Common use of Initial and Updated Commercialization Plans Clause in Contracts

Initial and Updated Commercialization Plans. No later than immediately prior to the completion of the submission of all Regulatory Approval filings for a Collaboration Product in any given country, Genzyme shall develop and submit to the Steering Committee for review and approval an initial Commercialization Plan in accordance with its customary standard for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan. Each Commercialization Plan shall be updated annually by Genzyme, in consultation with Dyax below as herein provided, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax and Genzyme. While minor adjustments to the Commercialization Plan may be made from time to time without Steering Committee approval, 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 Commercialization Plan must be approved by the Steering Committee, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty (60) days following the end of each calendar quarter after the filing of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product), each of Dyax and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis.

Initial and Updated Commercialization Plans. No later than immediately prior to the completion of Upon the submission of all Regulatory Approval filings for a Collaboration Product in any given country, Genzyme shall develop and submit to the Steering Committee for review and approval an initial Commercialization Plan in accordance with its customary standard for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax Diacrin regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan, including without limitation the coordination of manufacturing with sales and marketing. Diacrin shall be primarily responsible for developing the detailed manufacturing plan included within each Commercialization Plan and shall deliver such plan to Genzyme within a reasonable period of time prior to the date Genzyme expects to submit the overall Commercialization Plan to the Steering Committee. Each Commercialization Plan shall be updated annually by Genzyme, in consultation with Dyax below Diacrin as herein provided, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax Diacrin and Genzyme. While minor adjustments to the Commercialization Plan may be made from time to time without Steering Committee approval, 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 Commercialization Plan must be approved by the Steering Committee, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty (60) days following the end of each calendar quarter after the filing of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product), each of Dyax and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis.

Initial and Updated Commercialization Plans. No later than ------------------------------------------- immediately prior to the completion of the submission of all Regulatory Approval filings for a Collaboration Product in any given country, Genzyme shall develop and submit to the Steering Committee for review and approval an initial Commercialization Plan in accordance with its customary standard for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax BioMarin regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan. Each Commercialization Plan shall be updated annually by Genzyme, in consultation with Dyax BioMarin below as herein provided, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax BioMarin and Genzyme. While minor adjustments to the Commercialization Plan may be made proposed by either of Genzyme or BioMarin from time to time without Steering Committee approval, 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 Commercialization Plan must be approved by the Steering Committee, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty (60) days following the end of each calendar quarter after the filing of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product)Approval, each of Dyax BioMarin and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis.

Initial and Updated Commercialization Plans. No later than immediately prior to the completion of the submission of all Regulatory Approval filings for a Collaboration Product in any given country, Genzyme shall develop and submit to the Steering Committee for review and approval an initial Commercialization Plan in accordance with its customary standard for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan. Each Commercialization Plan shall be updated annually by Genzyme, in consultation with Dyax below as herein provided, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax and Genzyme. While minor adjustments to the Commercialization Plan may be made from time to time without Steering Committee approval, 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 Commercialization Plan must be approved by the Steering Committee, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty (60) days following the end of each calendar quarter after the filing of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product), each of Dyax and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis. Confidential material omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omissions.

Initial and Updated Commercialization Plans. No later than immediately prior to the completion of the submission of all Regulatory Approval filings for a Collaboration Product in any given country, Genzyme shall develop and submit to the Steering Committee for review and approval an initial Commercialization Plan in accordance with its customary standard for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax GTC and any Third Party distributor selected by the Steering Committee pursuant to Section 6.7 below regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan. Each Commercialization Plan shall be updated annually by Genzyme, in consultation with Dyax GTC and any Third Party distributor selected by the Steering Committee pursuant to Section 6.7 below as herein provided, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax GTC and Genzyme. While minor adjustments to the Commercialization Plan may be made from time to time without Steering Committee approval, 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 Commercialization Plan must be approved by the Steering Committee, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty (60) days following the end of each calendar quarter after the filing of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product), each of Dyax and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis.

Initial and Updated Commercialization Plans. No later than ------------------------------------------- immediately prior to the completion of the submission of all Regulatory Approval filings for a Collaboration Product in any given country, Genzyme shall develop and submit to the Steering Committee for review and approval an initial Commercialization Plan in accordance with its customary standard for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax BioMarin regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan. Each Commercialization Plan shall be updated annually by Genzyme, in consultation with Dyax BioMarin below as herein provided, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax BioMarin and Genzyme. While minor adjustments to the Commercialization Plan may be made proposed by either of Genzyme or BioMarin from time to time without Steering Committee approval, 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 Commercialization Plan must be approved by the Steering Committee, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty (60) days following the end of each calendar quarter after the filing of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product)Approval, each of Dyax BioMarin and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis.

Initial and Updated Commercialization Plans. No later than immediately prior to the completion of the submission of all Regulatory Approval filings for a Collaboration Product in any given country, Genzyme shall develop and submit to the Steering Committee for review and approval an initial Commercialization Plan in accordance with its customary standard for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax GTC and any Third Party distributor selected by the Steering Committee pursuant to Section 6.7 below regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan. Each Commercialization Plan shall be updated annually by Genzyme, in consultation with Dyax GTC and any Third Party distributor selected by the Steering Committee pursuant to Section 6.7 below as herein provided, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Dyax GTC and Genzyme. While minor adjustments to the Commercialization Plan may be made from time to time without Steering Committee approval, 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 Commercialization Plan must be approved by the Steering Committee, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty (60) days following the end of each calendar quarter after the filing of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product), each of Dyax and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis.

Initial and Updated Commercialization Plans. No later than immediately prior to the completion of the submission of all Regulatory Approval filings […***…] for a Collaboration Product in any given country, Genzyme the applicable JSC shall develop and submit to the Steering Committee for develop, review and approval approve an initial Commercialization Plan for such a Product in accordance with its customary standard standards for a product of comparable market potential, taking into consideration factors such as market conditions, regulatory factors, competition and the costs and profits of such Collaboration Product. Genzyme shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Dyax regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan. Each Commercialization Plan shall be updated annually by Genzymethe Marketing Party, in consultation with Dyax below the other Party as herein provided, and shall be submitted to the Steering Committee JSC for approval not later than sixty November 30th of each year for the following year. The JSC shall not unreasonably withhold, delay, or condition its approval of any Commercialization Plan or annual update thereto. In the event the JSC does not take any action with respect to the written approval or rejection of any Commercialization Plan or annual update thereto within thirty (6030) days prior of its submission to January 1 of each yearthe JSC, it shall be deemed to be approved. Each Commercialization Plan approved by the Steering Committee JSC shall be signed by an authorized representative of each of Dyax MethylGene and GenzymeEVP, until such time as either Party has a Unilateral Right to Approve, in which case it shall be signed only by an authorized representative of the Majority Party. While minor adjustments to the Commercialization Plan may be made proposed by the Marketing Party from time to time without Steering Committee JSC approval, 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 Commercialization Plan Plan, on a line item and Collaboration Product-by-Collaboration Product basis, must be approved by the Steering CommitteeJSC, and in the absence of such approval, the provisions of the most recently approved Commercialization Plan shall remain in effect. Within sixty thirty (6030) days following the end of each calendar quarter after the filing approval of the first application for a Regulatory Approval (other than an application for "orphan drug" designation of a Collaboration Product)initial Commercialization Plan, each of Dyax MethylGene and Genzyme EVP shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Commercialization Plan, including, if reasonably available, sales information for each Collaboration Product on a country-by-country basis.