Development and Commercialization Responsibilities. Licensee shall have the sole right and responsibility for, and control over, all development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products and Licensed Services in the Field.
Development and Commercialization Responsibilities. (a) Disc shall be responsible for all Development and Commercialization activities with respect to Licensed Antibodies and Licensed Products in the Licensed Territory. Mabwell shall be responsible for all Development and Commercialization activities with respect to Licensed Antibodies and Licensed Products in the Mabwell Territory. Disc shall have the right to generate, or otherwise make or Exploit any Combination Product in the Licensed Territory solely in accordance with the following: if Disc desires to generate, or otherwise make or Exploit any Combination Product, Disc shall promptly notify Mabwell in writing, including the other active pharmaceutical ingredient being incorporated in such Combination Product and any proposed update to the Development Plan with respect thereto. Disc shall have the right to generate, or otherwise make or Exploit such Combination Product pursuant to the Development Plan, as amended from time to time pursuant to Section 2.2(c).
(b) All Development of each Licensed Antibody and Licensed Product by or on behalf of Disc under this Agreement will be conducted pursuant to a written development plan that sets forth, in reasonable detail, all pre-clinical, clinical and regulatory activities (and the anticipated timelines) to be conducted by or on behalf of Discs to obtain Regulatory Approval of at least one Licensed Product in the Licensed Territory (including but not limited to the Major Markets) (the “Development Plan”). As of the Effective Date, the Parties have agreed on the initial Development Plan, which is attached hereto as Schedule 2.2(b). From time to time, but at least [***], Disc will propose updates or amendments to the Development Plan in consultation with the JSC and submit such proposed updated or amended plan to the JSC for its review and approval before adopting such update or amendment. Disc shall also provide to Mabwell, via the JSC, a reasonably detailed clinical development plan, including the protocols and dosing regimen for all clinical trials of the Licensed Products to be conducted by or behalf of Disc and all investigator-sponsored and investigator-initiated trials of the Licensed Products in the Licensed Territory(the “Clinical Development Plan”), in each case prior to any patient enrollment, for review and approval by the JSC.
(c) All Commercialization of each Licensed Antibody and Licensed Product by or on behalf of Disc will be conducted, pursuant to a written plan that sets forth in reasonable det...
Development and Commercialization Responsibilities. Dicerna shall have the sole right and responsibility for, and control over, all research, development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products in the Fields.
Development and Commercialization Responsibilities. Otonomy (itself or through its Affiliates or designees) shall pay for all costs related to and shall bear all responsibility for the development, manufacturing, registration and sale of the Licensed Product(s). Otonomy (itself or through its Affiliates or designees) shall pay for all costs related to and shall bear all responsibility for all marketing and promotional activities related to Licensed Product(s) in the Territory and shall decide on the strategy regarding such activities. Otonomy shall use Commercially Reasonable Efforts to develop, obtain Approvals for, promote and sell Licensed Product(s) being granted Approval in the Territory, it being understood that the efforts of Otonomy’s Affiliates and Sublicensees shall count towards Otonomy’s own Commercially Reasonable Efforts.
Development and Commercialization Responsibilities. (a) Sublicensee shall be solely responsible for, and shall bear the entire cost of performing or having performed, all Development of Licensed Compounds and Licensed Products in the Sublicensed Field in the Territory, and all Commercialization of Licensed Products in the Sublicensed Field in the Territory, and the satisfaction of all regulatory requirements with respect thereto. As between the Parties, and subject to the provisions of Article IV. Sublicensee shall assume responsibility for fulfilling the obligations set forth in Article 3 of the Head License for the Sublicensed Field in the Territory.
(b) Notwithstanding the provisions of Section 2.2(a), neither Party shall file for Regulatory Approval or apply for or seek to obtain any designation, priority, exclusivity, accelerated approval, priority review voucher or similar right (including any orphan drug, rare disease, pediatric disease, tropical disease or breakthrough therapy or similar designations) with respect to any Licensed Compounds and Licensed Products in any country or jurisdiction in the Territory (the Party first seeking Regulatory Approval, the “Filing Party”), without providing prior written notice to the non-Filing Party. If requested in writing by the non-Filing Party within seven (7) Business Days of receipt of such notice from the Filing Party, the Parties shall discuss the regulatory pathway for the Licensed Compounds and Licensed Products in the Territory, and the Parties shall agree whether or not the Filing Party will file for Regulatory Approval and which Party shall be responsible for listings in the FDA’s Orange Book, and under similar or equivalent laws in other countries or jurisdictions in the Territory, seeking to obtain any designation, priority, exclusivity, accelerated approval, priority review voucher or similar right (including any orphan drug, rare disease, pediatric disease, tropical disease or breakthrough therapy or similar designations), and for which Patents the Parties will file patent term extensions; provided, however, that in the event the Parties are not able to agree to any of the foregoing within a period of thirty (30) days following the date of receipt of the initial notice provided to the non-Filing Party, Sublicensor shall make the final determination in respect thereto; provided, such determination must be reasonable under the then-existing circumstances. Without limiting the foregoing, neither Party shall be required to provide legally privileged ...
Development and Commercialization Responsibilities. Subject to paragraph (a), the Licensee will comply with the current Development Plan including all timeframes set out in the Development Plan. Licensee shall have the sole right and control over, all of its development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products in the Field and in the Territory. Licensee will update the Development Plan and provide a copy of the same to the Licensor at least once every six (6) months. The format of such updated Development Plan shall be no less detailed than, and consistent with the format of, the version annexed at Schedule 1 at the Effective Date, unless agreed otherwise by the Parties.
(a) Licensee may request in writing that Licensor consent to revise the applicable time within which to attain a Key Milestone if supported by evidence of technical difficulties or delays in pre-clinical, clinical studies or regulatory processes that are outside of Licensee’s reasonable control, including, but not limited to, any delay that would result (a) from emerging safety issues causing the clinical program to be put on hold by a regulatory agency or sponsor and/or mandate before further preclinical works be conducted, (b) from a poor pharmacokinetic or pharmacodynamic profile or efficacy in man that would require further formulation or preclinical development to be conducted, (c) from any administrative issues in preclinical or clinical trial conduct (e.g. contract research or manufacturing organization failing to deliver work in due time, delays in patient recruitments), or (d) from preclinical or clinical findings requiring further investigations to be conducted. The parties will discuss any such request in good faith and Licensor will not unreasonably deny a request for appropriate extension provided that sufficient objective evidence of the nature set forth above is provided.
Development and Commercialization Responsibilities. Subject to this Section 6.7, NeuroSystec shall pay for all costs related to and shall bear all responsibility for the development, manufacturing, registration and sale of the Licensed Product(s). Subject to this Section 6.7, NeuroSystec shall pay for all costs related to and shall bear all responsibility for all marketing and promotional activities related to Licensed Product(s) in the Territory and shall decide on the strategy regarding such activities. NeuroSystec shall use Commercially Reasonable Efforts to develop, obtain Approvals for, promote and sell Licensed Product(s) being granted Approval in the Territory.
Development and Commercialization Responsibilities. During the Term, Curis shall have the sole right and responsibility for, and control over, all research, development, manufacturing and commercialization activities, including all regulatory activities, with respect to Licensed Products, at Curis’ sole cost and expense.
Development and Commercialization Responsibilities. Subject to Section 3.1, all decisions concerning the Research, Development, Manufacture and Commercialization of the Licensed Product, including the clinical and regulatory strategy of the Licensed Product, the marketing and sales of the Licensed Product, and the design, price, and promotion of the Licensed Product, shall be at the sole discretion of Fulcrum. If Fulcrum reasonably requests assistance or input from CAMP4 with respect to Research or Development activities being undertaken by Fulcrum in respect of a Licensed Product, CAMP4 shall (at Fulcrum’s expense), use its Commercially Reasonable Efforts to cooperate in good faith with Fulcrum in response to such request (e.g., by responding to regulatory inquiries relating to the pre-clinical development of a Licensed Product by CAMP4, intellectual property matters with respect to Licensed Patents and Know-How, etc.).
Development and Commercialization Responsibilities. (i) During the term of this Agreement, Sorrento shall have sole control over all Licensed Products in the Field in the Territory. As between the Parties, following receipt of Regulatory Approval for a Licensed Product, and subject to ACEA’s obligation to supply Product Materials to Sorrento as provided hereunder or pursuant to one or more Supply Agreements (including CMC and clinical development obligations), and further subject to any other obligations of ACEA under this Agreement or in any Supply Agreement, Sorrento shall be solely responsible, at its own expense, for all aspects of the development (including, but not limited to, chemistry manufacturing controls, and clinical development), manufacture, registration and commercialization (including, but not limited to, marketing, promoting, selling, distributing and determining pricing) of such Licensed Product in the Field in the Territory.
(ii) Sorrento shall make Commercially Reasonable Efforts to commercialize the Licensed Products. As between the Parties, and subject to ACEA’s obligation to supply Product Materials to Sorrento as provided hereunder or pursuant to one or more Supply Agreements, and further subject to any other obligations of ACEA under this Agreement or in any Supply Agreement (including CMC and clinical development obligations), Sorrento shall conduct all activities relating to the commercialization of the Licensed Products in the Field within the Territory at its own expense.
