INDICATIONS AND USAGE Sample Clauses

INDICATIONS AND USAGE. LUNESTA is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study, at the end of both 2-week studies and at the end of the 6-month study. None known. Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including LUNESTA. Because some of the important adverse effects of LUNESTA appear to be dose-related, it is important to use the lowest possible effective dose, especially in the elderly (see DOSAGE AND ADMINISTRATION). A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with LUNESTA alone at therapeutic doses, the use of alcohol and other CNS depressants with LUNESTA appears to increase the risk of such behaviors, as does the use of LUNESTA at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of LUNESTA should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., prepari...
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INDICATIONS AND USAGE. EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia. EXPAREL has not been studied for use in patients younger than 18 years of age.
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INDICATIONS AND USAGE. KOVALTRY®, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: —Development Agreement, 1992, page 4 Bayer’s 30-year Development Agreement with the City of Berkeley (DA) is the product of a company acutely aware of the long-term risk it was taking in building one of the earliest biopharmaceutical manufacturing facilities—with all the long-term investment and complex processes the venture required—and a city willing to under- stand and respond to those risks. In 1992, after a year of negotiations, Bayer and the City signed this historic agreement which provides the streamlined development processes that have allowed Bayer to develop the site over time. In return, the City has received a broad array of mitigations and community benefits. 2015 was a watershed year for the DA, showing that foresight and decades of collaboration pay off for a business and its employees, a community and its citizens, and patients around the world. Since 1992, Berkeley has served as Bayer’s global hub of biotech manufacturing, producing Kogenate®, a recombinant Factor VIII protein that replaces the clotting factors missing in patients born with the devastating disease of hemophilia A. Over the years, Kogenate® has become one of Bayer’s best-selling products. The construction of the new Product Testing Facility, begun in 2015 near ▇▇▇▇▇’▇ ▇▇▇▇▇▇▇ Street entrance, represents the most recent investment in a site development process that began seven years ago with the mission of building state-of-the-art facilities, housing the state-of-the-art equipment needed for the manufacture of new generations of Bayer’s hemophilia treatments. As Bayer’s drug discovery researchers advanced the new therapies through the complex and highly regulated development pipeline, the dedicated employees at the Berkeley site made sure that the physical plant and all our people would be ready, once the new products were finally approved by regulatory authorities in the international marketplace. In December, 2015, Kovaltry®—the first of Bayer’s next- generation hemophilia treatments—was shipped from Berkeley to patients in Europe, with worldwide distribution expected over the next two years. We were indeed ready, and we thank the City of Berkeley for being so instrumental in helping us get there.
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Related to INDICATIONS AND USAGE

  • 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.

  • Limitations and Exclusions The Company shall not be responsible for, and this limited warranty does not cover, any loss resulting from any of the following: • The use of other manufacturers’ products unless such products are specifically recommended or approved by the Company in writing in advance of their installation, in connection with the use of the Products. • Any repairs, replacements, penetrations, or alterations of the Products by any person or entity other than authorized representatives of the Company without prior written consent of the Company. • Water passing through any portion of a structure or building component other than directly through the Products due to a failure in the Products and/or connections between the Products (so long as the connections are Company Products), or any interior moisture, vapor, or condensation. • Construction, design, specification, storage, application, exposure, installation practices, use of the Products, or use of material, that is not in compliance with the Company’s published literature. • Unauthorized changes in the Products’ details or specifications for the project that were not reviewed and approved in advance by the Company in writing. • Failure to maintain the building and the Products with reasonable care. • Mold, mildew, insects, pests, fungi, algae, bacteria, air quality, and similar conditions. • Improper design, engineering, application installation or workmanship of any portion or component of the Products or the structure; or failure, distortion or structural movement of the walls, foundation, or any other portion or component of the structure, including, but not limited to, movement, cracking, deflection, settling of the building or movement of the framing members. • Impact with objects, hurricanes, tropical storms, tornadoes, high winds, hailstorms, earthquakes, sandstorms, floods, natural disasters, fires, vandalism, war, terrorism, animals, other similar acts of God or nature, force majeure events, or significant or unintended immersion or pooling of water. • Abuse, misuse, neglect, damage, or negligence by the Owner, the Applicator, the general contractor, or other trades performing work on the project, or any third party. • Change in principal usage or amount of usage of structure without prior written approval of the Company. • Intermixing of the Products with other chemicals or materials not specifically required by the Company’s specifications or application instructions. If, at the Owner’s request, the Company performs any services or supplies any materials as a mitigation or remediation measure in connection with any unwarranted loss described above, the Company shall be entitled to compensation for such services or materials. The Company makes no warranty with respect to appearance or color. No representative of the Company has the authority to make any representations, warranties, or promises except as stated herein. No waiver by the Company of any limitation, term or condition of this warranty shall operate as a waiver of any other limitation, term or condition applicable to any claim, whether of like or different nature. No delay or failure on the Company’s part to enforce any right or claim, which it may have hereunder, shall constitute a waiver of such right or claim. If any part of this warranty shall be determined to be invalid, then such portion shall be deemed severed from the warranty and the remaining terms, exclusions and limitations shall apply. The Company’s obligations under this warranty are expressly conditioned upon receipt of full payment for the Products. Any delay in full payment to the Company shall not extend the warranty term. This warranty is issued to the above-named Owner and is not assignable or transferable, except upon the express written consent of the Company. THE COMPANY UNDERTAKES NO RESPONSIBILITY FOR THE QUALITY OF THE PRODUCTS EXCEPT AS PROVIDED IN THIS LIMITED WARRANTY. IN OTHER WORDS, THE COMPANY EXPRESSLY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY. THE COMPANY ASSUMES NO RESPONSIBILITY THAT THE PRODUCTS WILL BE FIT FOR ANY PARTICULAR PURPOSE FOR WHICH THE PRODUCTS MAY BE PURCHASED, EXCEPT AS PROVIDED IN THIS LIMITED WARRANTY. IN OTHER WORDS, THE COMPANY EXPRESSLY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE. THE COMPANY MAKES NO OTHER OR FURTHER WARRANTIES IN CONNECTION WITH THE PRODUCTS EXCEPT AS EXPRESSLY STATED IN THIS WARRANTY DOCUMENT. THE COMPANY WILL NOT BE RESPONSIBLE UNDER THIS LIMITED WARRANTY FOR ANY INCIDENTAL, SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES, WHETHER ARISING IN CONTRACT OR TORT (INCLUDING INTENTIONAL, NEGLIGENCE OR OTHERWISE), FOR BREACH OF WARRANTY OR UNDER ANY OTHER THEORY OF LIABILITY, WHETHER OR NOT ARISING FROM OR RELATING TO, DIRECTLY OR INDIRECTLY, THIS WARRANTY, OR THE PERFORMANCE OF, DEFECTS IN, OR IN ANY WAY CONNECTED WITH, THE PRODUCTS COVERED BY THIS WARRANTY. THE COMPANY WILL HAVE NO LIABILITY FOR, AND EXPRESSLY DISCLAIMS LIABILITY FOR, ANY OTHER DAMAGE TO THE BUILDING OR THE CONTENTS OF THE BUILDING AND FOR ANY OTHER CLAIMED DAMAGES, LOSSES, COSTS AND EXPENSES OTHER THAN AS EXPRESSLY SET FORTH IN THIS WARRANTY. THIS REMEDY EXPRESSLY SET OUT IN THIS WARRANTY WILL BE THE EXCLUSIVE REMEDY FOR ALL PERSONS ENTITLED TO WARRANTY COVERAGE AS DESCRIBED ABOVE. NO OTHER REMEDY SHALL BE APPLICABLE. SOME JURISDICTIONS LIMIT OR DO NOT ALLOW THE DISCLAIMER OF CERTAIN REMEDIES OR THE EXCLUSION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES. THE EXCLUSIONS AND LIMITATIONS OF REMEDIES AND DAMAGES IN THIS SECTION FULLY APPLY TO THE EXTENT NOT PROHIBITED BY APPLICABLE LAW. The terms of this warranty may not be altered, modified, or supplemented except in a writing signed by an officer of the Company that expressly refers to this warranty document and number. In the event the Owner: (i) fails to provide the Company with timely notice as described above, (ii) fails to provide required access to the installed Products, (iii) undertakes or permits any actions that cause or contribute to failures, such as unauthorized repairs or perforations of the Products, or (iv) otherwise fails to fulfill its responsibilities as described herein, the Company reserves the right to void this warranty upon written notice to the Owner. To expedite processing, this document may be completed and delivered in electronic form only. This limited warranty applies only to Products installed in the United States and Canada. Under the Quebec Consumer Protection Act, the Company must provide a warranty to consumers, as defined in the Act, that the Company’s products shall be fit for the purpose for which such products of that kind are ordinarily used and that the Products must be durable in normal use for a reasonable length of time, having regard to their price and other factors. For more information about your rights if you are a consumer as defined in the Act, you should consult the Quebec Consumer Protection Act at ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇.▇▇.▇▇/en/capsules/legal-warranty-automatic- protection-consumers. Since the Products are building materials and are not intended to be sold to a “consumer” except as part of real estate or as a major addition thereto, this warranty shall not apply to any party constituting a “consumer” as such term is defined by the ▇▇▇▇▇▇▇▇-▇▇▇▇ Warranty Act.

  • Funding Restrictions and Order Quantities The Agency reserves the right to reduce or increase estimated or actual quantities in whatever amount necessary without prejudice or liability to the Agency, if: 12.3.1 Funding is not available; 12.3.2 Legal restrictions are placed upon the expenditure of monies for this category of service or supplies; or, 12.3.3 The Agency’s requirements in good faith change after award of the contract.

  • CONDITIONS TO ALL BORROWINGS The obligations of the Lenders to make any Loan or issue any Letter of Credit, whether on or after the Closing Date, shall also be subject to the satisfaction of the following conditions precedent:

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