text stringlengths 1 5.46k |
|---|
9.2.18 The CollPlant Know-How has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the Knowledge of CollPlant and its Affiliates, no breach of such confidentiality has been committed by any Third Party; |
9.2.19 CollPlant and its Affiliates have generated, prepared, maintained and retained and will generate, prepare, maintain and retain all Regulatory Filings with respect to CollPlant Collagen that are required to be maintained or retained pursuant to and in accordance with good laboratory, manufacturing and clinical pr... |
9.2.20 CollPlant and its Affiliates have conducted and covenants that it will conduct, and their respective contractors and consultants have conducted and CollPlant covenants will conduct, all Development of the CollPlant Collagen, including any and all pre-clinical and clinical studies related to the CollPlant Collage... |
9.2.21 The Processing of Personal Data by CollPlant (including any transfer of Personal Data across national borders) in connection with the Exclusive Products is and has been in compliance with Data Security and Privacy Laws in all countries and jurisdictions in the Territory, all privacy related consents and notices ... |
9.2.22 In the last five (5) years, CollPlant has not received written notice of any alleged material violation from a Governmental Authority or other Third Party of any Privacy and Security Obligations and has no Knowledge of facts that would give rise to such a violation. CollPlant is not under investigation by any Go... |
9.2.23 The execution, delivery and performance of this Agreement and the other agreements and instruments contemplated hereby, and the consummation of the transactions contemplated hereunder, complies with the Privacy and Security Obligations. CollPlant has the full right and authority to provide to AbbVie the Personal... |
56 88878677_21 |
9.2.24 Neither CollPlant nor any of its Affiliates, nor any of its or their respective officers, employees or agents has (a) committed an act, (b) made a statement or (c) failed to act or make a statement that, in any case ((a), (b) and (c)), that (x) would be or create an untrue statement of material fact or fraudulen... |
9.2.25 The representations and warranties of CollPlant in this Agreement and the information, documents and materials furnished to AbbVie in connection with its period of diligence prior to the Effective Date, do not, taken as a whole, (a) contain any untrue statement of a material fact or (b) omit to state any materia... |
9.3 Mutual Covenants. Each Party hereby covenants to the other Party that: |
9.3.1 such Party shall cause all Persons who perform Development activities (including regulatory activities) or Manufacturing activities for such Party under this Agreement or who conceive, discover, develop or otherwise make any Know-How or Patent Rights by or on behalf of such Party or its Affiliates or its or their... |
9.3.2 in performing its obligations or exercising its rights under this Agreement, such Party, its Affiliates, and its and their (sub)licensees, shall comply with all applicable Law, including all anti-corruption Laws. |
9.4 Additional Covenants of CollPlant. |
9.4.1 From and after the Effective Date, CollPlant shall not, and shall cause its Affiliates not to, (a) misappropriate any valid and enforceable intellectual property rights of a Third Party in connection with its activities under this Agreement, or (b) enter into any agreement, whether written or oral, with respect t... |
9.4.2 During the Term, CollPlant shall not, and shall cause its Affiliates not to, encumber, breach or diminish the rights granted to AbbVie hereunder, including by not committing any acts or permitting the occurrence of any omissions that would cause breach of the IIA Terms. CollPlant shall promptly provide AbbVie wit... |
9.5 Disclaimer. Except as otherwise expressly set forth in this Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENT RIGHTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FIT... |
57 88878677_21 |
9.6 Anti-Bribery and Anti-Corruption Compliance. Each Party represents, warrants, and covenants to the other in connection with this Agreement that each Party and its Affiliates (a) have complied and will comply with all applicable Laws, rules, regulations and industry codes governing bribery, money laundering, and oth... |
ARTICLE 10 - INDEMNIFICATION; INSURANCE |
10.1 Indemnification by AbbVie. Subject to Section 10.3 (Procedure), AbbVie shall indemnify, hold harmless and defend CollPlant and its Affiliates, and its or their respective directors, officers, employees, and agents, from and against any and all liabilities, damages, losses, costs and expenses, including the reasona... |
10.1.1 the negligence, recklessness or willful misconduct of AbbVie, any of its Affiliates or any Third Party Transferee, or its or their respective directors, officers, employees, or agents, in connection with performance by or on behalf of AbbVie of AbbVie's obligations or exercise of AbbVie's rights under this Agree... |
10.1.2 any breach of this Agreement, including any representation or warranty or covenant, by AbbVie; or |
10.1.3 the Development, Commercialization, or other Exploitation conducted by or on behalf of AbbVie, any of its Affiliates, subcontractors or any Third Party Transferee of any Exclusive Product in the Territory (excluding Development or Manufacturing carried out by CollPlant hereunder or under the Supply Agreement), i... |
58 88878677_21 |
except, in each case (Section 10.1.1, Section 10.1.2 and Section 10.1.3), to the extent that CollPlant has an obligation to indemnify AbbVie for Losses pursuant to Section 10.2 (Indemnification by CollPlant), as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Lo... |
10.2 Indemnification by CollPlant. Subject to Section 10.3 (Procedure), CollPlant shall indemnify, hold harmless and defend AbbVie and its Affiliates, its and their Third Party Transferees and Distributors and its or their respective directors, officers, employees and agents, from and against any and all Losses to the ... |
10.2.1 the negligence, recklessness or willful misconduct of CollPlant or any of its Affiliates or subcontractors, or its or their respective directors, officers, employees, or agents, in connection with performance by or on behalf of CollPlant of CollPlant's obligations or exercise of CollPlant's rights under this Agr... |
10.2.2 any breach of this Agreement or the Supply Agreement, including any representation or warranty or covenant, by CollPlant; |
10.2.3 the Development or Manufacturing activities conducted by or on behalf of CollPlant or its Affiliates hereunder or under the Supply Agreement; |
10.2.4 the infringement or misappropriation by CollPlant or its Affiliates of any Third Party intellectual property rights in connection with its conduct of activities under the Agreement or the Supply Agreement; or |
10.2.5 any amount owed to the Israel Innovation Authority by CollPlant or its Affiliates or due to activities under this Agreement or the Supply Agreement; |
except, in each case (Section 10.2.1 through Section 10.2.5), to the extent that AbbVie has an obligation to indemnify CollPlant for Losses pursuant to Section 10.1 (Indemnification by AbbVie), as to which Losses each Party shall indemnify the other to the extent of their respective liability for such Losses. |
10.3 Procedure. |
10.3.1 Notice. All indemnification claims in respect of a Party, its Affiliates or, in the case of AbbVie, its or their Third Party Transferees or Distributors, or its or their respective directors, officers, employees and agents (each, an "Indemnitee") shall be made solely by such Party (the "Indemnified Party"). The ... |
10.3.2 Control of Defense. |
59 88878677_21 |
(a) In General. Subject to the provisions of Sections 7.4 (Infringement Claims by Third Parties), 7.5 (Invalidity or Unenforceability Defenses or Actions) and 7.6 (Product Trademarks), at its option, the Indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party... |
(b) Right to Participate in Defense. Without limiting Section 10.3.2(a) (In General), any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided that such employment shall be at the Indemnified Party's ... |
60 88878677_21 |
(c) Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the Indemnified Party's becoming subject to injunctive or other relief or otherwise adversely affecting the business of the Indemnified Party in any manner, and ... |
(d) Cooperation. If the Indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall, and shall cause each Indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences,... |
61 88878677_21 |
(e) Expenses. Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall be reimbursed on a Calendar Quarter basis in arrears by the Indemnifying Party, without prejudice to the... |
10.4 Insurance. Each Party shall obtain and carry in full force and effect the minimum insurance requirements set forth herein from an insurance company properly licensed to provide the required insurance. Such insurance (a) shall be primary insurance with respect to each Party's own participation under this Agreement,... |
10.4.1 Types and Minimum Limits. The types of insurance, and minimum limits shall include at least the following: |
(a) Worker's Compensation with statutory limits in compliance with the Worker's Compensation laws of Israel and of the state or states in which the Party has employees in the United States (excluding Puerto Rico), as applicable. |
(b) Product Liability Insurance (combined limit of liability with Public Liability Insurance) with a limit of liability of Ten Million Dollars ($10,000,000). |
(c) Employer's Liability coverage with a minimum limit of Five hundred thousand Dollars ($500,000) per occurrence; provided that a Party has employees in Israel or the United States (excluding Puerto Rico). |
(d) Public Liability Insurance (combined limit of liability with Product Liability Insurance) with a limit of liability of Five Million Dollars ($5,000,000) per occurrence and Ten Million Dollars ($10,000,000) in the aggregate. If applicable, clinical trial insurance must be maintained throughout the life of any such c... |
Each Party shall at all times maintain in force any insurance policy that is required by any federal, state, national or other such applicable Law that may govern or have jurisdiction over any provision of this Agreement and at all times remain fully compliant with any such applicable Law. |
10.4.2 Certificates of Insurance. Upon request by a Party, the other Party shall provide Certificates of Insurance evidencing compliance with the above requirements of this Section 10.4 (Insurance). The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then su... |
62 88878677_21 |
10.4.3 Self-Insurance. Notwithstanding the foregoing, AbbVie may self-insure, in whole or in part, the insurance requirements described above. |
10.5 Limitation of Liability. EXCEPT (A) FOR A BREACH OF 4.1 (GRANT OF EXCLUSIVE RIGHTS TO ABBVIE) OR ARTICLE 8 - (CONFIDENTIALITY), (B) AS PROVIDED UNDER SECTION 12.11 (EQUITABLE RELIEF), OR (C) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY FOR CLAIMS THAT ARE SUBJECT TO INDEMNIFICATION UNDER... |
ARTICLE 11 - TERM AND TERMINATION |
11.1 Term. This Agreement shall commence as of the Effective Date and, unless terminated earlier, this Agreement shall continue in full force and effect until the end of the last to expire Royalty Term (the "Term"). Following the expiration of the Royalty Term for an Exclusive Product in a country, the rights granted t... |
11.2 Termination. |
11.2.1 Termination for Cause. |
(a) Material Breach. If either Party (the "Non-Breaching Party") believes that the other Party (the "Breaching Party") has materially breached one (1) or more of its material obligations under this Agreement or the Supply Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breachin... |
63 88878677_21 |
(b) Invocation of Termination for Material Breach. Notwithstanding the foregoing, the Parties agree that termination pursuant to this Section 11.2.1 (Termination for Cause) is a remedy to be invoked only if the breach cannot be adequately remedied through a combination of specific performance and the payment of money d... |
11.2.2 Termination by AbbVie. |
(a) AbbVie may terminate this Agreement in its entirety effective immediately upon written notice to CollPlant if AbbVie reasonably believes that it is not advisable for AbbVie to continue to Develop or Commercialize the Exclusive Products as a result of a perceived serious safety issue regarding the use of any Exclusi... |
(b) AbbVie may terminate this Agreement, either in its entirety or on an Exclusive Product-by-Exclusive Product or country-by-country basis, for any or no reason, upon sixty (60) days' prior written notice to CollPlant. |
11.2.3 Termination for Insolvency. In the event that either Party (or a parent of such Party) (a) files for protection under bankruptcy or insolvency Laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is no... |
11.2.4 Termination for Anti-Bribery or Anti-Corruption Non-Compliance. AbbVie may terminate this Agreement in accordance with Section 9.6 (Anti-Bribery and Anti-Corruption Compliance). |
11.3 Modification in Lieu of Termination. If, at any time during the Term, AbbVie has the right to terminate this Agreement pursuant to Section 11.2.1 (Termination for Cause), Section 11.2.3 (Termination for Insolvency) or Section 11.2.4 (Termination for Anti-Bribery or Anti-Corruption Non-Compliance), then AbbVie may,... |
11.3.1 the royalty rates set forth in Section 6.5.1 (Royalties for Exclusive Products) shall be reduced by twenty-five percent (25%) with respect to any Net Sales of Exclusive Products thereafter (and, for clarity, the royalty adjustments set forth in Section 6.7 (Royalty Adjustments) shall continue to apply to such Ne... |
64 88878677_21 |
11.3.2 the amount of any contingent or milestone payments payable by AbbVie to CollPlant under Section 6.3 (Contingent Payments) or Section 6.4 (Milestone Payments) for any contingent or milestone event achieved thereafter shall be reduced by twenty-five percent (25%) of the applicable amount set forth in Section 6.3 (... |
11.3.3 AbbVie's diligence obligations under this Agreement will terminate; and |
11.3.4 all other provisions of this Agreement shall remain in full force and effect without change. |
11.3.5 Notwithstanding Sections 11.3.1 and 11.3.2, in the event that Section 11.3 is invoked by AbbVie as a result of a material breach on the part of CollPlant, if CollPlant subsequently cures such breach the reductions set forth in Sections 11.3.1 and 11.3.2 shall prospectively be eliminated following such cure such ... |
11.4 Effects of Termination of Agreement. |
11.4.1 Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of any termination of this Agreement, all rights granted by either Party to the other Party under this Agreement will immediately terminate with respect to the Terminated Products and Terminated T... |
11.5 Effects of Termination in Terminated Territory. Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of a termination of this Agreement with respect to a country by AbbVie pursuant to Section 11.2.2 (Termination by AbbVie) (but not in the case of any ... |
11.6 Accrued Rights; Surviving Provisions of the Agreement. |
11.6.1 Accrued Rights. Termination or expiration of this Agreement either in its entirety or with respect to one (1) or more Exclusive Products for any reason shall be without prejudice to any rights that shall have accrued to the benefit of either Party prior to such termination or expiration, including the payment ob... |
65 88878677_21 |
11.6.2 Surviving Provisions of the Agreement. Without limiting Section 11.6.1 (Accrued Rights), the following Sections and Articles shall survive the termination of this Agreement in its entirety or expiration of this Agreement for any reason, in accordance with their respective terms and conditions, and for the durati... |
11.6.3 Notwithstanding the termination of AbbVie's rights under this Agreement, AbbVie and its Affiliates and Third Party Transferees shall have the right for twelve (12) months after the effective date of such termination to sell or otherwise dispose of all Terminated Products then in its or their respective inventory... |
ARTICLE 12 - MISCELLANEOUS |
12.1 Governing Law; Service. |
12.1.1 Governing Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the Laws of the State of New York without reference to conflicts of laws principles; provided that, subject to the requirements of the IIA, all questions ... |
12.1.2 Service. Each Party further agrees that service of any process, summons, notice or document by certified mail to its address set forth in Section 12.5 (Notices) shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
66 88878677_21 |
12.2 Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 6.10.2 (Audit Dispute) or Section 12.11 (Equitable Relief), if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, including the ... |
12.2.1 General. Any Dispute shall first be referred to the Executive Officers of the Parties, who shall confer on the resolution of the issue. Any final decision mutually agreed to by the Executive Officers shall be conclusive and binding on the Parties. If the Executive Officers are not able to agree on the resolution... |
12.2.2 ADR. Subject to Section 12.2.1 (General) and Section 12.2.3 (Intellectual Property Disputes), any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 12.2.2 (ADR). |
12.2.3 Intellectual Property Disputes. Unless otherwise agreed by the Parties in writing, a Dispute between the Parties relating to the validity, enforceability or patentability of any Patent Right, Trademark or other intellectual property rights, if not resolved in accordance with Section 12.2.1 (General), shall not b... |
12.2.4 Adverse Ruling. Any determination pursuant to this Section 12.2 (Dispute Resolution) that a Party is in material breach of its material obligations hereunder shall specify a (nonexclusive) set of actions to be taken to cure such material breach, if feasible. |
12.2.5 Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 12.2 (Dispute Resolution) shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if nec... |
12.3 Assignment. |
67 88878677_21 |
12.3.1 This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred (except as provided in Sections 5.4 (Subcontracting)), whether by operation of law or otherwise, in whole or in part, by either Party without the written consent of the other Party, w... |
12.3.2 AbbVie agrees that, notwithstanding any provision of this Agreement to the contrary, if CollPlant undergoes a Change of Control, AbbVie will not have any rights under this Agreement to any Patent Right, Know-How or other intellectual property or other proprietary rights directed to the Exclusive Product and/or C... |
12.4 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable contro... |
68 88878677_21 |
12.5 Notices. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, (b) sent by facsimile transmission (with transmission confirmed... |
If to CollPlant, addressed to: CollPlant Ltd. Oppenheimer 4 Rehovot, Israel 7670104 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.