Lead Commercialization Party Clause Samples
Lead Commercialization Party. At least [***] months prior to the anticipated start of any pivotal trial that may be used for BLA filing to a Regulatory Authority, the Parties will agree as part of the Commercialization Agreement on which Party will become Lead Commercialization Party for which Region. Within the framework of the overall Commercialization strategy, cf. Section 4.2 above, the Lead Commercialization Party shall be responsible for setting-up and operating the distribution network in its Region, including, but not limited to, the following: warehousing and distribution logistics, supply and packaging, invoicing and collection, preparing of marketing materials, handling reimbursement issues as well arranging for medical affairs functions to support the commercial endeavors in such Region. The Lead Commercialization Party shall in addition be responsible for preparing, supervising, implementing and adapting the regional marketing strategy for the relevant Region in compliance with the overall marketing strategy as approved by the competent Joint Commercialization Committee and endorsed by the Joint Steering Committee pursuant to Section 4.2. Regional marketing strategy includes, but is not limited to, key opinion leader development, pre-launch advisory board meetings, primary market research with customers, health economic and reimbursement studies, local customary discounts, local advertising strategy, competitor analysis, un-met need analysis, local product positioning, other promotional strategies (such as sampling, give-away items, PR) and prescribing guideline inclusion. Notwithstanding the above, the Parties agree that Genmab shall book worldwide sales.
Lead Commercialization Party. Acadia shall lead the global Commercialization strategy (“Commercialization Strategy”) and related strategic activities throughout the Territory for each SYNGAP1 Co-Co Product. Subject to Acadia’s lead role with respect to strategic issues, the Parties will share responsibility for leading execution with respect to specific commercial activities relating to the SYNGAP1 Co-Co Products as set forth herein (each Party, with respect to such specified activities is the “Lead Commercialization Party”). Unless otherwise so designated by the JSC, with respect to specific commercial activities under SYNGAP1 Co-Commercialization Plan, the Lead Commercialization Party shall be whichever Party has been assigned responsibility for executing such specific commercial activities under the SYNGAP1 Co-Commercialization Plan. If a particular Commercialization activity is allocated to both Parties to perform jointly under a SYNGAP1 Co-Commercialization Plan, then both Parties shall coordinate to jointly conduct such activity in collaboration with each other. All Commercialization activities for SYNGAP1 Co-Co Products in the Territory shall be conducted solely as set forth in the relevant SYNGAP1 Co-Commercialization Plan, and the Parties shall not perform any Commercialization activities in the Territory for any SYNGAP1 Co-Co Product other than those set forth in the applicable SYNGAP1 Co-Commercialization Plan. In the event a Party wishes to conduct a Commercialization activity with respect to a SYNGAP1 Co-Co Product that is not included in the current applicable SYNGAP1 Co-Commercialization Plan, then such Party may propose such new Commercialization activity to the JCC for consideration.