Commercialization Plans. 10.3.1 In-Vivo [***] Commercialization Plans. Subject to Applicable Law, NVS will prepare and provide to HMI (through the JSC): (a) an initial high-level summary of the anticipated Commercialization strategy and activities to be conducted for an In-Vivo [***] Product; and (b) an associated budget, no later than [***] for such In-Vivo [***] Product. In addition, NVS will prepare and provide to the JSC a Commercialization plan for each In-Vivo [***] Product that contemplates the commercial launch of, and the Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the Territory excluding the U.S. if HMI is the Commercializing Party and including the U.S. if NVS is the Commercializing Party (the “Global In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then HMI will prepare and provide to the JSC a Commercialization plan for each In-Vivo [***] Product that contemplates the commercial launch of, and the Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the U.S. (the “U.S. In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then each Party will provide the applicable Commercialization plan to the other Party no later than [***] such In-Vivo [***] Product in such Party’s territory. Subject to Applicable Law, (i) the strategic objectives and activities in the U.S. In-Vivo [***] Commercialization Plan will be consistent with the strategic objectives and activities in the Global In-Vivo [***] Commercialization Plan, unless otherwise agreed by the Parties; and (ii) the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan will each be reviewed, discussed, and approved by the JSC. Thereafter, at least once each [***], NVS will submit an updated Global In-Vivo [***] Commercialization Plan for each In-Vivo [***] Product, and HMI will submit an updated U.S. In-Vivo [***] Commercialization Plan, in each case, to the JSC for review, discussion, and approval.
Appears in 3 contracts
Samples: Collaboration and License Agreement (Homology Medicines, Inc.), Collaboration and License Agreement (Homology Medicines, Inc.), Collaboration and License Agreement (Homology Medicines, Inc.)
Commercialization Plans. 10.3.1 In-Vivo The JCC will oversee the Commercialization of the Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of each Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval a global Commercialization Plansplan (each, a “Global Commercialization Plan”) that sets forth at a high level the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of such Shared Product in the Territory. Subject The JCC will update each Global Commercialization Plan on an annual basis (or more frequently as needed) and submit it to Applicable Law, NVS the JSC for approval. Each Global Commercialization Plan will prepare and provide to HMI (through the JSC): include (a) an initial high-level summary of the anticipated Commercialization strategy and activities to be conducted for an In-Vivo [***] Product; and a Global Brand Strategy, (b) an associated budgeta Global Communication Strategy, (c) a Global Market Access and Value Strategy, (d) a Global Pricing Strategy, and (e) a budget for activities conducted under the Global Commercialization Plan (the “Global Commercialization Budget”). In addition, no later than [***] for such In-Vivo prior to the anticipated launch of each Shared Product in the applicable country, each Lead Commercialization Party will develop one or [***] Product= Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. In additionTable of Contents more regional or country-level Commercialization plans (each, NVS will prepare a “Regional Commercialization Plan”) for (a) in the case of CRISPR, the U.S. and provide to (b) in the JSC a Commercialization plan for each In-Vivo case of Vertex, the Major [***] Product that contemplates Countries. Each Party will submit such Regional Commercialization Plans to the commercial launch of, JCC for review and approval. Each Lead Commercialization Party will update its Regional Commercialization Plan(s) on an annual basis (or more frequently as needed) and submit them to the JCC for approval. Each such Regional Commercialization activities to Plan must be taken in consistent at all times with the first [***] after the First Commercial Sale of, such Inthen-Vivo [***] Product in the Territory excluding the U.S. if HMI is the Commercializing Party and current Global Commercialization Plan (including the U.S. if NVS is the Commercializing Party (the “Global In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then HMI will prepare and provide to the JSC a Commercialization plan Budget) for each In-Vivo [***] Product that contemplates the commercial launch of, and the Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the U.S. (the “U.S. In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then each Party will provide the applicable Commercialization plan to the other Party no later than [***] such In-Vivo [***] Product in such Party’s territory. Subject to Applicable Law, (i) the strategic objectives and activities in the U.S. In-Vivo [***] Commercialization Plan will be consistent with the strategic objectives and activities in the Global In-Vivo [***] Commercialization Plan, unless otherwise agreed by the Parties; and (ii) the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan will each be reviewed, discussed, and approved by the JSC. Thereafter, at least once each [***], NVS will submit an updated Global In-Vivo [***] Commercialization Plan for each In-Vivo [***] Shared Product, and HMI will submit an updated U.S. In-Vivo [***] Commercialization Plan, in each case, to the JSC for review, discussion, and approval.
Appears in 2 contracts
Samples: Development and Commercialization Agreement, Joint Development and Commercialization Agreement (CRISPR Therapeutics AG)
Commercialization Plans. 10.3.1 In-Vivo The JCC will oversee the Commercialization of the Shared Products by the Parties in the Field in the Territory. No later than [***] Commercialization Plans. Subject prior to Applicable Law, NVS will prepare and provide to HMI (through the JSC): (a) an initial high-level summary of the anticipated launch of each Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval a global Commercialization strategy and plan (each, a “Global Commercialization Plan”) that sets forth at a high level the Commercialization activities to be conducted for an In-Vivo undertaken by the [***] Product; = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would cause competitive harm if publicly disclosed. Parties with respect to the Commercialization of such Shared Product in the Territory. The JCC will update each Global Commercialization Plan on an annual basis (or more frequently as needed) and submit it to the JSC for approval. Each Global Commercialization Plan will include (a) a Global Brand Strategy, (b) an associated budgeta Global Communication Strategy, (c) a Global Market Access and Value Strategy, (d) a Global Pricing Strategy, and (e) a budget for activities conducted under the Global Commercialization Plan (the “Global Commercialization Budget”). In addition, no later than [***] prior to the anticipated launch of each Shared Product in the applicable country, each Lead Commercialization Party will develop one or more regional or country-level Commercialization plans (each, a “Regional Commercialization Plan”) for such In-Vivo (a) in the case of CRISPR, the U.S. and (b) in the case of Vertex, the Major [***] ProductCountries. In addition, NVS Each Party will prepare and provide submit such Regional Commercialization Plans to the JSC a JCC for review and approval. Each Lead Commercialization plan Party will update its Regional Commercialization Plan(s) on an annual basis (or more frequently as needed) and submit them to the JCC for each Inapproval. Each such Regional Commercialization Plan must be consistent at all times with the then-Vivo [***] Product that contemplates the commercial launch of, and the current Global Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the Territory excluding the U.S. if HMI is the Commercializing Party and Plan (including the U.S. if NVS is the Commercializing Party (the “Global In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then HMI will prepare and provide to the JSC a Commercialization plan Budget) for each In-Vivo [***] Product that contemplates the commercial launch of, and the Commercialization activities to be taken in the first [***] after the First Commercial Sale of, such In-Vivo [***] Product in the U.S. (the “U.S. In-Vivo [***] Commercialization Plan”). If HMI is the Commercializing Party, then each Party will provide the applicable Commercialization plan to the other Party no later than [***] such In-Vivo [***] Product in such Party’s territory. Subject to Applicable Law, (i) the strategic objectives and activities in the U.S. In-Vivo [***] Commercialization Plan will be consistent with the strategic objectives and activities in the Global In-Vivo [***] Commercialization Plan, unless otherwise agreed by the Parties; and (ii) the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan will each be reviewed, discussed, and approved by the JSC. Thereafter, at least once each [***], NVS will submit an updated Global In-Vivo [***] Commercialization Plan for each In-Vivo [***] Shared Product, and HMI will submit an updated U.S. In-Vivo [***] Commercialization Plan, in each case, to the JSC for review, discussion, and approval.
Appears in 1 contract
Samples: Joint Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)