text stringlengths 1 5.46k |
|---|
First Commercial Sale following Regulatory Approval in the first of the following six (6) countries: U.S., UK, Spain, Italy, Germany, and France |
6.4.2 Injectable Breast Implant Product Milestones. If APIL exercises its Injectable Breast Implant Product Option in accordance with Section 2.3.1 (Injectable Breast Implant Product Option), then the definitive license agreement entered into by the Parties under Section 2.3.1 (Injectable Breast Implant Product Option)... |
Injectable Breast Implant Product Milestone Event |
Dosing of the first patient in the first in human Clinical Trial of an Injectable Breast Implant Product |
Dosing of the first patient in the first Pivotal Clinical Trial of an Injectable Breast Implant Product |
First Commercial Sale of the first Injectable Breast Implant Product following Regulatory Approval and Pricing Approval (if applicable) in the first of the following six (6) countries: U.S., UK, Spain, Italy, Germany, and France |
6.4.3 Photocurable Dermal Filler Product Milestones. If APIL exercises its Photocurable Dermal Filler Product Option in accordance with Section 2.3.2 (Photocurable Dermal Filler Product Option), then the definitive license agreement entered into by the Parties under Section 2.3.2 (Photocurable Dermal Filler Product Opt... |
Photocurable Dermal Filler Product Milestone Event |
Dosing of the first patient in the first in human Clinical Trial of a Photocurable Dermal Filler Product |
Dosing of the first patient in the first Pivotal Clinical Trial of a Photocurable Dermal Filler Product |
First Commercial Sale of the first Photocurable Dermal Filler Product following Regulatory Approval and Pricing Approval (if applicable) in the first of the following six (6) countries: U.S., UK, Spain, Italy, Germany, and France |
6.5 Royalties. |
6.5.1 Royalties for Exclusive Products. Commencing upon the First Commercial Sale of an Exclusive Product in a country in the Territory, on an Exclusive Product-by-Exclusive Product and country-by-country basis, AbbVie shall pay to CollPlant royalties at the rate of eight percent (8%) of annual Net Sales of each Exclus... |
6.5.2 Royalties for Injectable Breast Implant Products. If APIL enters into negotiations regarding the Injectable Breast Implant Product Option in accordance with Section 2.3.1 (Injectable Breast Implant Product Option), then, unless otherwise mutually agreed upon by APIL and CollPlant in writing, the definitive licens... |
6.5.3 Royalties for Photocurable Dermal Filler Products. If APIL enters into negotiations regarding the Photocurable Dermal Filler Product Option in accordance with Section 2.3.2 (Photocurable Dermal Filler Product Option), then, unless otherwise mutually agreed upon by APIL and CollPlant in writing, the definitive lic... |
6.6 Royalty Term. On a country-by-country and product-by-product basis, royalty payments with respect to the Net Sales of an Exclusive Product or, if payable under a definitive license agreement pursuant to Section 2.3.1 (Injectable Breast Implant Product Option) or Section 2.3.2 (Photocurable Dermal Filler Product Opt... |
6.7 Royalty Adjustments. Notwithstanding Section 6.5 (Royalties) but subject to Section 6.7.4 (Mechanics of Adjustments to Royalties): |
6.7.1 Valid Claim Expiration. From and after the date on which an Exclusive Product is sold in a particular country and is not covered by a Valid Claim within a CollPlant Patent for such product, that would be infringed by AbbVie's manufacture, use, or sale of such product in such country, the royalty rate for such Exc... |
6.7.2 Trigger Products. |
(a) Exclusive Products. On an Exclusive Product-by-Exclusive Product and country-by-country basis, if, in any Calendar Quarter following the first commercial sale of an EP Trigger Product with respect to an Exclusive Product and a country, the Net Sales of such Exclusive Product in such country is lower than or equal t... |
(b) Option Products. If CollPlant and APIL enter into a definitive license agreement pursuant to Section 2.3.1 (Injectable Breast Implant Product Option) or Section 2.3.2 (Photocurable Dermal Filler Product Option), unless otherwise agreed upon by the parties thereto in writing, such definitive license agreement will p... |
6.7.3 Stacking. If AbbVie, any of its Affiliates or any Third Party Transferee obtains a license from a Third Party under any Patent Right (a) that covers any Exclusive Product or the development, manufacture, use, import, offer for sale, sale or Exploitation of any Exclusive Product or (b) where, in AbbVie's reasonabl... |
6.7.4 Mechanics of Adjustments to Royalties. Any reductions set forth in Section 6.7 (Royalty Adjustments) shall be applied to the royalty rate payable to CollPlant under Section 6.5.1 (Royalties for Exclusive Products) in the order in which the event triggering such reduction occurs; provided that the adjustments made... |
6.8 Reports; Payment of Royalty. During the Term, following the First Commercial Sale of any Exclusive Product in any country in the Territory, AbbVie shall furnish to CollPlant a written report within ninety (90) days after the end of each Calendar Quarter showing, on an Exclusive Product-by-Exclusive Product and coun... |
6.9 Financial Records. AbbVie shall, and shall cause its Affiliates and shall contractually require its and their Third Party Transferees to, keep full, clear and accurate records pertaining to Net Sales for a minimum period of three (3) years (or such longer period as required by applicable Law) after the relevant pay... |
6.10 Audit; Audit Dispute. |
6.10.1 Audit. At the request of CollPlant, AbbVie shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by CollPlant and reasonably acceptable to AbbVie, at reasonable times during normal business hours and upon reasonable notice of not less ... |
6.10.2 Audit Dispute. In the event of a dispute with respect to any audit under Section 6.10.1 (Audit), CollPlant and AbbVie shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitt... |
6.11 Methods of Payments; Offsets. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reim... |
6.12 Taxes. |
6.12.1 Withholding Taxes. Each Party shall be responsible for its own taxes, duties, levies, imposts, assessments, deductions, fees, withholdings or similar charges imposed on or measured by net income or overall gross income (including branch profits), gross receipts, capital, ability or right to do business, property... |
6.12.2 Indirect Taxes. Notwithstanding anything to the contrary herein, this Section 6.12.2 (Indirect Taxes) shall apply with respect to any value added tax, ad valorem, goods and services or similar tax chargeable on the supply or deemed supply of goods or services, sales and use taxes, transaction taxes, consumption ... |
6.12.3 Allocation of Payment. The Parties hereby agree that for all tax purposes, the payment in Section 6.1 (Upfront Fee) is allocated as follows: Thirteen Million Nine Hundred and Ninety-Nine Thousand Nine Hundred Dollars ($13,999,900.00) is allocated to the rights granted in Section 4.1 (Grant of Exclusive Rights to... |
6.13 Late Payments. In the event that any payment due under this Agreement is not paid when due in accordance with the applicable provisions of this Agreement, the payment shall accrue interest at a monthly interest rate equal to the U.S. prime interest rate, as reported by The Wall Street Journal (New York edition) fo... |
6.14 Financial Obligations under In-License Agreements. CollPlant shall be responsible for all payments owed to Third Parties under the In-License Agreements unless otherwise agreed by the Parties. |
ARTICLE 7 - INTELLECTUAL PROPERTY RIGHTS |
7.1 Ownership of Intellectual Property; Disclosure. |
7.1.1 Ownership. |
(a) CollPlant Inventions. Subject to the rights herein, as between the Parties, all right, title and interest in and to all inventions conceived, discovered, developed or otherwise made by or on behalf of either Party (or its respective Affiliates), including those inventions made by subcontractors on behalf of either ... |
(b) AbbVie Inventions. Subject to the rights herein, as between the Parties, all right, title and interest in and to all inventions conceived, discovered, developed or otherwise made by or on behalf of either Party (or its respective Affiliates), including those inventions made by subcontractors on behalf of either Par... |
(c) Ownership of Other Intellectual Property. Ownership of other intellectual property not addressed in Section 7.1.1(a) (CollPlant Inventions) or Section 7.1.1(b) (AbbVie Inventions) shall be based on inventorship. The Parties do not plan to conduct any activities that would lead to any jointly-invented intellectual p... |
7.1.2 United States Law. The determination of inventorship, as well as whether an invention or Know-How is conceived, discovered, developed or otherwise made by or on behalf of a Party or its Affiliates for the purpose of allocating proprietary rights (including patent, copyright or other intellectual property rights) ... |
7.1.3 Disclosure of Inventions. During the Term: |
(a) CollPlant shall, and shall cause its Affiliates and permitted subcontractors to, promptly disclose in writing to AbbVie the development, making, conception or reduction to practice of any CollPlant Know-How and AbbVie Inventions by CollPlant or any of its Affiliates; and |
(b) AbbVie shall, and shall cause its Affiliates to, promptly disclose in writing to CollPlant the development, making, conception or reduction to practice of any CollPlant Inventions by AbbVie or any of its Affiliates. |
7.2 Patent Prosecution and Maintenance. |
7.2.1 General Prosecution Terms. Except as otherwise set forth in this Agreement, as between the Parties, each Party shall have the sole right to prepare, file, prosecute, defend in any opposition or post-grant proceedings, and maintain Patent Rights owned or otherwise Controlled by such Party at such Party's sole cost... |
7.2.2 Exercise of Prosecution Rights. Notwithstanding anything to the contrary in this Agreement, (a) neither CollPlant nor its Affiliates will file any new patent application disclosing or claiming any use of CollPlant Collagen in or as a product that would be an Exclusive Product if Developed by or on behalf of AbbVi... |
7.2.3 UPC Opt-Out and Opt-In. The Parties shall coordinate and agree on any decision regarding whether or not to elect Opt-Out or Opt-In with respect to any CollPlant Patent; provided that the Party that controls the prosecution of a Patent Right shall have final say regarding any such Opt-Out or Opt-In with respect to... |
7.2.4 Patent Term Extension and Supplementary Protection Certificate. With respect to an Exclusive Product, AbbVie shall be responsible for making decisions regarding patent term extensions, including supplementary protection certificates, pediatric exclusivity, and any other extensions that are now or become available... |
7.2.5 Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution, defense and maintenance of the CollPlant Patents at their own expense. Cooperation shall include: |
(a) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, so as to (i) effectuate the ownership of intellectual property set forth in Section 7.1.1 (Ownership); (ii) enable the other Party to apply for and to prosecute patent applications in the Territor... |
(b) consistent with this Agreement, assisting in any license registration processes with applicable Governmental Authorities that may be available in the Territory for the protection of a Party's interests in this Agreement; and |
(c) promptly informing the other Party of any matters coming to such Party's attention that may materially affect the preparation, filing, prosecution, defense or maintenance of any such Patent Rights arising under this Agreement in the Territory. |
7.3 Enforcement of Patent Rights. |
7.3.1 Enforcement of CollPlant Technology. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement or misappropriation of the CollPlant Technology by a Third Party in the Territory of which such Party becomes aware based on the Exploitation of, or an application to seek reg... |
7.3.2 Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 7.3 (Enforcement of Patent Rights). Where a Party brings such an action, the other Party shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary pa... |
7.3.3 Enforcement of Other CollPlant Patent Rights. Except as otherwise set forth in Section 7.3 (Enforcement of Patent Rights), AbbVie will not have the right to enforce any CollPlant Technology against any Third Party actions that do not constitute a Competitive Infringement without first obtaining the prior written ... |
7.3.4 Option Products. If CollPlant and APIL enter into a definitive license agreement pursuant to Section 2.3.1 (Injectable Breast Implant Product Option) or Section 2.3.2 (Photocurable Dermal Filler Product Option), such definitive license agreement will provide, unless otherwise mutually agreed by the parties theret... |
7.4 Infringement Claims by Third Parties . If the Exploitation of an Exclusive Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by a Party (or its Affiliates or Third Party Transferees) (a "Third Party Infringe... |
7.5 Invalidity or Unenforceability Defenses or Actions. |
7.5.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity, unpatentability or unenforceability of any of the CollPlant Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
7.5.2 Responsibility. The Party responsible for prosecuting a Patent Right under Section 7.2 (Patent Prosecution and Maintenance) will have the right to defend and control the defense of the validity, patentability and enforceability of such Patent Right at its own expense in the Territory, provided that if the asserti... |
7.5.3 Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 7.5 (Invalidity or Unenforceability Defenses or Actions), including by providing access to relevant documents and other e... |
7.6 Product Trademarks. |
7.6.1 Ownership of Product Trademarks. As between the Parties, AbbVie shall have the sole right to determine and shall own all right, title and interest in and to the Trademarks that are used in connection with any Exclusive Product anywhere in the world (the "Product Trademarks"). CollPlant shall not and shall cause i... |
7.6.2 Enforcement of Product Trademarks. As between the Parties, AbbVie shall have the sole right to take such action as AbbVie deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like o... |
7.6.3 Third Party Claims. As between the Parties, AbbVie shall have the sole right to defend against (including the right to settle) any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates, or otherwise violate... |
7.6.4 Notice and Cooperation. CollPlant shall, and shall cause its Affiliates and its and their (sub)licensees to, (a) provide prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory and of any actual or threatened claim that the use of the Product Trademarks in the Ter... |
7.7 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's inventors under any applicable inventor remuneration laws, including without limitation under Section 134 of the Israeli Patent Law-1967. |
7.8 International Nonproprietary Name. As between the Parties and if as to the extent applicable, AbbVie shall have the sole right and responsibility to select the International Nonproprietary Name or other name or identifier for any Exclusive Product. AbbVie shall have the sole right and responsibility to apply for su... |
ARTICLE 8 - CONFIDENTIALITY |
8.1 Product Information. CollPlant recognizes that by reason of AbbVie's rights under this Agreement, AbbVie has an interest in CollPlant's maintaining the confidentiality of certain information of CollPlant. Accordingly, during the Term, CollPlant shall, and shall cause its Affiliates and permitted subcontractors and ... |
8.2 Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration hereof in its entirety, each Party shall, and shall cause its Affiliates, permitted subcontractors, and its and their respective officers, directors, employees and agents to, keep confide... |
8.2.1 has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party; |
8.2.2 has been in the receiving Party's possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Regulatory Filings; |
48 88878677_21 |
8.2.3 is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
8.2.4 that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
8.2.5 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information as evidenced by competent records. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combin... |
8.3 Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
8.3.1 in the reasonable opinion of the receiving Party's legal counsel, required to be disclosed pursuant to applicable Law or a valid order of a Governmental Authority of competent jurisdiction, (including by reason of filing with securities regulators or to comply with rules of a securities exchange on which the secu... |
8.3.2 made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for any Regulatory Approval in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confiden... |
8.3.3 made by or on behalf of the receiving Party to a patent authority as may be necessary or reasonably useful for purposes of preparing, obtaining, defending or enforcing a Patent Right in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment o... |
49 88878677_21 |
8.3.4 made to its or its Affiliates' financial and legal advisors who have a need to know such disclosing Party's Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each cas... |
8.3.5 made by the receiving Party or its Affiliates to potential or actual investors or acquirers as may be necessary in connection with their evaluation of such potential or actual investment or acquisition; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such ... |
8.3.6 made by AbbVie or its Affiliates or Third Party Transferees to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, Third Party Transferees, or other Third Parties as may be necessary or useful in connection with the Ex... |
8.3.7 made by CollPlant or its Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, and the like to the extent necessary in assisting with CollPlant's activities contemplated by this Agreement; provided that such Persons shall be subject to obligations of confidentialit... |
8.4 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo, or Trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity withou... |
50 88878677_21 |
8.5 Public Announcements. Neither Party shall issue any public announcement, press release, or other public disclosure regarding this Agreement or the Supply Agreement or their respective subject matter without the other Party's prior written consent, except for any such disclosure that is, in the opinion of the disclo... |
8.6 Publications. CollPlant shall not publish, present, or otherwise disclose, and shall cause its Affiliates and any permitted subcontractors and its and their respective employees and agents not to disclose any information relating to the Exclusive Products without the prior written consent of AbbVie, except as requi... |
8.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such first Party does not retain rights under the surviving provisions of this Agr... |
8.8 Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 8.2 (Confidentiality Obligations). |
51 88878677_21 |
ARTICLE 9 - REPRESENTATIONS AND WARRANTIES |
9.1 Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that: |
9.1.1 such Party is duly organized, validly existing and in good standing (in jurisdictions where the concept of good standing is recognized) under the Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.