coming within the product claims of said letters patent or applications therefor excepting 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. 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. (a) The Licensee shall cooperate with the Licensor to defend the rights under all patent applications and letters patent covered by this license, including interferences and attacks of third parties upon the validity of said patent applications and letters patent. (b) The Licensee shall not do any act or thing which might lessen or endanger said protection or unfavorably effect the full enjoyment of the Licensor's and Licer see's rights in and to said products and processes. (c) The cost of prosecuting any actions instituted by the Licensor for infringement of any letters patent covered by this license and the cost of defending any suit that may be instituted against any of such letters patent shall be borne by the parties in a ratio to be agreed upon. 11. 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. 12. If a petition in bankruptcy or proceedings under the Bankruptcy Law shall be filed by or against 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 insolvent 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. 13. From and after June 17, 1955, 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 hereafter granted patent covered by this license. On December 31, 1955, 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 cortin field for the full life thereof. 14. Upon any termination of this Agreement and the license hereby granted the Licensee 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 products as the Licensee shall have had on hand and ready for delivery at the date of termination. 15. If one or more provisions of this Agreement shall be or become unenforceable, all other provisions shall nevertheless continue in full force and effect. 16. For all purposes of this Agreement any notice required or permitted to be given to a party hereto shall be effectively given if directed to the party at its last known head office and sent by registered mail. 17. The Licensee accepts the license hereby granted and agrees to comply with all the conditions of this Agreement requiring compliance on the part of the Licensee. 18. The Licensor agrees to comply with all the conditions of this Agreement requiring compliance on the part of the Licensor. IN WITNESS WHEREOF the parties hereto have executed this Agreement in duplicate as of the date first above written. STATE OF NEW JERSEY, County of Essex, 88: ROCHE-ORGANON, INC. CIBA PHARMACEUTICAL PRODUCTS, INC. On this 10th day of April, 1940, before me personally came E. H. Bobst, to me known, who being by me duly sworn, did depose and say: That he resides at No. 120 Lloyd Road, Montclair, N. J.; that he is President of ROCHE-ORGANON, INC., the corporation described in and which executed the foregoing instrument; that he knows the seal of said corporation; that the seal affixed to said instrument is such corporate seal; that it was so affixed by order of the Board of Directors of said corporation and that he signed his name thereto by like order. [SEAL] My commission expires July 10, 1944. STATE OF NEW JERSEY, County of Union, ss: JOHN MOONEY, Notary Public of New Jersey. On this 15th day of May, 1940, before me personally came Henry Kamp, to me known, who being by me duly sworn, did depose and say: That he resides at No. 106 South Harrison Street, East Orange, N. J.; that he is Vice President of CIBA PHARMACEUTICAL PRODUCTS, INC., the corporation described in and which executed the foregoing instrument; that he knows the seal of said corporation; that the seal affixed to said instrument is such corporate seal; that it was so aflixed by order of the Board of Directors of said corporation and that he signed his name thereto by like order. Discount to wholesalers, jobbers, and hospitals 20%. Trade Price $2.50 box 4.50 box 7.00 vial EXHIBIT No. 232 CIBA PHARMACEUTICAL PRODUCTS, INC., AND RARE CHEMICALS, INC.-LICENSE AGREE MENT (Male Hormones) JANUARY 1, 1941. AGREEMENT dated January 1, 1941, between CIBA PHARMACEUTICAL PRODUCTS, INC., a New Jersey corporation with its head office at Summit, New Jersey (the Licensor) and RARE CHEMICALS, INC., a New York corporation with its head office at Flemington, New Jersey (the Licensee). WHEREAS the Licensor is the sole owner of United States Letters Patent No. 2,109,400 issued February 22, 1938, for "Esters of Testosterone and process of making same"; and WHEREAS the Licensee wishes to acquire from the Licensor a license under the said Letters Patent and under such other letters patent and applications therefor in the male sex hormone field as the Licensor may from time to time acquire, 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 as non-exclusive, non-assignable license to manufacture, use, and sell the products described and claimed in the said Letters Patent and to practice the processes described and claimed therein throughout the United States of America, its territories and possessions, but only in the male sex hormone field, for a period beginning January 1, 1941, 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 or hereafter acquired by the Licensor in the male sex hormone field (other than United States Letters Patent No. 2,109,400); 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 the said Letters Patent or applications therefor, or of the processes relating thereto, except that the Licensor may without the Licensee's consent grant any such license or right to Schering Corporation, Bloomfield, New Jersey, and 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 thirteen and two-thirds percent (13%) of all the royalties received by the Licensor from all licenses during the period commencing January 1, 1941, and ending December 31, 1954, granted under the said letters patent or applications therefor to others than Schering Corporation and Roche-Organon, Inc. 3. (a) The Licensee shall pay unto the Licensor a royalty or license fee of 3% of the Licensee's turn-over during the period commencing January 1, 1941, and ending December 31, 1954, of all products and preparations containing male sex hormones. (b) The "male sex hormone field" includes all products and preparations containing male sex hormones of natural or synthetic origin and/or such substances as increase their effectiveness (activators), but activators only insofar as used as such. "Male sex hormone" means horinones of the sterol series, as, for instance, androsterone or testosterone, or their derivatives, as well as any materials having similar effects, and materials with physiological and clinical effects analogous to those of testosterone and androsterone insofar as they may be used therapeutically like testosterone and androsterone, and all materials derived from the male sex organs, but not materials and compounds with prevailing cortin or female hormone character and not aphrodisiacs like yohimbime, and not prolan or other like materials derived from urine or serum, and not prolanlike extracts from the hypophysis or other organs. (c) The Licensor's right to royalties on such turn-over shall not depend on whether or not the process described and claimed in said letters patent is used for the manufacture of male sex hormone products or preparations and shall not depend on whether or to what extent patent protection shall be maintained for said products or preparations in the United States of America, its territories, and possessions. (d) The turn-over 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; and stamp taxes and other public taxes directly imposed on the sale of said products; but no commissions, cost of distribution, overhead, or any other deduction of any kind or nature whatsoever. For products not distributed by the Licensee in whole or in part directly to the trade or to physicians or hospitals, but distributed through agents, the turn-over subject to royalty shall be determined on the basis of the invoices of such agents to such agents' customers. 4. (a) The Licensee shall render to the Licensor at the end of each quarter of each calendar year a statement setting forth separately for each product for each month of said quarter the royalty and the turn-over for each such quarter, which statement shall contain an itemization of the specific deductions allowed. Each of such statements shall be supplied to the Licensor within one (1) month after the end of each quarter. Royalties shall be paid on or before the 14th day after each such statement is due. (b) The Licensor shall render to the Licensee within a reasonable time after the end of each calendar year a statement showing the turn-over of the Licensor of male hormone products except androstin for such calendar year. 5. The Licensee 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 Licensor; 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 male 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 included in the license hereby granted, as long as such product is covered by letters patent, a price lower, or with a discount greater, or on terms and conditions in any respect more favorable to the purchaser, than as fixed therefor 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: Ampules 1 cc.-5 mgm. Solution-cartons of 3 cartons of 6 cartons of 50 10 mgm. Solution-cartons of 3 cartons of 6 cartons of 50 25 mgm. Solution-cartons of 3 cartons of 6 cartons of 50 Ointments-Packages of 50 grams (one tube) Packages of 25-2-gram containers Tablets of 10 mg, Methyl Testosterone each-cartons of 15 cartons of 30 (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 (1) 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. 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 the said letters patent or applications therefor excepting 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 products in bulk. 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. (a) The Licensee shall cooperate with the Licensor to defend the rights under the said letters patent and applications therefor, including interferences and attacks of third parties upon the validity of the 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 the said letters patent and the cost of defending any suit instituted against the said letters patent shall be borne 86%% by the Licensor and 13%% by the Licensee. 11. 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 liabiliy to the other party for damages or loss resulting from the default. 12. If a petition in bankruptcy or proceedings under the Bankruptcy Law shall be filed by or against 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 insolvent 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. 13. On December 31, 1954, this agreement, if then in force, shall terminate, except that the Licensee if not then in default shall have a free license under all letters patent and applications therefor, then owned by the Licensor in the male sex hormone field for the full life thereof. 14. 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 un to the date of termination; and if the termination occurs prior to December 31, 1954, the Licensee may for not longer than six months after termination continue to sell. subject to the provisions of this agreement and to the navment of any applicable royalties, such licensed products as the Licensee shell have had on hand and ready for delivery at the date of termination. 15 If one or more provisions of this agreement shall be or become unerforceable, all other provisions shall nevertheless continue in full force and effect. |