Adverse Experience and Reaction Reporting Sample Clauses

Adverse Experience and Reaction Reporting. Until the later of ten (10) years following the Closing Date or the payment in full of the last Royalty Payment to become due and payable, Seller shall notify Purchaser of any information concerning any serious or unexpected side effects, injuries, toxicities, sensitivity reactions, adverse experiences, or other incidents relating to the Product, of which Seller receives notice on or after the Closing Date, including providing copies of all such adverse experience or reaction reports within two (2) weeks of Seller’s receipt of such reports. For purposes of this Section 6.4 and Section 7.5: (A) “serious” means an experience or reaction which is fatal or life threatening, results in persistent or significant disability, requires inpatient hospitalization or prolongation of existing inpatient hospitalization, is a congenital anomaly, cancer, or the result of an overdose, or is another important medical event (even if not life-threatening, resulting in death, or requiring hospitalization) if, based upon appropriate medical judgments, such medical event may jeopardize the patient’s or subject’s health or may require medical or surgical intervention to prevent one of the other outcomes listed previously, and (B) “unexpected” means a condition or development not listed in the then-current FDA-approved labeling for the Product, and includes those experiences or reactions that show a significant increase in incidence or severity over what appears on the labeling of the Product or in NDA trials or that are a failure of the Product to achieve claimed activity.
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Adverse Experience and Reaction Reporting. Effective on the Closing Date and continuing until the later of ten (10) years following the Closing Date or the payment in full of the last Royalty Payment to become due and payable, Purchaser shall be responsible for reporting adverse experiences and reactions with respect to the Product in conformance with all applicable laws, rules and regulations and shall send to Seller, throughout the term of this Agreement, copies of all such adverse experience or reaction reports, with all serious and unexpected adverse experiences as defined in Section 6.4 hereof (and relevant government reporting forms) sent within two (2) weeks of Purchaser’s receipt, and all adverse experiences or reactions other than serious or unexpected adverse experiences (and relevant government reporting forms) sent to Seller on a quarterly basis addressed to Seller.
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Adverse Experience and Reaction Reporting. For one (1) year after the Closing Date, Xxxxxx shall notify Targacept of any information concerning any serious or unexpected side effects, injuries, toxicities, sensitivity reactions, adverse experiences, or other incidents relating to the Product, of which Xxxxxx receives notice on or after the Closing Date, including providing copies of all such adverse experience or reaction reports to Targacept’s Chief Medical Officer within seven (7) days of Xxxxxx’x receipt of such reports. For purposes of this Section 6.6: (i) “serious” means an experience or reaction which is fatal or life threatening, results in persistent or significant disability, requires inpatient hospitalization or prolongation of existing inpatient hospitalization, is a congenital anomaly, cancer, or the result of an overdose, or is another important medical event (even if not life-threatening, resulting in death, or requiring hospitalization) if, based upon appropriate medical judgments, such medical event may jeopardize the patient’s or subject’s health or may require medical or surgical intervention to prevent one of the other outcomes listed previously, and (ii) “unexpected” means a condition or development not listed in the then-current FDA-approved labeling for the Product, and includes those experiences or reactions that show a significant increase in incidence or severity over what appears an the labeling of the Product or in NDA trials or that represent a failure of the Product to achieve claimed activity.
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Adverse Experience and Reaction Reporting. 7.4.1 Each Party shall, and shall cause its respective Affiliates to, furnish timely notice as required by applicable worldwide regulations (i.e. currently seven (7) calendar days for deaths and immediately life-threatening adverse reactions and fifteen calendar (15) days for serious adverse reactions) to all competent governmental agencies in the Territory of all side effects, drug interactions and other adverse effects identified or suspected with respect to a Merck Product, the Genetronics Device, or both, for the Indications administered, distributed, marketed and sold under authority of any IND or NDAs issued by such Regulatory Authority. Each Party shall provide the other Party hereto with all necessary assistance in complying with all adverse reaction reporting requirements established by, or required under, any applicable IND and/or NDAs in the Territory. Genetronics shall provide Merck with timely information, in accordance with the time frames set forth in this Article 15.1 above, on any serious adverse reactions relating to the Genetronics Device to the extent that such serious adverse reactions could affect the NDA for the Merck Product in the Territory, or relate to the safety, efficacy or potency of the Merck Product. 7.4.2 Each Party shall, and shall cause its Affiliates to, furnish the other Party within five (5) calendar days of “date first learned” written notice of all such side effects, drug interactions and other adverse effects reported to such Party or its Affiliates regarding Merck Products or Genetronics Devices, pursuant to Section 7.4.1. Each Party shall also use its best efforts to obtain, and to furnish to the other Party hereto, such information, including, but not limited to, patients, circumstances, consequences and sources of information, reasonably sufficient to permit that other Party to evaluate such side effects, drug interactions or other adverse effects of the Genetronics Device and/or Merck Product for the Indications. Each Party shall retain all documents, reports, studies and other materials relating to any and all such side effects, drug interactions, or other adverse effects, as the case may be. Upon reasonable written notice, each Party shall permit the other Party hereto to inspect, and to make copies of, all such documents, reports, studies and other materials. 7.4.3 Each Party shall provide the other Party hereto with such assistance as the other Party shall reasonably request in connection with the identific...
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Related to Adverse Experience and Reaction Reporting

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Management Reporting (a) Provide periodic reports, in accordance with agreed upon frequency and content parameters, to the Funds. As reasonably requested by the Funds, the Transfer Agent shall furnish ad hoc reports to the Funds.

  • Accident Reporting 25.1 If You or an Authorised Driver has an Accident or if the Vehicle is stolen You must report the Accident or theft to Us within 24 hours of it occurring and fully complete an Accident/Theft report form. 25.2 If the Vehicle is stolen or if You or an Authorised Driver of the Vehicle has an Accident where: (a) any person is injured; (b) the other party has failed to stop or leaves the scene of the Accident without exchanging names and addresses; or (c) the other party appears to be under the influence of drugs or alcohol, You or the Authorised Driver must also report the theft or Accident to the Police. 25.3 If You or an Authorised Driver has an Accident You and the Authorised Driver must: (a) exchange names and addresses and telephone numbers with the other driver and drivers licence details; (b) take the registration numbers of all vehicles involved; (c) take as many photos as is reasonable showing: (i) the position of the Vehicles before they are moved for towing or salvage; (ii) the Damage to the Vehicle; (iii) the damage to any third party vehicle or property; and (iv) the general area where the Accident occurred, including any road or traffic signs; (d) obtain the names, addresses and phone numbers of all witnesses; (e) not make any admission of fault or promise to pay the other party's claim or release the other party from any liability; (f) forward all third party correspondence or court documents to Us within 7 days of receipt together with a fully completed Accident Report Form (if not already submitted); and (g) co-operate with Us in the prosecution of any legal proceedings that We may institute or defence of any legal proceedings which may be instituted against You or Us as a result of an Accident, including: (i) attending Our lawyer's office; and (ii) any Court hearing.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • CHILD ABUSE REPORTING CONTRACTOR hereby agrees to annually train all staff members, including volunteers, so that they are familiar with and agree to adhere to its own child and dependent adult abuse reporting obligations and procedures as specified in California Penal Code section 11164 et seq. and Education Code 44691. To protect the privacy rights of all parties involved (i.e., reporter, child and alleged abuser), reports will remain confidential as required by law and professional ethical mandates. A written statement acknowledging the legal requirements of such reporting and verification of staff adherence to such reporting shall be submitted to the LEA.

  • Litigation Reporting If Contractor is served with a pleading or other document in connection with an action before a court or other administrative decision making body, and such pleading or document relates to this Participating Addendum or may affect Contractor’s ability to perform its obligations under this Participating Addendum, Contractor shall, within 10 days after being served, notify the State of such action and deliver copies of such pleading or document to the State’s primary contact identified in §5 of the Participating Addendum .

  • Progress Reporting 5. The IP will submit to UNICEF narrative progress reports against the planned activities contained in the Programme Document, using the PDPR. Unless otherwise agreed between the Parties in writing, these reports will be submitted at the end of every Quarter. The final report will be submitted no later than thirty (30) calendar days after the end the Programme and will be provided together with the FACE form.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower’s part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower’s part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Information Reporting We may report your performance under this Agreement to credit reporting agencies, including your failure to make minimum payments on time. A negative credit report may significantly harm your ability to obtain credit from other sources. We may also obtain follow-up credit reports on you (for example, when we review your Account for a credit line increase). We may exchange information about you or your Account with our affiliates, and, to the extent permitted by law, with other third parties. However, if you prefer that we not share such information with our affiliate companies, just call us at (000) 000-0000 or outside the Albuquerque area, 0-000-000-0000. You may also write to us at Nusenda Federal Credit Union, P.O. Box 8530, Albuquerque, New Mexico 87198. Closing Your Account. You may close your Account at any time by notifying us in writing. However, you remain responsible to pay the balance according to the terms of this Agreement. We may close your Account or suspend your Account privileges at any time without prior notice. We may also reissue a different Card, Account number, or different checks at any time. You must return the Card or the checks to us upon request. Lost or Stolen Cards. If any Card, Account Number or PIN is lost or stolen, or if you think someone used or may use them without your permission, notify us at once by calling the telephone number shown on the billing statement or by calling 0-000-000-0000. We may require you to provide certain information in writing to help us find out what happened. Do not use the Card after we've been notified, even if it is found or returned. You will not be liable for any unauthorized purchases or cash advances made after we've been notified of the loss or the theft; however, you must identify for us the charges on the billing statement that were not made by you or someone authorized by you, and from which you received no benefit. Credit Authorizations. We are not responsible if we do not approve a purchase or cash advance on your Account, or if a third party refuses to accept or honor the Card, even if you have sufficient credit available. We may limit the number of purchases or cash advances which may be approved in one day. If we detect unusual or suspicious activity on your Account, we may temporarily suspend your credit privileges until we can verify the activity. We may approve purchases or cash advances that cause the balance to exceed your credit line without waiving any of our rights under the Agreement. Waiver. Our failure to exercise, or our delay in exercising any of our rights under this Agreement for any reason does not mean that we will be unable to exercise these rights later.

  • Incident Reporting Transfer Agent will use commercially reasonable efforts to promptly furnish to Fund information that Transfer Agent has regarding the general circumstances and extent of such unauthorized access to the Fund Data.

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