Schedule B.-Ciba-Schering-Male hormones Leopold Rusicka.. Karl Miescher & Albert Wett- mann. Leopold Ruzicka & Albert Wett- Leopold Ruzicka. Leopold Ruzicka. Karl Miescher & Albert Wett- Leopold Ruzicka.. Leopold Ruzicka. Process of Making the Esters of Polynuclear Hydroxyketones. Compounds of the Cyclopentano-Hydrophenanthrene Series and Process of Making Same. Karl Miescher & Werner Fischer. Process for the Separation and Purification Karl Miescher & Albert Wett- Karl Miescher & Hans Kaegi Karl Miescher & Hans Kaegi and of Carbonyl Compounds. Preparation Having Enhanced Sexual Carbonic Acid Derivatives. Monoformate of Androstenediol and Process for Producing Same. Production of Male Sexual Hormones. Process for the Manufacture of Carbonyl Compounds of the Cyclopentanopolyhydrophenanthrene Series. Max Hartmann & Albert Wett-3-Keto-Cyclopentanopolyhydrophenanstein. Karl Miescher, Albert Wettstein Karl Miescher & Albert Wettstein. threnes. Carbonyl Compounds of Steroids and Proc- Process for the Manufacture of Polynuclear EXHIBIT No. 223 SCHERING CORPORATION AND CIBA PHARMACEUTICAL PRODUCTS, INC.-LICENSE AGREEMENT (Follicular Hormones) JULY 1, 1938. AGREEMENT dated July 1, 1938, between SCHERING CORPORATION, a New Jersey corporation with its head office at Bloomfield, New Jersey (the Licensor) and CIBA PHARMACEUTICAL PRODUCTS, INC., a New Jersey corporation with its head office at Summit, New Jersey (the Licensee). WHEREAS the Licensor is the sole owner of United States Letters Patent No. 2,096,744, for "Hydrogenation Products of Follicle Hormones and method of producing the same" and of United States Letters Patent No. 2,033,487 for “Acyl Derivatives of the Dihydro follicular Hormone and method of making the same" and is the sole owner of other United States letters patent and patent applications in the female sex hormone field as hereinafter defined; and WHEREAS the License wishes to acquire from the Licensor a license under the said Letters Patent Nos. 2,096,744 and 2,033,487 and under the other letters patent and patent applications now owned by the Licensor and under such other patents and applications as the Licensor may from time to time acquire in the female sex hormone field upon the terms and conditions hereinafter stated; NOW, THEREFORE, the parties hereto, each in consideration of the covenants of the other herein contained, hereby agree as follows: 1. (a) The Licensor hereby grants to the Licensee upon the terms and conditions hereinafter stated a nonexclusive, nonassignable license to manufacture, use, and sell the products described and claimed in the said Letters Patent Nos. 2,096,744 and 2,033,487 and to practice the processes described and claimed therein throughout the United States of America, its territories, and possessions, but only in the female sex hormone field, for a period beginning July 1, 1938, and ending at the end of the term for which the last expiring patent that may be included in this license is or shall be granted or sooner as hereinafter provided. (b) The Licensor shall give to the Licensee written notice at least three months prior to offering for sale any product described or claimed in or made in accordance with any process described or claimed in any United States letters patent or application therefor now owned or hereafter acquired by the Licensor in the female sex hormone field (other than United States Letters Patent Nos. 2,096,744 and 2,033,487); and the Licensor shall specify in said notice the prices, forms, and standards for the sale of the product as provided in Article 7 of this Agreement; and thereupon the said letters patent or the said application and the letters patent issuing thereon shall forthwith become included in the license hereby granted. 2. (a) Neither party hereto shall, without the written consent of the other party first obtained in each instance, give any license or sublicense, or any right of exploitation covering any of the products of said letters patent or applications therefor covered by this license or of the processes relating thereto, except that the Licensor may without the Licensee's consent grant any such license or right to Roche-Organon, Inc., Nutley, New Jersey. (b) The Licensee shall manufacture under this license only in its own plant or plants located in the United States of America, and distribution of products under this license shall be made only by the Licensee and only under a single corporate name and/or trade name. (c) The Licensor shall pay unto the Licensee during the period commencing January 1, 1939, and ending December 31, 1956, fifteen percent (15%) of all the royalties received by the Licensor from all licenses granted to the said Roche-Organon, Inc., Nutley, N. J., in the female sex hormone field and twentyeight and three quarters percent (28%) of all the royalties received by the the Licensor from all licenses granted to others than the Licensee and RocheOrganon in the female sex hormone field. 3. (a) The Licensee shall pay unto the Licensor a royalty or license fee of 6% of the Licensee's turnover in the United States during the period commencing January 1, 1939, and ending December 17, 1952, of all products and preparations containing female sex hormones, except on its preparations AGOMENSIN and SISTOMENSIN and on preparations containing as its basic ingredient estrone and its esters, and except as otherwise provided in subdivision (c) of this Article 3. The royalty or license fee shall be payable as herein provided regardless whether or not the process described and claimed in the said letters patent and applications therefor is used for the manufacture of female sex hormone products or preparations and regardless whether or not or to what extent patent protection shall be maintained for said products or preparations in the United States of America, its territories and possessions. (b) The "female sex hormone field" includes all products and preparations containing female sex hormones of natural or synthetic origin and/or such substances as increase the effectiveness thereof (activators), but activators only in so far as used as such. "Female sex hormones" means (i) hormones of the follicular (but not corpus luteum) hormone series (e. g. estrone, estradiol or oestriol) or their derivatives, as well as other materials derived from the female sex organs having similar effects, and as well as (ii) compounds and materials with physiological and clinical effects analogous to those of female sex hormones, insofar as they may be used therapeutically life female sex hormones and the activators of such compounds and materials, but activators only insofar as they are used as such. (c) Any product or preparation in the female sex hormone field shall be subject to royalty if it is sold or distributed under a trade-mark used or formerly used by the Licensee for a female sex hormone product or preparation. (d) The turnover subject to royalty shall be determined by deducting from the sum of all invoices sent out by the Licensee during the period (whether such invoices are paid or not) 2% of such invoices as representing the cost of the outer shipping or mailing containers; ordinary trade discounts incurred, allowed or paid by Licensee; stamp taxes and other public taxes directly imposed on the sale of said products; and all credits made by the Licensee in the same period for cancelled invoices. 4. (a) Each party hereto shall render to the other party within two (2) months after the close of each calendar quarter a statement showing separately the turnover of products containing female sex hormones for each preparation during the preceding quarter. (b) Each party shall render to the other within three calendar months after the end of each calendar year a statement setting forth the royalty payable for the preceding calendar year by the party rendering the statement. The Licensor's statement shall set forth the royalties received by the Licensor from others than the Licensee. Royalties due from either party hereto to the other for any calendar year shall be paid on or before the 30th day of April following the close of that calendar year. 5. Each party hereto shall keep on file accurate records of its sales and shall permit such records and its books of account to be inspected at all reasonable times by reputable certified public accountants representing but not regularly employed by the other party; but such accountants shall not have access to accounts pertaining to matters not covered by this agreement and the extracts or notes taken by them shall relate exclusively to the subject matter of this agreement and shall contain no reference to names or addresses of customers or to extraneous matters. 6. Each party hereto shall forthwith upon making, discovering, conceiving, or otherwise acquiring any other processes, whether secret or not, or any formulae, or any technical, clinical, experimental or manufacturing data, and any other discoveries in the female sex hormone field, disclose the same forthwith to the other party hereto and shall assist the other party in every way in the application and further development thereof; provided, however, that neither party shall be obligated to disclose to the other any information regarding its costs of manufacture, production, or distribution. 7. (a) Subject to the provisions of Article 9, the Licensee shall not sell or offer for sale any product described and claimed in the said letters patent embodying and made in accordance with and by use of any of the inventions of the said letters patent, as long as such product is covered by letters patent, at a price lower, or with a discount greater, or on terms and conditions in any respect more favorable to the purchaser, than as fixed thereafter by the Licensor and followed by the Licensor in making its sales. Until changed by the Licensor as hereinafter provided the prices, discounts, terms, and conditions fixed by the Licensor are those set forth in Schedule A annexed hereto. (b) The prices, discounts, terms, and conditions set forth in Schedule A may be changed by the Licensor from time to time upon two months written notice to the Licensee. (c) The Licensee shall not sell or offer for sale any product made pursuant to any of the process claims or any product coming within the product claims of the said letters patent in forms other than as tablets, ampules, ointments, solutions, or suppositories and other therapeutic forms and for each of such forms the Licensee will adhere to the standards as now established, or hereafter established by the Licensor with respect to units or quantity per package, to dosage or strength per unit, and to designation of units. The forms in which the Licensor now sells such products and the Licensor's established standards for use thereof (which are to be adhered to by the Licensee) are as follows: (d) The Licensor may from time to time change the dosage, units, quantities, and/or forms of said products contained in the individual tablets, ampules, ointments, solutions, or suppositories and other therapeutic forms or may add new preparations, but the Licensor shall not sell or offer for sale any such changed or new preparation without giving to the Licensee written notice of its intention to do so, which notice shall be given not less than three months nor more than nine months prior to the first offering for sale. (I) Upon the expiration of the three months' notice mentioned in the preceding paragraph of this subdivision (d), the Licensee may offer for sale any changed or new preparation therein specified, if within one month after receiving the said three months' notice the Licensee shall have given to the Licensor written notice of its intention to do so, and if the first offering for sale shall be made not later than six months after the expiration of the said three months' notice. (II) Except as otherwise provided in the preceding paragraph (I), the Licensee shall not offer for sale any such changed or new preparation without giving to the Licensor prior written notice of its intention to do so, which notice shall be given not less than three months nor more than nine months prior to the first offering for sale. (e) The distribution of samples to hospitals and the like by both Licensor and Licensee shall be subject to agreement between the parties. 8. (a) Subject to the provisions of Article 9, neither party shall sell or offer for sale any product made pursuant to any of the process claims or any product coming within the product claims of said letters patent or applications therefor except in a form ready for use by the consumer, completely packed and packaged under its own name or trade-mark, nor shall either party sell or offer for sale or deliver directly or indirectly any product made pursuant to any of the process claims or any product coming within the product claims of said letters patent or applications therefor to others for use by them in putting up such products in commercial form for resale by them, nor sell the said product in bulk. (b) The provisions of the foregoing paragraph (a) shall not apply to the sale of estrone. 9. The provisions of the foregoing Articles 7 and 8 shall not apply to sales by the Licensor or the Licensee of any of the products mentioned therein, if such sales are made to licensees under the said letters patent or applications therefor, nor shall such provisions apply to sales to others when written consent of both parties is first obtained. 10. Both parties shall be free to manufacture and sell nonpharmaceutical products which contain female sex hormones, provided, however, that prior to December 17, 1952, the Licensee shall not manufacture, sell, or distribute cosmetics containing estradiol or its derivatives. 11. (a) The Licensee shall cooperate with the Licensor to defend the rights under said letters patent and applications therefor, including interferences and attacks of third parties upon the validity of said letters patent. (b) The Licensee shall not do any act or thing which might lessen or endanger said protection or unfavorably affect the full enjoyment of the Licensor's and Licensee's rights in and to said products and processes. (c) The cost of prosecuting any actions instituted by the Licensor for infringement of said letters patent and the cost of defending any suit instituted against any of said letters patent shall be borne 71% by the Licensor and 28% by the Licensee. 12. If and whenever either party hereto shall be in default in complying with any of the applicable terms of this agreement and the default shall continue unremedied or be repeated during a period of thirty days after the other party hereto shall have given to the defaulting party written notice specifying the default, then upon the expiration of the thirty-day period the party giving the notice of default shall have the right at its option to terminate this agreement and the license hereby granted by giving to the other party in default written notice to that effect; whereupon this agreement and the license hereby granted shall terminate forthwith, except that the party in default shall not thereby be discharged from any liability to the other party for damages or loss resulting from the default. 13. If a petition in bankruptcy or proceedings under the Bankruptcy Law shall be filed by or against the Licensee, or if a receiver or trustee shall be appointed for the property of Licensee, or if the Licensee shall make a general assignment or take the benefit of any insolvency act, or upon the liquidation or dissolution of Licensee, then, and upon the happening of any of the foregoing contingencies, the Licensor may at its option terminate this agreement and the license hereby granted by giving to the Licensee written notice to that effect; whereupon this agreement and the license hereby granted shall terminate forthwith. 14. From and after December 17, 1952, if this agreement be then in force and if the Licensee be not then in default, the Licensee shall have a royalty-free license to manufacture, use, and sell under the letters patent and applications therefor then covered by this license until the expiration of the last now or here. after granted patent covered by this license. On December 31, 1956, this agreement, if then in force, shall terminate, except that the Licensee if not then in default shall have a free license under all patents and applications therefor then owned by the Licensor in the female sex hormone field for the full life thereof. 15. Upon any termination of this agreement and the license hereby granted the parties hereto shall nevertheless remain liable for the payment of any royalties due and accrued up to the date of termination; and the Licensee may for not longer than six months after termination continue to sell, subject to the provisions of this agreement and to the payment of any applicable royalties, such licensed |