Development of Companion Diagnostics Sample Clauses

Development of Companion Diagnostics. (a) In connection with the Development of Licensed Products, Five Prime shall use Commercially Reasonable Efforts to develop companion diagnostic products to be used in connection with Licensed Products (“Companion Diagnostics”). Without limiting Zai’s reimbursement obligations under Section 5.4 (which pertain to the Development of Licensed Products, including the manufacture and use of Companion Diagnostics to screen patients for such Development, rather than the development of Companion Diagnostics, which is addressed in this Section 5.10), Five Prime shall be responsible for the cost and expenses it incurs to develop and commercialize Companion Diagnostics outside the Territory, provided that Zai shall reimburse Five Prime for: (i) all costs incurred by Five Prime that are related to the development, registration and commercialization of Companion Diagnostics solely in the Territory, and (ii) [***] of all costs incurred by Five Prime that are related to the development of Companion Diagnostics both in and outside the Territory. Five Prime shall invoice Zai for such costs on a [***] and Zai shall pay the amount invoiced within [***] after the date of any such invoice.
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Development of Companion Diagnostics. In connection with the Development or Commercialization of any Licensed Product for which the JSC has approved a Territory-Specific Development Plan (as applicable) contemplating the Development of one or more companion diagnostic products to be used in connection with such Licensed Product (each a “Companion Diagnostic”), Zai may elect to Develop one or more Companion Diagnostics solely in the Territory. Unless otherwise allocated to Zai under a Global Development Plan for a Licensed Product, Blueprint will be responsible for Developing Companion Diagnostics for Licensed Products if such Companion Diagnostics are to be used with one or more Licensed Products inside and outside of the Territory. If JSC determines that Zai will Develop a Companion Diagnostic for use with the Commercialization of any Licensed Product in the Territory, then Zai will be responsible [****]. Without limiting Xxx’s reimbursement obligations under Section 5.13 (Responsibility for Development Costs) (which obligations pertain to the Development of each Licensed Product, including the cost to purchase Companion Diagnostics [****] to screen patients in connection with the Development of such Licensed Products), Blueprint will be responsible for [****] Notwithstanding Blueprint’s responsibility for [****] if Zai wishes to use any Companion Diagnostic Developed by Blueprint in connection with Xxx’s Commercialization of any Licensed Product in the Territory, then Zai will reimburse Blueprint for: (a) [****] that are related to the Development of Companion Diagnostics for use with a Licensed Product solely in the Territory [****] and (b) with respect to [****] that are related to the Development of Companion Diagnostics for use [****] the Territory [****]. Article 6
Sample 1
Development of Companion Diagnostics. If a Territory Development Plan contemplates the Development of one or more companion diagnostic products to be used in connection with a Licensed Product in the Territory (each, a “Companion Diagnostic”), then, at Partner’s request, ImmunoGen will (a) reasonably assist Partner’s efforts to enter into an agreement [***] for the development and commercialization of such a Companion Diagnostic to be used in the Territory, and (b) to the extent [***], ImmunoGen will provide Partner with (i) a copy of all physical and tangible Know-How that are included in the ImmunoGen Know-How related to such a Companion Diagnostic and (ii) reasonable assistance to understand and use the foregoing. Notwithstanding any provision to the contrary set forth in this Agreement, in no event will Partner or any of its Affiliates have the right to Develop or Commercialize any Companion Diagnostic except [***] in accordance with the terms of this Section 5.12 (Development of Companion Diagnostics) or [***] approved by ImmunoGen in accordance with Section 2.2 (Sublicensing and Subcontractors). Article 6
Sample 1

Related to Development of Companion Diagnostics

  • 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.

  • 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.

  • 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 Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • 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.

  • Collaboration Each Party shall provide to the enforcing Party reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including to be named in such action if required by Applicable Laws to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any such efforts, including determination of litigation strategy and filing of material papers to the competent court. The non-enforcing Party shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the enforcing Party.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • 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.

  • Development Plan As defined in Section 3.2(a).

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

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