Study Rationale and Purpose Sample Clauses

Study Rationale and Purpose. The new contact lens in development is intended for the optical correction of refractive ametropia in persons with non-diseased eyes. The purpose of this study is to obtain on-eye performance data to inform contact lens product development. The primary endpoint was selected to address the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Biofinity contact lenses were chosen as the control product because these lenses have the same wear modality and replacement schedule.
Sample 1
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Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population. The primary endpoint was selected to fulfil the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Oasys 1-Day, MyDay, and Moist contact lenses were chosen as the control products because these lenses have the same wear modality. The new contact lens in development is intended for the optical correction of refractive myopia in persons with non-diseased eyes. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Sample 1
Study Rationale and Purpose. The contact lenses for this study are intended for the optical correction of refractive myopia in persons with non-diseased eyes who are dryness symptomatic with their habitual weekly/monthly contact lenses. The primary purpose of this study is to conduct a pilot study with DAILIES TOTAL1 and Acuvue Oasys 1-Day to guide the protocol development of the subsequent larger scale head- to-head phase 4 trial. Additionally, this study is being conducted to re-fit habitual weekly/monthly symptomatic wearers into DAILIES TOTAL1 and Acuvue Oasys 1-Day The primary endpoint was selected to support the overall study objective. Procedures for measurement of this endpoint are standard in eye care professional practice. The design of this study is justified based upon preclinical and clinical testing, as described within the product´s Instructions for Use. Acuvue Oasys 1-Day contact lenses were chosen as the control product because these lenses have the same wear modality and a similar material to the DAILIES TOTAL1 lenses. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Sample 1
Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to aid contact lens product development. The primary and secondary endpoints were selected to fulfil the primary and secondary objectives of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon FDA approval and information, as described within the Package Inserts. BIOFINITY contact lenses were chosen as the control product because these lenses have the same wear modality, material, and parameters to the test product BIOFINITY ENERGYS, and are the spherical design as compared to the aspherical design, respectively. There are no immediate plans to submit the results of this early clinical development study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Sample 1
Study Rationale and Purpose. The new contact lens in development is intended for the optical correction of refractive ametropia in persons with non-diseased eyes. The purpose of this study is to evaluate performance of two commercially available daily wear frequent replacement silicone hydrogel soft contact lenses as compared to investigational test product (LID018869) to obtain on-eye performance data The primary endpoint was selected to address the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments.
Sample 1
Study Rationale and Purpose. The purpose of this study is to evaluate biocompatibility of an investigational contact lens compared to marketed contact lenses (PureVision/Biofinity) which have been pre- cycled in OPTI-FREE RepleniSH multi-purpose disinfecting solution (RepleniSH) and/or Biotrue multi-purpose solution (Biotrue). The primary endpoint (average % area of corneal staining) was selected to fulfill the primary objective of the study. RepleniSH was chosen as a representative solution containing the Polyquarterium-1 preservative and Biotrue was chosen as a representative solution containing the polyaminopropyl biguanide (PHMB) preservative.
Sample 1
Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population. The primary endpoint was selected to fulfill the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Clariti 1 Day contact lenses were chosen as the control product because these lenses have the same wear modality. The new contact lens in development is intended for the optical correction of refractive myopia in persons with non-diseased eyes. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Sample 1
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Study Rationale and Purpose. PRECISION1 is a new daily disposable silicone hydrogel contact lens with a material that combines high oxygen transmissibility with a low modulus of elasticity. PRECISION1 contact lenses are intended for the optical correction of refractive ametropia in persons with non-diseased eyes requiring subjects to wear spectacles for vision correction. The purpose of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to INFUSE contact lenses
Sample 1

Related to Study Rationale and Purpose

  • Scope and Purpose 1.01 This document is intended to set out general guidelines and principles regarding child welfare sector integrations during the term of this agreement which are mandated by the Ministry and for which local Human Resources Adjustment Plans (HRAP) are required to be negotiated. Subject to the following terms, these principles will serve as the framework for the treatment of bargaining unit employees and will apply to subsequent negotiations with unions, as may be required, as part of an integration arising within the context of the Ontario Labour Relations Act (OLRA) or PSLRTA, whichever is applicable. 1.02 Employees who may be impacted by an integration are valued and are to be treated fairly and respectfully. The parties agree that they will make reasonable efforts to reduce any negative affect on employees as a result of an integration in accordance with the following.

  • Parties and Purpose This agreement (the “Agreement”) is entered by and between certain portfolios and classes thereof, specified below and in Schedule C, of Franklin Xxxxxxxxx Variable Insurance Products Trust, an open-end management investment company organized as a statutory trust under Delaware law (the “Trust”), Franklin/Xxxxxxxxx Distributors, Inc., a California corporation which is the principal underwriter for the Trust (the “Underwriter,” and together with the Trust, “we” or “us”), the insurance company identified on Schedule A (together “you”) and your distributor, on your own behalf and on behalf of each segregated asset account maintained by you that is listed on Schedule B, as that schedule may be amended from time to time (“Account” or “Accounts”). The purpose of this Agreement is to entitle you, on behalf of the Accounts, to purchase the shares, and classes of shares, of portfolios of the Trust (“Portfolios”) that are identified on Schedule C, consistent with the terms of the prospectuses of the Portfolios, solely for the purpose of funding benefits of your variable life insurance policies or variable annuity contracts (“Contracts”) that are identified on Schedule D. This Agreement does not authorize any other purchases or redemptions of shares of the Trust.

  • Introduction and Purpose Introduction • Neighbourhood Development Plans • Neighbourhood Development Orders

  • Background and Purpose Executive was employed by the Company. Executive's employment is ending effective __________ under the conditions described in Section 3.1 of the Executive Change of Control Agreement ("Agreement") by and between Executive and the Company dated _____________, 2012. The purpose of this Release is to settle, and the parties hereby settle, fully and finally, any and all claims the Releasing Parties may have against the Released Parties, whether asserted or not, known or unknown, including, but not limited to, claims arising out of or related to Executive's employment, any claim for reemployment, or any other claims whether asserted or not, known or unknown, past or future, that relate to Executive's employment, reemployment, or application for reemployment.

  • Formation and Purpose Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below. Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree to not create a Committee (other than the JSC and the IPC), the creation of such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee. Joint Steering Committee (“JSC”) Establish projects for the Bacteriophage Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans (except for decisions of the IPC). The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Bacteriophage Program. Regulatory Committee (“RC”) Review and approve all research and development plans and projects, including clinical projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval for new Ampliphi Products under the Bacteriophage Program; and review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for Commercialization activities under the Bacteriophage Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Intellectual Property Committee (“IPC”) Evaluate all intellectual property issues in connection with the Bacteriophage Program; review and approve itemized budgets with respect to the foregoing.

  • INTENT AND PURPOSE The Employer and the Union each represent that the purpose and the intent of this Agreement is to promote cooperation and harmony, to recognize mutual interests, to provide a channel through which information and problems may be transmitted from one to the other, to formulate rules to govern the relationship between the Union and the Employer, to promote efficiency and service, and to set forth herein the basic agreements covering rates of pay, hours of work, and conditions of employment.

  • Exclusive Use (A) After the Occupancy Date, Lessee expressly agrees and warrants that the Leased Premises will be used exclusively as a Champps Restaurant or other casual dining sit-down restaurant. In any other such case, after obtaining Lessor's prior written consent, such consent not to be unreasonably withheld or delayed, Lessee may conduct any lawful business from the Leased Premises. Lessee acknowledges and agrees that any other use without the prior written consent of Lessor will constitute a default under and a violation and breach of this Lease. Lessee agrees: To open for business within a reasonable period of time after completion of construction of the contemplated Improvements; to operate all of the Leased Premises during the Term or Renewal Terms during regular and customary hours for businesses similar to the permitted exclusive use stated herein, unless prevented from doing so by causes beyond Lessee's control or due to remodeling; and to conduct its business in a professional and reputable manner. (B) If the Leased Premises are not operated as a Champps Restaurant or other casual dining sit-down restaurant or other permitted use hereunder, or remain closed for thirty (30) consecutive days (unless such closure results from reasons beyond Lessee's reasonable control) and in the event Lessee fails to pay Rent when due or fulfill any other obligation hereunder, then Lessee shall be in default hereunder and Lessor may, at its option, cancel this Lease by giving written notice to Lessee or exercise any other right or remedy that Lessor may have; provided, however, that closings shall be reasonably permitted for replacement of trade fixtures or during periods of repair after destruction or due to remodeling.

  • Geographic Area and Sector Specific Allowances, Conditions and Exceptions The following allowances and conditions shall apply where relevant. Where the Employer does work which falls under the following headings, the Employer agrees to pay and observe the relevant respective conditions and/or exceptions set out below in each case.

  • Integration Clause Except for documents and instruments specifically referenced herein, this Agreement constitutes the entire agreement between Bank and Borrower regarding the Loan and all prior communications verbal or written between Borrower and Bank shall be of no further effect or evidentiary value.

  • Background Screening VENDOR shall comply with all requirements of Sections 1012.32 and 1012.465, Florida Statutes, and all of its personnel who (1) are to be permitted access to school grounds when students are present, (2) will have direct contact with students, or (3) have access or control of school funds, will successfully complete the background screening required by the referenced statutes and meet the standards established by the statutes. This background screening will be conducted by SBBC in advance of VENDOR or its personnel providing any services under the conditions described in the previous sentence. VENDOR shall bear the cost of acquiring the background screening required by Section 1012.32, Florida Statutes, and any fee imposed by the Florida Department of Law Enforcement to maintain the fingerprints provided with respect to VENDOR and its personnel. The parties agree that the failure of VENDOR to perform any of the duties described in this section shall constitute a material breach of this Agreement entitling SBBC to terminate immediately with no further responsibilities or duties to perform under this Agreement. VENDOR agrees to indemnify and hold harmless SBBC, its officers and employees from any liability in the form of physical or mental injury, death or property damage resulting from VENDOR’s failure to comply with the requirements of this section or with Sections 1012.32 and 1012.465, Florida Statutes.

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