Common use of Initial and Updated Development Plan Clause in Contracts

Initial and Updated Development Plan. A preliminary initial Development Plan has been agreed to by the Parties for the period beginning on the Effective Date and ending on December 31, 1997. Within thirty (30) days after the Effective Date, Diacrin, in consultation with the Program Management Team, shall submit to the Steering Committee for review and approval the definitive initial Development Plan for the period beginning on the Effective Date and ending on December 31, 1997, upon which approval such definitive initial Development Plan shall be signed by an authorized representative of each of Diacrin 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 (i) 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, (ii) a detailed description and budget for the 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 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 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 Diacrin 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 ********************************** of the total amount budgeted in any calendar year 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. A preliminary initial Development Plan has been agreed to by the Parties for the period beginning on the Effective Date and ending on December 31, 1997. Within thirty (30) days after the Effective Date, Diacrin, in consultation with the Program Management Team, shall submit to the Steering Committee for review and approval the definitive initial Development Plan for the period beginning on the Effective Date and ending on December 31, 1997, upon which approval such definitive initial Development Plan shall be signed by an authorized representative of each of Diacrin 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 (ia) 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, Approvals and (iib) a detailed description and budget for the development and pre-commercialization 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 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, respectivelyyear. The Program 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 Diacrin Genzyme and Genzyme 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 Diacrin 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. A preliminary initial Development Plan has been The Parties have ------------------------------------ agreed to by an initial budget for the Parties development and pre-commercialization activities of BioMarin/Genzyme LLC for the period beginning on the Effective Date and ending on December 31, 19971998. Within thirty (30) days after the Effective Date, Diacrin, in consultation with the The Program Management Team, Team shall submit to the Steering Committee for review and approval the definitive an initial Development Plan for the period beginning on the Effective Date and ending on December 31, 1997, upon which 1998 to the Steering Committee for review and approval such definitive initial Development Plan shall be signed by an authorized representative of each of Diacrin and Genzymenot later than 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 year during the Development Program. Each such updated Development Plan shall include (ia) 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, Approvals and (iib) a detailed description and budget for the development and pre- commercialization 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 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, respectivelyyear. The Program 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 Diacrin Genzyme and Genzyme 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 Diacrin 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. A preliminary initial Development Plan has been agreed to by the Parties ------------------------------------ for the period beginning on the Effective Date and ending on December 31, 19972003 has been agreed upon by the Parties and is attached hereto as Schedule 5.1.3. Within thirty (30) days after the Effective Date, Diacrin, in consultation with the Program Management Team, shall submit to the Steering Committee for review and approval the definitive initial Development Plan for the period beginning on the Effective Date and ending on December 31, 1997, upon which approval such definitive initial Development Plan shall be signed by an authorized representative of each of Diacrin and Genzyme. -------------- The Development Plan shall be updated annually by the Program Management Team Genzyme, in consultation with Aptein, and submitted to the Steering Committee for review and approval not later than sixty (60) days prior to January 1 October 31 of each year during the Development Program. Each such updated Development Plan shall include (ia) 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, (ii) a detailed description and budget for the 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 description of for the development and budget for all pre-commercialization activities related to the construction, validation and operation of the Dedicated Facility proposed for the following four (4) calendar years, and (c) a detailed, rolling four-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 financial forecast containing a committed budget for the major tasks first calendar year and detailed activities required to perform good faith estimates of the updated Development Planbudget for the following three (3) calendar years. Each such updated Development Plan approved by the Steering Committee shall be signed by an authorized representative of each of Diacrin Genzyme and GenzymeAptein. The members of the Program Management Team shall actively consult with one on 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 [********************************** ] 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 and budget shall remain in effect. Notwithstanding the foregoing, if the Steering Committee does not approve the budget increase and such increase is necessitated by a significant change in an activity for which one of the Parties has primary responsibility as described in Section 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 increased Development Costs at a level not to exceed the percentage of such costs being funded by such Party during such year. If such budget increase is necessitated by an activity for which the Parties share joint responsibility, either Party may choose to fund such activity on its own, provided that such funding will only be considered a Development Cost if the aggregate amount funded by such Party in a calendar year under this sentence does not exceed [***].

Initial and Updated Development Plan. A preliminary initial Development Plan has been The Parties have agreed to by the Parties an initial three (3) year development plan and budget for the period beginning on the Effective Date and ending on December 31, 1997. Within thirty 2010, which is attached hereto as Appendix A. The rolling three (303) days after the Effective Date, Diacrin, in consultation with the Program Management Team, shall submit to the Steering Committee for review and approval the definitive initial Development Plan for the period beginning on the Effective Date and ending on December 31, 1997, upon which approval such definitive initial Development Plan shall be signed by an authorized representative of each of Diacrin and Genzyme. The year 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 (ia) 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 (iib) a detailed description and budget for the 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 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, respectivelycovered period. The Program 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 Diacrin Genzyme and Genzyme 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 Diacrin 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 Any changes in the scope or direction of the work and any changes in funding exceeding ********************************** of to 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. [**] = 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.

Initial and Updated Development Plan. A preliminary initial Development Plan has been The Parties have agreed to by the Parties an initial three (3) year development plan and budget for the period beginning on the Effective Date and ending on December 31, 1997. Within thirty 2010, which is attached hereto as Appendix A. The rolling three (303) days after the Effective Date, Diacrin, in consultation with the Program Management Team, shall submit to the Steering Committee for review and approval the definitive initial Development Plan for the period beginning on the Effective Date and ending on December 31, 1997, upon which approval such definitive initial Development Plan shall be signed by an authorized representative of each of Diacrin and Genzyme. The year 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 (ia) 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 (iib) a detailed description and budget for the 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 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, respectivelycovered period. The Program 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 Diacrin Genzyme and Genzyme 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 Diacrin 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 Any changes in the scope or direction of the work and any changes in funding exceeding ********************************** of to 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.