Common use of Initial and Updated Development Plan Clause in Contracts

Initial and Updated Development Plan. The JSC shall use reasonable efforts to agree upon an initial high-level Development Plan for each Project for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of the Effective Date, provided that until such Development Plan has been adopted by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. Each Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, and in each case submitted to the JSC for review and approval not later than October 31 of each Calendar Year during the Term. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, (i) an outline of an overall Development plan for each Product that sets forth all major Development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, (ii) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year and, solely for Products for which an IND has been filed, good faith estimates of the budget for the following two (2) Calendar Years. The members of each Project Management Team, on a Project-by-Project basis, shall actively consult with one another throughout the Term so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development work performed; provided, however, that, while minor adjustments to such Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project must be approved by the JSC, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts to agree upon an initial high-level Development Plan for each Project for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of the Effective Date, provided that until such Development Plan has been adopted by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. Each Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, the Program Management Team and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, and (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year development and pre-commercialization activities proposed for the forthcoming calendar year. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with Genzyme and Dyax regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] one hundred ten percent (110%) of the then-total amount budgeted in any Calendar Year calendar year for such Project the Development Program must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts to agree upon an A preliminary initial high-level Development Plan for each Project has been agreed to by the Parties for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty 1997. Within thirty (12030) days of after the Effective Date, provided that until such Diacrin, in consultation with the Program Management Team, shall submit to the Steering Committee for review and approval the definitive initial Development Plan has been adopted by for the JSC, the Parties will work in good faith period beginning on the commencement of activities for each Project in accordance with the preliminary action plan Effective Date and associated budget set forth in Schedule 4.1 and any ending on December 31, 1997, upon which approval such definitive initial Development costs incurred thereunder Plan shall be considered Development Costs hereundersigned by an authorized representative of each of Diacrin and Genzyme. Each The Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, the Program Management Team and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (i) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertainedApprovals, (ii) a detailed description of, and allocation of responsibility for, all proposed Development activities budget for the time period applicable to each such Product, development activities proposed for the forthcoming calendar year and (iii) until the initial Commercialization Plan is submitted in accordance with Section 6.1.2., (a) an overall plan which sets forth all major tasks remaining to be accomplished prior to submission of filings for Regulatory Approval of the Dedicated Facility and (b) a detailed financial forecast containing a committed description of and budget for all activities related to the construction, validation and operation of the Dedicated Facility proposed for the calendar year to which the Development Plan relates, in each case including estimated time lines to accomplish such major tasks or detailed activities, respectively. The Program Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, in connection with the preparation of such updates, shall consult with Diacrin and Genzyme regarding the identification, timing and execution of and budget for the next Calendar Year and, solely for Products for which major tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an IND has been filed, good faith estimates authorized representative of the budget for the following two (2) Calendar Yearseach of Diacrin and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] ******************************** of the then-total amount budgeted in any Calendar Year for such Project calendar year must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts to agree upon an A preliminary initial high-level Development Plan for each Project for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of 1998 has been prepared by GTC. The Program Management Team shall submit a definitive initial Development Plan for the period beginning on the Effective DateDate and ending on December 31, provided that until such Development Plan has been adopted by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. Each Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, and in each case submitted 1998 to the JSC Steering Committee for review and approval not later than October 31 thirty (30) days after the Effective Date. Upon such approval, the definitive initial Development Plan shall be signed by an authorized representative of each Calendar Year of Genzyme and GTC. The Development Plan shall be updated annually by the Program Management Team and submitted to the Steering Committee for review and approval not later than sixty (60) days prior to January 1 of each year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals Approvals, (b) a detailed description and budget for the development and pre-commercialization activities proposed for the forthcoming calendar year and (c) until the initial Commercialization Plan is submitted in accordance with Section 6.1.2 below, (i) an overall plan which sets forth all major tasks remaining to be accomplished prior to submission of filings for Regulatory Approval of the extent such tasks are known or can reasonably be ascertained, New Facility and (ii) a detailed description ofof and budget for all activities related to the construction, validation and allocation operation of responsibility for, all the New Facility proposed Development activities for the calendar year to which the Development Plan relates, in each case including estimated time period applicable lines to each accomplish such Productmajor tasks or detailed activities. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, in connection with the preparation of such updates, shall consult with Genzyme and (iii) a detailed financial forecast containing a committed GTC regarding the identification, timing and execution of and budget for the next Calendar Year and, solely for Products for which major tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an IND has been filed, good faith estimates authorized representative of the budget for the following two (2) Calendar Yearseach of GTC and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] one hundred five percent (105%) of the then-total amount budgeted in any Calendar Year calendar year for such Project the Development Program must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding GTC and Genzyme shall each submit reports to the foregoingProgram Management Team no later than the tenth (10th) business day of each calendar month stating such Party's estimate of the amount by which 18 Development Costs incurred by such Party during the preceding calendar month exceeded the amount budgeted for the work undertaken by such Party for such month, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters)any.

Initial and Updated Development Plan. The JSC shall use reasonable efforts Parties have ------------------------------------ agreed to agree upon an initial highbudget for the development and pre-level Development Plan for each Project commercialization activities of BioMarin/Genzyme LLC for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of 1998. The Program Management Team shall submit an initial Development Plan for the period beginning on the Effective DateDate and ending on December 31, provided that until such Development Plan has been adopted by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. Each Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, and in each case submitted 1998 to the JSC Steering Committee for review and approval not later than October 31 thirty (30) days after the Effective Date. The Development Plan shall be updated annually by the Program Management Team and submitted to the Steering Committee for review and approval not later than sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, and (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year development and pre- commercialization activities proposed for the forthcoming calendar year. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with Genzyme and BioMarin regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of BioMarin and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [** * *] of the then-total amount budgeted in any Calendar Year calendar year for such Project the Development Program must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts Parties have agreed to agree upon an initial high-level a preliminary Development Plan and initial budget for each Project the Program for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of 1998. The Program Management Team shall submit an updated Development Plan and budget for the period beginning on the Effective DateDate and ending on December 31, provided that until such Development Plan has been adopted by 1999 to the JSCSteering Committee for approval no later than December 1, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder1998. Each The Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, the Program Management Team and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, and (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year development and pre-commercialization activities proposed for the forthcoming calendar year. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with Confidential material omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omissions. Genzyme and Dyax regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] *********** of the then-total amount budgeted in any Calendar Year calendar year for such Project the Development Program must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts to agree upon an initial high-level A Development Plan for each Project ------------------------------------ for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of the Effective Date, provided that until such Development Plan 2003 has been adopted agreed upon by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in is attached hereto as Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder5.1.3. Each -------------- The Development Plan shall be updated at least annually by IncyteGenzyme, in consultation with AgenusAptein, and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertainedApprovals, (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Productdevelopment and pre-commercialization activities proposed for the following four (4) calendar years, and (iiic) a detailed detailed, rolling four-year financial forecast containing a committed budget for the next Calendar Year and, solely for Products for which an IND has been filed, first calendar year and good faith estimates of the budget for the following two three (23) Calendar Yearscalendar years. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of Genzyme and Aptein. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one on another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [***] of the then-total amount budgeted in any Calendar Year calendar year for such Project the Development Program must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC Steering Committee does not approve the budget increase and such increase is (1) associated with necessitated by a significant change in an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) 5.1.4 below, the Party responsible for such activity may independently determine to increase the applicable budget. The other Party shall then have the option, exercisable within (30) days of the decision to increase the applicable budget, to fund a percentage of such activity itself and increased Development Costs at a level not to exceed the percentage of such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with costs being funded by such Party during such year. If such budget increase is necessitated by an activity for which Agenus has primary responsibility as described in Section 4.1(d) belowthe Parties share joint responsibility, Incyte may, in its sole discretion, either Party may choose to fund such activity and on its own, provided that such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but funding will only be included considered a Development Cost if the aggregate amount funded by such Party in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided a calendar year under this Agreement, shall sentence does not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than exceed [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters)*].

Initial and Updated Development Plan. The JSC shall use reasonable efforts to agree upon an A preliminary initial high-level Development Plan for each Project has been agreed to by the Parties for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty 1997. Within thirty (12030) days of after the Effective Date, provided that until such GelTex, in consultation with the Program Management Team, shall submit to the Steering Committee for review and approval the definitive initial Development Plan has been adopted by for the JSCperiod beginning on the Effective Date and ending on December 31, 1997. Upon such approval, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any definitive initial Development costs incurred thereunder Plan shall be considered Development Costs hereundersigned by an authorized representative of each of GelTex and Genzyme. Each The Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, the Program Management Team and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, and (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year development activities proposed for the forthcoming calendar year, in each case including estimated time lines to accomplish such major tasks or detailed activities, respectively. The Program Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with GelTex and Genzyme regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of GelTex and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Program so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] * of the then-total amount budgeted in any Calendar Year for such Project calendar year must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts to agree upon an A preliminary initial high-level Development Plan for each Project has been agreed to by the Parties for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty 1997. Within thirty (12030) days of after the Effective Date, provided that until such GelTex, in consultation with the Program Management Team, shall submit to the Steering Committee for review and approval the definitive initial Development Plan has been adopted by for the JSCperiod beginning on the Effective Date and ending on December 31, 1997. Upon such approval, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any definitive initial Development costs incurred thereunder Plan shall be considered Development Costs hereundersigned by an authorized representative of each of GelTex and Genzyme. Each The Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, the Program Management Team and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, and (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year development activities proposed for the forthcoming calendar year, in each case including estimated time lines to accomplish such major tasks or detailed activities, respectively. The Program Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with GelTex and Genzyme regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of GelTex and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Program so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] ******* of the then-total amount budgeted in any Calendar Year for such Project calendar year must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts to agree upon an A preliminary initial high-level Development Plan for each Project for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of 1998 has been prepared by GTC. The Program Management Team shall submit a definitive initial Development Plan for the period beginning on the Effective DateDate and ending on December 31, provided that until such Development Plan has been adopted by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. Each Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, and in each case submitted 1998 to the JSC Steering Committee for review and approval not later than October 31 thirty (30) days after the Effective Date. Upon such approval, the definitive initial Development Plan shall be signed by an authorized representative of each Calendar Year of Genzyme and GTC. The Development Plan shall be updated annually by the Program Management Team and submitted to the Steering Committee for review and approval not later than sixty (60) days prior to January 1 of each year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals Approvals, (b) a detailed description and budget for the development and pre-commercialization activities proposed for the forthcoming calendar year and (c) until the initial Commercialization Plan is submitted in accordance with Section 6.1.2 below, (i) an overall plan which sets forth all major tasks remaining to be accomplished prior to submission of filings for Regulatory Approval of the extent such tasks are known or can reasonably be ascertained, New Facility and (ii) a detailed description ofof and budget for all activities related to the construction, validation and allocation operation of responsibility for, all the New Facility proposed Development activities for the calendar year to which the Development Plan relates, in each case including estimated time period applicable lines to each accomplish such Productmajor tasks or detailed activities. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, in connection with the preparation of such updates, shall consult with Genzyme and (iii) a detailed financial forecast containing a committed GTC regarding the identification, timing and execution of and budget for the next Calendar Year and, solely for Products for which major tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an IND has been filed, good faith estimates authorized representative of the budget for the following two (2) Calendar Yearseach of GTC and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development work performed; provided, however, that, while minor adjustments to such Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project must be approved by the JSC, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).development work

Initial and Updated Development Plan. The JSC shall use reasonable efforts Parties have ------------------------------------ agreed to agree upon an initial highbudget for the development and pre-level Development Plan for each Project commercialization activities of BioMarin/Genzyme LLC for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of 1998. The Program Management Team shall submit an initial Development Plan for the period beginning on the Effective DateDate and ending on December 31, provided that until such Development Plan has been adopted by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. Each Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, and in each case submitted 1998 to the JSC Steering Committee for review and approval not later than October 31 thirty (30) days after the Effective Date. The Development Plan shall be updated annually by the Program Management Team and submitted to the Steering Committee for review and approval not later than sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, and (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year development and pre- commercialization activities proposed for the forthcoming calendar year. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with Genzyme and BioMarin regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of BioMarin and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] one hundred ten percent (110%) of the then-total amount budgeted in any Calendar Year calendar year for such Project the Development Program must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts Parties have agreed to agree upon an initial high-level Development Plan for each Project three (3) year development plan and budget for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty 2010, which is attached hereto as Appendix A. The rolling three (1203) days of the Effective Date, provided that until such Development Plan has been adopted by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. Each year Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, the Program Management Team and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, and (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year activities proposed for the covered period. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with Genzyme and BioMarin regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of BioMarin and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while minor adjustments to such Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Management Team, significant . Any changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] of to the then-total amount budgeted in any Calendar Year calendar year for such Project the Development Program must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters)Commission.

Initial and Updated Development Plan. The JSC Within sixty (60) days after the Effective Date, the Program Management Team shall use reasonable efforts submit to agree upon an the Steering Committee for review and approval the definitive initial high-level Development Plan for each Project for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of the Effective Date2008, provided that until upon which approval such definitive initial Development Plan has been adopted by the JSC, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereundersigned by an authorized representative of each of Cyberkinetics and NEUROMetrix. Each The Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, the Program Management Team and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 forty-five (45) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (i) an outline of the major research activities which are to be undertaken, and the personnel that will be used for such research, (ii) when Collaboration Products are known and specified, an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertainedApprovals, (ii) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed description and budget for the next Calendar Year research and development activities proposed for the forthcoming calendar year and (iv) until the initial Commercialization Plan is submitted in accordance with Section 6.02, an overall plan which sets forth all major tasks remaining to be accomplished prior to submission of filings for Regulatory Approval. The Program Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with Cyberkinetics and NEUROMetrix regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [***] of the then-total amount budgeted in any Calendar Year for such Project calendar year must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).

Initial and Updated Development Plan. The JSC shall use reasonable efforts Parties have agreed to agree upon an initial high-level a preliminary Development Plan and initial budget for each Project the Program for the period beginning on the Effective Date and ending on December 31, 2015 within one hundred twenty (120) days of 1998. The Program Management Team shall submit an updated Development Plan and budget for the period beginning on the Effective DateDate and ending on December 31, provided that until such Development Plan has been adopted by 1999 to the JSCSteering Committee for approval no later than December 1, the Parties will work in good faith on the commencement of activities for each Project in accordance with the preliminary action plan and associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder1998. Each The Development Plan shall be updated at least annually by Incyte, in consultation with Agenus, the Program Management Team and in each case submitted to the JSC Steering Committee for review and approval not later than October 31 sixty (60) days prior to January 1 of each Calendar Year year during the TermDevelopment Program. Each such updated Development Plan shall include, with respect to the relevant Project, and the Products therein, to the extent possible, include (ia) an outline of an overall Development development plan for each Collaboration Product that which sets forth all major Development development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained, and (iib) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the next Calendar Year development and pre-commercialization activities proposed for the forthcoming calendar year. The Project Management Team shall be primarily responsible for preparing the annual updates to the Development Plan and, solely for Products for which an IND has been filedin connection with the preparation of such updates, good faith estimates shall consult with Genzyme and Dyax regarding the identification, timing and execution of the and budget for the following two (2) Calendar Yearsmajor tasks and detailed activities required to perform the updated Development Plan. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax and Genzyme. The members of each Project the Program Management Team, on a Project-by-Project basis, Team shall actively consult with one another throughout the Term term of the Development Plan so as to adjust the specific work performed under the applicable Development Plan to conform to evolving developments in technology and the results of the Development development work performed; provided, however, that, while . While minor adjustments to such the Development Plan that do not result in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Project may be made from time to time upon approval of the applicable Project Program Management Team, significant changes in the scope or direction of the work and any changes in budgeted funding exceeding [**] one hundred ten percent (110%) of the then-total amount budgeted in any Calendar Year calendar year for such Project the Development Program must be approved by the JSCSteering Committee, in the absence of which approval the most recently approved Development Plan and budget shall remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase and such increase is (1) associated with an activity for which one of the Parties has primary responsibility as described in Section 4.1(d) below, the Party responsible for such activity may fund such activity itself and such expenditure shall not be a Development Cost or Allowable Expense, as applicable, hereunder, or (2) subject to clause (1), associated with an activity for which Agenus has primary responsibility as described in Section 4.1(d) below, Incyte may, in its sole discretion, fund such activity and such expenditure shall be considered an Allowable Expense if such expenditure relates to a Profit-Share Product or a Profit-Share Project but will only be included in the calculation of Profit-or-Loss under Section 7.3 after the First Commercial Sale in any country of such Profit-Share Product (or the first Profit-Share Product under such Profit-Share Project), or may be credited against any amounts payable by Incyte to Agenus pursuant to Section 7.6 with respect to the relevant Royalty-Bearing Product if such expenditure relates to such Royalty-Bearing Product or the relevant Royalty-Bearing Project; provided, however, that any such credit, together with any other offsets against royalties provided under this Agreement, shall not reduce the royalties payable to Agenus in any Calendar Quarter, as applicable, by more than [**] with any such credits not applied in any Calendar Quarter due to the foregoing limit to be carried forward to future Calendar Quarters).