Cystic Fibrosis Sample Clauses

Cystic Fibrosis. (a) Notwithstanding anything to the contrary contained herein, the provisions of Sections 2.13.1, 2.13.2 and 2.13.3 will not apply with respect to the discovery, research, development, manufacture or commercialization of any product for the treatment of cystic fibrosis by Vertex or its Affiliates and Vertex and its Affiliates will not be restricted from conducting such activities.
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Cystic Fibrosis. Vertex’s Option with respect to Cystic Fibrosis may be exercised at any time prior to the date that is [***] following the later of (a) the conclusion of the first two years of the Research Term or (b) the conclusion of the last Research Extension for the Cystic Fibrosis Research Program (as applicable); provided that, prior to the exercise of the Option for Cystic Fibrosis, Vertex shall have the right to evaluate the Capsids in [***], and provided further, that if Vertex is so evaluating a Capsid(s) for Cystic Fibrosis on the date that is [***] following the later of (a) or (b) above, or is scheduled to commence such evaluation within [***] thereafter, then the Option will expire upon the earlier of (i) [***] after Vertex’s receipt of the final data from such evaluation, or (ii) [***] following the later of (A) the conclusion of the first two years of the Research Term or (B) the conclusion of the last Research Extension for the Cystic Fibrosis Research Program (as applicable) (such period, the “CF Option Exercise Period”). Upon timely notice to Company during the CF Option Exercise Period that Vertex wishes to exercise the Option for Cystic Fibrosis and payment to Company of a one-time, non-refundable, non-creditable option exercise fee of [***] (the “CF Option Fee”), the covenant set forth in Section 4.7.2 with respect to Cystic Fibrosis shall expire. For the avoidance of doubt, Vertex’s exercise of the Option for Cystic Fibrosis shall not affect Company’s obligation to conduct Research Activities with respect to Cystic Fibrosis in accordance with Section 2.1 during the first two years of the Research Term and during any applicable Research Extension for the Cystic Fibrosis Research Program, as applicable. If Vertex does not make a timely exercise of the Option for Cystic Fibrosis during the CF Option Exercise Period, the Option for Cystic Fibrosis will lapse and the diagnosis, treatment and prevention of Cystic Fibrosis shall no longer be included in the Field, effective as of the conclusion of the CF Option Exercise Period, and any and all rights granted hereunder by Company to Vertex with respect to Cystic Fibrosis as a Vertex Disease will revert automatically to Company, and all exclusivity obligations of Company and its Affiliates and successors under Section 4.7.1 with respect to Cystic Fibrosis shall automatically terminate. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOT...
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Cystic Fibrosis. (a) Notwithstanding anything to the contrary contained herein, the provisions of Sections 2.13.1, 2.13.2 and 2.13.3 will not apply with respect to the discovery, Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Triple asterisks denote omissions. research, development, manufacture or commercialization of any product for the treatment of cystic fibrosis by Vertex or its Affiliates and Vertex and its Affiliates will not be restricted from conducting such activities.
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Cystic Fibrosis. (a) Notwithstanding anything to the contrary contained herein, the provisions of Sections 2.13.1, 2.13.2 and 2.13.3 will not apply with respect to the discovery,
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Cystic Fibrosis. Impact Treatment Do you get exhausted when you do sports? Do you feel tired during the day? Do you get out of breath? Do you need to rest more than others? Does it bother you that you must take your enzymes before every meal? Does it bother you that you have to eat a special diet to keep you healthy? Does it bother you that you have to spend a lot of time having treatment? Are you bothered because you have to do physiotherapy everyday? Have you felt that your treatment takes up too much of your free time? Do you feel bothered that you have to stop playing or doing things for treatment? Diabetes mellitus Impact Treatment Does diabetes stop you from doing the things you want to do? Does diabetes rule your day? Does it bother you that you have to be careful about what you eat? Is it difficult for you to stick to your diet? Do you worry about your blood sugar level? Does it bother you that others can always eat and drink as much as they like? Are you annoyed that you have to carry the testing equipment with you? Are you bothered that you have to plan everything? Do you mind taking insulin? Do you get fed up with measuring your blood sugar levels?
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Cystic Fibrosis. Understand the general pediatrician's role in the management of cystic fibrosis. Discuss the presenting signs and symptoms of cystic fibrosis and refer the patient for appropriate confirmatorytesting, education, and treatment. Discussion should include high-risk populations, associated symptoms, treatment options and expected course of the disease. Participate in development and implementation of a coordinated pulmonary and nutritional treatment plan for a patient with cystic fibrosis, including recognition and treatment of acute episodic illnesses, nutritional deficiencies, intestinal obstruction and psychosocial issues. Discuss the multidisciplinary approach to cysticfibrosis care and the role of the general pediatrician. Identify indicators that signify an exacerbation of pulmonary symptoms. Provide appropriate initial treatment and referral to a specialty center for further evaluation and treatment. GOAL: Pediatric Competencies. Demonstrate high standards of professional competence while working with patients under the care of a subspecialist.
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Related to Cystic Fibrosis

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • 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.

  • Commercial Milestones In partial consideration of the rights granted by AstraZeneca to Licensee hereunder, Licensee shall pay to AstraZeneca the following payments, which shall be non-refundable, non-creditable and fully earned upon the first achievement of the applicable milestone event:

  • 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.

  • 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.

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests 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 Disclosure Package or Prospectus.

  • 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.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • 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

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