Responsibility for Commercialization of Licensed Products Sample Clauses

Responsibility for Commercialization of Licensed Products. As between the Parties, Lilly shall be solely responsible, at its sole cost and expense, for the conduct of all aspects of the Commercialization of Licensed Products in the Territory, including (a) the conduct of: (i) all activities related to Clinical Trials, and (ii) all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or databases and post-marketing safety surveillance); (b) making all Regulatory Filings for Licensed Products and filing and prosecuting all Drug Approval Applications and otherwise seeking all Regulatory Approvals for any Licensed Products within the Territory, as well as all correspondence and communications with Regulatory Authorities regarding such matters; (c) reporting of all Adverse Events to Regulatory Authorities if and to the extent required by Applicable Laws; (d) the timing for the launch of Licensed Products and for submitting applications for reimbursement with respect to Licensed Products in any country in the Territory; and (e) booking all sales of Licensed Products in the Territory.
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Responsibility for Commercialization of Licensed Products. Clementia shall be solely responsible, at its sole cost and expense for conduct of all aspects of the Commercialization of any Licensed Product in the Clementia Field in the Territory, including without limitation, (a) all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or databases and post-marketing safety surveillance); (b) the timing of the launch of any Licensed Products and for submitting applications for reimbursement with respect to any Licensed Product in any country in the Territory and (c) booking all sales of Licensed Products in the Territory.
Sample 1
Responsibility for Commercialization of Licensed Products. Subject to ARQULE’s Co-Commercialization Option, DS shall have the sole right and responsibility, at its sole expense, for all aspects with respect to the Commercialization of Licensed Products in accordance with the applicable Product Commercialization Plan, in the Field and in the Territory and shall have the sole right and responsibility, at its sole expense, for order fulfillment and distribution of Licensed Product and for booking all sales of Licensed Product in the Territory, including, without limitation, the conduct of: (a) all activities relating to the development and scale-up of processes for Manufacture of API and Licensed Product for commercial sale and the Manufacture and supply of Licensed Products for Commercialization; and (b) all marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, conducting sales and marketing activities, post-marketing safety surveillance (other than Phase 4 Clinical Trials or Phase 5 Clinical Trials) and maintaining databases).
Sample 1
Responsibility for Commercialization of Licensed Products. Except as expressly stated herein to be an ARQULE Decision, a Joint Decision or a Unanimous Decision and subject to ARQULE’s Co-Commercialization Option, DS shall have the sole right and responsibility, including the right to make any decision at sole discretion, at its sole expense, for all aspects with respect to the Commercialization of Licensed Products in accordance with the applicable Product Commercialization Plan, in the Field and in the Territory and shall have the sole right and responsibility, at its sole expense, for order fulfillment and distribution of Licensed Product and for booking all sales of Licensed Product in the Territory, including, without limitation, the conduct of: (a) all activities relating to the development and scale-up of processes for Manufacture of API and Licensed Product for commercial sale and the Manufacture and supply of Licensed Products for Commercialization; and (b) all marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, conducting sales and marketing activities, creating and approving all Product Promotional Materials for the Licensed Product, post-marketing safety surveillance (other than Phase 4 Clinical Trials or Phase 5 Clinical Trials) and maintaining databases).
Sample 1
Responsibility for Commercialization of Licensed Products. Astellas will inform PTI of the time it initiates activities with respect to the Commercialization of each Licensed Product for each Indication that such Licensed Product receives Regulatory Approval. Subject to the diligence obligations set forth in Section 4.4 (Commercialization Diligence for all Licensed Products) and PTI’s Co-Promotion Option in accordance with Section 4.2(a) (Co-Promotion Option), Astellas will have the sole right and responsibility for, and will have full control and authority over, at its sole cost and expense, the Commercialization of each Licensed Product, including making all strategic and tactical decisions with respect thereto, conducting all Commercialization activities and establishing the methods and means by which it performs such activities under this Agreement. Astellas may, in its sole discretion, delegate any work performed on Commercialization of such Licensed Product to any of its Third Party Collaborators, or to any other Third Party consultants, clinical investigators or service providers; provided, however, that such party enter into a written agreement with Astellas in advance of any work being performed which assigns any Inventions or other Know-How to Astellas and contains confidentiality provisions at least as protective as those in this Agreement covering the disclosure of any information of either Party that is the subject of the Collaboration, and provided further, that Astellas will remain responsible hereunder for the performance of any such Persons.
Sample 1
Responsibility for Commercialization of Licensed Products. As between the Parties, Affini-T shall be responsible for the Commercialization of Licensed Products in the Territory, including (a) the conduct of all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or databases and post-marketing safety surveillance); (b) reporting of all adverse, including serious, events to Regulatory Authorities if and to the extent required by Applicable Laws; (c) the timing for the launch of Licensed Products and for submitting applications for reimbursement with respect to Licensed Products in any country in the Territory; and (d) booking all sales of Licensed Products in the Territory.
Sample 1

Related to Responsibility for Commercialization of Licensed Products

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • Commercialization Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

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