Biosimilar Applicants. If either Party receives a copy of an application for a Biosimilar Product in the Territory referencing a Licensed Product, or otherwise becomes aware that such an application has been submitted to a Regulatory Authority for Regulatory Approval in the Territory (such as in an instance described in Section 351(l)(9)(C) of the PHSA), then this Section 5.3.8 shall apply, and, within [***], such Party shall notify the other Party. The Party that is not the “reference product sponsor,” as defined in Section 351(l)(1)(A) of the PHSA, shall have the right, but not the obligation, to seek permission or take other steps necessary to view the application and related confidential information from the filer of the application for a Biosimilar Product (“Biosimilar Filer”) to the extent permitted under Sections 351(l)(1)(B)(iii) and (C) of the PHSA (or the equivalent Applicable Laws in a country other than the U.S. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Product application: (a) Licensee shall have the sole right to manage and prosecute biosimilar litigation in the Territory, subject to the provisions of this Section 5.3.8. (b) Licensee will have the sole right to designate pursuant to Section 351(l)(1)(B)(i) and (ii) of the PHSA the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Product application and manufacturing process information of the Biosimilar Filer. (c) Licensee shall have the sole right to (i) list any Patents, including those licensed hereunder, insofar as they claim or cover the applicable Licensed Product as required pursuant to Section 351(l)(3)(A), Section 351(l)(5)(b)(i)(II), or Section 351(l)(7) of the PHSA, (ii) respond to any communications with respect to such lists from the Biosimilar Filer (including as described in 351(l)(3)(C)), and (iii) negotiate with the Biosimilar Filer as to whether to utilize a mechanism for information exchange other than that specified in Section 351(l)(1) of the PHSA and as to the Patents that will be subject to the initial litigation procedure as described in Section 351(l)(4) of the PHSA, to decide which Patent or Patents shall be selected for initial litigation under Section 351(l)(5)(B)(i)(II) of the PHSA. *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANG...

Biosimilar Applicants. (a) Notwithstanding anything to the contrary in this Agreement, [***] shall have the sole right, but not the obligation, to prosecute, manage and settle any litigation with respect to Biosimilar Products and any proceedings associated therewith, including any invalidity, unpatentability or unenforceability challenges, oppositions, and post-grant proceedings in connection therewith. If [***] receives notice or a copy of an application submitted to the FDA or its foreign counterpart for a Biosimilar Product (a “Biosimilar Application”) for which a Licensed Product is a “reference product,” as such term is used in Section 351(i)(4) of the PHSA or the same or like term used in the foreign counterpart, whether or not such notice or copy is provided under any Applicable Law, or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for a Drug Approval Application, [***] shall, within [***] Business Days, notify and provide [***] copies of such notice or communication to the extent permitted by Applicable Law. [***] shall carry out any such rights and responsibilities of the “reference product sponsor,” as defined in Section 351(l)(1)(A) of the PHSA, for purposes of such Biosimilar Application, including bringing an action for patent infringement under Section 351(1)(6) of the PHSA based on any Patents. If requested by [***], [***] shall seek to obtain access to the Biosimilar Application and related confidential information, including in accordance with Section 351(l)(1)(B)(iii) of the PHSA, if applicable. (b) If permitted pursuant to Applicable Law, upon [***]’s request, [***] shall assist [***] in identifying and listing any Patents pursuant to Section 351(l)(1)(3)(A) or Section 351(l)(7) of the PHSA, in preparing, pursuant to section 351(l)(3)(C) of the PHSA, a detailed statement regarding the reference product sponsor’s opinion that the Patent will be infringed and a response to the statement by the filer of the Biosimilar Application concerning validity and enforceability, in negotiating with the filer of the Biosimilar Application pursuant to Section 351(l)(4) of the PHSA, and in selecting Patents for and conducting litigation pursuant to Section 351(l)(5), Section 351(l)(6), and Section 351(l)(9) of the PHSA, to the extent applicable, and shall cooperate with [***] in responding to relevant communications with respect to such lists and statements from the filer of the Biosimilar Application. Upon [***]’s re...

Biosimilar Applicants. 12.4.1 Notwithstanding the foregoing, AbbVie shall have the sole right to prosecute and manage any litigation with respect to Biosimilar Products to the extent applicable to any AbbVie Background Patent Rights, AbbVie Research Antibody Patent Rights, Voyager Research Antibody Patent Rights, Voyager Background VA Patent Rights, Collaboration Patent Rights or Joint Patent Rights, in accordance with this Section 12.4, but subject to the expense reimbursement and settlement approval provisions of Section 12.3.3 and the recovery provisions of Section 12.3.4, as applicable. If either Party receives notice or a copy of an application submitted to the FDA or its foreign counterpart for a Biosimilar Product for which a Licensed Product is a “reference product,” as such term is used in the BPCI Act (a “Biosimilar Application”), whether or not such notice or copy is provided under any applicable Laws, or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for Regulatory Approval (such as in an instance described in Section 351(1)(9)(C) of the PHSA), the remainder of this Section 12.4.1 shall apply. If either Party receives such notice or communication or any equivalent or similar communication or notice in the United States, such Party shall, within [**], notify and provide the other Party copies of such notice or communication to the extent permitted by applicable Law. AbbVie shall carry out the rights and responsibilities of the “reference product sponsor,” as defined in Section 351(l)(1)(A) of the PHSA, for purposes of such Biosimilar Application, in consultation with Voyager to the extent requested by AbbVie and permitted under applicable Law. If requested by AbbVie, Voyager shall seek to obtain access to such Biosimilar Application and related confidential information, including in accordance with Section 351(l)(1)(B)(iii) of the PHSA, if applicable. 12.4.2 If permitted pursuant to applicable Law, upon AbbVie’s request, Voyager shall assist AbbVie in identifying and listing any AbbVie Background Patent Rights, AbbVie Research Antibody Patent Rights, Voyager Research Antibody Patent Rights, Voyager Background Patent Rights, Collaboration Patent Rights or Joint Patent Rights as required pursuant to Section 351(l)(1)(3)(A) or Section 351(l)(7) of the PHSA, in negotiating with the filer of the Biosimilar Application pursuant to Section 351(l)(4) of the PHSA, and in selecting patents for and conducting litigation pu...

Biosimilar Applicants. If either Party receives a copy of an application for a Biosimilar Product in the Territory referencing a Licensed Product, or otherwise becomes aware that such an application has been submitted to a Regulatory Authority for Regulatory Approval in the Territory (such as in an instance described in the Biosimilar Regulations), then this Section 6.3.6 shall apply, and, within ten (10) Business Days, such Party shall notify the other Party. The Party that is not the “reference product sponsor,” as defined in the Biosimilar Regulations, shall have the right, but not the obligation, to seek permission or take other steps necessary to view the application and related confidential information from the filer of the application for a Biosimilar Product (“Biosimilar Filer”) to the extent permitted under the Biosimilar Regulations. Regardless of the Party that is the “reference product sponsor” for purposes of such Biosimilar Product application: (a) Licensee shall have the sole right to manage and prosecute biosimilar litigation in the Territory, subject to the provisions of this Section 6.3.6. (b) Licensee will have the sole right to designate pursuant to the Biosimilar Regulations the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Product application in the Territory and manufacturing process information of the Biosimilar Filer in the Territory. (c) Licensee shall have the sole right to (i) list any Patents, including those licensed hereunder, insofar as they claim or cover the applicable Licensed Product in the Territory as required pursuant to the Biosimilar Regulations, (ii) respond to any communications with respect to such lists from the Biosimilar Filer in the Territory, and (iii) negotiate with the Biosimilar Filer in the Territory as to whether to utilize a mechanism for information exchange other than that specified in the Biosimilar Regulations and as to the Patents that will be subject to the initial litigation procedure as described in the Biosimilar Regulations, to decide which Patent or Patents shall be selected for initial litigation under the Biosimilar Regulations. (d) Licensee shall consult with Licensor prior to identifying any Licensed Patents or Licensee Patents to a Biosimilar Filer as contemplated by this Section 6.3.6. Licensee shall consider in good faith advice and suggestions with respect thereto received from Licensor, and notify Licensor of any such lists or communications promptly after the...

Biosimilar Applicants. Notwithstanding the foregoing, if either Party receives notice or a copy of an application submitted to a Regulatory Authority in the Territory for a Biosimilar Product or similar notice or communication pursuant to which the Biosimilar Product is claimed to be interchangeable with the Product, whether or not such notice or copy is provided under any applicable Law, or otherwise becomes aware that such an application, notice or communication has been submitted to a Regulatory Authority in the Territory for approval, such Party shall notify and provide the other Party copies of such application, notice, communication and any other relevant information to the extent permitted by applicable Law. The Parties shall cooperate in good faith with one another with respect to the foregoing, including with respect to proceedings related thereto, in a manner consistent with the rights and obligations of the Parties set forth in Section 13.1 and Section 13.5, as applicable.

Biosimilar Applicants. Notwithstanding the other provisions of Section 6.3, if either Party receives a copy of an application for a Biosimilar Product referencing a Licensed Product, or otherwise becomes aware that such an application has been submitted to a Regulatory Authority for Regulatory Approval (such as in an instance described in Section 351(l)(9)(C) of the PHSA), then such Party shall promptly notify the other Party, and the Parties shall discuss in good faith a strategy for responding to such application for a Biosimilar Product.

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Applicants If the NRMP's investigation of an alleged Match violation by an applicant results in a finding that an applicant has committed a violation of this Agreement, the processing of the applicant's rank order list may be interrupted. The NRMP at its discretion may withdraw the applicant from the SMS Match. If a matched applicant is the subject of a violation investigation, the program to which the applicant matched may not fill the position with another applicant until the NRMP has issued the Final Report or granted a waiver, whichever is earlier. If the violation investigation has not concluded by the start date of training, the program shall begin training the matched applicant unless NRMP has granted a waiver or issued a deferral. The NRMP’s Final Report on the confirmed violation will be delivered to the applicant with copies to: (1) the applicant's medical school official, with a request that the Final Report be placed in the applicant’s permanent file (2) the Educational Commission for Foreign Medical Graduates if the applicant is a graduate of an international medical school (3) the NRMP institutional official and the director of the program to which the applicant matched (4) the NRMP institutional official and the director of the program to which the applicant has applied or switched (if known) (5) the party who originally reported the violation (6) the NRMP Executive Committee (7) the American Board of Medical Specialties (8) the American Osteopathic Association (9) the applicant's residency program director (10) the Federation of State Medical Boards if the applicant is to be permanently identified as a Match violator or permanently barred from future NRMP Matches (11) any parties whom the NRMP has determined are relevant to its investigation (12) state medical licensure boards, if requested by the applicant In addition, the applicant may be barred from subsequent NRMP Matches and/or identified as a Match violator to participating programs for one to three years or permanently, as determined by the NRMP. The applicant also may be barred for one year from accepting an offer of a position or a new training year, regardless of the start date, in any program sponsored by a Match-participating institution, and/or starting a position or a new training year in any program sponsored by a Match-participating institution if training would commence within one year from the date of issuance of the Final Report. Further, any applicant who has been denied a waiver of a binding commitment and who does not accept the matched position may be barred for one year from accepting an offer of a position or a new training year, regardless of the start date, in any program sponsored by a Match- participating institution and/or from starting a position or a new training year in any program sponsored by a Match- participating institution if training would commence within one year from the date of the NRMP's decision on the waiver. The decision conveyed in the Final Report will be displayed in the R3 system Applicant Match History for one to three years or permanently, as determined by the NRMP. Term limits of any sanction(s) imposed for the violation will be included to identify the length of time the action is in effect. The NRMP has sole discretion to determine which of the sanctions described above shall be applied in the event an applicant violates this Agreement. Failure to comply with sanctions levied as a result of a confirmed violation that is final may result in a new investigation and additional sanctions.
Eligible Applicants The rules of eligibility of project promoters and project partners are set in Article 7.2 of the Regulation.
RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.
Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.
Orally Administered Anticancer Medication In accordance with RIGL § 27-20-67, prescription drug coverage for orally administered anticancer medications is provided at a level no less favorable than coverage for intravenously administered or injected cancer medications covered under your medical benefit.
Product Information EPIZYME recognizes that by reason of, inter alia, EISAI’s status as an exclusive licensee in the EISAI Territory under this Agreement, EISAI has an interest in EPIZYME’s retention in confidence of certain information of EPIZYME. Accordingly, until the end of all Royalty Term(s) in the EISAI Territory, EPIZYME shall keep confidential, and not publish or otherwise disclose, and not use for any purpose other than to fulfill EPIZYME’s obligations, or exercise EPIZYME’s rights, hereunder any EPIZYME Know-How Controlled by EPIZYME or EPIZYME Collaboration Know-How, in each case that are primarily applicable to EZH2 or EZH2 Compounds (the “Product Information”), except to the extent (a) the Product Information is in the public domain through no fault of EPIZYME, (b) such disclosure or use is expressly permitted under Section 9.3, or (c) such disclosure or use is otherwise expressly permitted by the terms and conditions of this Agreement. For purposes of Section 9.3, each Party shall be deemed to be both the Disclosing Party and the Receiving Party with respect to Product Information. For clarification, the disclosure by EPIZYME to EISAI of Product Information shall not cause such Product Information to cease to be subject to the provisions of this Section 9.2 with respect to the use and disclosure of such Confidential Information by EPIZYME. In the event this Agreement is terminated pursuant to Article 12, this Section 9.2 shall have no continuing force or effect, but the Product Information, to the extent disclosed by EPIZYME to EISAI hereunder, shall continue to be Confidential Information of EPIZYME, subject to the terms of Sections 9.1 and 9.3 for purposes of the surviving provisions of this Agreement. Each Party shall be responsible for compliance by its Affiliates, and its and its Affiliates’ respective officers, directors, employees and agents, with the provisions of Section 9.1 and this Section 9.2.
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.
Generic Generic drugs must be substituted where applicable in order for the insurance provisions to apply.
Regulatory Applications (a) Western and PNB and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare all documentation, to effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary to consummate the transactions contemplated by this Agreement. Western and PNB shall use their reasonable best efforts to make all required bank regulatory filings, including the appropriate filing with the Regulatory Authorities. Each of Western and PNB shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to all material written information submitted to any third party or any Governmental Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party appraised of the status of material matters relating to completion of the transactions contemplated hereby. (b) Each party agrees, upon request, to furnish the other party with all information concerning itself, its Subsidiaries, directors, officers and shareholders and such other matters as may be reasonably necessary or advisable in connection with any filing, notice or application made by or on behalf of such other party or any of its Subsidiaries to any third party or Governmental Authority.
Recall Employees who have been laid off shall be re-employed in seniority order from most senior to least senior. Employees whose positions have been eliminated through layoff or otherwise, shall be called first to fill a vacancy within their job family. 1. Prior to other employees being recalled from the recall list, an employee who displaced another employee pursuant to provisions contained in this article shall have the right to be recalled to a vacant position for which they are qualified. However, the employee who displaces another employee shall not be eligible for a position at a higher pay grade than the one he/she originally held at the time of layoff. If the employee who displaced another employee fills a vacancy in his/her original department, then the employee whom he/she displaced will automatically be recalled into the position from which he/she previously held. After this process, other employees will be recalled to fill a vacancy for which they are qualified in the same department they were assigned at the time of their layoff. 2. Employees may be offered a position outside their department/program for which they are qualified. Employees may refuse a position outside their department/program. Employees who refuse such a position a second time shall have no further rights to recall. 3. Each employee on layoff shall be required to provide the District Personnel Office, in writing, with a current address to which a letter of recall may be sent. Employees being recalled shall be notified by “Certified Mail Delivery Confirmation” and shall have five (5) working days from the date of the receipt of notice to respond to the School Board’s offer and return to work. The School Board reserves the right to temporarily assign an employee to the vacancy until the recalled employee reports to work. If the letter is mailed to the address provided by the employee and is returned to the School Board because the address is incorrect, the School Board has fulfilled the obligation of this sub-section. If the School Board does not receive an affirmative response, the employee will be moved to the bottom of the recall list. If the recall notice is returned in the allotted time, yet not marked appropriately by the Human Resources & Equity Department, the employee shall retain his/her place on the recall list for the next job opening for which he/she is qualified. However, after the third returned notice, the employee’s name will be dropped from the recall list and the School Board shall have no further obligation to the employee. 4. An employee whose contract is non-renewed due to reorganization shall be entitled to recall rights for a layoff period of eighteen (18) months. All other employees shall be entitled to recall rights for a layoff period of twelve (12) months. 5. The employee laid off pursuant to this Article shall be given the opportunity to continue insurance coverages in existing programs during the layoff provided that the premium for such insurance programs shall be paid by the employee on a monthly basis in advance of the month due. 6. No new or substitute appointments may be made while there are laid off employees available who are qualified to fill the vacancies, except that employees may be hired into positions that have been offered and refused by employees on the layoff/recall list.

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