Psychiatric Indications Sample Clauses

Psychiatric Indications. Roche shall pay to Memory with respect to any 3454 Product the following non-refundable and non-creditable payments upon the first occurrence of the following Events for such 3454 Product: Event Payment (mio US$) [*] (or foreign equivalent) for a Psychiatric Indication [*] [*] for a Psychiatric Indication [*] [*] for a Psychiatric Indication [*]
Sample 1Sample 2Sample 3
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Psychiatric Indications. Roche shall pay to Memory, in order to maintain its license rights with respect to 3454 Products pursuant to Section 4.4 of this Agreement and the other provisions of the Agreement with respect to such 3454 Products, the following non-refundable and non-creditable payments upon the first occurrence of the following Events for any such 3454 Product.
Sample 1
Psychiatric Indications. Roche shall pay to Memory, in order to maintain its license rights pursuant to Section 2.1 and the other provisions of this Agreement with respect to such Product, the following non-refundable and non-creditable payments upon the first occurrence of the following events for such Product if such Product contains a different Memory Compound than any Memory Compound contained in a Product for which any payment has been made under Section 4.4(a): EVENT PAYMENT (MIO US$) ----- ----------------- [*] (or foreign equivalent) for Psychiatric Indication [*]* and delivery of the data and reports specified in Schedule 1 [*] (or foreign equivalent) for a Psychiatric Indication [*]** and delivery of the data and reports specified in Schedule 1 [*] (or foreign equivalent) for a Psychiatric Indication [*]*** and delivery of the data and reports specified in Schedule 1 Each payment in Section 4.4 (a) and 4.4 (b) shall be due and payable by Roche within sixty (60) days after occurrence of the applicable event. Roche will make each of such payments only once for each Product, for the first occurrence of a respective event, regardless of how many times the event may be subsequently achieved with such Product. For the avoidance of doubt, the Parties confirm and agree that no amount payable under this Article 4 shall reduce any royalties payable under Article 5.
Sample 1
Psychiatric Indications. Roche shall pay to Memory, in order to maintain its license rights pursuant to Section 2.1 and the other provisions of this Agreement with respect to such Product, the following non-refundable and non-creditable payments upon the first occurrence of the following events for such Product if such Product contains a different Memory Compound than any Memory Compound contained in a Product for which any payment has been made under Section 4.4(a): -------------------------------------------------------------- EVENT PAYMENT (MIO US$) -------------------------------------------------------------- [*] (or foreign equivalent) for [*]* Psychiatric Indication and delivery of the data and reports specified in Schedule 1 -------------------------------------------------------------- [*] (or foreign equivalent) for [*]** a Psychiatric Indication and delivery of the data and reports specified in Schedule 1 -------------------------------------------------------------- [*] (or foreign equivalent) for [*]*** a Psychiatric Indication and delivery of the data and reports specified in Schedule 1 -------------------------------------------------------------- Each payment in Section 4.4 (a) and 4.4 (b) shall be due and payable by Roche within sixty (60) days after occurrence of the applicable event. Roche will make each of such payments only once for each Product, for the first occurrence of a respective event, regardless of how many times the event may be subsequently achieved with such Product. For the avoidance of doubt, the Parties confirm and agree that no amount payable under this Article 4 shall reduce any royalties payable under Article 5.
Sample 1
Psychiatric Indications. Roche shall pay to Memory the following non-refundable and non-creditable payments upon the first occurrence of the following Events for a Product having an NCE that is different from an NCE for which any payment occurred under Sections 4.3(a). Event Payment (mio US$) ----- ----------------- [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*]** [*] [*] for anxiety [*] ** In the US, the Product does not have a black box warning in its label at time of Launch and does not receive one during its first 6 months on the market in the US. During that period there is not any "Dear Doctor" letters issued by the US FDA regarding this Product. The Product is the first PDE4 inhibitor having regulatory approval in the US for the treatment of depression, and a second PDE4 inhibitor having regulatory approval for the treatment of depression does not launch in the US during the 6 month period following the Launch of the Product in the US.
Sample 1
Psychiatric Indications. Roche shall pay to Memory, in order to maintain its license rights with respect to 3454 Products pursuant to Section 4.4 of this Agreement and the other provisions of the Agreement with respect to such 3454 Products, the following non-refundable and non-creditable payments upon the first occurrence of the following Events for any such 3454 Product. Event Payment (mio US$) [*] (or foreign equivalent) for a Psychiatric Indication and delivery of the data and reports specified in Schedule 1 [*] [*] (or foreign equivalent) for a Psychiatric Indication and delivery of the data and reports specified in Schedule 1 [*] 1 If any 3454 Product is for a Neurological indication other than Alzheimer’s Disease, then the payment shall be [*] dollars ($[*]). [*] CONFIDENTIAL TREATMENT IS REQUESTED Each payment in Section 1(a) and 1(b) shall be due and payable by Roche within sixty (60) days after occurrence of the applicable Event. Roche will make each of such payments only once.2 For the avoidance of doubt, the Parties confirm and agree that no amount payable under Section 4.4 of the Agreement or this Exhibit B or any of the other Exhibits thereto shall reduce any royalties payable under Article 5 of the Agreement or any of the other Exhibits thereto.
Sample 1
Psychiatric Indications. Roche shall pay to Memory the following non-refundable and non-creditable payments upon the first occurrence of the following Events for a Product having an NCE that is different from an NCE for which any payment occurred under Sections 4.3(a). Event Payment (mio US$) ----- ----------------- [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*]** [*] [*] for anxiety [*] [*] CONFIDENTIAL TREATMENT IS REQUESTED ** In the US, the Product does not have a black box warning in its label at time of Launch and does not receive one during its first 6 months on the market in the US. During that period there is not any "Dear Doctor" letters issued by the US FDA regarding this Product. The Product is the first PDE4 inhibitor having regulatory approval in the US for the treatment of depression, and a second PDE4 inhibitor having regulatory approval for the treatment of depression does not launch in the US during the 6 month period following the Launch of the Product in the US.
Sample 1
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Psychiatric Indications. Roche shall pay to Memory, in order to maintain its license rights with respect to 3454 Products pursuant to Section 4.4 of this Agreement and the other provisions of the Agreement with respect to such 3454 Products, the following non-refundable and non-creditable payments upon the first occurrence of the following Events for any such 3454 Product. Event Payment (mio US$) [*] (or foreign equivalent) for a Psychiatric Indication and delivery of the data and reports specified in Schedule 1 [*] [*] (or foreign equivalent) for a Psychiatric Indication and delivery of the data and reports specified in Schedule 1 [*+] Each payment in Section 1(a) and 1(b) shall be due and payable by Roche within sixty (60) days after occurrence of the applicable Event. Roche will make each of such payments only once. * If any Product is for a Neurological indication other than Alzheimer’s Disease, then the payment shall be [*]. + If any Product is for a Psychiatric Indication other than schizophrenia, then the payment shall be [*].
Sample 1

Related to Psychiatric Indications

  • 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).

  • 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 and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • 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:

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • 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.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • 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.

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