Initial and Updated Commercialization Plans Sample Clauses

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.