as reasonably determined by the Parties) and shall contain a corresponding budget for U.S. activities. Such updated and amended Development Plan shall reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to the then-then- current Development Plan. In addition, the JDC may prepare amendments for approval of the JSC to the Development Plan and corresponding Development Budget from time to time during the Calendar Year in order to reflect changes in such plan and budget for such Calendar Year, in each case, in accordance with the foregoing. At the request of either Party, but no more frequently than quarterly, the JDC shall review the Development Budget and propose any necessary amendments to the JSC for approval. Once approved by the JSC, the amended annual Development Plan and Development Budget shall become effective for the applicable period on the date approved by the JSC (or such other date as the JSC shall specify). Any JSC-approved amended Development Plan and Development Budget shall supersede the previous Development Plan and Development Budget for the applicable period. (ii) Each Party shall notify the other Party promptly upon becoming aware that it is likely to exceed, or has exceeded, the budget for a particular activity for U.S. Development of the Product allocated to such Party in the Development Plan. Thereafter, the JDC shall promptly meet and determine whether to amend the Development Plan or Development Budget accordingly, provided that the JDC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control or that the Parties agree includes expenses reasonably incurred in the performance of the Development Plan. Any such amendment proposed by the JDC shall not be subject to the JSC’s review and will be deemed automatically approved by the JSC, unless such amendment would cause the total Development Costs incurred by a Party in any Calendar Year to exceed [*] percent ([*]%) of the budgeted Development Costs for such Party in such Calendar Year, in which event JSC approval will be required; provided that the JSC shall not unreasonably withhold its agreement to any budget amendment proposed by either Party that results from causes outside of such Party’s reasonable control and that the Parties agree includes expenses reasonably incurred in the performance of the Development Plan.the