Initial Indications Clause Samples

Initial Indications. In the event that Genentech does not exercise the Genentech Option, Altus may request, in writing, that Genentech provide to Altus access to and the right to use certain clinical and other data generated by Genentech following the Effective Date reasonably necessary to Altus's pursuit of Marketing Authorizations for Products in the Initial Indications outside the North American Territory. [***] following such written request from Altus, Genentech shall provide Altus with an invoice in the amount of [***] of the [***]. [***] of Altus's written approval of such invoice, [***], Genentech shall provide Altus with the requested data and associated right to use such data as reasonably necessary for obtaining Marketing Authorizations for Products outside the North American Territory. Altus shall provide Genentech with written notice of any such submission [***] thereof. Altus shall [***] associated with transferring the requested data to Altus.
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Initial Indications. (a) NYCOMED and PHARMACYCLICS agree that the initial focus with respect to External Cancers will be upon the Initial External Cancers. PHARMACYCLICS shall have the responsibility for conducting all pre-clinical and Phase I clinical trials with respect to a Licensed Product for each of the External Cancers. The initial Development Plan and Budget for the Licensed Products for the Initial External Cancers is set forth in that certain letter from PHARMACYCLICS to NYCOMED, dated September 5, 1997, and incorporated herein by reference; however, the Parties agree and acknowledge that such initial Development Plan and Budget may be modified dependent upon the review of the JDC following the Effective Date, or upon recommendations of the EMEA and/or the FDA. NYCOMED's commitment for development of the Initial External Cancers shall not exceed [*] as per that memo dated September 5, 1997 from PHARMACYCLICS to NYCOMED for such indication as amended by the JDC. (b) NYCOMED and PHARMACYCLICS agree that the initial focus with respect to Internal Cancers will be upon the Initial Internal Cancers. PHARMACYCLICS shall have the responsibility for conducting all pre-clinical and Phase I clinical trials with respect to a Licensed Product for each of the Initial Internal Indications. Following the conduct of Phase I clinical trials, should PHARMACYCLICS determine to propose pursuing the further development for such Initial Internal Cancer, it shall provide to NYCOMED a proposed Development Plan and Budget for such indication. NYCOMED agrees that, upon review of such Development Plan and Budget, it will pursue such development for such Initial Cancer Indication as a Licensed Product under this Agreement unless it reasonably demonstrates that there is an insufficient commercial opportunity in the Territory for the sale of the Licensed Product for such Initial Internal Cancer.
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Initial Indications. The term “
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Initial Indications. (a) With respect to the psoriasis Indication only, Genentech agrees to be responsible for the following specific activities necessary to complete development of Anti-CD11a up to completion of Phase II Clinical Trials: (i) Transfer all preclinical data, assays and associated materials, protocols, procedures and any other information in Genentech's possession required to initiate clinical development of Anti-CD11a for the psoriasis Indication at no cost to XOMA. (ii) Complete development of a pilot process to manufacture Anti-CD11a for the psoriasis Indication. Transfer the cell bank for Anti-CD11a production as well as all associated assays, procedures and other information required for XOMA to supply Licensed Product for any IND-enabling studies and human clinical trials to the end of Phase II Clinical Trials for the psoriasis Indication. The Joint Core Team will determine if any process improvements or refinements are required and which Party will be responsible for such improvements or refinements. XOMA will pay all costs incurred in making such improvements or refinements after Genentech has transferred the pilot process to XOMA and XOMA has accepted it, such acceptance not to be unreasonably withheld. (b) Subject in each case to XOMA's rights with respect to each Organ Transplant Indication as described in Section 2.1 and with respect to the renal Organ Transplant Indication only during such period as the Parties are jointly developing such indication, XOMA agrees to be responsible for the following specific activities necessary to complete development of Anti-CD11a up to the successful completion of Phase II Clinical Trials for the Initial Indications: (i) Use Commercially Reasonable and Diligent Efforts to conduct all IND-enabling studies and human clinical studies for the Initial Indications through the successful completion of Phase II Clinical Trials and make all filings with and all supporting communications with the U.S. Food and Drug Administration ("FDA") necessary to conduct such studies, as set forth in the Development Plan. (ii) Upon transfer of manufacturing technology by Genentech, use Genentech's process at XOMA's manufacturing facilities (upgrading such facilities if necessary) to supply all requirements of Licensed Product for preclinical and human clinical trials up to the successful completion of the above referenced Phase II Clinical Trials for psoriasis in the Co-Promotion Territory. (c) No Opt-In Fee. Genentech will not be obligat...
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Initial Indications. Subject to the terms of this Agreement, Allergan and Assembly shall be jointly responsible for all Development Costs incurred in the conduct of activities under the R&D Plan for Development of a Licensed Compound (other than a Backup Compound) and a Licensed Product incorporating such Licensed Compound for an Initial Indication. On a Licensed Compound-by-Licensed Compound basis, Allergan shall be obligated to fund up to Fifty Million USD ($50M) and Assembly shall be obligated to fund up to Twenty Five Million USD ($25M) of such Development Costs through the completion of all activities related to the first POC Trial of a Licensed Product incorporating such Licensed Compound for the Initial Indications, including Completion of such POC Trial and completion of the final clinical study report for such POC Trial (the “Initial Indication Development Costs”). The Parties shall fund up to such aggregate of Seventy-Five Million USD ($75M) of Initial Indication Development Costs on a pro-rata basis in the manner of two-thirds (2/3) borne by Allergan and one-third (1/3) borne by Assembly.
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Initial Indications. Arctic Vision (either itself or through its Affiliates and Sublicensees) shall use Commercially Reasonable Efforts to Develop and Commercialize (a) the MicroLine Product for the treatment of presbyopia in the Territory and (b) the MicroPine Product for the treatment of myopia in the Territory.
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Initial Indications. If there is a [***] an [***] as a result of the Additional Development conducted pursuant to Section 4.2.1(b) (Licensee Proposal) or Section 4.2.1(c) (Akebia Proposal) and if such Additional Development is for the purpose of [***] (and [***]), then [***]% of the total Development costs will be allocable to the Territory.
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Related to Initial Indications

  • 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.

  • 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 Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • 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 Milestone Payments TriSalus shall pay (or cause to be paid) to Dynavax, in accordance with and subject to the terms of this Section 2.3, Section 2.4 and Section 6.4 (each such milestone, a “Development Milestone”, and each payment in respect thereof, a “Development Milestone Payment”): (i) Upon the successful completion by a Milestone Obligor after the Closing of a [**] study with respect to a Product using PEDD, a payment of [**] US Dollars ($[**]), with such Development Milestone Payment being payable only once (for purposes of the foregoing, successful completion means completion of such study in accordance with the plan for such study); (ii) For the first patient Dosed by a Milestone Obligor in each Phase 1 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iii) For the first patient Dosed by a Milestone Obligor in each Phase 2 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iv) For each Phase 2 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 2 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 2 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (v) For each Phase 3 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 3 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 3 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (vi) Upon receipt by a Milestone Obligor of each Regulatory Approval for any Product for any Indication in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (vii) Upon receipt by a Milestone Obligor for each Regulatory Approval of any Product for any Indication in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (viii) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vi) for receipt of such Regulatory Approval), regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; and (ix) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vii) for receipt of such Regulatory Approval), regardless ​ of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval.