LIFE SCIENCE LIABILITY PACKAGE INSURANCE POLICY

Transcription

1 LIFE SCIENCE LIABILITY PACKAGE INSURANCE POLICY

2 Introduction This is an Ayalon commercial liability insurance policy. This Policy contains four sections: Section 1: Public Liability Section 2: 2A Product and Service Liability; and 2B Clinical Trials Section 3: Product and Service Errors and Omissions Liability Please read the entire policy carefully. Insuring Agreement Ayalon Insurance Company Ltd. (the Company ) agrees to provide the insurance described in each applicable Section of this insurance policy (the Policy ) subject to the following conditions: the Insured must have paid or agreed to pay the premium set out in the Schedule. the information contained in the proposal made by the Insured together with any additional information supplied to the Company on behalf of the Insured form the basis of and are part of this Policy. Please Note All parts of this Policy, including the Schedule and any endorsements, shall be read together and considered as one contract. The operative Sections of this Policy are indicated in the Schedule. Unless a particular Section is identified in the Schedule as operative, it is of no effect and no cover is granted under it. Cover under sections 2 and 3 of this Policy are provided on a claims made and reported basis. Save as otherwise stipulated, it applies only in respect of Claims first made against the Insured and reported to the Company during the Period of Insurance or as otherwise stipulated in this policy. Please read the Claims Conditions in this Policy. Words that appear in bold print are defined in the Definitions. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 1 of 37

3 LIABILITY INSURANCE This Life Science Liability Package Policy is as follows: Page Section 1 Public Liability 3 Section 2 (A) Product and Service Liability 3 Section 2 (B) Clinical Trials 5 Section 3 Product and Service Errors and Omissions Liability 6 Limits of Indemnity 7 Extensions 9 Exclusions 19 Conditions 30 Definitions 36 CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 2 of 37

4 Section 1 Bodily Injury, Property Damage and Nuisance Section 2 Public Liability Under this Section, the Company will indemnify the Insured for damages and related claimants costs that the Insured becomes legally liable to pay in respect of: bodily injury; property damage; or nuisance; caused by an occurrence in connection with the Insured s business. This Section will apply only if such bodily injury, property damage or nuisance happens: during the Period of Insurance; and within the Territorial Limits. This Section does not apply to any damages, loss, cost or expense arising out of the Insured s product or the Insured s service or any clinical trial. Product and Service Liability and Clinical Trials Cover under this Section is divided into two sub-sections: Section 2A (Product Liability) and Section 2B (Clinical Trials). Both Sections 2A and 2B are subject to the overall Limit of Indemnity for Section 2 shown in the Schedule. Section 2A Bodily Injury and Property Damage Product and Service Liability Under this Section 2A, the Company will indemnify the Insured for damages and related claimants costs that the Insured becomes legally liable to pay arising out of: bodily injury; or property damage; caused by an occurrence in connection with the Insured s business and resulting from the Insured s product or the Insured s service. This Section 2A will apply only if: 1. such bodily injury or property damage happens after the Retroactive Date shown in the Schedule and before the end of the Period of Insurance; 2. such bodily injury or property damage happens within the Territorial Limits; CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 3 of 37

5 3. a claim by a person or organisation for damages for such bodily injury or property damage is both first made against the Insured and reported to the Company in writing: during the Period of Insurance or within 30days of its termination; during any Extended Reporting Period provided; or in accordance with the condition entitled Insured s Duty to Report Circumstances ; and 4. such claim is made within the Territorial Limits. This Section 2A does not apply to any damages, loss, cost or expense arising out of any injury or damage sustained by any research subject in connection with any activities relating to any clinical trial conducted by or on behalf of the Insured. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 4 of 37

6 Section 2B Bodily Injury and Property Damage Clinical Trials Under this Section 2B, the Company will indemnify the Insured for: Agreed Compensation Cover compensation agreed under the applicable Clinical Trial Compensation Guidelines; or Legal Liability Cover damages and related claimants costs that the Insured becomes legally liable to pay, if and to the extent that settlement is not concluded under the Agreed Compensation Cover (above); arising out of bodily injury or property damage: sustained by a research subject; caused by an occurrence in connection with the Insured s business; and resulting from a clinical trial conducted by or on behalf of the Insured. This Section 2B will apply only if: 1. such bodily injury or property damage happens after the Retroactive Date stated in the Schedule and before the end of the Period of Insurance; 2. such bodily injury or property damage happens within the Territorial Limits; 3. a claim by a person or organisation for such compensation or damages (as applicable) for such bodily injury or property damage is both first made against the insured and reported to the Company in writing: during the Period of Insurance or within 30days of its termination; during any Extended Reporting Period provided; or in accordance with the condition entitled Insured s Duty to Report Circumstances ; and 4. such claim is made within the Territorial Limits. Furthermore, notwithstanding anything to the contrary above, this Section 2B applies only to clinical trials if: the product being investigated is a life science product; exposure to such product upon or within research subjects during such trial first happened after the Retroactive Date stated in the Schedule and before the end of the Period of Insurance; and the Insured has acted in compliance with the Clinical Trials Special Conditions set out in this Policy. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 5 of 37

7 Section3 Financial Injury Product and Service Errors and Omissions Liability Under this Section, the Company will indemnify the Insured for damages and related claimants costs that the Insured becomes legally liable to pay in respect of financial injury caused by an act in connection with the Insured s business and resulting from: 1. a defect, deficiency or inadequacy in: the Insured s product; or the Insured s service; or 2. the failure: of the Insured s product to perform; or to perform the Insured s service; This Section will only apply if: 1. such act happens after the Retroactive Date shown in the Schedule and before the end of the Period of Insurance; 2. such act happens within the Territorial Limits; 3. a claim by a person or organisation for damages for such financial injury is both first made against the Insured and reported to the Company in writing: during the Period of Insurance or within 30 days of its termination; during any Extended Reporting Period provided; or in accordance with the condition entitled Insured s Duty to Report Circumstances ; and 4. such claim is made within the Territorial Limits. Notwithstanding anything to the contrary above, where cover under this Section applies in respect of injury or damage resulting from a clinical trial, cover will only apply if the Insured has acted in compliance with the Clinical Trials Special Conditions set out in this Policy. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 6 of 37

8 Limits of Indemnity Limits of Indemnity If more than one Section of this Policy would otherwise apply to the same occurrence, act or claim or series of occurrences, acts or claims consequent on or attributable to the same or substantially the same source or original cause, then the aggregate maximum Limit of Indemnity under all Sections shall not exceed the highest applicable Limit of Indemnity under any one Section. The Limits of Indemnity apply separately to each consecutive annual period and to any remaining period of less than 12 months, starting with the beginning of the Period of Insurance shown in the Schedule, unless the Period of Insurance is extended after issuance for an additional period. In that case, the additional period will be deemed to form part of the last preceding period for purposes of determining the Limits of Indemnity. The Company s obligations end when the applicable Limit of Indemnity has been exhausted. Section 1 (Public Liability) Section 2 (Product and Service Liability and Clinical Trials) Irrespective of the number of claims, the liability of the Company under Section 1 for: damages and related claimants costs; other amounts described as reducing the Limits of Indemnity (see below); arising out of the same occurrence or series of occurrences consequent on or attributable to the same or substantially the same source or original cause shall not exceed the applicable Limit of Indemnity stated in the Schedule. Irrespective of the number of claims or occurrences, the liability of the Company under Section 2 for: compensation or damages (as applicable) and related claimants costs; and other amounts described as reducing the Limits of Indemnity (see below); CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 7 of 37

9 shall not exceed the applicable aggregate Limit of Indemnity stated in the Schedule. Any such sums the Company pays will reduce the amount of such aggregate limit available for any other payment. The remaining amount of the aggregate limit is the most that will be available for any other payment. Section 3 (Errors and Omissions Liability) Pollution and Contamination Payments that Reduce the Limits of Indemnity Irrespective of the number of claims or acts, the liability of the Company under Section 3for: damages and related claimants costs; and other amounts described as reducing the Limits of Indemnity (see below); shall not exceed the applicable aggregate Limit of Indemnity stated in the Schedule. Any such sums the Company pays will reduce the amount of such aggregate limit available for any other payment. The remaining amount of the aggregate limit is the most that will be available for any other payment. Subject to all other Limits of Indemnity, irrespective of the number of occurrences or claims, the liability of the Company in connection with pollution or contamination under all Sections for: damages and related claimants costs; and other amounts described as reducing the Limits of Indemnity (see below); shall not exceed the applicable aggregate Limit of Indemnitystated in the Schedule. Any such sums the Company pays will reduce the amount of such aggregate limit available for any other payment. The remaining amount of the aggregate limit is the most that will be available for any other payment. Payments made: for any compensation or damages (as applicable) and related claimants costs; under the Extension entitled Defence Costs (save for Section 1, Public Liability); and for any amounts under any other Extension; will reduce the applicable Limits of Indemnity. Under Section 1 only, payments made by the Company under the Extension entitled Defence Costs will not reduce the applicable Limits of Indemnity. Notwithstanding the above, it is agreed that in the event of compensation or damages, including defence costs, exceeding the total aggregate Limit of Indemnity, then in addition this policy shall cover CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 8 of 37

10 reasonable defence costs above the Limit of Indemnity, in accordance with Section 66 to the Insurance Contract Law, With regard to claims filed outside the State of Israel, the reasonable defence costs will be in addition to the Limit of Indemnity. However such reasonableness will be measured based on reasonable costs in Israel and in accordance with the Israeli law. Extensions Extensions are subject to the terms and conditions (including Exclusions and, save where provided to the contrary, Limits of Indemnity) applicable to the Section(s) under which the Extension is provided. The Company s obligations under any Extension end when the applicable Limit of Indemnity has been exhausted. Defence Costs Extended Reporting Period Under Sections 1, 2, and 3, the Company will indemnify the Insured for legal defence costs provided they are incurred with the Company's prior written consent, which shall not be unreasonably withheld or delayed. Under Sections 1, 2 and 3,the Company will indemnify the Insured for the following, provided they are incurred with the Company's prior written consent: legal fees for representation of the Insured at a coroner's inquest or similar inquiry or court proceedings in connection with an alleged breach of statutory duty resulting from an occurrence which may be the subject of indemnity under this Part of this Policy; and legal fees for defence of the Insured against criminal proceedings resulting from an occurrence which may be the subject of indemnity under this Part of this Policy. 1. Annual Policies: (i)under Sections 2A and 3, if for a reason other than for non-payment of premium or fraud, the Company cancels or refuses to renew this Policy, then the Insured may: by giving written notice to the Company no later than 30days after the effective date of cancellation or non-renewal; and upon payment of a non-refundable additional premium of 75% of the Policy premium (for those Sections to which it applies), paid to the Company within 30 days of the cancellation or nonrenewal; CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 9 of 37

11 secure an Extended Reporting Period of 365 days following the effective date of such cancellation or non-renewal to report claims made against the Insured, notice of which has been received and recorded by the Insured during that period. Provided that the injury or damage or act (as applicable) giving rise to the claim happened prior to the effective date of cancellation or non-renewal, such claims shall be deemed to have been made and reported during the Period of Insurance. (ii) Under Section 2B the Insured may: by giving written notice to the Company no later than 60 days after the effective date of cancellation or non-renewal; and upon payment of a non-refundable additional premium of 250% of the Policy premium for this section, paid to the Company within 30 days of the cancellation or non-renewal; secure an Extended Reporting Period of 7 years following the effective date of non-renewal of the policy to report claims made against the Insured, notice of which has been received and recorded by the Insured during that period.provided that the injury or damage or act (as applicable)giving rise to the claim happened prior to the effective date of cancellation or non-renewal, such claims shall be deemed to have been made and reported during the Period of Insurance. An Extended Reporting Period: does not extend the Period of Insurance or change the scope of cover provided. does not reinstate or increase any Limit of Indemnity. may not be cancelled once in effect. 2. Single Clinical Trial Policy This policy includes an Extended Reporting Period of 7 years following the end of the policy period in which the insured may report claims made against the Insured, notice of which has been received and recorded by the Insured during that period. Provided that the injury or damage or act (as applicable)giving rise to the claim happened prior to the end of the policy period, but with respect to Section 2B provided that the injury occurred as a result of the covered clinical trial, such claims shall be deemed to have been made and reported during the Period of Insurance. An Extended Reporting Period: does not extend the Period of Insurance or change the scope of cover provided. does not reinstate or increase any Limit of Indemnity. may not be cancelled once in effect. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 10 of 37

12 Indemnity to Others Clinical Trial Contractors or Life Science Product Sales Contractors or Life Science Service Contractors Under Section 2 only, at the request of the Insured, the Company will indemnify against liability: clinical trial contractors; life science product sales contractors; or life science product service contractors; with respect to their liability for damages for bodily injury or property damage incurred in the regular course of their business, but only: if and to the minimum extent that the Insured is obliged (pursuant to a written contract or agreement between the Insured and such person or organisation ) to provide them with cover under this Policy; and with respect to activities happening after the execution of such contract or agreement. In respect of clinical trial contractor, this Extension will apply only if such injury or damage results from activities in connection with a clinical trial to which this Policy applies. In respect of life science product sales contractors, this Extension will apply only if such injury or damage results from the distribution or sale of the Insured s life science product to which this Policy applies. In respect of life science product service contractors, this Extension will apply only if such injury or damage results from activities within the scope of the Insured s life science product service to which this Policy applies. However, this Extension does not apply to any: assumption of liability or obligations by any such clinical trial contractor, life science product sales contractor or life science product service contractor in a contract or agreement. This limitation does not apply to the liability for damages for bodily injury or property damage, to which this Policy applies, that such person or organisation would have in the absence of such contract or agreement. In respect of life science product sales contractors; or life science product service contractors: representation or warranty unauthorized by the Insured. In respect of life science product sales contractors or Life science product service contractors: chemical or physical change in the Insured s product made intentionally by such person or organisation. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 11 of 37

13 In respect of life science product sales contractors:of the Insured s products which, after distribution or sale by the Insured, have been labeled or relabeled or used as a container, ingredient or part of any other thing or substance by or for such person or organisation. This limitation does not apply to: the relabeling of the Insured s product in the regular course of dispensing or furnishing the required amount or dosage of such product. clinical trial contractor. life science product service contractors. Partners, Directors, Officers, Employees, Principals Or Various Others 1. Under Sections 1, 2, and 3, at the request of the Insured, the Company will indemnify against liability the Insured s partners, directors, officers or employees (whilst acting within the scope of their duties as such). 2. Under Sections 1 and 2, at the request of the Insured, the Company will indemnify against liability: a. officers or members of the Insured s social, canteen, welfare or first aid organisations or fire or ambulance services in their respective capacities as such. b. principals for whom the Insured is or has been carrying out work, in respect of an occurrence for which the Insured is responsible, but only: if and to the minimum extent that the Insured is obliged (pursuant to a written contract or agreement between the Insured and such person or organisation ) to provide them with cover under this Policy; and with respect to activities happening after the execution of such contract or agreement. Vendors Under Section 2 only, at the request of the Insured, the Company will indemnify against liability vendors of the Insured s product with respect to their liability for damages for bodily injury or property damage resulting from the distribution or sale of the Insured s product in the regular course of their business, but only: with respect to activities happening after the execution of such contract or agreement; and if and to the extent that this Policy applies to such products. However, this Extension does not apply to any: assumption of liability by any such vendor in a contract or agreement. This limitation does not apply to the liability for damages for bodily injury or property damage,to which this Policy applies, CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 12 of 37

14 that such vendor would have in the absence of such contract or agreement. representation or warranty unauthorized by the Insured. chemical or physical change in the Insured s product made intentionally by such vendor. of the Insured s products which, after distribution or sale by the Insured, have been labelled or relabelled or used as a container, ingredient or part of any other thing or substance by or for such vendor. repackaging, unless unpacked solely for the purpose of inspection, demonstration or testing, or the substitution of parts under instruction from the manufacturer and then repacked in the original container. failure to make such inspections, adjustments, tests or servicing as such vendor has agreed to make or normally undertakes to make in the regular course of their business in connection with the distribution or sale of the Insured s product. demonstration, installation, servicing or repair operations, except such operations performed at such vendor s premises in connection with the distribution or sale of the Insured s product. Limitations on Indemnity to Others The provisions of this Indemnity to Others Extension apply provided that: the injury or damage results from activities in connection with the Insured s business; such person or organisation be subject to the terms and conditions of this Policy; the Company shall be entitled (but not obliged) to take over and conduct the investigation, defence and settlement of any claim at its discretion. However, this Extension does not apply to any rendering of or failure to render any healthcare service whether or not such service is ordinary to the Insured s profession and regardless of whether or not a claim is brought by any client or other person or organisation. This limitation does not apply to clinical trial contractors. Further, no indemnity will be provided to any person or organisation from whom the Insured has acquired its product, or any container, ingredient or part entering into, accompanying or containing such product. Indemnity to Ethics Committees Under Section 2B (Clinical Trials) only, at the request of the Insured, the Company will indemnify an ethics committee and its individual members (whilst acting within the scope of their duties as members of such ethics committee): against liability; and for legal fees for their defence against proceedings for manslaughter (including appeal against conviction) incurred with CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 13 of 37

15 the Company s prior written consent; resulting from an occurrence in connection with a clinical trial which may be the subject of indemnity under this Policy, but only: provided that: with respect to activities happening after the execution of such contract or agreement. the injury or damage results from activities in connection with the Insured s business; subject to the terms and conditions of this Policy; the Company shall be entitled (but not obliged) to take over and conduct the investigation and defence and settlement of any claim at its discretion. This Extension does not apply to any assumption of liability or obligations by any such person or organisation in a contract or agreement. This limitation does not apply to the liability for damages for bodily injury or property damage, to which this Policy applies, that such person or organisation would have in the absence of such contract or agreement. Legal Costs Limitations on Legal Costs The provisions of this Legal Costs Extension apply provided that the proceedings relate to an occurrence: in connection with the Insured's business; and which may be the subject of indemnity under this Policy. In the event of any dispute arising concerning whether any prosecution should be defended, or an appeal made, such dispute shall be referred to leading counsel (the identity of whom shall be mutually agreed between the Insured and the Company, or in default of agreement nominated by the President of the Law Society) whose decision shall be final and binding on both parties. New Acquisitions Under Sections 1, 2 and 3, at the request of the Insured, the Company will indemnify against liability a subsidiary organisation acquired or formed by the Insured during the Period of Insurance, provided that the total annual turnover of such subsidiary, does not exceed 15% of the total annual turnover of the Insured and the business of the subsidiary organisation is similar to the Insured s business. If such subsidiary does not meet with the condition above, than the Company will indemnify against liability of the subsidiary organisation provided that in respect of any newly acquired or formed organisation: full underwriting information is provided within 30 days of CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 14 of 37

16 acquisition or formation, or within such other period as may be agreed by the Company; the business of the subsidiary organisation is similar to the Insured s business; and the Insured accepts any additional terms and conditions determined by the Company and pays any additional premium required. Personal Overseas Liability Under Section 1, at the request of the Insured, the Company will indemnify the Insured s partners, directors, officers or employees, or members of their families, against liability for damages in respect of bodily injury or property damage incurred in a personal capacity whilst temporarily outside their normal country of residence in connection with the Insured s business. This Extension does not apply to liability for any damages, loss, cost or expense arising out of any: ownership or occupation of any land or building; or possession, ownership or use of any motor vehicle for which insurance or security is required under the provision of any road traffic legislation Exclusions The following exclusions apply to all Sections of this Policy. This Policy does not apply to any: Assumed Liability In respect of Sections 1 and2: damages, loss, cost or expense arising out of any liability or obligation assumed in a contract or agreement. This exclusion does not apply to liability for damages for bodily injury or property damage, to which this Policy applies, that the Insured would have in the absence of such contract or agreement. In respect of Section 3: damages, loss, cost or expense arising out of any assumption of liability or obligations of others in a contract or agreement. This exclusion does not apply to liability for damages for financial injury, to which this Policy applies, that the Insured would have in the absence of such contract or agreement. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 15 of 37

17 Deliberate Acts damages, loss, cost or expense arising out of any act or omission that: is intended by the Insured; or would reasonably be expected from the perspective of a person in the circumstances of the Insured; to cause injury or damage, even if the actual injury or damage caused is of a different degree or type than expected or intended. This exclusion does not apply to bodily injury or property damage: which is intended to result from reasonable use of a medicinal product or other life science product within or upon research subjects during a clinical trial; which may be expected, from the perspective of a reasonable professional conducting a clinical trial, to result from reasonable use of a medicinal product or other life science product within or upon research subjects during a clinical trial; or resulting from the use of reasonable force to protect persons or tangible property. Fines, Penalties or Restitution Abuse or Molestation Adjustment, Recall, Repair or Replacement liquidated damages or penalties (contractual or otherwise) or any criminal or civil fines. amount that constitutes unjust enrichment, including any restitution or return of any fees or expenses or any consideration owed (whether or not disputed) or paid to the Insured. loss, cost or expense to perform any obligation assumed by or on behalf of the Insured. loss, cost or expense incurred, or agreed to, by or on behalf of the Insured, in a settlement, except as agreed to by the Company. damages, loss, cost or expense arising out of any: 1. actual or threatened abuse or molestation, by anyone, of any person; or 2. retention, employment, investigation or supervision, or reporting to or failure to report to the proper authorities, of anyone for whom the Insured is or ever was legally responsible and whose conduct would be excluded in subparagraph 1 above. In respect of Sections 1 and 2: damages, loss, cost or expense arising out of any loss of use of or adjustment, disposal, inspection, recall, removal, repair, replacement or withdrawal of: the Insured s product; or any property containing or incorporating the Insured s product; CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 16 of 37

18 if such product or property is recalled or withdrawn from the market or from use by any person or organisation because of a known or suspected defect, deficiency, inadequacy or dangerous condition in it. In respect of Section 3: damages, loss, cost or expense arising out of any adjustment, disposal, inspection, recall, removal, repair, replacement or withdrawal of: the Insured s product or the Insured s service; any property containing or incorporating the Insured s product or the Insured s service; any property on which the Insured s service is or was performed; or any content, information or material. Aircraft, Spacecraft, Aerial or Aerospatial Device or Missile Products Asbestos damages, loss, cost or expense arising out of any aircraft, spacecraft, aerial or aerospatial device or missile, or any related product, including any: article, equipment, material, part or spare part installed or otherwise incorporated in, on or under any aircraft, spacecraft, aerial or aerospatial device or missile, or furnished or used in connection therewith; air or space communication, guidance or navigation system; ground control, handling or support equipment or tools furnished or used in connection therewith; equipment or tools furnished or used in connection with manufacturing, repairing or servicing any of the foregoing; blueprints, designs, drawings, information, instructions, manuals, maps, opinions, reports, representations, software, specifications, surveys, training aids, warnings or warranties or engineering or other data furnished or used in connection with any of the foregoing; or engineering or other advice, instruction, labour or service relating to any of the foregoing. damages, loss, cost or expense arising out of or in any way related to any: actual, alleged or threatened contaminative, pathogenic, toxic or other hazardous properties of asbestos; request, demand, order or regulatory or statutory requirement that the Insured or others test for, monitor, clean up, remove, contain, treat, detoxify or neutralize, or in any way respond to, or assess the effects of asbestos; or claim or proceedings by or on behalf of a government authority or others for any damages, loss, cost or expense arising out of any testing for, monitoring, cleaning up, containing, treating, detoxifying or neutralizing, or in any way responding to, or assessing the effects of asbestos. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 17 of 37

19 Cross Liabilities Damage to the Insured s Product damages, loss, cost or expense arising out of any injury or damage sustained by: 1. the Insured. 2. any person or organisation that either directly or indirectly controls the Insured through: controlling or holding a majority of its voting rights; or the right to appoint or remove a majority of its board of directors. 3. any subsidiary organisation. 4. any manager, member or partner of any limited liability company, partnership or joint venture in which the Insured has an interest. 5. any partner, director, officer or employee of any person or organisation described above, other than in their capacity as a customers and/or Research Subject 6. any agent, heir, representative or successor of any person or organisation described above. damages, loss, cost or expense for any property damage to the Insured s product if arising out of it or any part of it. Damage to Property in the Insured s Care, Custody or Control (except leased or rented premises or personal effects) Employees damages, loss, cost or expense arising out of any property damage to: 1. any property owned, held in trust or occupied by, leased or rented to or in the care, custody or control of the Insured. 2. that particular part of any property upon which the Insured or any employee of the Insured is or has been carrying out work, if arising out of such work. In respect only of Section 1 (Public Liability), subparagraph 1. of this exclusion does not apply to property damage to: personal property of partners, directors, officers or employees of the Insured or of visitors to the Insured s premises. premises or the fittings or fixtures thereof while leased or rented to the Insured. premises or the fittings or fixtures thereof, not owned by or leased or rented to the Insured, while temporarily occupied by the Insured for the purpose of carrying out work in or on such premises. damages, loss, cost or expense arising out of any injury or damage sustained by any employee arising out of or in the course of employment by the Insured. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 18 of 37

20 Healthcare or Other Professional Services Information Distribution Laws damages, loss, cost or expense arising out of the rendering of, or failure to render any: In respect of Sections 1 and 2: healthcare service; or professional service or advice other than a life science product service; In respect of Section 3: healthcare service; or accounting, actuarial, architectural, surveying or legal service or advice; whether or not such service or advice is ordinary to the Insured s profession and regardless of whether or not a claim or proceedings are brought by any client or any other person or organisation. In respect of Sections 1 and 2 only, this exclusion does not apply to bodily injury or property damage to which this Policy applies: caused by cardiopulmonary resuscitation or other first aid services (other than in connection with a clinical trial); or resulting from the service provided within the scope of and in accordance with the applicable written protocol of a clinical trial. damages, loss, cost or expense arising out of any actual or alleged breach of any law or regulation relating to any unsolicited communication, distribution, publication, sending or transmitting of content, information or material. Intellectual Property Laws or Rights Nuclear damages, loss, cost or expense arising out of, giving rise to or in any way related to any actual, alleged or threatened assertion, infringement or violation by any person or organisation of any intellectual property law or right. damages, loss, cost or expense arising out of or in any way related to any: ionising radiation or contamination by radioactivity from any nuclear fuel or from any nuclear waste from the combustion of nuclear fuel; or radioactive, toxic, explosive or other hazardous properties of any nuclear assembly or nuclear component thereof. With respect to Sections 1 and 2 only, this exclusion does not apply to bodily injury or property damage caused by radioactive isotopes used as a component of or in connection with a medical device or used in medical research. Pollution or damages, loss, cost or expense arising out of or in any way related to any: CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 19 of 37

21 Contamination Prior Claims or Known Circumstances 1. actual, alleged or threatened discharge, dispersal, seepage, migration, release or escape of smoke, vapours, soot, fumes, acids, alkalis, chemicals, waste materials or other solid, liquid, gaseous or thermal irritants, contaminants or pollutants; 2. request, demand, order or regulatory or statutory requirement that the Insured or others test for, monitor, clean up, remove, contain, treat, detoxify or neutralize, or in any way respond to, or assess the effects of any irritants, contaminants or pollutants; or 3. claim or proceedings by or on behalf of a government authority or others for any damages, loss, cost or expense arising out of any testing for, monitoring, cleaning up, containing, treating, detoxifying or neutralizing, or in any way responding to, or assessing the effects of any irritants, contaminants or pollutants. In respect of Sections 1 and 2, subparagraph 1. of this exclusion does not apply to liability for damages for bodily injury or property damage to which this Policy applies, caused by a sudden, identifiable, unintended and unexpected event happening anywhere in the world, other than in the United States of America or its possessions or territories. (with respect to coverage for an individual person or organisation against liability to which this Policy applies) damages, loss, cost or expense arising out of any: injury, damage, claim or other circumstance known by such person or organisation, before the beginning of the Period of Insurance, which could reasonably be expected to result in any payment under this Policy; or injury or damage known by such person or organisation, before the beginning of the Period of Insurance, to have happened or to have begun, including any change, continuation or resumption thereof at any time. Furthermore, no person or organisation is entitled to any indemnity under this Policy in connection with any damages, loss, cost or expense arising out of any: 1. injury, damage, claim or other circumstance: reported, in whole or in part at any time, to the Company or any other insurer under any insurance that is prior to this insurance; or known by any of the Insured s directors, partners or officers, before the beginning of the Period of Insurance, which could reasonably be expected to result in any payment under this Policy; or 2. injury or damage known by any of the Insured s directors, partners or officers, before the beginning of the Period of Insurance, to have happened or to have begun, including any change, continuation or resumption there of at any time. For the purposes of this exclusion, such injury, damage, claim or other CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 20 of 37

22 circumstance will be considered known by an organisation if such circumstance was known by such organisation s officers. Specific Diseases damages, loss, cost or expense arising out of any: 1. specific disease, including any similar or other condition, injury, illness or disease related thereto, by whatever name known; 2. causative agent of any such condition, injury, illness or disease, regardless of whether such agent gives rise to any such condition, injury, illness or disease or any other condition, injury, illness or disease, by whatever name known; or 3. actual or attempted counselling or testing for, or containing, detoxifying, mitigating, monitoring or neutralizing of, or responding to, or assessing the effects of any: condition, injury, illness or disease; or causative agent; described in subparagraph 1 or 2 above, including any: actual or attempted cure, diagnosis, prevention or treatment of any suchcondition, injury, illness or disease; actual or attempted cleaning-up, disposing, handling or removing of any such causative agent; or failure to perform any of the foregoing Specific Products or Specific Classes of Products damages, loss, cost or expense arising out of any defect, deficiency, inadequacy or dangerous condition in, including the actual, alleged or threatened contaminative, pathogenic, toxic or other hazardous properties of any: 1. specific products in any form, including their presence or use in any alloy, by-product, compound or other material or waste; 2. goods, products or materials that have the same or substantially the same chemical formula as any goods, products or materials described in subparagraph 1 above, by whatever name known; or 3. goods, products or materials that are derivatives of any goods, products or materials described in subparagraphs 1 or 2 above, by whatever name known; or 4. specific classes of products, by whatever name known. Successor Liability damages, loss, cost or expense arising out of any: ownership, maintenance or use of any assets, business or organisation acquired by the Insured; or conduct of any person or organisation in connection with any assets, business or organisation acquired by the Insured; for any act, occurrence, injury or damage happening, in whole or in part, before such acquisition is executed. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 21 of 37

23 Unapproved Clinical Trials damages, loss, cost or expense, in connection with any clinical trial, arising out of any unapproved exposure to material, upon or within research subjects during such a trial, that happens after: a hold has been placed on the trial; clinical trial authorization or similar authorization applicable to the trial has been withdrawn; or the trial has been ordered to be discontinued; by any governmental or regulatory authority having jurisdiction. Unapproved Goods or Products damages, loss, cost or expense arising out of the actual, alleged or threatened hazardous properties of goods or products: 1. declared unsafe by any governmental or regulatory authority on the basis of such hazardous properties, regardless of whether such goods or products were declared unsafe before or after: the goods or products were sold, supplied, leased or licensed to others, manufactured, repaired, installed, inspected, adjusted, erected, altered, cleaned or treated; or such damages, loss, cost or expense were incurred; or 2. Knowingly or recklessly sold, supplied, leased or licensed to others, manufactured, repaired, installed, inspected, adjusted, erected, altered, cleaned or treated without approval by the applicable governmental or regulatory authority. Subparagraph 1 above does not apply to the Insured s product, to which this Policy applies, if such goods or products were sold, supplied, leased or licensed to others, manufactured, repaired, installed, inspected, adjusted, erected, altered, cleaned or treated before it was known by an officer of the Insured, that the goods or products had been declared unsafe. Vehicles damages, loss, cost or expense arising out of any ownership, maintenance, possession or use by or on behalf of the Insured of any: 1. mechanically propelled vehicle or trailer attached thereto whilst being used in circumstances which require compulsory insurance or equivalent security to comply with the requirements of any legislation applicable to the use of such vehicle, including road traffic legislation. 2. aircraft, spacecraft, aerial or aerospatial device, hovercraft or waterborne craft. In respect of Section 1 only, subparagraph 2. of this exclusion does not apply to bodily injury or property damage caused by the use of a waterborne craft that is: a hand or sail propelled craft of less than 15 metres in length: or not owned by the Insured, provided that such craft is rented to the Insured, with a supplied crew, for business entertainment. CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 22 of 37

24 This Exclusion does not apply to cover provided under the Extension entitled Motor Liability - Contingent, Incidental Movement, Loading/Unloading or Tool of Trade. Terrorism Notwithstanding any provision to the contrary within this insurance or any endorsement thereto it is agreed that this insurance excludes loss, damage, cost or expense caused by, resulting from or in connection with terrorism. War damages, loss, cost or expense arising out of war. Exclusions Section 3 (Product and Service Errors and Omissions Liability) The insurance provided by Section 3 does not apply to any: Bodily Injury, Property Damage or Nuisance damages, loss, cost or expense for any bodily injury, property damage or nuisance. Ceasing Support Continuing Acts Following Non-Renewal or Cancellation Crime, Dishonesty Or Fraud Disappearance or Theft Delay in Delivery or Performance damages, loss, cost or expense arising out of any actual, alleged or threatened decision by the Insured: not to provide or support; or to cease to provide or support; the Insured s product or service. damages, loss, cost or expense arising out of any continuation or resumption of any act, following non-renewal or cancellation of this Policy or subsequent renewal or replacement of this Policy that is issued by the Company and which would otherwise apply to such act. damages, loss, cost or expense arising out of any criminal, dishonest, fraudulent or malicious conduct committed by any party with the consent or prior knowledge of any officer, director or partner, or spouse of any officer, director or partner of the Insured. damages, loss, cost or expense arising out of any burglary, inventory shortage, inventory shrinkage, mysterious disappearance, robbery or theft. damages, loss, cost or expense arising out of any actual, alleged or threatened: CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 23 of 37

25 1. a. delay in delivery of; or b. failure to deliver; the Insured s product or any part or phase thereof; or 2. a. delay in performance of; or b. failure to begin; the Insured s service or any part or phase thereof. Government Claims or Proceedings damages, loss, cost or expense arising out of any claim made or proceedings brought by or on behalf of any central or local governmental authority. This exclusion does not apply to financial injury sustained by such authority resulting from its ownership, maintenance or use of the Insured s product or the Insured s service. Maintenance of Contracts or Licenses Reputational Injury damages, loss, cost or expense arising out of any actual, alleged or threatened: failure to effect, maintain, procure or secure; or cancellation, lapse, modification, non-renewal, revocation, suspension or other impairment of; in whole or in part at any time, any bond, insurance, lease, licence, order, permit or other contract or agreement that the Insured is obliged to effect, maintain, procure or secure. damages, loss, cost or expense arising out of any actual, alleged or threatened reputational injury by any person or organisation. Conditions The following Conditions apply to all parts of this Policy Adjustment Adverse Event Reporting If any part of the Premium is calculated on estimates, then the Insured shall within one month from the expiry of each Period of Insurance furnish such details as the Company may require, and the Premium for such period shall be adjusted subject to any Minimum Premium. Reporting an adverse event to the Company, another insurer or a governmental or regulatory authority, in itself does not constitute: a conclusion that the Insured s product or the Insured s service caused or contributed to such event; an admission or assumption of liability; a notice as described under the claims condition entitled Insured s Duty to Report Circumstances ; CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 24 of 37

26 knowledge of a circumstance that would be expected to result in payment under this Policy; or that injury or damage was expected or intended. Assignment Audits or Inspections Cancellation Assignment of interest under this Policy shall not bind the Company without its prior consent. At any time during the Period of Insurance or thereafter, the Insured shall make available to the Company (and the Company shall have the right to audit, inspect and copy) any books, papers and other records of the Insured (including those of its agents and brokers) in connection with a claim under this Policy None Cancellation other than due to none payment of premium or Section 7 of the Insurance Contract Law Changes Choice of Law and Forum Currency First Named Insured Material Change in Risk Prohibition Reasonable Care This Policy may be changed only by a written endorsement issued by a duly authorised representative of the Company. Any dispute concerning the interpretation of the terms, validity and effect of this Policy is understood and agreed by both the Insured and the Company to be governed by Israelilaw. Any dispute or difference arising under or in respect of this Policy shall be subject to and determined within the exclusive jurisdiction of the Courts of Israel. All sums are in the currency expressed in the Schedule, and all payments will be made in that currency. If any calculation or payment is to be made in any other currency, then the rate of exchange to apply shall be that applicable on the date of settlement as published by the Bank of Israel and/or the London Financial Times, as applicable. The person or organisation first named as the Insured in the Schedule is primarily responsible for the payment of all premiums. The first named Insured will act on behalf of all other persons or organisations indemnified under this Policy for the giving and receiving of all notices and the receipt of any return premiums that become payable under this Policy. The Insured shall advise the Company within a reasonable timein writing of any material change, of which it is aware, in the risk insured under this Policy. This Policy does not apply to the extent that trade or economic sanctions or other laws or regulations prohibit the Company from providing such insurance. The Insured is obliged, at its own expense, to take all reasonable precautions to prevent injury, damage or loss which may give rise to liability, to comply with all statutory or other obligations and to take all CCI/TIS/LS/LIABPKGE/07/2C-POL CCITISLS072C 25 of 37