Prescription Drugs and Diabetic Equipment or Supplies Biological products for allergen immunotherapy and vaccinations. • Blood fractions. • Compound prescription drugs that are not made up of at least one legend drug. • Bulk powders and chemicals used in compound prescriptions that are not FDA approved, are not covered unless listed on our formulary. • Prescription drugs prescribed or dispensed outside of our dispensing guidelines. • Prescription drugs ordered or prescribed based solely on online questionnaires, telephonic interviews, surveys, emails, or any other marketing solicitation methods, whether alone or in combination. • Prescription drugs that have not proven effective according to the FDA. • Prescription drugs used for cosmetic purposes. • Prescription drugs purchased from a non-designated pharmacy, if a pharmacy has been designated for you through the Pharmacy Home Assignment program. • Experimental prescription drugs including those placed on notice of opportunity hearing status by the Federal Drug Efficacy Study Implementation (DESI). • Prescription drugs provided to you that are not dispensed by a network pharmacy or covered under your medical plan. • Prescription drugs and diabetic equipment and supplies purchased at a non-network pharmacy unless indicated as covered in the Summary of Pharmacy Benefits. • Prescription drug related medical supplies except for diabetic, regardless of the reason prescribed, the intended use, or medical necessity. Examples include, but are not limited to, alcohol pads, bandages, wraps or pill holders. • Off-label use of prescription drugs except as described in Experimental or Investigational Services in Section 3; • Prescribed weight-loss drugs. • Replacement of prescription drugs resulting from a lost, stolen, broken or destroyed prescription order or refill. • Therapeutic devices and appliances, including hypodermic needles and syringes except when used to administer insulin. • Prescription drugs, therapeutic equivalents, or any other pharmaceuticals used to treat sexual dysfunctions. • Vitamins, unless specifically listed as a covered healthcare service. • A prescription drug refill greater than the refill number authorized by your physician, more than a year from the date of the original prescription, or limited by law. • Long acting opioids and other controlled substances, nicotine replacement therapy, and specialty prescription drugs when purchased from a mail order pharmacy. • Prescription drugs and specialty prescription drugs when the required prescription drug preauthorization is not obtained. • Certain prescription drugs that have an over-the-counter (OTC) equivalent. • Prescriptions filled through an internet pharmacy that is not a verified internet pharmacy practice site certified by the National Association of Boards of Pharmacy. • Illegal drugs, including medical marijuana, which are dispensed in violation of state and/or federal law. • Services of a nurse's aide. • Services of a private duty nurse: o when the primary duties are limited to bathing, feeding, exercising, homemaking, giving oral medications or acting as companion or sitter; o after the caregiver or patient have demonstrated the ability to carry out the plan of care; o provided outside the home. Examples include at school, or in a nursing or assisted living facility; o that are duplication or overlap of services. Examples include when a person is receiving hospice care services or for the same hours of a skilled nursing home care visit; o that are for observation only; and o provided as part-time/intermittent and not continuous care. • Maintenance care when the condition has stabilized including routine ostomy care or tube feeding administration or if the anticipated need is indefinite. • Twenty-four (24) hour private duty nursing care for a person without an available caregiver in the home. • Respite care (e.g., care during a caregiver vacation) or private duty nursing so that the caregiver may attend work or school. • Abdominoplasty. • Brow ptosis surgery. • Cervicoplasty. • Chemical exfoliations, peels, abrasions, dermabrasions, or planing for acne, scarring, wrinkling, sun damage or other benign conditions. • Correction of variations in normal anatomy including augmentation mammoplasty, mastopexy, and correction of congenital breast asymmetry. • Dermabrasion. • Ear piercing or repair of a torn earlobe. • Excision of excess skin or subcutaneous tissue except for panniculectomy. • Genioplasty. • Hair transplants. • Hair removal including electrolysis epilation, unless in relation to gender reassignment services or skin grafting. • Inverted nipple surgery. • Laser treatment for acne and acne scars. • Osteoplasty - facial bone reduction. • Otoplasty. • Procedures to correct visual acuity including but not limited to cornea surgery or lens implants. • Removal of asymptomatic benign skin lesions. • Repeated cauterizations or electrofulguration methods used to remove growths on the skin. • Rhinoplasty.
Manufacturing Technology Transfer Except as provided in Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, then, in each case upon the written request of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.
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.
DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK
Technology Transfer Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo’s expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [***] days after receipt of an invoice therefor. Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined. Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product). Promptly after MedCo’s written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products. Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo’s written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment. Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer. Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.