Initial Plan and Amendments. Within a reasonable time (but no less than six (6) months) prior to the anticipated Regulatory Approval of each Product in the Advaccine Territory, Advaccine shall prepare and present to the JSC an initial Commercialization Plan for review and discussion (but not approval) by the JSC. From time to time (but at least on an annual basis) during the Term, Advaccine shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan (including to take into account changed circumstances that are material to the Commercialization of Product, including changes in the marketplace, relative success of the Product, and other relevant factors influencing such plan and activities), and shall submit all updates and amendments to the Commercialization Plan to the JSC for review and discussion (but not approval). Notwithstanding anything to the contrary contained in this Agreement, the Commercialization Plan, and any updates and amendments thereto, shall not require the approval of the JSC or Inovio.
Initial Plan and Amendments. The initial Commercialization Plan shall be delivered to the JCC no later than [ * ] after the Effective Date or [ * ] before the anticipated launch of the Product in the Licensed Territory, whichever is later, for review and comment, after which the JCC shall submit such initial Commercialization Plan to the JSC for review and discussion. On at least an annual basis, Mundipharma shall prepare an amendment, as appropriate, to the then-current Commercialization Plan. Mundipharma shall submit all amendments to the Commercialization Plan to the JCC for review and comment, after which the JCC shall submit such amendment to the JSC for review and discussion. Once reviewed by the JSC, the amended Commercialization Plan shall become effective and supersede the previous Commercialization Plan as of the date of such review.
Initial Plan and Amendments. Within a reasonable time (but no less than [***]) prior to the anticipated Regulatory Approval of each Licensed Product in the Terns Territory, Terns shall prepare and present to the JSC an initial Commercialization Plan for review and discussion (but not approval) by the JSC. From time to time (but at least on an annual basis) during the Term, Terns shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan, and shall submit all updates and amendments to the Commercialization Plan to the JSC for review and discussion (but not approval). Notwithstanding anything to the contrary contained in this Agreement, the Commercialization Plan, and any updates and amendments thereto, shall not require the approval of the JSC or Genfit.
Initial Plan and Amendments. The initial Commercialization Plan for a particular Licensed Product shall be delivered to the JSC no later than nine (9) months prior to the anticipated date of first Regulatory Approval of such Licensed Product in the Licensed Territory. GSK shall periodically (at least on an annual basis) prepare updates and amendments to the Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces, relative success of the Licensed Products and other relevant factors influencing such plans and activities. GSK shall submit all updates and amendments to the Commercialization Plan to the JSC for review and discussion. Neither the JSC nor Impax shall have approval authority over the Commercialization Plan or any amendment thereto.
Initial Plan and Amendments. No later than [*****] months before the anticipated NDA approval of KP415 by the FDA, Company shall prepare, and shall provide KemPharm for review and discussion, the initial Commercialization Plan. Thereafter, no later than [*****] of each Calendar Year, Company shall provide KemPharm with a copy of the then-current version of such Commercialization Plan to cover the Commercialization activities of such Product in the next Calendar Year. For clarity, Company will have no obligation to provide a Commercialization Plan with respect to any Product other than KP415.
Initial Plan and Amendments. Within a reasonable time (but no less than [***]) prior to the anticipated first Pricing Approval for each Licensed Product in the Kaken Territory, Kaken shall prepare and present to the JSC an initial Commercialization Plan for review and discussion (but not approval) by the JSC. From time to time (but at least on an annual basis) during the Term, Kaken shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan, and shall submit all updates and amendments to the Commercialization Plan to the JSC for review and discussion (but not approval). Notwithstanding anything to the contrary contained in this Agreement, the Commercialization Plan, and any updates and amendments thereto, shall not require the approval of the JSC or Spruce; provided, however, that the Commercialization Plan shall be consistent with Spruce’s global commercialization strategy for the Licensed Products in the Field as communicated by Spruce to Kaken in writing.
Initial Plan and Amendments. Within a reasonable time (but no less than [***]) prior to the anticipated Regulatory Approval of each Licensed Product in the 3D Medicines Territory, 3D Medicines shall prepare and present to the JSC an initial Commercialization Plan for review and discussion (but not approval) by the JSC. From time to time (but at least on an annual basis) during the Term, 3D Medicines shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan, and shall submit all updates and amendments to the Commercialization Plan to the JSC for review and discussion (but not approval). Notwithstanding anything to the contrary contained in this Agreement, the Commercialization Plan, and any updates and amendments thereto, shall not require the approval of the JSC or Aravive.
Initial Plan and Amendments. Within a reasonable time (but no later than six (6) months) prior to the anticipated Regulatory Approval of each Licensed Product in the Luoxin Territory, Luoxin shall prepare and present to the JSC (or a Subcommittee established by JSC to oversee Commercialization of Licensed Products in the Luoxin Territory) the initial Commercialization Plan for review and discussion by the JSC. From time to time during the Term (at least on an annual basis), Luoxin shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan, and shall submit all updates and amendments to the Commercialization Plan to the JSC for review and discussion. Once approved by the JSC, the Commercialization Plan shall become effective and supersede the previous Commercialization Plan as of the date of such approval.
Initial Plan and Amendments. Within a reasonable time (but no later than [***]) prior to the anticipated Regulatory Approval of each Licensed Product in the Apollomics Territory, Apollomics shall prepare and present to the JDC the initial Commercialization Plan for review and discussion (but not approval) by the JDC. From time to time (but at least on an annual basis) during the Term, Apollomics shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan, and shall submit all updates and amendments to the Commercialization Plan to the JDC for review and discussion (but not approval). Notwithstanding anything to the contrary contained in this Agreement, the Commercialization Plan, and any updates and amendments thereto, shall not require the approval of the JDC or GlycoMimetics, provided that Apollomics considers in good faith any comments by the JDC or GlycoMimetics concerning consistent global marketing of Licensed Products.
Initial Plan and Amendments. At least [ * ] months prior to the anticipated date of the First Commercial Sale of the first Licensed Product in the SymBio Territory, SymBio shall prepare and present the initial Commercialization Plan to the JSC for review and approval in accordance with Section 3.3. At least [ * ], SymBio shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan and shall submit such updates and amendments to the JSC for review and approval. Once so approved, each amended Commercialization Plan shall become effective and shall supersede the previous Commercialization Plan as of the date of such approval.
