Common use of Initial and Updated Development Plan Clause in Contracts

Initial and Updated Development Plan. The Parties have agreed to a preliminary Development Plan and initial budget for the Program for the period beginning on the Effective Date and ending on December 31, 1998. The Program Management Team shall submit an updated Development Plan and budget for the period beginning on the Effective Date and ending on December 31, 1999 to the Steering Committee for approval no later than December 1, 1998. 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 Development Program. Each such updated Development Plan shall include (a) an overall development plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and (b) a detailed description and budget for the 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, in connection with the preparation of such updates, shall consult with Genzyme and Dyax regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect.

Initial and Updated Development Plan. The Parties have agreed Within sixty (60) days after the Effective Date, the Program Management Team shall submit to a preliminary the Steering Committee for review and approval the definitive initial Development Plan and initial budget for the Program for the period beginning on the Effective Date and ending on December 31, 1998. The Program Management Team shall submit an updated 2008, upon which approval such definitive initial Development Plan shall be signed by an authorized representative of each of Cyberkinetics and budget for the period beginning on the Effective Date and ending on December 31, 1999 to the Steering Committee for approval no later than December 1, 1998NEUROMetrix. 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 forty-five (6045) days prior to January 1 of each year during the Development Program. Each such updated Development Plan shall include (ai) 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 plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and Approvals, (biii) a detailed description and budget for the research and development and pre-commercialization activities proposed for the forthcoming calendar yearyear 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 Project 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 Genzyme Cyberkinetics and Dyax NEUROMetrix regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) [***] of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect.

Initial and Updated Development Plan. The Parties have agreed to a A preliminary initial Development Plan and initial budget for the Program for the period beginning on the Effective Date and ending on December 31, 19981998 has been prepared by GTC. The Program Management Team shall submit an updated a definitive initial Development Plan and budget for the period beginning on the Effective Date and ending on December 31, 1999 1998 to the Steering Committee for review and approval no not later than December 1thirty (30) days after the Effective Date. Upon such approval, 1998the definitive initial Development Plan shall be signed by an authorized representative of each 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 Development Program. Each such updated Development Plan shall include (a) an overall development plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and Approvals, (b) a detailed description and budget for the development and pre-commercialization activities proposed for the forthcoming calendar yearyear 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 New Facility and (ii) a detailed description of and budget for all activities related to the construction, validation and operation of the New 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. 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 Dyax GTC regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax GTC and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect.work

Initial and Updated Development Plan. The Parties have agreed to a preliminary Development Plan and initial budget for the Program for the period beginning on the Effective Date and ending on December 31, 1998. The Program Management Team shall submit an updated Development Plan and budget for the period beginning on the Effective Date and ending on December 31, 1999 to the Steering Committee for approval no later than December 1, 1998. 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 Development Program. Each such updated Development Plan shall include (a) an overall development plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and (b) a detailed description and budget for the 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, in connection with the preparation of such updates, 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 and budget for the 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 authorized representative of each of Dyax and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) ************* of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect.

Initial and Updated Development Plan. The Parties have agreed JSC shall use reasonable efforts to a preliminary agree upon an initial high-level Development Plan and initial budget for the Program each Project for the period beginning on the Effective Date and ending on December 31, 1998. The Program Management Team shall submit an updated 2015 within one hundred twenty (120) days of the Effective Date, provided that until such Development Plan and budget for has been adopted by the period beginning JSC, the Parties will work in good faith on the Effective Date commencement of activities for each Project in accordance with the preliminary action plan and ending on December 31, 1999 to the Steering Committee for approval no later than December 1, 1998associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. The Each Development Plan shall be updated at least annually by the Program Management Team Incyte, in consultation with Agenus, and in each case submitted to the Steering Committee JSC for review and approval not later than sixty (60) days prior to January 1 October 31 of each year Calendar Year during the Development ProgramTerm. Each such updated Development Plan shall include include, with respect to the relevant Project, and the Products therein, to the extent possible, (ai) an outline of an overall development Development plan for each Collaboration Product which that sets forth all major development Development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and to the extent such tasks are known or can reasonably be ascertained, (bii) a detailed description of, and allocation of responsibility for, all proposed Development activities for the time period [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. applicable to each such Product, and (iii) a detailed financial forecast containing a committed budget for the 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 next Calendar Year and, in connection with solely for Products for which an IND has been filed, good faith estimates of the preparation of such updates, shall consult with Genzyme and Dyax regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax and Genzymefollowing two (2) Calendar Years. The members of the Program each Project Management Team Team, on a Project-by-Project basis, shall actively consult with one another throughout the term of the Development Plan 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 Development work performed. While ; provided, however, that, while minor adjustments to the 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 Program applicable Project 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 the Development Program such Project must be approved by the Steering CommitteeJSC, 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 Parties have A preliminary initial Development Plan has been agreed to a preliminary Development Plan and initial budget for by the Program Parties for the period beginning on the Effective Date and ending on December 31, 19981997. The Within thirty (30) days after the Effective Date, GelTex, in consultation with the Program Management Team Team, shall submit an updated to the Steering Committee for review and approval the definitive initial Development Plan and budget for the period beginning on the Effective Date and ending on December 31, 1999 to 1997. Upon such approval, the Steering Committee for approval no later than December 1, 1998definitive initial Development Plan shall be signed by an authorized representative of each of GelTex and Genzyme. 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 Development Program. Each such updated Development Plan shall include (a) an overall development plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and (b) a detailed description and budget for the development and pre-commercialization activities proposed for the forthcoming calendar year, in each case including estimated time lines to accomplish such major tasks or detailed activities, respectively. The Project 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 GelTex and Genzyme and Dyax regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax GelTex and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan Program so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) * of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect.

Initial and Updated Development Plan. The Parties have A preliminary initial Development Plan has been agreed to a preliminary Development Plan and initial budget for by the Program Parties for the period beginning on the Effective Date and ending on December 31, 19981997. The Within thirty (30) days after the Effective Date, GelTex, in consultation with the Program Management Team Team, shall submit an updated to the Steering Committee for review and approval the definitive initial Development Plan and budget for the period beginning on the Effective Date and ending on December 31, 1999 to 1997. Upon such approval, the Steering Committee for approval no later than December 1, 1998definitive initial Development Plan shall be signed by an authorized representative of each of GelTex and Genzyme. 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 Development Program. Each such updated Development Plan shall include (a) an overall development plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and (b) a detailed description and budget for the development and pre-commercialization activities proposed for the forthcoming calendar year, in each case including estimated time lines to accomplish such major tasks or detailed activities, respectively. The Project 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 GelTex and Genzyme and Dyax regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax GelTex and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan Program so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) ********* of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect.

Initial and Updated Development Plan. The Parties have agreed to a A preliminary initial Development Plan and initial budget for the Program for the period beginning on the Effective Date and ending on December 31, 19981998 has been prepared by GTC. The Program Management Team shall submit an updated a definitive initial Development Plan and budget for the period beginning on the Effective Date and ending on December 31, 1999 1998 to the Steering Committee for review and approval no not later than December 1thirty (30) days after the Effective Date. Upon such approval, 1998the definitive initial Development Plan shall be signed by an authorized representative of each 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 Development Program. Each such updated Development Plan shall include (a) an overall development plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and Approvals, (b) a detailed description and budget for the development and pre-commercialization activities proposed for the forthcoming calendar yearyear 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 New Facility and (ii) a detailed description of and budget for all activities related to the construction, validation and operation of the New 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. 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 Dyax GTC regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax GTC and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten five percent (110105%) of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect. GTC and Genzyme shall each submit reports to the Program 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 any.

Initial and Updated Development Plan. The Parties have ------------------------------------ agreed to a preliminary Development Plan and an initial budget for the Program development and pre-commercialization activities of BioMarin/Genzyme LLC for the period beginning on the Effective Date and ending on December 31, 1998. The Program Management Team shall submit an updated initial Development Plan and budget for the period beginning on the Effective Date and ending on December 31, 1999 1998 to the Steering Committee for review and approval no not later than December 1, 1998thirty (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 year during the Development Program. Each such updated Development Plan shall include (a) an overall development plan for each Collaboration Product which sets forth all major development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and (b) a detailed description and budget for the development and pre-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, in connection with the preparation of such updates, shall consult with Genzyme and Dyax BioMarin regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax BioMarin and Genzyme. The members of the Program Management Team shall actively consult with one another throughout the term of the Development Plan so as to adjust the specific work performed under the Development Plan to conform to evolving developments in technology and the results of the development work performed. While minor adjustments to the Development Plan may be made from time to time upon approval of the Program Management Team, significant changes in the scope or direction of the work and any changes in funding exceeding one hundred ten percent (110%) [* * *] of the total amount budgeted in any calendar year for the Development Program must be approved by the Steering Committee, in the absence of which approval the most recently approved Development Plan shall remain in effect.

Initial and Updated Development Plan. The Parties have agreed JSC shall use reasonable efforts to a preliminary agree upon an initial high-level Development Plan and initial budget for the Program each Project for the period beginning on the Effective Date and ending on December 31, 1998. The Program Management Team shall submit an updated 2015 within one hundred twenty (120) days of the Effective Date, provided that until such Development Plan and budget for has been adopted by the period beginning JSC, the Parties will work in good faith on the Effective Date commencement of activities for each Project in accordance with the preliminary action plan and ending on December 31, 1999 to the Steering Committee for approval no later than December 1, 1998associated budget set forth in Schedule 4.1 and any Development costs incurred thereunder shall be considered Development Costs hereunder. The Each Development Plan shall be updated at least annually by the Program Management Team Incyte, in consultation with Agenus, and in each case submitted to the Steering Committee JSC for review and approval not later than sixty (60) days prior to January 1 October 31 of each year Calendar Year during the Development ProgramTerm. Each such updated Development Plan shall include include, with respect to the relevant Project, and the Products therein, to the extent possible, (ai) an outline of an overall development Development plan for each Collaboration Product which that sets forth all major development Development tasks remaining to be accomplished prior to submission of filings for Regulatory Approvals and to the extent such tasks are known or can reasonably be ascertained, (bii) 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 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 next Calendar Year and, in connection with solely for Products for which an IND has been filed, good faith estimates of the preparation of such updates, shall consult with Genzyme and Dyax regarding the identification, timing and execution of and budget for the 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 authorized representative of each of Dyax and Genzymefollowing two (2) Calendar Years. The members of the Program each Project Management Team Team, on a Project-by-Project basis, shall actively consult with one another throughout the term of the Development Plan 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 Development work performed. While ; provided, however, that, while minor adjustments to the 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 Program applicable Project 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 the Development Program such Project must be approved by the Steering CommitteeJSC, 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 [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. EXHIBIT 10.22 CONFIDENTIAL TREATMENT MATERIAL 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).