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: [*] (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 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
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. 1 If any 3454 Product is for a Neurological indication other than Alzheimer’s Disease, then the payment shall be reduced to three million dollars ($3,000,000). (i) [*] (or foreign equivalent) for a Psychiatric Indication and delivery of the data and reports specified in Schedule 1 [*] (ii) The randomization of 212 patients or the last patient randomized if less than 212 patients are randomized pursuant to Roche’s request in accordance with Section 1(a)(d) of the Fifth Amendment. 5 (iii) The date that Memory reports to Roche top-line results (including safety and efficacy) of the CIAS Trial.
Sample 1
Psychiatric Indications. Roche shall pay to Memory, in order to maintain its license rights pursuant to Section 2.1 and the other provisions of this Agreement with respect to such Product, the following non-refundable and non-creditable payments upon the first occurrence of the following events for such Product if such Product contains a different Memory Compound than any Memory Compound contained in a Product for which any payment has been made under Section 4.4(a): -------------------------------------------------------------- EVENT PAYMENT (MIO US$) -------------------------------------------------------------- [*] (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 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. [*] (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 ($[*]). Each payment in Section 1(a) and 1(b) shall be due and payable by Roche within sixty (60) days after occurrence of the applicable Event. Roche will make each of such payments only once.2 For the avoidance of doubt, the Parties confirm and agree that no amount payable under Section 4.4 of the Agreement or this Exhibit B or any of the other Exhibits thereto shall reduce any royalties payable under Article 5 of the Agreement or any of the other Exhibits thereto.
Sample 1
Psychiatric Indications. Roche shall pay to Memory the following non-refundable and non-creditable payments upon the first occurrence of the following Events for a Product having an NCE that is different from an NCE for which any payment occurred under Sections 4.3(a). Event Payment (mio US$) ----- ----------------- [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*] for depression [*] [*]** [*] [*] for anxiety [*] ** 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 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
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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. [*] (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

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • 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.

  • Organ Transplants This plan covers organ and tissue transplants when ordered by a physician, is medically necessary, and is not an experimental or investigational procedure. Examples of covered transplant services include but are not limited to: heart, heart-lung, lung, liver, small intestine, pancreas, kidney, cornea, small bowel, and bone marrow. Allogenic bone marrow transplant covered healthcare services include medical and surgical services for the matching participant donor and the recipient. However, Human Leukocyte Antigen testing is covered as indicated in the Summary of Medical Benefits. For details see Human Leukocyte Antigen Testing section. This plan covers high dose chemotherapy and radiation services related to autologous bone marrow transplantation to the extent required under R.I. Law § 27-20-60. See Experimental or Investigational Services in Section 3 for additional information. To speak to a representative in our Case Management Department please call 1-401- 000-0000 or 1-888-727-2300 ext. 2273. The national transplant network program is called the Blue Distinction Centers for Transplants. SM For more information about the Blue Distinction Centers for TransplantsSM call our Customer Service Department or visit our website. When the recipient is a covered member under this plan, the following services are also covered: • obtaining donated organs (including removal from a cadaver); • donor medical and surgical expenses related to obtaining the organ that are integral to the harvesting or directly related to the donation and limited to treatment occurring during the same stay as the harvesting and treatment received during standard post- operative care; and • transportation of the organ from donor to the recipient. The amount you pay for transplant services, for the recipient and eligible donor, is based on the type of service.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • 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.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

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