Clinical Supply In connection with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faith.
Proposed Goods and Services Proposed Goods and Services pdf D/M/WBE Certification OPTIONAL No response Warranty No response
PROPOSED MOBILITY PROGRAMME The proposed mobility programme includes the indicative start and end months of the agreed study programme that the student will carry out abroad. The Learning Agreement must include all the educational components to be carried out by the student at the receiving institution (in table A) and it must contain as well the group of educational components that will be replaced in his/her degree by the sending institution (in table B) upon successful completion of the study programme abroad. Additional rows can be added as needed to tables A and B. Additional columns can also be added, for example, to specify the study cycle-level of the educational component. The presentation of this document may also be adapted by the institutions according to their specific needs. However, in every case, the two tables A and B must be kept separated, i.e. they cannot be merged. The objective is to make clear that there needs to be no one to one correspondence between the courses followed abroad and the ones replaced at the sending institutions. The aim is rather that a group of learning outcomes achieved abroad replaces a group of learning outcomes at the sending institution, without having a one to one correspondence between particular modules or courses. A normal academic year of full-time study is normally made up of educational components totalling 60 ECTS* credits. It is recommended that for mobility periods shorter than a full academic year, the educational components selected should equate to a roughly proportionate number of credits. In case the student follows additional educational components beyond those required for his/her degree programme, these additional credits must also be listed in the study programme outlined in table A. When mobility windows are embedded in the curriculum, it will be enough to fill in table B with a single line as described below: Component code (if any) Component title (as indicated in the course catalogue) at the sending institution Semester [autumn / spring] [or term] Number of ECTS* credits Mobility window … Total: 30 Otherwise, the group of components will be included in Table B as follows: Component code (if any) Component title (as indicated in the course catalogue) at the sending institution Semester [autumn / spring] [or term] Number of ECTS* credits Course x … 10 Module y … 10 Laboratory work … 10 Total: 30 The sending institution must fully recognise the number of ECTS* credits contained in table A if there are no changes to the study programme abroad and the student successfully completes it. Any exception to this rule should be clearly stated in an annex of the Learning Agreement and agreed by all parties. Example of justification for non-recognition: the student has already accumulated the number of credits required for his/her degree and does not need some of the credits gained abroad. Since the recognition will be granted to a group of components and it does not need to be based on a one to one correspondence between single educational components, the sending institution must foresee which provisions will apply if the student does not successfully complete some of the educational components from his study programme abroad. A web link towards these provisions should be provided in the Learning Agreement. The student will commit to reach a certain level of language competence in the main language of instruction by the start of the study period. The level of the student will be assessed after his/her selection with the Erasmus+ online assessment tool when available (the results will be sent to the sending institution) or else by any other mean to be decided by the sending institution. A recommended level has been agreed between the sending and receiving institutions in the inter-institutional agreement. In case the student would not already have this level when he/she signs the Learning Agreement, he/she commits to reach it with the support to be provided by the sending or receiving institution (either with courses that can be funded by the organisational support grant or with the Erasmus+ online tutored courses). All parties must sign the document; however, it is not compulsory to circulate papers with original signatures, scanned copies of signatures or digital signatures may be accepted, depending on the national legislation. * In countries where the "ECTS" system it is not in place, in particular for institutions located in partner countries not participating in the Bologna process, "ECTS" needs to be replaced in all tables by the name of the equivalent system that is used and a weblink to an explanation to the system should be added. The section to be completed during the mobility is needed only if changes have to be introduced into the original Learning Agreement. In that case, the section to be completed before the mobility should be kept unchanged and changes should be described in this section. Changes to the mobility study programme should be exceptional, as the three parties have already agreed on a group of educational components that will be taken abroad, in the light of the course catalogue that the receiving institution has committed to publish well in advance of the mobility periods and to update regularly as ECHE holder. However, introducing changes might be unavoidable due to, for example, timetable conflicts. Other reasons for a change can be the request for an extension of the duration of the mobility programme abroad. Such a request can be made by the student at the latest one month before the foreseen end date. These changes to the mobility study programme should be agreed by all parties within four to seven weeks (after the start of each semester). Any party can request changes within the first two to five-week period after regular classes/educational components have started for a given semester. The exact deadline has to be decided by the institutions. The shorter the planned mobility period, the shorter should be the window for changes. All these changes have to be agreed by the three parties within a two-week period following the request. In case of changes due to an extension of the duration of the mobility period, changes should be made as timely as possible as well. Changes to the study programme abroad should be listed in table C and, once they are agreed by all parties, the sending institution commits to fully recognise the number of ECTS credits as presented in table C. Any exception to this rule should be documented in an annex of the Learning Agreement and agreed by all parties. Only if the changes described in table C affect the group of educational components in the student's degree (table B) that will be replaced at the sending institution upon successful completion of the study programme abroad, a revised version should be inserted and labelled as "Table D: Revised group of educational components in the student's degree that will be replaced at sending institution". Additional rows and columns can be added as needed to tables C and D. All parties must confirm that the proposed amendments to the Learning Agreement are approved. For this specific section, original or scanned signatures are not mandatory and an approval by email may be enough. The procedure has to be decided by the sending institution, depending on the national legislation.
Product Supply 5.1 In the event that Eisai notifies Radius of its desire to purchase bulk substance of Compound from Radius, Radius shall supply Eisai with all amount of such bulk substance of Compound, which meets specifications for the Product determined by Radius in the course of its Development activities pursuant to this Agreement, required by Eisai for commercial sales of Product in Japan With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai the bulk substance of Compound for * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of the bulk substance of Compound required for clinical trials in Japan. Radius shall charge Supply Price for applicable bulk substance of Compound. Radius shall ship such bulk substance of Compound, FOB point of manufacturing. 5.2 In the event that Eisai notifies Radius of its desire to purchase Semi-Product from Radius which meets specifications determined by Radius in the course of its Development activities pursuant to this Agreement, Radius shall supply Eisai with all amount of Semi-Product required by Eisai for commercial sales of Product in Japan. With respect to Eisai clinical development activities for Product in Japan, upon Eisai’s request, Radius shall supply Eisai Semi-Product for the conduct of the Eisai Development activities in the amounts and at the times determined by the SC, having reference to the quantity of Semi-Product required for clinical trials in Japan. Radius shall charge Supply Price for Semi-Product. Radius shall ship such Semi-Product, FOB point of manufacturing. 5.3 The Parties agree that they shall, in good faith, discuss, negotiate and execute necessary agreements containing mutually acceptable terms, including but not limited to, a supply agreement for either bulk substance of Compound or Semi-Product as well as a quality control agreement of either bulk substance of Compound or Semi-Product, in the event that Eisai notifies Radius as set forth in Article 5.1 or 5.2. 5.4 As manufacturer of the Product, Radius shall be responsible for: (a) the control of the quality of the Product promoted and sold under the Radius trademarks; as provided in Article 2.3; and (b) ensuring that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable good manufacturing practices (GMP) and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product; and Radius warrants that all bulk substance of Compound or Semi-Product supplied to Eisai pursuant to this Article 5 shall be manufactured in accordance with the applicable GMP and shall meet the then applicable specifications for the bulk substance of Compound or Semi-Product and will be free from defects in material and workmanship. Radius shall resolve any product liability issues in the Territory relating to the Product and shall resolve any product liability issues in Japan relating to the Product or the bulk substance of Compound or Semi-Product, as the case may be, supplied to Eisai pursuant to this Article 5 in the event and to the extent related to a breach of the warranty set forth in Article 5.4(b) at its own expense and subject to Article 5.5. 5.5 Radius’ obligations with respect to product liability in the Territory and Japan shall include the following responsibilities, each to be taken at Radius’ expense: (a) Radius shall report, at its expense, to appropriate authorities, in accordance with local requirements, all adverse events related to use of the Product in the Territory or Japan. Eisai shall provide to Radius, upon Radius’ request, reasonable assistance in connection with the reporting of all of adverse events, responding to safety queries and assessing safety issues, in each case, to the extent related to the Product in Japan. Adverse events shall be recorded in a single, centralized database, which shall be held and owned by Radius. Radius will provide, upon request by Eisai, any safety information in Radius’ control and reasonably required by Eisai in connection with the development and commercialization of the Product in Japan and all reasonable assistance in responding to safety queries related to the Product and in assessing safety issues related to the Product in Japan. Details of safety reporting activities relating to the Product will be addressed in a pharmacovigilance contract, which the Parties shall enter into after the Effective Date. (b) In the event that (i) Radius determines that an event, incident, or circumstance may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (ii) any regulatory authority in the Territory threatens to remove a Product from the market; or (iii) any regulatory authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent regarding the use of Product, Radius shall promptly advise Eisai in writing, and shall provide Eisai with copies of all relevant correspondence, notices and the like. Notwithstanding anything the contrary herein, Radius shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product in the Territory. After establishing SC pursuant to Article 3.5, all decisions relating to any recall, market withdrawal or other corrective action with respect to the Product shall be decided by the SC as set forth in Article 3.6; provided that in the event that the Parties take different positions with respect to recall, market withdrawal or other corrective action with respect to the Product, then Radius shall have the right to cease supplying bulk substance of Compound or Semi-Product to Eisai for Japan if, after good faith discussions with Eisai, Radius reasonably believes that that continued supply to Eisai exposes Radius to liability as a result of its decision with respect to the Territory. If Radius elects to cease supply, it will terminate supply in an orderly manner, as soon as practical and in accordance with a schedule agreed to by Eisai and Radius. In the event of a recall, market withdrawal or other corrective action with respect to the Product in Japan, and at Radius’ request, Eisai shall provide reasonable assistance to Radius, at Radius’ cost and expense, in conducting any such recall, market withdrawal or other corrective action with respect to the Product in Japan. 5.6 THE WARRANTY IN SECTION 5.4(b) IS IN LIEU OF ANY OTHER WARRANTY WITH RESPECT TO THE PRODUCT, BULK SUBSTANCE OF COMPOUND OR SEMI-PRODUCT SUPPLIED BY RADIUS HEREUNDER, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE).
Water Supply The system may or may not meet state and local requirements. It is the right and responsibility of Buyer to determine the compliance of the system with state and local requirements. [For additional information on this subject, request the “Water Supply and Waste Disposal Notification” form.]
Bona Fide Request/New Business Request Process for Further Unbundling 6.1 BellSouth shall, upon request of <<customer_name>>, provide to <<customer_name>> access to its network elements at any technically feasible point for the provision of <<customer_name>>'s telecommunications service where such access is necessary and failure to provide access would impair the ability of <<customer_name>> to provide services that it seeks to offer. Any request by <<customer_name>> for access to a network element, interconnection option, or for the provisioning of any service or product that is not already available shall be treated as a Bona Fide Request/New Business Request (BFR/NBR), and shall be submitted to BellSouth pursuant to the BFR/NBR process. 6.2 <<customer_name>> shall submit any BFR/NBR in writing to <<customer_name>>’s Account Manager. The BFR/NBR shall specifically identify the requested service date, technical requirements, space requirements and/or such specifications that clearly define the request such that BellSouth has sufficient information to analyze and prepare a response. The BFR/NBR also shall include <<customer_name>>’s designation of the request as being (i) pursuant to the Telecommunications Act of 1996 or (ii) pursuant to the needs of the business.
BY THE COMPETITIVE SUPPLIER As a material inducement to entering into this ESA, the Competitive Supplier hereby represents and warrants to the Town as of the Effective Date of this ESA as follows: a) it is duly organized, validly existing and in good standing under the laws of the jurisdiction of its formation and is qualified to conduct its business in those jurisdictions necessary for it to perform its obligations under this ESA; b) it has all authorizations from any Governmental Authority necessary for it to legally perform its obligations under this ESA or will obtain such authorizations in a timely manner prior to when any performance by it requiring such authorization becomes due; c) the execution, delivery and performance of this ESA are within its powers, have been duly authorized by all necessary action and do not violate any of the terms or conditions in its governing documents or any contract to which it is a party or any Governmental Rule applicable to it; d) subject to the conditions set forth in Article 2.4, this ESA constitutes a legal, valid and binding obligation of the Competitive Supplier enforceable against it in accordance with its terms, and the Competitive Supplier has all rights such that it can and will perform its obligations to the Town in conformance with the terms and conditions of this ESA, subject to bankruptcy, insolvency, reorganization and other laws affecting creditor’s rights generally and general principles of equity; e) no Bankruptcy is pending against it or to its knowledge threatened against it; f) none of the documents or other written information furnished by or on behalf of Competitive Supplier to the Town pursuant to this ESA, contains any untrue statement of a material fact or omits to state any material fact required to be stated therein or necessary to make the statements contained herein or therein, in the light of the circumstances in which they were made, not misleading; and g) all information furnished by Competitive Supplier in response to the Request for Proposals for competitive electric supply services is true and accurate.
Interconnection Request The Interconnection Customer’s request, in accordance with the Tariff, to interconnect a new Small Generating Facility, or to materially increase the capacity of, or make a material modification to the operating characteristics of, an existing Small Generating Facility that is interconnected with the New York State Transmission System or the Distribution System. For the purposes of this Agreement, this definition of Interconnection Request shall supersede the definition of Interconnection Request set out in Attachment X to the ISO OATT. Interconnection Study – Any study required to be performed under Sections 32.2 or 32.3 of the SGIP. Material Modification – A modification that has a material impact on the cost or timing of any Interconnection Request with a later queue priority date. New York State Transmission System – The entire New York State electric transmission system, which includes: (i) the Transmission Facilities under ISO Operational Control; (ii) the Transmission Facilities Requiring ISO Notification; and (iii) all remaining transmission facilities within the New York Control Area. NYISO Deliverability Interconnection Standard – The standard that must be met, unless otherwise provided for by Attachment S to the ISO OATT, by (i) any generation facility larger than 2MW in order for that facility to obtain XXXX; (ii) any Class Year Transmission Project proposing to interconnect to the New York State Transmission System and receive Unforced Capacity Delivery Rights; (iii) any entity requesting External XXXX Rights, and (iv) any entity requesting a XXXX transfer pursuant to Section 25.9.5 of Attachment S to the ISO OATT. To meet the NYISO Deliverability Interconnection Standard, the Interconnection Customer must, in accordance with the rules in Attachment S to the ISO OATT, fund or commit to fund any System Deliverability Upgrades identified for its project in the Class Year Deliverability Study. NYISO Minimum Interconnection Standard – The reliability standard that must be met by any generation facility or Class Year Transmission Project that is subject to NYISO’s Large Facility Interconnection Procedures in Attachment X to the ISO OATT or the NYISO’s Small Generator Interconnection Procedures in this Attachment Z, that is proposing to connect to the New York State Transmission System or Distribution System, to obtain ERIS. The Minimum Interconnection Standard is designed to ensure reliable access by the proposed project to the New York State Transmission System or to the Distribution System. The Minimum Interconnection Standard does not impose any deliverability test or deliverability requirement on the proposed interconnection. Operating Requirements – Any operating and technical requirements that may be applicable due to Regional Transmission Organization, Independent System Operator, control area, or the Connecting Transmission Owner’s requirements, including those set forth in the Small Generator Interconnection Agreement. Operating Requirements shall include Applicable Reliability Standards. Party or Parties – The NYISO, Connecting Transmission Owner, Interconnection Customer or any combination of the above. Point of Interconnection – The point where the Interconnection Facilities connect with the New York State Transmission System or the Distribution System. Reasonable Efforts – With respect to an action required to be attempted or taken by a Party under this Agreement, efforts that are timely and consistent with Good Utility Practice and are otherwise substantially equivalent to those a Party would use to protect its own interests. Small Generating Facility – The Interconnection Customer’s facility, no larger than 20 MW for the production and/or storage for later injection of electricity identified in the Interconnection Request if proposing to interconnect to the New York State Transmission System or Distribution System, but shall not include (i) facilities proposing to simply receive power from the New York State Transmission System or the Distribution System; (ii) facilities proposing to interconnect to the New York State Transmission System or the Distribution System made solely for the purpose of generation with no wholesale sale for resale nor to net metering; (iii) facilities proposing to the New York State Transmission System or the Distribution System made solely for the purpose of net metering; (iv) facilities proposing to interconnect to LIPA’s distribution facilities; and (v) the Interconnection Customer’s Interconnection Facilities. A facility will be treated as a single Small Generating Facility if all units within the facility are behind a single facility meter, even if such units are different technology types. System Deliverability Upgrades – The least costly configuration of commercially available components of electrical equipment that can be used, consistent with Good Utility Practice and Applicable Reliability Requirements, to make the modifications or additions to the existing New York State Transmission System that are required for the proposed project to connect reliably to the system in a manner that meets the NYISO Deliverability Interconnection Standard for Capacity Resource Interconnection Service. System Upgrade Facilities – The least costly configuration of commercially available components of electrical equipment that can be used, consistent with Good Utility Practice and Applicable Reliability Requirements to make the modifications to the existing transmission system that are required to maintain system reliability due to: (i) changes in the system, including such changes as load growth and changes in load pattern, to be addressed in the form of generic generation or transmission projects; and (ii) proposed interconnections. In the case of proposed interconnection projects, System Upgrade Facilities are the modification or additions to the existing New York State Transmission System that are required for the proposed project to connect reliably to the system in a manner that meets the NYISO Minimum Interconnection Standard. Tariff – The NYISO’s Open Access Transmission Tariff, as filed with the FERC, and as amended or supplemented from time to time, or any successor tariff. Trial Operation shall mean the period during which Interconnection Customer is engaged in on- site test operations and commissioning of the Small Generating Facility prior to Commercial Operation. Upgrades – The required additions and modifications to the Connecting Transmission Owner’s portion of the New York State Transmission System or the Distribution System at or beyond the Point of Interconnection. Upgrades may be System Upgrade Facilities or System Deliverability Upgrades Distribution Upgrades. Upgrades do not include Interconnection Facilities.
Advance Notice of Layoff Unless legislation is more favourable to the Employees, the Employer shall notify Employees who are laid off with a written notice thirty (30) calendar days prior to the effective date of layoff. If the Employee has not had the opportunity to work the days as provided in this Article, they shall be paid for the days for which work was not made available.
PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.