Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.
Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).
SEXUAL EXPLOITATION 18.1 The Contractor shall take all appropriate measures to prevent sexual exploitation or abuse of anyone by it or by any of its employees or any other persons who may be engaged by the Contractor to perform any services under the Contract. For these purposes, sexual activity with any person less than eighteen years of age, regardless of any laws relating to consent, shall constitute the sexual exploitation and abuse of such person. In addition, the Contractor shall refrain from, and shall take all appropriate measures to prohibit its employees or other persons engaged by it from, exchanging any money, goods, services, offers of employment or other things of value, for sexual favors or activities, or from engaging in any sexual activities that are exploitive or degrading to any person. The Contractor acknowledges and agrees that the provisions hereof constitute an essential term of the Contract and that any breach of this representation and warranty shall entitle UNDP to terminate the Contract immediately upon notice to the Contractor, without any liability for termination charges or any other liability of any kind. 18.2 UNDP shall not apply the foregoing standard relating to age in any case in which the Contractor’s personnel or any other person who may be engaged by the Contractor to perform any services under the Contract is married to the person less than the age of eighteen years with whom sexual activity has occurred and in which such marriage is recognized as valid under the laws of the country of citizenship of such Contractor’s personnel or such other person who may be engaged by the Contractor to perform any services under the Contract.
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.
Product Quality (a) Tesoro warrants that all Products delivered under this Agreement or any Purchaser Order shall meet the latest applicable pipeline specifications or otherwise mutually agreed upon specifications for that Product upon receipt at the applicable Terminal and contain no deleterious substances or concentrations of any contaminants that may make it or its components commercially unacceptable in general industry application. Tesoro shall not deliver to any of the Terminals any Products which: (i) would in any way be injurious to any of the Terminals; (ii) would render any of the Terminals unfit for the proper storage of similar Products; (iii) would contaminate or otherwise downgrade the quality of the Products stored in commingled storage; (iv) may not be lawfully stored at the Terminals; or (v) otherwise do not meet applicable Product specifications for such Product that are customary in the location of the Terminal. If, however, there are Products that do not have such applicable specifications, the specifications shall be mutually agreed upon by the Parties. Should Tesoro’s commingled Products not meet or exceed the minimum quality standards set forth in this Agreement or any applicable Terminal Service Order, Tesoro shall be liable for all loss, damage and cost incurred thereby, including damage to Products of third parties commingled with Tesoro’s unfit Products. (b) TLO shall have the right to store compatible Products received for Tesoro’s account with Products belonging to TLO or third parties in TLO’s commingled storage tanks. TLO shall handle Tesoro’s fungible Products in accordance with TLO’s prevailing practices and procedures for handling such Products. The quality of all Products tendered into commingled storage for Tesoro’s account shall be verified either by Tesoro’s refinery analysis or supplier’s certification, such that Products so tendered shall meet TLO’s Product specifications. All costs for such analysis shall be borne solely by Tesoro. TLO shall have the right to sample any Product tendered to the Terminals hereunder. The cost of such sampling shall be borne solely by TLO. All Products returned to Tesoro shall meet or exceed Product specifications in effect on the date the Products are delivered to Tesoro. Notwithstanding any other provision herein, any and all Products that leave the Terminals shall meet all relevant ASTM, EPA, federal and state specifications, and shall not leave the Terminals in the form of a sub-octane grade Product. (c) TLO shall exercise reasonable care to ensure that all Products delivered by third parties into commingled storage with Tesoro’s Products meet applicable Product specifications for such Product that are customary in the location of the Terminal. In the event that Tesoro’s Products are commingled with third-party Products that do not meet or exceed the minimum quality standards set forth in this Agreement or any Terminal Service Order, TLO shall be liable for all loss, damage and cost incurred thereby.
Third Party Products and Services Any third-party hardware, software and/or services that is delivered by ResMed for use either standalone or in conjunction with ResMed products and/or services, shall be subject to the third-party terms and conditions and/or license agreements between Customer and the third party. Such third-party hardware, software and/or services is provided by ResMed "AS IS," without any warranty of any kind. Any representations or warranties as to such hardware, software and/or services shall only be as granted by the applicable third parties, if any, that accompany such products and/or software and/or services. Any representations, warranties, or other similar obligations with respect to such third-party hardware, software and/or services flow directly from the third party to Customer and ResMed shall have no responsibility at all for any such representations, warranties, obligations or lack thereof.
Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.
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.
Product Development (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during the term of this Agreement that have potential application to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information. (b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation of Intellectual Property rights with respect to any Program will be set forth in writing in the Development Agreement. (c) In the absence of a Development Agreement, (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product.
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.